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NJAC 13 - Division of Consumer Affairs

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					     STATE BOARD OF PHARMACY



                               CHAPTER 39                                        SUBCHAPTER 2. REQUIREMENTS FOR INITIAL
                                                                                        LICENSURE
                  STATE BOARD OF PHARMACY                                        13:39-2.1 Requirements for initial licensure as a phannacist
                                                                                 13:39-2.2 Licensure examination scores
                                Aul....rily                                      13:39-2.3 Proof of character
                        NJ.SA 45:1-15.1 and 45:1447.                             13:39-2.4 Criminal history background cheek
                                                                                 13:39-2.5 Refusal to license
                                                                                 13:39·2,6 Internship and externsbip practicai experience require-
                          SoPfCe and Effeetive Date                                             ments
                     R.20IOd,09Q,effectiveMay 17, 2010.                          13:39-2,7 Pharmacy intern registration requirements
                    See: 42 NJ.R, 132(a),42 NJ.R, 1221(0).                       13:39-2.8 through 13:39-2.20 (Reserved)

                                                                                 SUBCHAPTER 2A, REQUIREMENTS FOR RECIPROCAL
                           Chapter Expiration nate                                      LICENSURE
       Chapter 39, Stale Board ofPbannaey, expire. on May 17,2015,               13:39-2A, I Requirements for reciprocalliccnsure
                                                                                 13:39-2A.2 Proof of character
                             Chapter Hisiorini NolO                              13:39-2A3 Refusal 10 license
                                                                                 13:39-2A4 Criminal history background check
       Chapter 39, State Board of Phannacy, was adopted and became               13:39-2A.5 Multistate Jurisprudence Pharmacy Examination
     effective prior 10 September 1, 1969,
       Chapter 39, State Board of Pbannacy, was repealed and adopted as          SUBCHAPTER 3. PHARMACIST REQUIREMENTS
     new roles by R.1989 d.314, effective June 19, 1989, See: 20 NJ.R.           13:39-3, I Authorization to practice; display of license
     1648(0),21 NJ.R.1712(0).                                                    13:39-3.2 Replacement license
       Pursuant to Executive Order No. 66(1978), COOpter 39, Stale Board of      13:39-3.3 Change of name
     Phannacy, was readopted as R.1994 d.3'I, effective June 16, 1994,           13:39-3,4 Change of address of record; service of process
     See: 26 NJ,R, 1596(0), 26 N,J.R. 2905(b), 26 NJ.R. 3878(8).                 13:39-3.5 Verification of licensure
                                                                                 13:39-3,6 Reproduction oflicensc prohibited
       Subchapter 12, Nuclear Pbannaeies, was recodifted from Subchapter         13:39-3,7 Bicnnialliccnse renewal; administrative suspension
     II by R.1994 <1.476, effective September 19, 1994. See: 26 NJ.R.            13:39-3.8 Reinstatement from administrative and disciplinary
     1303(8),26 NJ.R. 3878(b),                                                                license suspensions
                                                                                 13:39-3.9 Inactive licensure
       Pursu&1lto Executive Order No. 66( 1978), Chapter 39, Stale Board of      13:39-3,10 Steering prohibited
     Pharmacy, was readopted as R.1999 d.214, effuctive June 16, 1999.           13:39-3.11 Responsibilities of pharmacists
     See: 31 NJ.R. 1151(a), 31 NJ.R. 1932(a).
       Subchapter 10, Automated Medication Systems, was adopted as               SlJBCHAPTER3A. CONTINUING EDUCATION
     R.2000 <1.28, effective JanuarY 18, 2000. See: 31 NJ,R. 2293(b), 32         13:39-3A.1 Continuing edueation credit hour requirements
     N,J.R. 317(a~                                                               13:39-3A,2 Criteria for conlinuing education credit
        Subchapter 3A, Continuing Education, was adopted as R.2003 <1.130,       13:39-3A3 Continuing education credil hour calculations
     effuetive March 17,2003, See: 34 NJ.R. 1089(0),35 NJ.R. 1433(8).            13:39-3A4 Continuing education credit hour reporting procedure
                                                                                 13:39-3A.S Waiver of continuing education requirements
        Chapter 39, State Board of Pharmacy, was readopted as R.2oo5 d.25,       !3:39-3A.6 Responsibilities of continuing education sponsors
     effective December 10,2004. See: 36 N.J.R. 3345(0), 37 NJ.R. 295(a).        13:39-3A. 7 Monitoring of continuing education programs or
                                                                                              courses
        Subchapter 2, Licensure Requirements, was renamed Requirements
     for Initial Licensure; Subchapter 2A, Requirements for Reciproeal Li-       SUBCHAPTER 4. PHARMACY PERMIT REQUIREMENTS
     censure, was adopted in part as new roles and recodified in part from
     Subchapter 3, Licensure by Reciprocity; Subchapter 3, Licensure by          13:394.1   New pharmacies; pharmacy departments; eligibility
     Reciprocity, was renanted Registered Pbann.cist Requirements; and                        and application
     Subchapter 8, Pharmacy Training Sites, was repealed by R.2009 d.247,        13:394.2 Issuance of permhs; permit renewals
     effective August 3, 2009, See: 41 N.J.R. 371(a), 41 N.J,R. 2969(b).         13:394.3 Display of permits
                                                                                 13:39-4,4 Death of owner or partner
        Chapter 39, State Board "fPharmacy, was readopted as R.2010 d.09Q,       13:39-4,5 Change of ownership; asset acquisition
     effective May 17, 2010. As a part of R.2010 d.Q90, Subchapter 3,            13:39-4.6 Change of corporate officers or stockholders of a pub-
     R.egisteted Pharmacist Requirements. was renamed Pharmacist Require~                     licly traded "rporation
     ments; and Subchapter 6, RegIstered Pharmacist-in-Cbarge; Phannacy          13:39-4.7 Change of location and/or address of licensed premises
     Personnel, was renamed Pharmacist-in-Charge; Pharmacy Personnel,            13:39-4.8 Remodeling of licensed premises
     effective June 21, 2010, See: Source and Effective Date, See, also,         13:394,9 Change of name
     section armotatjons.                                                        13:39-4.10 Discontinued phannacies
                                                                                 13:39-4.Il Availability of records upon tenniruttion of business
                    CHAPTER TABLE OF CONTENTS                                    13:39-4.12 Business hourS; unauthorized closing
                                                                                 13:39-4,13 Replacement permit
     SUBCHAPTER I. GImER.AL PROVISIONS                                           13:39-4.14 Reproduction of pennits
                                                                                 13:39-4.15 Security of pharmacies and pharmacy departments
     13:39-1.1 Purpose and scope                                                 13:39-4.16 Pennil>; specialized permits
     13:39-1.2 Definitions                                                       13:394.17 Steering prohibited
     13:39-1.3 Fee schedule                                                      13:39-4.18 Responsibilities of pennit holders
     13:39-1.4 Payment of penalties                                              13:39-4,19 Procedures for centralized prescription handling
     13:39-1.5 Opportunity to be heard                                           13:39-4.20 Out-of-State pharmacy registration
I    13:39-1.6 Waiver                                                            13:39-4,21 Procedures for physician ordered or government spon ..
",   13:39-1.7 Failure to complete application process                                        sored immunizations perfonned by phannacists


                                                                              39-1                                                 Supp.6-21-10
                                                                                   _____________L_A~W~AN~D~PUBLICSAFETY

SUBCHAPTER 5. RETAIL FAC[LlTY REQUIREMENTS                              13:39-9.2        Definitions
                                                                        13:39-9.3        Licensure of institutional phannacies
13:39-5.1 Purpose and scope                                             13:39-9.4        Contract pharmaceutical services; institutional pcnnit
13:39-5.2 Pharmacy ac<:ess and egress                                                      required
13:39-5.3 Pharmacy signs                                                13:39-9.5        Advisory committees
13:39-5.4 Spatial requirement of phannacy prescription area
13:39-5.5 Prescription counter                                          13:39-9.6        Pharmacy and Therapeutics Committee; applicability;
13:39-5.6 Prescription area sink                                                           polices and procedures
13 :39-5.7 Adequate storage                                             13:39-9.7        (Reserved)
13:39-5.8 Minimum equipment and supplies; cleanliness                   13:39-9.8        Control of health care pharmaceutical services; respon-
13:39-5.9 Prescription balances, scales, weights and automatic                             sibilities of the pharmacist-in-charge of the provider
               counting device                                                             pharmacy
13:39-5.10 Restriction on storage of prescription legend drugs and      13:39-9.9        (Reserved)
               controlled dangerous substances                          13:39-9.10       Phannaceuticals; drug supply; investigational drugs;
13:39-5.11 through 13:39-5.12    (Reserved)                                                controlled dangerous substances
                                                                        13:39-9.11        Drug dIsbursement; written orders
                                                                        13:39-9.12        Drug disbursement; oral orders
SUBCHAPTER 6. PHARMACIST-IN-CHARGE;                                     13:39-9.13        Monitoring of patient drug !lrerapy
       PHARMACY PERSONNEL                                               13:39-9.14        Medieation not dispensed in finished form
13:39-6.1 PulJ?Ose and scope                                            13:39-9.15        Drug labeling
13:39-6.2 Phannacist-in-charge                                          13:39-9.16        Use of patient's own medication
13:39-6.3 Identification tag                                            13:39-9.17        Drug-dispensing devices
13:39-6.4 Mealor restroom breaks                                        13:39-9.18        Disposal of unused medications
13:39-6.5 Prescription handling by pharmacy ",,!ems, interns or         13:39-9.19        Records and reports
             phannacy teehnicians                                       13:39-9.20        Drug infonnation and education
13:39-6.6 Phannacy technician registration and pharmacy tech-           13:39-9.21        After hours aceess to the institutional pharmacy
             nician applicants:                                         13:39-9.22        Pharmacy facilities; space
13:39-6.7 Authorization to practice as a pharmacy technician;           13:39-9.23        Storage and securitv
             display of registration                                    13:39-9.24        Equipment           -
13:39-6.8 Replacement of teehnician registration                        13:39-9.25        Institutional decentralized pharmacies
13:39-6.9 Technician change of name                                     13:39-9.26        Valid medication orders; out..of-State medication or-
13:39-6.10 Teehnieian change of address of reeord; service of                              ders
             process                                                    13:39-9.27        Prescriptions and medication orders transnti!ted by
13:39-6.11 Verification of technician registration                                          tectmo)ogicaI devices in an institution
13:39-6.12 Reproduction of teehnician registration prohibited
13:39-6.13 Biennial teehnieian registration renewal; administrative     SUBCHAPTER 10. AUTOMATED MEDICATION
             suspension                                                        SYSTEMS
13:39-6.14 Reinstatement from administrative and disciplinary
             suspensions of a phannacy teehnician's registration        13:39-10.1 Purpose and scope
13:39-6.15 Pharmacy technician duties and pharmaci.t-technician         13:39-10.2 "Automated medication system" defmition
                                                                        13:39-10.3 Authority to use auromated medication system
              ratios
                                                                        13:39·10.4 Wrinen policies and procedures of operation
                                                                        13:39-10.5 Personnel training requirements
SUBCHAPTER 7. DRUG DISPENSfNG AND                                       \3:39-10.6 Written program for quality assuronce
       PRESCRIPTION RECORDS                                             13:39-10.7 Written plan for recovery
13:39-7.1  V.lid prescriptions                                          13:39-10.8 Written program for preventative maintenance of
13:39-7.2 Lack of information on original prescri-ption                              automated medication system
13:39-7.3 Authorization for renewal of prescriptions; new pre--
             scriptions                                                 SUBCHAPTER II. COMPOUNDfNG IN RETAIL AND
13:39-7.4 Emergency dispensing                                                 fNSTITUTlONAL PHARMACIES FOR STERILE
13:39-7.5 Approval of FDA necessary                                            AND/OR NON-STERILE PREPARATIONS
13:39-7.6 Required records and documents
13:39-7.7 Copies of prescriptions and/or patient profile                13:39-11.1 Purpose and scope
13:39-7.8 Transfer of prescriptions between pbarmacies                  13:39-11.2 Definitions
13:39-7.9 Filing and storage of controlled substance prescriptions      13:39-11.3 Sterile and non·sterile preparation services; environ..
13:39-7.10 Prescriptions transmitted by f.csintile                                    ment
13:39-7.11 Electronically transmitted prescriptions                     13:39-11.4 General requirement for compounded sterile prepara-
                                                                                            tions; pre~approval
13:39-7.12 Labeling                                                                       Pharmacist in charge and permitholders' responsi-
13:39-7.13 Professional judgment in dispensing drugs                    13:39-11.5
13:39-7.14 Advertising and sale of prescription drugs                                       bilities
13:39-7.15 Restriction on sale of Schedule V over-the-counter               \3:39-1].6    Pharmacy technicians, interns and extems; required
             controlled substances                                                          supervision
13:39-7.16 Return of pres<;ription medication                           13:39-11.7        Training requirements for compounding sterile prep-
                                                                                      arations
13:39-7.17 Disposal of unwanted drugs                                   13:39-11.8  Batch preparation
13:39-7.18 Outdated drugs or drugs marked "sanlple"                     13:39-11.9  Documentation
13:39-7.19 Patient profile record system                                13:39-11.10 Infonnation required to appear on prescription label
13:39-7.20 Drug utilization review                                                  Use by date of sterile preparalion
13:39-7.21 Patient counseling                                           13:39-11.11
                                                                        13 :39-11.12Handling, packaging and delivery
                                                                        [3:39-11.13 Policy and procedure manual for compounded sterile
SUBCHAPTER 8. (RESERVED)                                                              prepatnlions
                                                                        13:39-1 L14 Quality assurance program for compounded sterile
SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR                                             prepaIations
       HEALTH CARE FACILITIES                                           13:39-1 Ll5 Patient profile records for compounded sterile prep-
13:39-9.1 Purpose and seope                                                                 arations


Supp.6-21-10                                                         39-2
    STATE BOARD OF PHARMACY                                                                                                              13:39-1.2

    13:39-11.16 Controlled environment for compounded sterile          prep-       13:39-1.2     Definitions
                  arations: use, access, location; temperature
    13:39-11.17 Controlled environment for compounded sterile          prep~         'The following words and tenns when used in this chapter
                  arations: construction
)   13:39-J 1.18 Controlled environment for compounded sterile         prep-
                                                                                   shall have the following meanings, unless the eontext clearly
                  arations: stocking. maintenance and supplies                     indicates otherwise.
    13:39-11.19 Controlled environment for compounded sterile          prep-
                  arations: clean room                                               "Address of record" means an address designated by a li-
    13:39-11.20 Controlled environment for compounded sterile          prep-       censee or registrant. "Address of record" may be a licensee's
                     arations:   anteroom                                          or registrant's home, business or mailing address, but shall
    13:39-11.21 Vertical air laminar flow hoods for compouoded ster-
                   ile preparations                                                not be a post office box unless the licensee or registrant also
    13:39-11.22 Laminar air flow hoods not in a dean room for com-                 provides anotber address which includes a street, city, state
                   pounded sterile preparations                                    and zip code.
    13:39-11.23 Controlled environment for compounded !':o1erile prep-
                   arations: self-contained sterile glove boxes
    13 :39-11.24 Library references                                                    "Board" means the New Jersey State Board of Pharmacy.
    13:39-11.25 Disposal of drugs and malerials
    13:39-11.26 Security                                                              "Compounding" means the preparation, mixing, assem-
    13:39-11.27 (Reserved)                                                         bling, packaging and labeling of a drug or device as the result
                                                                                   of a practitioner's prescription or initiative based on the re-
    SUBCHAPTER 12. NUCLEAR PHARMACIES                                              lationship of the practitioner or patient with the pharmacist in
    13:39-12.1 Definitions                                                         the course of professional practice or for the purpose of, or
    13:39-12.2 General reqUirements for pharmacies providing radio-
                 pharmaceutical service                                            incident to, research, teaching or chemical analysis and not
    13:39-12.3 General requirements for. nuclear pharmacist                        for sale or dispensing. Compounding also includes the prep-
    13:39-12.4 Minimum requirements for space, equipment, sup-                     aration of drugs or devices in anticipation of prescription drug
                 plies, and library                                                orders based on routine, regularly observed prescribing pat-
    13:39--12.5 Quality control
                                                                                   terns.

                                                                                     "Device" means an instrument, apparatus, implement, ma-
                                                                                   chine, contrivance, implant, in vitro reagent or other similar
    SUBCHAPTER 1. GENERAL PROVISIONS                                               or related article, including any component part or accessory,
                                                                                   which is required under Federal or State law to be prescribed
    13:39-1.1      Purpose and scope                                               by an authorized prescriber and dispensed by a pharmacist, in
      (8) This chapter is promulgated by the New Jersey State                      the usual scope of pharmacy practice.
    Board of Phannacy. The rules contained in this chapter im-
                                                                                      "Dispense or dispensing" means the procedure entailing
    plement the provisions of the New Jersey Pharmacy Practice
                                                                                   the interpretation of a practitioner's prescription or medica-
    Act, NJ.s.A. 45:14-40 et seq., and regulate the practice of
                                                                                   tion order fur a drug, biological or device, and, pursuant to
    pharmacy within the State of New Jersey.
                                                                                   that order, the proper selection, measuring, compounding, la-
       (b) This chapter shall apply to aU pharmacies; pharmacists;                 beling and packaging in a proper container for the subsequent
    applicants for pennits, licensure or registration; interns; ex-                administration to, or use by, a patient 'The act of dispensing
    terns; pharmacy technicians; and anyone within the juris-                      shall include all necessary consultation by the pharmacist.
    diction ofthe Board of Pharmacy.
                                                                                       "Drug or medication" means:
    Amended by R1994 d.351, effective July 18. 1994.
    See: 26 N.1.R. 15%(.),26 NJ.R. 2905(b).                                              1. Articles recogniz£d in the official United States
    Amended by R2oo5 d.25, effective lanuary 18, 200S.                                 PharmacopoeiaiNationai Fonnulary, official Homeopathic
    S..: 36 NJ.R 3345(.), 37 NJ.R. 295(.).                                             Pharmacopoeia of the United States, or any official supple-
       In (b). substituted "pharmacy technicians" for "supportive personnel'"
    preceding "and anyone within the jurisdiction",                                    ment to any of them;
    Amended by R2010 d.09O. effective June 21, 2010.
    See: 42 NJ.R. 132(.),42 NJ.R 1221(3).                                                2. Articles intended for use in the diagnosis, cure, miti-
      Rewrote the section.                                                             gation, treatment or prevention of disease in human beings
                                                                                       or animals~
                                 Case Notes
       Violations ofN.1.A.C. 13:39-S.l4(h)2, 10 and 13 fooed as controlled
                                                                                          3. Articles (other than food) intended to affect the
    substances record.ct were improperly kept, misbranded drugs were in                structure of any function of the body of human beings or
    pharmacy and drugs were improperly stored, respectively; penalties                 animals; and
    (also cited as N.lA.C. 13:39-8.12). New Jer.ey State Bd. of Pbarmaey
    v. Yanuzzi, 4 N.J.A.R 489 (1981).                                                     4. Articles intended for use as components of any ar-
                                                                                       ticle specified in 1, 2 or 3 above, but not including devices
                                                                                       or their components, parts or accessories.




                                                                                39-3                                                 Supp.6-21-1O
13:39-1.2                                                                                                          LAW AND PUBLIC SAFETY
        ---~.---.----------------




   "Immediate personal supervision" means that the phar-                    tificates, and substituted a reference to the current license renewal period
macist is physically present in the compounding/dispensing                  for a reference to the CUJTent registration period.
                                                                            Amended by R,2005 d,25, effective January 18,2005.
area when interns, extems and pharmacy technicians are                      See: 36 N,J.R. 3345(0), 37 NJ,R, 295(0),
perfonning delegated duties, and the pharmacist conducts any                   Rewrote «Address of record", added "Immediate personal super-
necessary in-process checks and the fmal check in preparation               vision" and "Pbannacy technician", deleted "Direct supervision"" and
                                                                            uSupponive personnel",
and compounding of medications, including the checking of                   Amended by R.2007 d.283, elT.otive September 4,2007,
each ingredient used, the quantity of each ingredient whether               See: 38 N.J,R. 3 t37(0), 39 N.J,R. 3774(b),
weighed, measured or counted, the finished label and the                       In definition "Address of record". inserted "<or registrant" twice and
accuracy and appropriateness of the actions of pharmacy                     inserted .Ior registrant's"; and in definition "Pharmacy technician", up~
                                                                            dated the N,],A,C, referenc",
technicians, interns and externs.                                           Amended by R.2009 d305, etr.:<:tive Octo"'" 5. 2009,
                                                                            See: 40 NJ.R. 5170(a). 41 N.J,R. 3840(0).
  "Legend drug or device" means any drug or device that:                       Rewrote defmition "Prescription".
                                                                            Amended by R2010 d,09O, eITective June 21, 2010,
     I, Bears, at a minimum, the symbol "Rx only" or                        See: 42 NJ.R. 132(0),42 N,},R. 1221(a).
   words of similar import; andlor                                            Deleted defmitions "Authorized prescriber". "Ucensed practitioner'"
                                                                            and .. 'Registered pharmacist' or ~phannacisr"; rewrote defmitions
     2, Requires a prescription or order by a practitioner.                 "Compoundiog'\ "Dispense or dispensingn. "Immediate personal super~
                                                                            vision" and "Pharmacy technician"; substituted definition "Drug or
   "Pharmaceutical services" means all services provided by a               medication'" for definition "Drug or medicine"; added definitions "Phar-
                                                                            macist"~ "Pharmacy" and "Practitioner"; in paragmph 2 of definition
pbarmacist These services shall be concerned with, but nut                  "Legend drug or service" substituted "a practitioner" for ~'an authori2:ed
limited to: interpreting the prescription or medication order;              prescriber"; in def"mition "Pharmaceutical services". deleted "registered"
selecting, preparing, compounding, packaging, labeling, dis-                preceding "pharmacist". and substituted "labeling" for "labelling" and
                                                                            "counseling" for "oounseUing"; and in definition "'Professional judg-
tributing and dispensing prescribed drugs; the proper and safe              ment", substituted "practitioner" for "prescriber",
storage of drugs; the monitoring of drug therapy; the report-
ing and recording of adverse drug reactions and the provision
                                                                            13:39-1.3         Fee schedule
of appropriate drug infonnation; teaching and counseling on
the proper and safe use of drugs and medications,                              (a) The following fees shall be charged by the Board:

   "Phanoacist" means an individual holding an active license                     L For pharmacists as fullows:
to engage in the practice of pharmacy in this State,
                                                                                         i,    Application for licensure                        125.00,
  "Pharmacy" means a location pennitted by the Board to                                 ii.    Verification oflicensure                          25.00.
                                                                                       Hi.     Application for reciprocity                      125,00,
engage in the practice of pharmacy in this State,
                                                                                       iv,     Application for reinstatement
   "Phanoacy technician" means an individual registered with                                   (1) DiSCiplinary suspension                     225,00.
                                                                                               (2) Administrative suspension                   225,00,
the Board and who works under the immediate personal su-                                v,     Initia~   licensure fee
pervision of a pbarmacist in compliance with N,JAC, 13:39-                                     (I) If paid during the first year of a           140.00,
6.15. For purposes of this definition, interns, extems, casb-                                      biennial renewal period
iers, stocking and clerical help are not pharmacy technicians.                                 (2) If paid during the second year of             70,00.
                                                                                                   a biennial renewal period
   "Practitioner" means an individual currently licensed, reg-                         vi,     Biennial license renewa'                      140,00.
istered or otherwise authorized by the jurisdiction in wbich                           vii,    Replacement biennial license                   25,00,
the individual practices to administer or prescribe drugs andl                        viii.    Inactive license renewal           (To be determined
or devices in the course of professional practice.                                                                             by future rulemaking)
                                                                                       ix,     Late renewal fee                              100.00,
  "Prescription" means a lawful order of a practitioner for a                           x,     Replacement of initial wall license            40.00.
drug, device or diagnostic agent for a specific patient.                               xi.     Continuing education review fee                10.00,
                                                                                      xii.     Continuing education program or                SO.OO,
   "Professional judgment" means judiciousness and discre-                                     course: sponsor review fee
tion based upon tborough knowledge and sound epplication
of the specialized body of knowledge peculiar to the practice                     2, For in-State pharmacies as follows:
ofphanoacy, and an understanding of the relationship of this
                                                                                        i,     Pharmacy penni!s
knowledge and its application to the well-being of the patient
                                                                                               (I) Application for permit                       275,00.
and to the judgment of the practitioner.
                                                                                               (2) Annual permit renewal                        175,00,
Amended by RI994 d,351, eITective July 18, 1994,                                               (3) Change of ownership/name                     275.00,
See: 26 NJ,R I 596(a), 26 NJ.R. 2905(b),                                                       (4) Change of location                           275,00.
Amended by R.1999 d,214, eITective July 19, 1999,                                       ii,    Replacement of annual permit                      25,00,
See: 31 N.I.R. 11 5 I(a), 31 N.I,R. 1932(8),
  Inserted "Address ofreeord"; in "Legend drug or device'\ rewrote 1;                  iii.    Late renewal fee                                 100,00,
rewrote "Licensed practitioner"; and jn "'Registered pharmacist" or                    iv.     Veritication of pennit                            25,00.
«pbannacise", substituted a reference to licenses for a reference to eer-                                                                                  \'

Supp, 6-21-10                                                           39-4
    STATE BOARD OF PHARMACY                                                                                                                                       13:39-1.6

          3. For pharmacy technicians as follows:                                                     13:39-1.4     Payment of penalties
                   i.    Application for registration............................ $50.00;                (a) Any penalties levied by the Board shall be paid within
                  ii.    Initial registration fee:                                                    15 business days of the finalization ofa penalty letter or final
)                        (I) If paid during the first year of a                                       order of the Board unless otberwise prescribed by statute or
                         biennial renewal period ................................. $70.00;            terms of a final order.
                         (2) If paid during the second year of a
                         biennial renewal period ................................. $35.00;              (b) Failure to comply with this rule may result in action by
                 iii     Biennial registration renewal ...... "........... " .... $70.00;             the Board according to the provisions ofN.J.S.A. 45; 1-24.
                 iv.     Replw::ement biennial registration ................. $25.00;                 Amended by R.2005 d.25, effective January 18, 2005.
                  V.     Late renewal fee ............................................ $25.00;        See; 36 N.l.R. 3345(0),37 N.l.R. 295(a).
                  vi.    Verificatiun of registration ...................... $25.00; and              Amended by R.2010 d.090, effective June 21, 2010.
                 vii.    Reinstatement fee:                                                           See: 42 iU,R. 132(.),42 N.l.R. 1221(a).
                                                                                                        In (a), substituted "15 business" for "10 calendar".
                         (I) Disciplinary suspension ........................ $125.00;
                         (2) Administrative suspension .... (To be determined
                                                                                                      13:39-1.5     Opportunity to be heard
                                                                by future rulemaking).
          4. For out-of-State pharmacies as follows:                                                    (a) Any time the Board seeks to impose a disciplinary
                                                                                                      sanction upon a licensee, the licensee may request an op-
            i.     Pharmacy permits                                                                   portunity to be heard by the Board.
                   (I) Application for permi!.. ..................................        175.00
                   (2) AnnualpermitrenewaJ ...................................            175.00        (b) When demonstrated fuels are in dispute, a hearing shall
                   (3) Change of ownership/name ............................              175.00      be conducted pursuant to the Administrative Procedure Act,
                   (4) Change of location.........................................        175.00      N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative
           ii.     Replacement of annual permit ..............................             25.00      Procedure Rules, NJ.A.C. J:t.
          iii.     Late renewal fee ...................................................   100.00
          iv.      Verification of permit ..........................................       25.00      Amended by R.2005 d.25, effective January IS, 2005.
                                                                                                      See: 36 NJ.R. 3345(a), 37 NJ.R. 295(0).
          5. For pharmacy interns as fullows:                                                           Re\\rote the section,

                   i.   Application for registration                                       50.00      13:39-1,6     Waiver
                  ii.   Initial registration fee                                           70.00
                 iii.   Registration renewal (One time only)                               70.00        (a) The rules in this chapter may be relaxed by the Board
                                                                                                      upon a showing of undue hardship, economic or otherwise,
    Amended by R.1993 d.414, effective Augusl 16, 1993.                                               on an applicant; that the waiver of the rule would not unduly
    See: 25 NJ.R. 1666(3),25 NJ.R. 3839(0).                                                           burden any affected parties; and (hat the waiver is consistent
    AmendedbyR.l999d.214,effe<tiveJuly 19, 1999.
    See; 31 N.I.R. 1151(a),31 NJ.R.1932(0).                                                           with the underlying purposes of the Pbarmacy Practice Act,
       In (a)l, rewrote ii, substituted a reference to licensure fees for a ref..                     N.J.S.A 45: 14-40 et seq. and the implementing rules of this
    """'ce to "'Ijistration fees in the introductory paragraph of v, substituted                      chapter.
    a reference to license renewal for a reference to registration in vi, sub-
    stituted a reference to biennial licenses for a reference to registration                           (b) Waiver requests shall be submitted to the Board in
    certificates in vii, and substituted a referenee to licenses fur a reference
    to certificates in x.                                                                             writing and shall include the following:
    Amended by R.2003 d.l30, effective March 17,2003.
    See; 34 NJ.R. 1089(a), 35 NJ.R. 1433(a).                                                                 I. The specific rule(s) or part(s) of the rule(s) for which
       In (a)xii, added "or course" and substituted «sponsor» for ''provider'',                           the waiver is requested;
    Amended by R.2oo5 d.25, effective January 18,2005.
    See; 36 N.1.R. 3345(a), 37 N.l.R. 295(a).                                                                2. The reasons for requesting the waiver, including a
       ReMote the section.                                                                                statement detailing the hardship that would result to the
    Amended by R.2oo7 d.2S3. effuetive September 4, 2007.
    See: 38 NJ.R. 3137(a), 39 N.1.R. 3774(b).                                                             applicant if the waiver is not approved; and
       Added (0)3.
    Amended by R.2007 d.351, effective November 19, 2007,                                                   3. Documentation which supports the applicant's re-
    See: 38 N.l.R. 4630(0),39 NJ.R. 4935(a).                                                              quest for the waiver, if applicable.
       In (0)2, inserted "ill-State"; and added (0)4.
    Amended by R.2009 d.247, effe<tiveAugust 3, 2009.                                                    (c) Absent a request for a waiver, the Board may waive the
    See; 41 NJ.R. 371(0), 41 N.J.R. 2969(b).                                                          rules in this chapter if full compliance wi(h the rules, or parts
       In (a)liv{2), substituted "225.00" for "(To be determined by future
    rulemakiog)"; and added (a)5.                                                                     of the rules, would endanger the health, safety and wellilre of
    Amended by R.2010 d.090, effe<.'1iveJune 21, 2010.                                                the general public.
    See: 42 N.1.R. 132(0),42 NJ,R. 1221(a).
        Deleted (a)biii.                                                                              New Rule, R.2007 d,351, effective November 19, 2007.
                                                                                                      See: 38 N.l.R. 4630(3), 39 NJ.R. 4935(.).




                                                                                                   39-5                                                        Supp. 6-21-10
13,39-1.7                                                                                           LAW AND PUBLIC SAFETY

13:39-1.7     Failure to complete application process                    zation to test from NABP allowing the applicant to be ad-
                                                                         mitted to the MJPE examination;
   If an applicant for a permit, license or registration issued
pursuant to the requirements of this chapter fails to complete              4. If tbe applicant is applying for initial licensure more
the application process within two years of the date of initial          than two years following bis or ber graduation from phar-
application, the Board shall administratively close the appli·           macy scbool, the applicant shall complete 1.440 hours of
cation. Following such action, an applicant making reapplica-            practical experience in a Board-approved internship. The
tion to the Board shall resubmit all required documentation              applicant sball register with the Board as an intern and
and the applicable application fee set forth at N.J.A.C. 13:39-          shall satisfy all internship requirements set forth in
1.3.                                                                     NJ.A.C. 13:39-2.6 within the two-year period immediately
                                                                         preceding the date of application; and
New Rule. R.201Q d.09O, efIective}une 21, 2010.
See: 42 N.J.R. 132(3),42 N.J.R. 122I(a).                                   5. The applicant shall have satisfied the good moral
                                                                         character and criminal history background check require-
                                                                         ments set forth in N.J.A.C. 13:39-23 and 2.4.
SUBCHAPTER 2. REQUIREMENTS FOR INITIAL                                 (b) An applicant for initial licensure as a pharmacist in
        LICENSURE                                                    New Jersey wbo has graduated from a scbool or college of
                                                                     phal1Docy in a foreign country that has not been accredited by
13:39-2.1     Reqllirements for iniliallicensure as a                ACPE or has not been deemed ACPE·equivalent by ACPE,
              pharmacist                                             shall satisfy the following requirements:
  (a) An applicant for initial licensure as a pharmacist in                L The applicant shall be at least J S years of age and
New Jersey shall satiSfy the following requirements:                     shall submit a completed application for initial licensure,
                                                                         which shall include a passport size photo of the applicant
    I. The applicant shall be at least 18 years of age and               and the application fee set forth in NJ.A.C. 13:39-1.3;
  shall submit a completed application for initial licensure.
  which shall includa a passport size photo of the applicant               2. The applicant shall have graduated with either a
  and tbe application ree set forth in N.J.A.C. 13:39·1.3;               degree of Bachelor of Science in pharmacy with a min-
                                                                         imum five-year course of study or with a Doctor of Phar-
    2. The applicant shall have graduated with either a                  macy;
  degree of Bachelor of Science in pbarmacy with a min·
  imum five-year course of study, or with a Doctor of                       3. The applicant shall have a valid certification from
  Pbermacy, from a school or college of pharmacy accredited              the Foreign Pharmacy Graduate Examination Committee
  by the American Council of Pharmaceutical Education                    (f'PGEC) ofNABP;
  (ACPE) or deemed ACPE-equivalent by ACPE;
                                                                            4. The applicant shall complete 1,440 hours of practical
        i.  The applicant shall submit an official transcript            experience in a Board-approved internShip. lhe applicant
     from the registrar of the school or college of pharmacy             shall register with the Board as an intern and shall satisfy
     substantiating that the applicant has graduated;                    all internship requirements set forth in N.J.A.C. 13:39-2.6
                                                                         within the two-year period immediately preceding the date
        ii. An applicant who has received a pharmacy de-                 of application. The internship shall not commence before
     gree from a school or college of pharmacy located in a              the applicant has been certified by FPGEC;
     foreign country that has not been accredited hy ACPE or
     has not been deemed ACPE-equivalent by ACPE, shall                     5. The applicant shall have passed the NAPLEX and
     satisfy the requirements of (b) below;                              the MJPE, consistent with the requirements of N.JA.C.
                                                                          13:39-2.2. The applicant shall take the NAPLEX and the
     3. The applicant shall have passed the North American               MJPE only after providing the Board with an official
  Pharmacist Licensure Examination (NAP LEX) and the                     transcript and receiving authorization to test from NABP.
  Multistale Jurisprudence Pharmacy Examination (MJPE),                  An applicant wbo has already taken tbe NAPLEX and has
  consistent with the requirements of N.J.A.C. 13:39-2.2.                had his or her scores transferred to New Jersey within five
  The applicant shall take the NAPLEX and the MJPE only                  years of having passed the examination consistent with
  after providing the Board with an official transcript and              N.J.A.C. 13:39·2.2, shall take the MJPE only after pro·
  receiving authorization to test from the National Asso-                viding the Board with an official transcript and receiving
  ciation of Boards of Phal1Dacy (NABP). An applicant who                authorization to test from NABP allowing the applicant to
  has already taken the NAPLEX and has had his or her                    be admitted to the MJPE examination. An applicant shall
  scores transferred to New Jersey within five years of                  not be eligible to take the referenced examination until the
  having passed the examination ~'Onsistent with N.J.A.C.                completion of his or her internship; and
  13:39-2.2, shall take the MJPE only after providing the
  Board with an official transcript and receiving authori-




Supp.6·21·10                                                      39-6
STATE BOARD OF PHARMACY                                                                                                                        13:39-2.3

    6. The applicant shall have satisfied the good moral                    be licensed in the State, the Board shall consider evidence.
  character and criminal history background check require-                  which demonstrates that the applicant:
  ments set forth in N.JAC. 13:39-2.3 and 2.4.
                                                                                   I. Is not presently engaged in drug or alcohol use thai
New Rule. K2009 d.247, effective Augusl3, 2009.                                 is likely to impair the ability to practice pharmacy with
See: 41 N.1.R. 37 1(a), 41 N.1.R. 2969(b).
  Fortner N.J.A.C. 13:39-2.1, Examinations; score, was recodified to            reasonable skill and safety. For purposes oftbis section, the
N.1.A.C 13:39-2.2.                                                              term "presently" means at this time or any time within the
                                                                                previous 365 days;
13:39-2.2     Licensure examination scores
                                                                                  2. Has not been convicted of violating any law of this
   (.) An applicant for initial licensure shall attain a passing                State or any other state of tbe United States relating to
Score of not less than 75 on the North American Pharmacist                      controlled dangerous substances or other habit-forming
Licensure Examination (NAP LEX). If an applicant fails the                      drugs;
NAPLEX, he or she shall be required to repeat the exam-
ination.                                                                          3. Has not heen convicted of violating any law relating
                                                                                to the practice of pharmacy consistent witb N.J.S.A. 45:1-
  (h) An applicant for initiallieensure shall attain a pa.'5ing                 21(t);
score of nol less than 75 on the Multist"te Jurisprudence                          4. Has not been convicted of a crime involving moral
Pharmacy Examination (MJPE). If an applicant fuits the                          turpitude; and
MJPE, he or she shall he required to repeat the examination.
                                                                                   5. Has not had his or her license or, if a permit holder,
   (c) If an applicant fails either the NAPLEX or the MJPE                      his or her permit, suspended or revoked as a result of any
three times, the Board may direct the applicant to take re-                     administrative or disciplinary proceedings in this or any
medial courses at an accredited school or college of pharmacy                   other jurisdiction which proved the applicant to he in vio-
prior to retaking the failed examination(s).                                    lation of any laws, rules or regulations pertaining to the
                                                                                practice of pharmacy, and that the applicant is not currently
  (d) NAP LEX and MJPE results shaIl he valid only for a
                                                                                under suspension or revocation.
period of five years from the date that an applicant receives a
passing score on the respective examination.                                110e foliowing annotations apply 10 N.J.A. C. 13:39-2.3 prior 10 its repeal
                                                                               by R.20fJ9 d.2 47:
11oefal/owing armototimlS apply to N.J.A.C 13:39-2.2 prior I1J its repeal   Amended by Kim d.551, effective November 19, 1990.
  by 11.2009 <1.247:                                                        See: 22 NJ.R. 2395(b), 22 NJ.R. 3499(b).
Amended by Kl994 d.351, effective July 18, 1994.                              Cbanged filing deadline from 60 to 30 days.
See: 26 N.1.R. 1596(0),26 NJ.R. 2905(b).                                    Recodified li-om N.J.A.C 13:39-2.2 and amended by R.1999 d.214,
Recodified from N.JAC )3:39-2.1 and amended by K1999 <1.214,                  effective July 19, 1999.
   effective July 19, 1999.                                                 See: 31 N.J.R. 1151(.).31 NJ.R. 1932(0).
See: 31 N.J.K 1151(a), 31 NJ.K 1932(0).                                       Substituted a reference to NAPLEX and MJPE examJrnttions fur a
   In (a), substituted a reference to NAPLEX and MJPE examinations          reference to Mitten examinations. Former NJ.A.C. 13:39-2.3, Birth
for a reference to written examinations, Former N.l.A.C. J 3:39-2.2,        cerrifica«; repealed.
Application to be filed, recodifted 10 NJ.A.C \3:39-2.3.                    Amended by R.2005 d.25. effective Jaauary 18,2005.
Amended by KlOOS d.25, effective January 18, 2005.                          See: 36 NJ.K 3345(0). 37 NJ.R. 295(3).
See: 36 N.J.K 3345(a), 37 NJ.R. 295(.).                                       Rewrote the section.
   In (b), inserted "NAPLEX AND MJPE" preceding "exa:minatioos".            110e foli<lWlng annotations apply to N.J.A.C. 13:39-23 subsequent to its
11oeJailowing annotations apply 10 N.J.A.C. 13:39-2.2 subm/lvmt 10 its         recodificalkmfrom N.JA.C 13:39-2.5 by 11.20fJ9d.247:
  recadi/icatioofrom N.J.A.C J3:39-2.1 by 11.2009 d.U7:                     Amended by R.1994 d.351, effective July 18, 1994.
Recodified &om NJAC )3:39-2.10 and amended by KI999 d.214,                  See: 26 NJ.R. 1596(8),26 NJ.K 2905(b).
  effective July 19, 1999.                                                  Reendified li-om N.JAC. 13:39-2.7 and amended by KI999 d.214,
See: 31 N.1.R. 1151(0),31 N.J.R. 1932(a).                                      effeetiveJuly 19, 1999.
  Rewrote the section. Former N.1.A.C. 13:39-2.1, Education require-        See: 31 NJ.R. 1151(8),31 N.J.R. 1932(0).
ments, recodified to N.JAC. 13:39-2.2.                                         In (a), substitured a rererenee to NAPLEX and MJPE examinations
Amended by R.2005 d.25. effective January 18,2005.                          for a reference to written examinations in the introductory paragraph.
See: 36 NJ.R. 3345(0), 31 NJ.R. 295(0).                                     Former N.JAC \3:39-2.8, Proof or identity or applicant, recodified to
  In (c), substituted "failed" for "field" at the end.                      NJ.A.C \3:39-2.9.
RccodiflCd from NJAC 13:39-2.1 and amended by K2009 d.247,                  Recodified from N.J.A.C \3:39-2.8 and amended by R.2005 d.25,
  effective August 3, 2009.                                                    effective January 18,2005.
See: 41 NJ.K 371 (a), 41 NJ.K 2969(b).                                      See: 36 NJ.R. 3345(a). 37 N.1.K 295(0).
  Section was "Examinations; score". Rlewrote the section. Former           Recodified rrom N.1AC 13:39-2.5 and amended by R.2009 d.247.
N.1.A.C. 13:39-2.2, Education requirements, repealed.                          effective August 3~ 2009.
                                                                            See: 41 NJ.K 371(0),41 NJ.K 2969(b).
                                                                               In the introductory paragraph or (a). substituted "initial licensure" ror
13:39-2.3     Proof of character                                            !'the NAPLEX and MJPE euminatiom;'\ "shall be" for "i.sn ; and the last
                                                                            5eIltence for '\ and evidence that he or she:", deleted «. in advance, llIl
  (a) An applicant for initiallieensure shall submit evidence               application containing" following "submit", and inserted a comma fbi..
of good moral character, which shall he an ongoing require-                 lowing "character"; In (a)3 1 in~erted "consistent with Nl.S.A. 45:1-
ment for licensure. In determining whether the applicant shall              21(f)~; and in (a)5, deleted f.<.in the last five years"'" following "revoked"',
                                                                            Fotmer N.1.A.C. 13:39-2.3, Application fur examinations, repealed.



                                                                         39-7                                                            Supp.6-21-10
13:39-2.4                                                                                                 LAW AND PUBLIC SAFETY

13:39-2.4     Criminal bistory background cbeck                            qumng practical experience under the supervision of the
                                                                           school or college at which he or she is enrolled.
   An applicant for initial licensure as a pharmacist in the
State shall submit his or her name, address and fingerprints                 "Pharmacy intern" means a person who is employed in an
for purposes of a criminal history background check to be                  approved phannacy training site for the purpose of acquiring
conducted by the State of New Jersey pursuant to N.J.S.A.                  practical experience and who has fJrst registered for such
45:1-28 et seq., P.L. 2002, c. 104, to determine whether crim-             purposes with the Board pursuant to N.J.S.A. 45: 14-48b(2),
inal history record information exists which may be con-                   and who has:
sidered by the Board in detennining whether the applicant
shall be licensed in the State.                                                   I. Graduated from an ACPE-approved school or col-
                                                                               lege of pharmacy who is making an application for initial
The/oJ/owingaMOtations apply to NJ.A.C. 13:39-2,4 prior to its repeal          licensure as a pharmacist more than two years fullowing
  by R.lOO9 d. 147:
                                                                               the date of graduation;
Recodified from N.1.A.C. 13:39-2.6 and amended by RIm d.214,
   elfeclive July 19, 1999.                                                      2. Graduated from a school or college of pharmacy in a
See: 31 NJ.R.1151{a),31 N.1.R 1932(.).
   Subslituied a reterence to NAPLEX and MJPE examioations for a               foreign country that has not been accredited by ACPE or
reference to written examinations. Former NJ.A.C. 13:39-2.7, Proof of          that has not been deemed ACPE-equivalent by ACPE; or
charncter, recodified to N.1AC. 13:39-2.8.
Reeodified from NJAC. 13:39-2.7 by R.2005 d.25, elfeelive JMuary                 3. Applied to the Board for reciprocal licensure and has
   18,2005.                                                                    not been engaged in the practice of pharmacy for at least
See: 36 N.J.R. 3345(a), 37 N.1.R. 295(0).
                                                                               1,500 hours within the two-year period immediately pre-
11t£ fo/Jowing annotations apply to NJA.C. 13:39-2A subsequent (Q Us           ceding the date of application.
  recodi/icatkm from N.J.A. C. 13:39-2.6 by R 2009 d. 24 7:
New Rule, R.2005 d.25, effective January 18,2005.                            "Pharmacy internship or externship" means the program in
See: 36 NJ.R. 3345(.), 37 NJ.R 295(a).                                     which practical experience is acquired by a pharmacy intern
Recodified from N.J.A.C. 13:39·2.6 by R2oo9 d.247, effcedve August
  3,2009.                                                                  or extern.
See: 41 NJ.R 371(0),41 N.I.1l2969(b).
  Fo"""" N.J.A.C. \3:39·2.4, Age requirement, repealed.                       "Pharmacy training site" means a site tbat is licensed by
                                                                           the Board where drugs are dispensed or pharmaceutical care
13:39-2.5     Refusal to license                                           is provided by a licensed pharmacist and that bas a satis-
                                                                           filetory record of observance of Federal, State and municipal
   The Board may refuse to issue a license to any applicant                law and ordinances governing the activities in which it is or
who has violated any law related to the practice of phannacy               has been engaged.
or for any of the reasons set forth in N.J.S.A. 45:1-21 et seq.
                                                                             (b) The 1,440 hours of practical experience required for
New Rule, R.2009 d.247, effective August 3, 2009.
See: 41 NJ.R. 371(0), 41 NJ.R. 2969(b).                                    the successful completion of a pharmacy internship shall be
  Former N.J.A.C. 13:39-2.5, Proof of obaraeter. was recodified to         obtained consistent with the following:
N.JA.C. 13:39-2.3.
                                                                                 1. The 1,440 hours of practical experience shall be
13:39-2.6     Interllship and externsblp practical                             completed in no less than 34 weeks and no more than 104
              experiellce requlremeuts                                         weeks, under the supervision of an intern preceptor. Each
                                                                               week of practical experience shall consist of no less than
   (aJ The following words and terms, when used in this                        15 bours and no more than 45 hours of actual service per
section, shall bave the following meanings, unless the context                 week;
clearly indicates otherwise.
                                                                                  2. The intern preceptor and the pharmacy intern shall
  "Extern preceptor" means an individual approved by an                        keep accurate records of the time spent by the phannaey
American Council of Phannaceutical Education (ACPE) ap-                        intern for credit toward the requirements of (bJl above.
proved school or college of pbannacy, at which a pharmacy                      The Board shall provide appropriate fonns to be submitted
extern is enrolled, wbo assumes the responsibility to super-                   to the Board for approval of internship experience; and
vise and provide instructional training to a phannacy extern.
                                                                                 3. No credit shall be given for bours served as a phar-
  "Intern preceptor" means a phannacist licensed in this                       macy intent prior to the applicant's registration with the
Stale wbo assumes the responsibility to supervise and provide                  Board and approval of the intern preceptor by the Board.
instructional training to a phannacy intern as set forth in (f)
                                                                             (c) A pharmacist who wishes to be an intern preceptor
below.
                                                                           shall apply to the Board and shall finnish evidence that he or
   "Pharmacy extern" means any person who is in the fifth or               she:
sixth college year, or the third or fourth professional year, at
                                                                                  I. Has been licensed and employed on a full-time hasis
an AC'PE·approved school or college of pharmacy who is
                                                                               as a pharmacist in the area of practice in which he or she is
assigned to a pharmacy training site for the purpose of ae-
                                                                               to be engaged as a preceptor for at least two years imme-


Supp.6-21-10                                                            39-8
STATE BOARD OF PHARMACY                                                                                                                13:39-2.7
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ...- - -
   diately preceding the date of application and is currently                       whether the applicant shall be registered, the Board sball
   engaged in the practice of pharmacy in the State of New                          consider evidence, whicb demonstrates that the applicant:
   Jersey; and
                                                                                         i.   Is not presently engaged in drug or alcohol use
      2. Has not been convicted of a crime or offense relating                        that is likely to impair the ability to practice as a phar-
   adversely to the practice of pharmacy consistent with                              macy intern with reasonable skill and safety. For pur-
   N.J.S.A. 45:1-21(1) or a crime of moral turpitude and has                          poses of this section, the term "presently" means at the
   not been the subject of disciplinary action taken by a                             time of application or any time within the previous 365
   professional board resulting in the suspension, revocation                         days;
   or surrender of a license or the placement of significant
   limitations on such license.
                                                                                         Ii. Has not been convicted of violating any law of
                                                                                      this State or any other state of the United States relating
   (d) The Board shall approve an intern preceptor selected                           to controlled dangerous substances or other habit-
by each phannacy intern prior In the beginning of the intern-                         forming drugs;
ship. An intern preceptor shall not supervise the training of
more than one pharmacy intern at a time.                                                 iii. Has not been convicted of violating any law
                                                                                      relating to the practice of pharmacy consistent with
   (e) The intern preceptor in a pharmacy training site shall                         N.J.S.A. 45:1-21(1) or a crime of moral turpitude; and
provide the Board with a detailed written report outlining the                           iv. Has not had bis or her authority to engage in the
progress, aptitude and readiness to practice of any pharmacy                          activity regulated by the Board suspended or revoked as
intern under his or her supervision at the conclusion of the                          a result of any administrative or disciplinary proceedings
internship.                                                                           in this or any other jurisdiction that determined the 8p"
   (I) The intern preceptor shall be responsible for supervis-                        plicant to be in violation of any laws, rules or regulations
ing the activities of the pharmacy intern and providing the                           pertaining to the practice of pharmacy and that the appli-
pharmacy intern with experience and knowledge related to                              cant is not currently under suspension or revocation; and
tbe preceptor's area of practice.                                                    4. The application fee and registration fee set forth at
New Rule, R.2009 d.247, effective Ausust 3, 2009.                                   NJAC. 13:39-1.3.
See: 41 NJ.R. 371(8), 41 NJ.R. 2%9(b).
   Fonner N.J.A.C. 13:39-2.6, Criminal history background check, was               (c) A person who has been educated in a foreign country
recodified to NJ.A.C. 13:39-2.4.                                                in a college or school of pharmacy that has not been approved
Amended by R.20IOd09O, elfective June 21, 2010.                                 by the American Council of Pbarmaceutical Education
See: 42 NJ.R. 132(0),42 N.J.R. 1221(0).                                         (ACPE) or that has not been deemed ACPE-equivalent by
   In definition "Intern preceptor" in (a) and in (e)I, substituted
«licensed" for "registered"~ and in (c)I, inserted "on a full~time basis'"      ACPE, shall be certified by the Foreign Pharmacy Graduate
following '·employed'" and deJeted "'on a fun~timc basis" fullowing             Examination Committee (FPGEC) of the National Associ-
''preceptor''.                                                                  ation of Boards of Pharmacy prior to applying to the Board
                                                                                for registration as a pharmacy intern.
13:39-2.7        Pbarmaq intern registration requirements
                                                                                   (d) A pharmacy intern registration obtained pursuant to
  (a) No person shall be employed as a pbarmacy intern until                    this section shall be valid for a period of two years from the
be or she has been registered witb the Board pursuant to this                   date of issuance. Upon application to the Board, an intern
section and his or her preceptor bas been approved by the                       registration may be renewed one time only, on an individual
Board pursuant to N.J.A.C. 13:39-2.6(c).                                        hasis, for reasons of military service, hardship. illness or
  (b) An applicant for registration as a pharmacy intern shall                  disability.
submit a written application, on a form supplied by the Board,                    (e) A change in an intern preceptor shall require prior
and shall submit:                                                               Board approval, consistent with the requirements ofN.J.A.Co
                                                                                /3:39-2.6(d). The new intern preceptor shall be responsible
      1. His or her name, address and fingerprints· for pur-
                                                                                for making application to the Board for approval.
   poses of a criminal history background check to be con-
   ducted by the State of New Jersey pursuant to N.J.S.A.                         (I) The intern preceptor and the pharmacy intern sball
   45:1-28 et seq., (p.L. 2002, c. 104) to determine whether                    notify the Board in writing within 10 days of a change in the
   criminal history record information exists tbat may disqual-                 pharmacy training site and/or tbe tennination or resignation
   ify the applicant from beiflg registered as a pharmacy in-                   of the intern.
   tern by the Board;
                                                                                   (g) In addition to the notification requirements of (I)
      2. A passport size photo of the applicant;
                                                                                above, a pharmacy intern shall notify the Board in writing
     3. Evidence of good moral character, which shall be an                     within 10 days of any change in his or her name or address of
   ongoing requirement for registration. In detennining                         record, as defmed in N.J.A.C. 13:39-1.2.




                                                                             39-9                                                  Supp.6-21-10
13:39-2.7                                                                                                           LAW ANDPUBLlCSAFETY

Amended by RI990 d.55 I, effeetive November 19. 1990.                      13:39-2.13         (Reserved)
See: 22 NJ.R. 2395(b), 22 NJ.R 3499(b).
  Submission deadline changed from 60 to 30 doys in advance.               Recodified to NJAC. 13:39·3.4 by R.2009 d.247. effective August 3,
Recodified from NJAC. 13:39·2.8 and amended by RI999 d.214.                  2009.
  effective July 19. 1999.                                                 See: 41 NJ.R. 371(.), 41 N.J.R. 2969(b).
See: 31 NJ.R 1I51(a), 31 N.l.R. 1932(0).                                       Section was "Change of address of reoord; service of process",
  Substituted a reference to NAPLEX and MJPE examinations for a
referenee t() written examinati~ and substituted a reference to passport   13:39-2.14         (Reserved)
phologyaphs for a reference I<> bust photographs. Foonet NJ.A.C. 13:39·
2.9, Alleged violations of the Phsrmacy Act, reeodified to NJ.A.C.         Recodified to N.IAC. 13:39·35 by R.2009 d.247, effective August 3,
13:39·2.10.                                                                    2009.
Recodified from NJ.A.C. 13:39-2.9 and amended by R2oo5 d.25,               See: 41 N.l.R. 371(.). 41 NJ.R 2969(b).
   effective January 18.2005.                                                  See:liOil \f,I3S '''Veriflcadon of licensure".
See: 36 NJ.R. 3345(0),37 NJ.R 295(0).
   Deleted <Iwritten" following '«in advance of the date", Fonner .        13:39-2.15         (Reserved)
NJAC. 13:39·2.7, Age requirement, recodified to N.I.A.C. 13:39·2.4.
Repeal and New Rule, R2009 <i247, effective August 3. 2009.                Recodified to N.J.A.C. 13:39·3.6 by R2009 d.247, effective August 3,
See: 41 N.J.R371(a),41 NJ.R. 2969(b).                                        2009.
   Section was "Proof of identity of applieant".                           See: 41 NJ.R. 371(.), 41 N.l.R. 2969(b).
                                                                               Section was "Reproduction of initiallieense prohibited",
13:39·2.8     (Reserved)
                                                                           13:39-2.16         (Reserved)
Recodified from NJAC. 13:39·2.9 and amended by RI999 d.214,
   effective July 19. 1999.                                                Recodified to N.lAC. 13:39·3.7 by R2009 d.247, effective August 3,
See: 31 NJ.R 1151(0),31 NJ.R 1932(a).                                        2009.
   Substituted "being investigated for" for "involved in" following        Sec: 41 NJ.R 371(0), 41 NJ.R 2969(b).
"'examination is", Fonner N.I.A.C, 13:39~2.1O. Written examinations;           Section was "'Biennial license rene,val~ administrative suspension".
grades, reeodified to NJ.A.C. 13:39·2.1.
Recodified from N.lAC. 13:39·2.10 by R200S d.2S, effective January         13:39-2.17         (Reserved)
   18,2005.
See: 36 N.l.R 3345(0),37 N.J.R 295(.).                                     Recodified to N.IAC. 13:39·3.8 by R.2009 <i247, effective August 3,
   Former N.J.A.C. 13:39-2.8, Proof of character, recodified to NJAC.        2009.
13:39-2.5.                                                                 See: 41 NJ,R. 371(.), 41 N.l.R. 2969i,b).
Repealed by R2009 d.247, effective August 3, 2009.                           Sed:ion was "Reinstatement funn administrative and disciplinary
See: 41 NJ.R 371(.), 41 NJ.R2969(b).                                       license suspensions".
   Section was "Alleged violations of the Pharmacy Aet".
                                                                           13:39·2.18          (Reserved)
13:39-2.9     (Reserved)
                                                                           Recodified to N.J.A.C. 13:39·3.9 by R.2oo9 d.247, effective August 3,
Amended by RI994 <i351, efli:ctive July 18, 1994.                            2009.
See: 26 N.J.R 1596(.126 NJ.R. 2905(8).                                     See: 41 NJ.R. 371(.),41 N.l.R 2969(b).
Amended by RI999 d.214, elfuctive July 19, 1999.                               Section was "Inactive licensw-e".
See: 31 NJ.R \151(0),31 N.J.R 1932(.).
  Rewrote the section.                                                     13:39-2.19         (Reserved)
Recodified from N.IAC. 13:39·3.11 and amended by R2005 d.25,
   effective JlI1lUary IS, 2005.                                           Recodified to N.l.A.C. 13:39·3.10 by R2009 <1.247, effective August 3,
See: 36 NJ.R. 3345(3), 37 N.J.R. 295(0).                                     2009.
   Added (d). Former N.I.A.C. 13:39·2.9, Proof of identity of applicant,   See: 41 NJ.R. 371(0), 41 N.l.R. 2969(b).
recodified to N.J.A.C. 13:39-2.1.                                            Section was '~teering probibited~!.
Repealed by R2009 d.247, effective August 3, 2009.
See: 41 NJ.R 371(.), 41 N.J.R 2969i,b).                                    13:39-2.20         (Reserved)
   Section was "Applicants educated in a foreign oountry",
                                                                           Re<odified to N.l.A.C. 13:39·3.11 by R2009 d.247, effective August 3,
13:39-2.10      (Reserved)                                                   2009.
                                                                           See: 41 N.l.R. 371(0).41 N.l.R 2969(b).
Recodified to N.J.A.C. 13:39-3.1 by R.2009 <i247, effective August 3,          Section was "Responsibilities of pharmacists".
  2009.
See: 41 NJ.R. 371(a),41 N.J.R.2969(b),
  Section was "Authoriz.tion to practice; display oflicen5O".
                                                                           SUBCHAPTER 2A. REQUIREMENTS FOR
13:39-2.11      (Reserved)                                                     RECIPROCAL LICENSURE
Recodified to N.lAC. 13:39·3.2 by R.2009 d.247, effective AUgust 3,
  2009.                                                                    13:39-2A.l          Requirements for redprocallicensure
See: 41 NJ.R 371(.), 41 N.I.R 2969(b).
  ~on     was "Replacement license~r,                                         (a) Reciprocal licensure of out-of·State pharmacists shall
                                                                           be limited to those pharmacists who have been duly licensed
13:39-2.12      (Reserved)                                                 in mutually reciprocating states and who satisfY the require-
Recodified to N.1.A.C. 13:39·3.3 by R2009 d.247, effi:ctlve August 3,      ments of this section.
  2009.
See: 41 NJ.R371(0),41 N.I.R2969(b).
  Section'iN3S "Change of name",


Supp.6-21-10                                                           39·10
        STATE BOARD OF PHARMACY                                                                                                   13:39-2A.2

          (b) A pharmacist currently licensed in a mutually recipro-         license by reciprocity in this State shall satisfY the following
        cating jurisdiction shall satisfY the fullowing requirements in      requirements:
        order to obtain a license by reciprocity in New Jersey:
1
/
                                                                                    L The applicant shall be at least 18 years of age and
             I. The applicant shall be at least 18 years of age and              shall submit a completed application for reciprocity, in-
          shall submit a completed application for reciprocity, in-              cluding a passport size photo of the applicant and the ap-
          cluding a passport sil'.., photo of the applicant and the appli-       plication ree set forth in N.JAC. 13:39-1.3. The appli-
          cation fee set forth in N.JAC, 13:39-1.3. The application              cation shall substantiate that the applicant:
          shall substantiate that the applicant:
                                                                                      i. Has obtained his or her initial licensure by exam-
               i. Has obtained his or her initial licensure by ex-                 ination and that the initial license is in good standing;
             amination and that the initial license is in good standing;           and
             and
                                                                                      ii. Has not had any other license granted to the ap-
               ii.   Has not had any other license granted to the                  plicant by any other state suspended, revoked or other-
             applicant by any other state suspended, revoked or other-             wise restricted for any reason except for the failure to
             wise restricted for any reason except for the fuilure to              renew, or for the failure to obtain the required continuing
             renew, or for the failure to obtain the required continuing           education credits in any state where the applicant is
             education credits in any state where the applicant is cur-            currently licensed but is not engaged in the practice of
             rently licensed but is not engaged in the practic-e of                pharmacy;
             pharmacy;
                                                                                    2. The applicant sball have a valid certification from
            2. The applicant shall have graduated with either a                  the Foreign Pharmacy Graduate Examination Committee
          degree of Bachelor of Science in pharmacy with a min-                  (FPGEC) ofNABP;
          imum five-year course of study, or a Doctor of Pharmacy
          degree, from a college or school of pharmacy that has been
                                                                                   3. The applicant shall have graduated with either a
                                                                                 degree of Bachelor of Science in pharmacy with a mini-
          accredited by the American Council of Pharmaceutical
                                                                                 mum five-year course of study or a Doctor of Pharmacy
          Education (ACPE), or that has been deemed ACPE-
                                                                                 degree;
          equivalent by ACPE.
               i.   An applicant who has received a pharmacy                       4. The applicant shall have engaged in the practice of
                                                                                 pharmacy for a period of at least 1,500 hours within the
    )       degree from a school or college of pharmacy located in a
                                                                                 two-year period immediately preceding the date of appli-
            foreign country that has not been accredited by ACPE or
            that has not been deemed ACPE-equivalent by ACPE,                    cation.
            who wishes to obtain a license by reciprocity in this                     i.  An applicant who has engaged in the practice of
            State shall satisfy the requirement of (c) helow;                      pharmacy for less than 1,500 hours, shall register with
                                                                                   the Board as an intern and shall satisfY all internship
             3. The applicant shall have engaged in the practice of
                                                                                   requirements set forth in N.J.A.C. 13:39-2.6 within the
          pharmacy for a period of at least 1,500 hours within the
                                                                                   two-year period immediately pre;:eding the date of
          two-year period immediately preceding the date of appli-
                                                                                   application;
          cation; or shall have registered with the Board as an intern
          and shall have satisfied all internship requirements set forth           5. The applicant shan have passed the Multistate Juris-
          in N.J.A.c' 13:39-2.6 within the two-year period imme-                 prudence Pharmacy Examination (MJPE), consistent with
          diately preceding the date of application;                             N.J.A.C. 13:39-2A.5. The applicant shall take the MJPE
                                                                                 only after submitting all required documentation to the
            4. The applicant shall have passed the Multistate Juris-
                                                                                 Board and receiving authori1'1ltion to test from NABP; and
          prudence Pharmacy Examination (MJPE), consistent with
          NJ.A.C. 13:39-2A.5. The applicant shall take the MJPE                    6. The applicant shall have satisfied the good moral
          only after submitting all required documentation to the                character and criminal history hackground che;:k require-
          Board and receiving authorization to test from the National            ments set forth in N.JAc' 13:39-2A.2 and 2A.4.
          Association of Boards ofPharrnacy (NABP); and
                                                                                (d) In addition to the requirements set forth in (a) and (b)
            5. The applicant shall have satisfied the good moral             above, an applicant for licensure by reCiprocity shall meet all
          character and criminal history background check require-           licensure transfer criteria utilized by NABP.
          ments set forth in N.JAc' 13:39-2A.2 and 2A.4.
                                                                             New Rule, R.2009 d.247, effective August 3, 2009.
          (c) A pharmacist currently licensed in a mutually recipro-         See: 41 NJ.R. 371(0), 41 N.l.R. 2969(b).
        cating jurisdiction who received a pharmacy degree from a
        school or college of pharmacy located in a foreign country           13:39-2A.Z Proof of cbaracter
        that has not heen accredited by ACPE or that has not been              (a) An applicant for licensure by reciprocity shall submit,
        deemed ACPE-equivalent by ACPE, who wishes to obtain a               as part of his or her licensure application, evidence of good


                                                                         39-11                                                   Supp.6-21-10
13:39-2A.2                                                                                                  LAW AND PUBLIC SAFETY

moral character, which shall be an ongoing requirement for                 former N.l.A.C. 13:39-3.6, Reproduction of origin.l license
licensure. In determining whether the applicant shall be li-             prohibited, recedified to N.l.A.C. 13:39-2.15.
                                                                         Recodified from N.lAC. 13:39-3.6 by R.2009 d.247, olIeet!y. August
censed in the State, the Board shall consider evidence, which              3,2009.
demonstrates that the applicant:                                         See: 41 N.l.R 371(.), 41 N.J.R. 2969(b).

      I. Is not presently engaged in drug or alcohol use that            13:39-2A.5       Multislat. Jurisprudence Pharmacy
   is likely to impair the ability to practice pharmacy with                              Examination
   reasonable skill and safety. For purposes of this section, the
   term "presently" means at this time or any time within the              (a) An applicant for reciprocal licensure shall pass the
   previous 365 days;                                                    Multistate Jurisprudence Pharmacy Examination. A passing
                                                                         score of not less than 75 shall be attained. If an applicant fails
     2. Has not been convicted of violating any law of this              the examination, he or she shall be required to repeat the
   State or any other state of the United States relating to             examination.
   controlled dangerous substances or other habit-forrning
   drugs;                                                                   (b) If the applicant for reciprocal licensure fails the ex-
                                                                         amination three times, the Board may direct the applicant to
      3. Has not been convicted of violating any law relating            take remedial courses at an accredited school or college of
   to the practice of pharmacy consistent with N.J.S.A. 45:1-
                                                                         pharmacy prior to retaking the law examination.
   21(t);
                                                                         Amended by RI999 d.214, effective July 19, 1999.
      4. Has not been convicted of a crime involving moral               See: 31 N.1.R. 1151(a), 31 NJ.R. 1932(&).
   turpitude; and                                                          Rewrote the section.
                                                                         Recodified from N.J.A.C. 13:39-3.14 and amended by R.2OOS d.2S,
      5. Has not had his or her license suspended or revoked               effuctive January 18,2005.
   as a result of any disciplinary proceedings in this or any            See: 36 N'/.R. 3345(0), 37 N.J.R 295(3).
                                                                           In (8)+ substituted "scorel l for 'igrade" and 'lshaU" for "win". Fonner
   other jurisdiction, which proved the applicant to be in vio-          N.J.A.C. 13:39-3.7, Limitation of reciprocal licensure, reoedified to
   lation of any laws, rules or regulations pertaining to the            N'/.A.C.13:39-3.1.
   practice of pharmacy and that the applicant is not currently          Recodified from NJAC. 13:39-3.7 by R2009 d,247, effe<tive August
   under such suspension or revocation.                                     3,2009.
                                                                         See: 41 N.J.R. 371(0),41 N.J.R2969(b).
New Rule, R.2005 d.25, effe<tive January 18, 2005.
See: 36 NJ.R 3345(&), 37 N.J.R. 295(0).
   Former NJ.A.C. 13:39-3.3, Change of name, recodified to NJAC.
13:39-2.12.
Recodified from N.JAC. 13:39-3.3 and amended by R.2009 d.247,            SUBCHAPTER 3. PHARMACIST REQUIREMENTS
   effective August 3, 2009.
See: 41 N.J.R. 371(0), 41 NJ.R 2969(b).                                  13:39-3.1     Authoriz.alioD to practice; display orneen.e
   Rewrore the introductory paragraph of (a); in (a)3, inserted "con-
sistent with NJ,SA 4S:1-21(1)"; and in (a)5, deleted "in the last five      (a) An applicant who has successfully satisfted all Board
yeaIS"'" following «revoked" and a comma following "phannacy", and
insetted a comma following 'jurisdiction",                               requirements for licensure and has been approved by the
                                                                         Board to be licensed shall receive an authorization signed by
                                                                         the Executive Director of the Board granting the applicant the
13:39-1A.3      Refusal to /kens.
                                                                         right to practice pharmacy in the State of New Jersey until
   The Board may refuse to issue a license to any applicant              such time as an initial license may be issued. The licensee
for licensure by reciprocity that has violated any law relating          shall maintain such authorization on his or her person at all
to the practice of pharmacy or for any of the reasons set forth          times while engaging in the practice of pharrnacy until the
in N.J.S.A. 45:1-21 et seq.                                              initlallicense is issued.
New Rule, R.2009 <1.247, effe<tive August 3, 2009.                          (b) Upon issuance of a license, the current biennial re-
See: 41 N.J.R 371(0),41 NJ.R 2969(b).                                    newallicense shall be conspicuously displayed in the pharma-
                                                                         cist's principal place of employment.
13:39-2A.4      Criminal history background cbeck
                                                                            (c) A phannacist who is employed by more than one
   An applicant for licensure by reciprocity in the State shall
                                                                         pharrnacy in the State shall maintain the wallet-sized license
submit his or ber name, address and fingerprints for purposes
                                                                         issued by the Board on his or her person when he or she is
of a criminal history background check to be conducted by
                                                                         working at a location where his or her current biennial re-
tbe State of New Jersey pursuant to NJ.SA 45:1-28 et seq.,
                                                                         newallicense is not on display.
P.L. 2002, c.104, to detennine whether criminal history
record infilrmation exists which may be considered hy the                The folloWing aruwtations apply to N.J.A.c' 13:39-3.1 prior 10 its repeal
Board in deterrnining whether the applicant shall be licensed               by R.2Q09 d.U7:
in the State.                                                            Amended byRl999 d.214, effuctive July 19, 1999.
                                                                         See: 31 NJ.R1I51(a),31 N.J.RI932(a).
New Rule, R2005 d.25, effe<tive J""""'Y 18, 2005.                           In (a), substituted a reference to licensure for a reference to
See: 36 NJ.R 3345(&), 37 NJ.R. 295(0).                                   registration; and rewrote (b).


Supp.6-21-10                                                         39-11
    STATE BOARD OF PHARMACY                                                                                                                         13:39-3.4

    Recodified from NJ.A.C. 13:39-3.7 and amended by R200S d.25,                     or a certified copy of the court order or marriage certificate,
       effective January IS, 2005.                                                   which shall be retained by the Board. When a replacement
    See: 36 N.J.R. 3345(0), 37 NJ.R. 295(0).
                                                                                     license is issued, the initial license shall be returned for
)      Added a new (h): recodified former (h) as (e). Former N J.A.C. 13:39·
    3.1, License, recodilied to NJ.A.C. 13:39·2.10.                                  cancellation and the pharmacist shall remit the required fee as
    The following annotations apply 10 NJA. C, J3:31)..3./ subsequent to its         prescribed in NJ.A.C. 13:39-1.3.
      recodification from N.J.A.C 13:39·1.10 by R.2oo9 d.247:
    Amended by R.1999 d.214, effec.uve July 19,     1m.                              Amended by 111999 d.214, effeetive1uly 19, 1999.
    See: 31 NJ.R. 1151(a), 31 N.J.R. 1932(0).                                        See: 31 NJ.R. 1151(.),31 NJ.R. 1932(0).
       Substituted !} reference to the Executive Director for a reference to the        Substituted references to licenses for references to eertificates in the
    Secretary, and substituted a Nfe-renee to initial licenses for a reference to    last sentence.
    original certificates of registration.                                           Recodified from NJ.A.C. 13:39-3.3 and .mended by R.2oo5 d.2S,
    Recodified from NJ.A.C. 13:39·3.1 and amended by K2oo5 d.25,                       effeeti"" January 18,2005.
       effective January 18,2005.                                                    See: 36 NJ.R. 3345(.),37 N.J.R. 295{.).
    See: 36 NJ.R. 3345(a), 37 NJ.R. 295(0).                                            Rewrote the section.
       Rewrote the section. Fonner NJ.A.C, 13:39·2.10, Alleged violations            Recodified from N.JAC. 13:39·2.12 by R,2oo9 d.247, effective August
    of the Pharmaey Act, recodified to NJ.A.C. 13:39·2.8.                              3,2009.
    Recodified from NJ.A.C. 13:39·2.10 and amcoded by R2oo9 d.247,                   See: 41 NJ.R. 371(0), 41 NJ.R. 2969(b).
       effective August 3, 2009.                                                       former NJ.A.C. 13:39·3.3, Proof of eharacter, recodified to N.J.A.C.
    See: 41 NJ.R. 371(0), 41 NJ.R.2969(b).                                           13:39·2A.2.
       ]0 (b)~ deleted ~'initia1 Vo'all license and" preceding "current""; and in    Amended by R.2010 d.090, effective June 21, 2010.
    (e), deleted "wall license and" precoding "eurrent" and substituted the          See: 42 NJ.1l 132(0),42 NJ.1l 122I(a).
    fmal OCCUlTence ornis" fur "are", Former NJA.C. 13:39~3,1, Limitatiotl             Deleted "registeted" preceding the rll'St and thW occurrence of
    of reciprocal licensure, repealed,                                               "pbarmacisC and inserted a oomma following "«:rtificate".
    Amended by R.2010 d.09O, effuctive June 21, 20to.
    See: 42 NJ.R. 132(a), 42 N.J.R. 1221(0).                                         13:39-3.4     Change of address of record; service of
       In (1)), deleted "registered" prooeding "pharmacist's"; and in (e),
    deleted "registered" preeeding "pharmacist" and '4licensed'\ preceding                         process
    "pharmacy''',
                                                                                       (a) A phannadst shall notify the Board in writing of any
                                                                                     change in his or her address of record within 30 days.
    13:39-3.2      Replacement license
                                                                                        (b) Failure to notify the Board of any change in a phar-
       A replacement initial license or renewal license shall be
                                                                                     macist's address of record pursuant to (a) above may result in
    issued by the Board upon payment of a fee as prescribed in
                                                                                     disciplinary action in accordance with N.J's.A. 45:1-21(b)
    N.l.A.C. 13:39-1.3 and upon submission of proof of the
                                                                                     and N.l.A.C. 13:45C-I.3, and the imposition of penalties set
\   applicant's identity and reasonable proof of the loss or de·
                                                                                     forth in N.l.S.A. 45:1·25.
    struction of the initial license or renewal license, or upon
    return of the damaged initial license or renewal license to the                    (c) Service of any administrative complaint or other
    Board.                                                                           Board-initiated process at a pharmacist's address of record
    Tire following annotation applies to N.J.A.G. 13:39·3.2 prior ta lIS             shall be deemed adequate notice for the purposes ofN.J.A.C.
       repeal by R,2oo9 d.147:                                                       1:1·7.1 and the commencement of any disciplinary pro-
    New Rule, R.2005 d.25, effective January 18, 2OOS.                               ceedings.
    See: 36 NJ.R. 3345(.), 37 NJ.R. 295(0).
      Former N.J.A.C. 13:39·3.2, Duplicate license, recodified to NJ.A.C.             The following annotation applies to N.J.A.C. 13:39-3.4 prior to its
    13:39-2.11.                                                                         repeal by R,2009 d.247:
    The follOWing annotations apply to N.J.A.C. 13:39-3.1 subsequent to its           New Rule, R.2oo5 d.25, effective January 18,2ooS.
      r.-ijicalkm from N.J.A.C 13:39-1.11 by R,1(){)9 d,247:                          See: 36 NJ.R. 3345(0),37 NJ.R. 295(a).
    Amended by R.1999 d.214, effective July 19, 1999.                               .   former N.J.A.C. 13:39·3.4, Change of address of record, recodified to
    See: 31 N.J.R. 1151(a), 31 NJ.R. 1932(0).                                         NJ.A.C.I3:39·2.13.
      Substituted references to licenses for references to certificates of            The joJiuw;ng annotations apply to N.JA.C 13:39-3.4 subsequent to its
    registration throughout,                                                            recodificalkmfromN.JA.C. 13:39·2.13 by R.2oo9d.147:
    Recodified from NJ.A.C. 13:39-3.2 and amended by R.2oo5 d.25,                    Amended by R.1994d.35I, effective July 18, 1994.
      efTecth-e January 18,2005.                                                     See: 26 NJ.R. 1596(0),26 NJ.R, 2905(b).
    See: 36 NJ.R. 3345(.), 37 NJ.R. 295(0).                                          Amended by 111999 d.2t4, effective July 19, 1999.
      Rewrote the section.                                                           See: 31 NJ.R.IIS1(.), 31 NJ.R.1932(a).
    Recodified from NJ.A.C. 13:39-2.11 by R.2009 d.247, effective August               Substituted a reference to addresses of record for a reference to home
      3,2009.                                                                        add"".:....
    See: 41 N.J.R. 371(.), 41 N.J.R. 2%9(b).                                         Recodified from N.J.A.C. 13:39-3.4 and amended by R.2oo5 d.25,
      Former NJ.A.C. 13:39-3.2, Requiremenls         roc reciprocal licensure of       effecti"" January 18, 2OOS.
    pharntocist currently licensed in another jurisdiction, repealed.                See: 36 NJ.R. 3345(8), 37 N.J.R, 295(.).
                                                                                     Rewrote the section.
                                                                                     Recodified from NJ.A.C. 13:39·2.13 by R.2(){)9 d.247, effective August
    13:39-3.3      Change ofname                                                       3,2009.
      If a pharmacist legally changes the name under whicb he or                     See: 41 NJ.R. 371(.), 41 NJ.1l 2969(b).
                                                                                       Fonner N.l.A.C. 13:39-3.4, Proof of identity of applicant, repealed.
    she engages in the practice of pharmacy, the pharmacist shall                    Amended by R.2010d.09O, effective June 21, 2010.
    notify the Board within 30 days of such change. The                              See: 42 NJ.R. 132('),42 NJ.R. 1221(0).
    phannacist shall submit original proof of the change of name                       In (a), deleled "registered" preceding "'pharmacist"; and in (h) and (e),
                                                                                     deleted "registered" preceding "pharntacist's".


                                                                                39-13                                                          Supp.6·21-10
13:39·3.5                                                                                                        LAW AND PUBLIC SAFETY

13:39·3.5     Verification of licensure                                     ing. Such suspension shall be deemed an administrative sus-
                                                                            pension.
   A verification that the license of • pharmacist is in good
standing shall he supplied by the Board upon written request                  (b) A phannacist who continues to engage in the practice
and upon payment of the fee set forth in N.J.A.C. ]3:39·1.3.                of pharmacy with a suspended license shall be deemed to be
TIre following aflfU)talion applies to NJA.C. /1:19·1.5 prior    10   itA   engaging in the unauthorized practice of pharmacy and shall
   repeal by R.2009 d.247:                                                  be subject to the penallies set forth in N,J.S,A, 45: 1-25 et seq.
New Rule. R.2005 d.25, effective I.nuru:y 18.2005,
See: 36 NJ,R, 3345(0), 37 NJ.R, 295(0).                                        (c) The Board shall send a notice of renewal to each
Former N.J.A.C. 13:39·3.5. Certification of records, recodified to          pharmacist at least 60 days prior to the expiration of the
  NJAC. 13:39·2.14.                                                         license, Ifthe notice to renew is not sent at least 60 days prior
The lollowing annotations apply 10 N,JA. C. 11:39·3.5 subsequent 10 its     to the expiration date, no monetary penalties or fines shall be
  recodification from N.J.A, C. /1:39-2.14 by R.2009 d.247:
                                                                            imposed upon the phannacist for tltilure to renew.
Amended by R.l999 d,214, effective July 19. 1999.
See: 31 NJ.R. 1I51(a). 31 NJ,R. 1932(0),                                    New Rule, R,2oo5 d.25, effective JlIlluory 18,2005.
  Rewrote the seetion,                                                      See: 36 N.l,R. 3345(a}, 37 NJ.R. 295(0),
Recodified from NJAC. 13:39-3.5 and amended by R.2005 d.25,                 Recodified from NJAC. 13:39-2.16 by R,2009 d,]47, effective August
  effective Januory 18. 2005.                                                 3,2009,
See: 36 NJ.R. 3345(0), 37NJ,R. 295(.).                                      See: 41 NJ,R, 371(3), 41 NJ.R. 2969(b).
  Rewrote the section.                                                        Fonner NJ.A,C. 13:39-3,7, Multistate Jurisprudence Pharmacy Ex-
Recodified from NJ.A.c. 13:39·2.14 by R.2009 d.247. effective August        amination) re<::ooified to NJ.A.C.   13:3~2A.5.
   3,2009.
See: 41 NJ.R. 371(0). 41 N.J.R. 2969(b),
   Fonner NJ.A,C, 13:39-3.5, Alleged viol.tions of the Pharmacy Act,        13:39·3.8      Reinstatement Crom administrative and
repealed,                                                                                  disciplinary license suspensions
Amended by R.20tO d.09O, effective June 21, 2010.
See: 42 NJ.R. 132(0).42 NJ,R. 1221(0),                                         (a) A pharmacist who has had his or ber license admin-
   Deleted "registered" preceding "pharmacist".                             istratively suspended pursuant to NJ.A.C. 13:39-3.7 may ap-
                                                                            ply to the Board for reinstatement within five years following
13:39-3.6     Reproduction oC license prohibited                            the date of license expiration, A phannacist applying fur re-
   The biennial license or wallet-sized license issued by the               instatement shall submit:
Board to any phannacist shall not be reprinted, photographed,                      I. A renewal application, including an affidavit of em-
photostated, duplicated or reproduced by any other means                        ployment listing each job held during the period of license
either in whole or in part, except as provided in NJ,A.C.                       suspension, including the names. addresses, and telephone
13:39-3.2,                                                                      numbers of each employer;
Amended by R.1999 d,214, effective July 19, 1999,
See: 31 NJ,R. 1151(a}. 31 NJ.R.1932(a),
                                                                                  2. All past due renewal fees set forth in N.J.A.C,
  Rewrote the section.                                                          13:39-L3;
Reendified from NJ,A.C. 13:39-3,6 and amended by R.2005 d.25.
  effective Januru:y 18,2005,                                                     3, A reinstatement fee set fortb in N.JA.C. 13:39.1.3;
See: 36 NJ,R. 3345(8), 37 N.l,R. 295(0).
  Substituted ''initial'~ for "original" preceding "wall license" end             4. Any outstanding penalties imposed hy the Board;
amended tlle NJAC. reference.                                                   and
Recodified from NJAC. 13:39-2.15 and amended by R.2009 d,247,
  effective August 3, 2009.                                                        5, Evidence of having completed all delinquent con-
See: 41 NJ,R, 371(0), 41 NJ,R, 2969(b),                                         tinuing education credits consistent with the requirements
   Section was "Reproduction of initial license prohibited". Deleted
'initial waH license." preceding "biennial" and updated the N.l.A.C.            of N.J.AC. 13:39-3A to a maximum of five years or 75
reference, Fonner N,I,AC, 13:39-3.6, Crimin.l history background                credits.
check. recodified to NJAC. 13:39-2A.4,
                                                                              (b) If the license has been administratively suspended for a
13:39-3.7    Biennial license renewal; administrative                       period of more than five years, a phannacist applying for re-
             suspension                                                     instatement shall satisfy all requirements in (a) I through 4
                                                                            above and shall pass the MJPE and the NAPLEX.
   (a) A phannacist shall renew his or her license for a period
of two years from the last expiration date, The phannacist                     (e) A phannacist who has bad his or her license suspeoded
shall submit a renewal application to the Board, along with                 pursuant to disciplinary action taken by the Board may apply
the renewal ree set fortb in N,J.A.C. 13:39-1.3, prior to the               to the Board for reinstatement of his or her license at the
date of license expiration, A phannacist who submits a re-                  conclusion of the suspension period, A pharmacist applying
newal application within 30 days following the date of license              for reinstatement from a disciplinary suspension shall submit:
expiration shall submit the renewal fee, a.~ well as the late Cee
                                                                                  1. A reinstatement application, including an affidavit of
set forth in NJ.A,C. 13:39·1.3, A phannacist who fails to
                                                                                employment listing each job held during the period oC            (
submit a renewal application within 30 days of license expir-
ation shall have his or her license suspended without a hear-


Supp.6-21·l0                                                            39-14
    STATE BOARD OF PHARMACY                                                                                                           13:39-3A.l

      license suspension. including the names. addresses, and                  13:39-3.10     Steering prohibited
      telepoone numbers of each employer;
                                                                                  [t shall be unlawful for a pharmacist to enter into an
)        2. A reinstatement fee set forth in N.J.A.C. 13:39-1.3;               arrangement with a health care practitioner who is licensed to
                                                                               issue prescriptions for the purpose of directing or diverting
         3. The applicable renewal fee(s) set fortb in N.JAC.
                                                                               patients to or from a specified pharmacy or restraining in any
       13:39-1.3; and                                                          way a patient's freedom of choice to select a pharmacy.
         4. Evidence of baving met all conditions imposed by                   New Rule, R.200S d.2S, etleclive January 18, 2OOS.
      the Board pursuant to tbe disciplinary and/or reinstatement              See: 36 NJ.R. 3345(0), 37 NJ.R 295(0).
      orderCs).                                                                Recodifled from NJ.A.C. 13:39-2.19 by R2009 d.247, effective Augusl
                                                                                 3,2009.
    New Rule, R.2oo5 d.25, effective January 18,2005.                          See: 41 NJ.R. 371(a), 41 NJ.R. 2969(b).
    See: 36 NJ.R. 3345(0). 37 NJ.R. 295(0).
    Reoodified from NJ.A.C. 13:39-2.17 and amended by R.2009 d.247,
      effective August 3, 2009.                                                13:39-3.11     Responsibilities of pbarmacists
    See: 41 NJ.R. 371(0), 41 NJ.R. 2969(b).
      In lite introductory paragraph of (a), updated the N.l.A.C. reference.     (a) All pharmacists shall be responsible for compliance
                                                                               with all the rules, regulations and laws governing tbe practice
    13:39-3.9     Inactive licensure                                           of pharmacy.

       (a) A pharmacist may, upon application to the Board,                       (b) Any pharmacist fuund to have violated the New Jersey
    choose inactive statos. A pharmacist electing inactive status              Pharmacy Practice Act, N.l'sA 45: 14-40 et seq., or the rules
    shall not engage in the practice of pharmacy in New Jersey                 in this chapter, shall be subject to disciplinary action.
    for the entire biennial registration period. A licensee on in-
                                                                               New Rule, R.2oo5 d.25, effective January 18,2005.
    active status may resume the practice of pharmacy in New                   See: 36 NJ.R 3345(0), 37 N.1.R 295(0).
    Jersey upon application to the Board consistent with the                   Reoodified from NJ.A.C. 13:39-2.20 and amended by R.l009 d.147,
    following requirements:                                                       etred:ive August 3. 2009.
                                                                               See; 41 NJ.R. 371(8), 41 N.l.R. 296!l(b).
         I. If a licensee was practicing pharmacy in another                      In (h), inserted "New Jersey" and "Pmmice", updated lite NJ.S.A.
                                                                               reference. and substituted "or'" for "and".
      state where he or she is licensed, and practiced for at least
      1,000 hours within the two years immediately prior to the
      date of application for return to active status, the licensee
      shall remit payment of the renewal fee for the current                   SUBCHAPTER3A. CONTINUING EDUCATION
      biennial registration period set forth in NJ.A.C. 13:39-1.3;
         2. If a licensee was practicing pharmacy in' another                  13:39-3A.l     Continuing education credit bour
      state where be or sbe is licensed, but practiced for less than                          requirements
      1,000 hours within the two years immediately prior to the                   (a) Eacb applicant for biennial license renewal shall com-
      date of application fur return to active status, the licensce            plete a minimum of 30 credits of continuing education during
      shall submit evidence of having completed 30 credits of                  the preceding biennial period, except that the Board shall not
      continuing education, consistent with the requirements set               require completion of continuing education credits for an
      forth in N.l.A.C. 13:39-3A.I, within the two years imme-                 applicant's initial license renewal. At least to of the con-
      diately prior to the date of application. The licensee shall             tinuing education credits shall be obtained through didactic
      also remit tbe renewal fee for the ClllTent bieMial reg-                 instruction. For purposes of Ibis subsection, "didactic instruc-
      istration period set forth in N.J.A.C. 13:39-1.3; and                    tion" means in-person instruction and may include telephonic
         3. If a licensee bas not practiced pharmacy in another                or electronic instruction that is interactive, but shall not
      state during the inactive period, the licensee shall submit              include videotaped instruction. At least three continuing edu-
      evidence of having completed 15 credits of continuing                    cation credits shall be obtained in pharmacy law applicable to
      education per year, consistent with the requirements set                 the practice of pharmacy in New Jersey.
      forth in N.J.A.C. l3:39-3A to a maximum of75 credits. At
                                                                                 (b) Ten credits of continuing education may be carried
      least 30 credits shall have been completed within the two
                                                                               over into a succeeding biennial period only if such credits
      years immediately prior to the date of application to return
                                                                               were earned during the last six months of the preceding
      to active status. The licensee sball also remit the renewal
                                                                               biennial period and were not previously reported.
      fee for the cu.rrent biennial registration period set forth in
      N.l.A.C. 13:39·1.3.                                                      Amended by R.2OOS d.1S, effective January 18, 2005.
                                                                               See: 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
    New Rule, R.2oo5 d.2S, effeetive January 18, 2005.                            In (a), edded the fourth sentence.
    See: 36 NJ.R. 3345(a), 37 NJ.R. 295(0).                                    Amended by R.2010 d.09O, effective June 21, 2010.
    Recodified from N.1,A,C. 13:39-2.18 by R.2009 d.241, effective August      See: 42 NJ.R 132(0), 42 N.J.R. 1221(a).
      3,2009.                                                                     In (a), substimted "subsection" for "paragraph" and the second
    See: 41 N.J.R. 311(a)., 41 N.1.R 2969(b).                                  oee1.Ul'eJ1ce of "At" for "For the bIennial renewa1 perioo commencing
                                                                               May 2005 and thereafter, at".


                                                                           39-15                                                    Supp.6-21-1O
13:39-3A.2                                                                                        LAW AND PUBLIC SAFETY

13:39-3A.2      Criteria (or continuing education credit                  3. Teaching and research appointments related to the
                                                                       practice of phannacy shall be granted three continuing
   (aJ A licensee may obtain continuing education credit from
                                                                       education credits for each new program or course taught or
the following categories:
                                                                       subject matter researched by a licensee, to a maximum of
    I. Programs or courses offered by American Council of              six credits, "New," in this paragraph, means a program,
  Pharmaceutical Education approved providers;                         course or subject matter which the licensee has never
                                                                       taught or researched before in any educational or practice
    2. Programs and courses that have received prior Board             setting. A licensee who is employed as a teacher andlor as
  approval pursuant to N.J.A.C. 13:39-3A.6;                            a researcher on a full-time basis shall not be eligible to
    3. Graduate course work relevant to the practice of                obtain continuing education credit for such activities.
  pbarmacy. taken at an accredited college or university,                4, Participation as a preceptor in an extemship pro-
  beyond that required for professional licensure;                     gram, upon prior approval by a college of pharmacy, sball
    4. Participation in teaching andlor research appoint-              be granted three continuing education credits per srudent to
  ments;                                                               a maximum of six credits.

     5. Participation as a preceptor in externship programs;              5. Participation as a preceptor in an internship program
                                                                       shall be granted three continuing education credits per 160
    6. Participation as a preceptor in internsbip programs;            hours of work perfonned by the intern(s) and supervised by
  and                                                                  the licensee, to a maximum of six credits.
    7. Publication of an article related to the practice of              6. Publicalion of an article related to the praclice of
  pharmacy in a peer-reviewed professional journal.                    pharmacy in a peer-reviewed profeSSional journal shall be
                                                                       granted three continuing education credits per article to a
   (b) A licensee seeking credit for attendance at a program
                                                                       maximum of six credits.
or <nurse that is not offered by an American Council of
Pharmaceutical Education approved provider and that has not           (b) The Board shall not granl credit for, or approve as a
been approved by the Board pursuant to N.J.A.C. 13:39-3A.6,        component of a continuing education program, participation
shall submit for Board review and approval, on a form pro-         in tbe routine business portion of any meeting of a phar-
vided by the Board, information similar to that wbich is           maceutical org-dIIization or any presentation that is offered to
required to be submitted by a sponsor pursuant to N.J.A.C.         sell a product or promote a business enterprise.
13:39-3A.6(a), the continuing education review fee set forth
at N.J.A.C. 13:39-1.3 and the verification of attendance.          13:39-3A.4      Continuing education credit bour reporting
                                                                                   procedure
Amended by &.2010 d.090, effective June 21, 2010.
See: 42 NJ.R. 132(0),42 NJ.R. 1221(0).                                (a) A liccnsee shall specifY on bis or her application for
  Added (b).
                                                                   biennial license renewal that the required number of con-
                                                                   tinuing education credits has been completed. Falsification of
13:39-3A.3     Continuing education credit bour
                                                                   any information contained in the renewal application may
               calculations
                                                                   result in an appearance before the Board and the assessment
   (aJ Credit for continuing education shall be granted as         of penalties andlor license suspension pursuant to NJ.S.A.
follows for each biennial license period:                          45: 1-21 el seq.

     I. Attendance at approved programs or courses sball be           (b) A licensee shall maintain all documentation concerning
  granted one credit for each hour of attendance. Credit sball     the completion of continuiog education requirements for a
  not be granted for programs or courses which are less tban       period of five years from the completion of the credit hours
  one contact hour in duration, which is defmed as 50              and shall submil such documentation to the Board upon re-
  minutes of actual attendance in a program or course of           quest. Such documentation shall consist of:
  study. One balf credit sball be granted for each 30 minute
  segment of a program or course that is more than one                   1. For programs offered by American Council ofPhar-
  contact hour in duration. Completion of an entire program            maceutical Education approved providers, a certificate of
  or course is required in order to receive any continuing             completion from the course or program;
  education credit for the program or course.                            2. For programs and courses approved by tbe Board,
     2. Successful completion of graduale course work re-              the sponsors' written verification of attendance;
  lated to !be practice of pbannacy at an accredited college or          3. For teaching or research appoinUnents in an aca-
  university beyond that which is required for professional            demic setting, a stalemenl from the chairperson of the de-
  licensure shall be granted three continuing education cred-          partment verifYing completion of the assignment;
  its for each course credit awarded.




Supp.6-21-10                                                   39-16
    STATE BOARD OF PHARMACY                                                                                                 13:39-3A.o
                      .~------
          4. Por research appointments in an industrial setting, a              ii. A pbarmacist with a B.S. in Pharmacy or a
       statement from the project coordinator verifying comple-               Pharm.D. with expertise in the program or course subject
       tion of the assignment;                                                area;
)
         5. For participation !IS a preceptor in an externship pro-             iii. A pharmacist with a B.S. in Phannacy or a
       gram, a certificate from the college of pharmacy;                      Pharm.D. who is certitied by a nationally recognized
                                                                              board or association; or
         6. For participation as a preceptor in an internship pro-
       gram, a certificate from the Board; and                                   iv. A licensed health care professional who demon-
                                                                              strates special expertise in the lecture subject area.
          7. For publications in a peer-reviewed professional
       journal, submission of the published article.                      (b) A continuing education sponsor may request approval
                                                                        ror a program or course conducted by an individual who
      (c) The Board shall audit licensees on a random basis at
                                                                        possesses expertise in a subject area relevant to the practice of
    the end of each biennial period to determine compliance with
                                                                        pharmacy, provided that the program or course to be con-
    continuing education requirements.
                                                                        ducted by that individual satisfies the requirements of (a)l
    Amended by R.2010 d.09O, effective lune 21, 2QW.                    and 2 ahove.
    See, 42 N.J.R. 132(8), 42 N.J.R. 1221(0).
      In (a). inserted "t.hat.. , "required" and "has beent ,.            (c) Applications for pre-approval of continuing education
                                                                        programs or courses shall be submitted by the continuing ed-
    13:39-3A.5         Waiver of continuing education                   ucation sponsor on a fonn provided by the Board at least 45
                       requirements                                     days prior to tbe date the program or course is to be offered.
                                                                        Incomplete applications shall be returned to the sponsor.
      (a) The Board may waive continuing education require-
    ments on an individual bilSis for re!lSOOS of military service,        (d) Tbe Board shall approve only such continuing educa-
    hardship, illness or disability.                                    tion programs and courses as are available and advertised on
                                                                        a reasonable nondiscriminatory basis to all persons licensed
       (b) A licensee seeking a waiver of continuing education
                                                                        to practice pharmacy in the State. The Board sball maintain a
    requirements sball apply to the Board in writing and set forth
                                                                        list of all approved programs and courses at the Board office
    with specificity the reasons ror requesting the waiver. The
                                                                        and sball finnish the list to licensees upon request.
    licensee shall also provide the Board with such additional
)   infonnation as the Board may request in support of the appli-          ( e) A continuing education sponsor shall not make sub-
    cation for waiver.                                                  stantive changes to an approved program or course, such as a
                                                                        cbange in program or course content or instructor, without
      (c) A waiver of continuing education requirements granted
                                                                        prior Board approval.
    pursuant to this section sball be effective only for the biennial
    period in which such waiver is granted. If the condition(s)           (f) The continuing education sponsor sbalI monitor atten-
    whicb necessitated the waiver continues into the next biennial      dance at, or ensure completion of, each approved program or
    period, a licensee shall apply to the Board ror a renewal of        course and finnish to each enrollee a verification of atten-
    such waiver ror the new biennial period.                            dance which sball include at least the following information:

    13:39...3A.o      RespoosibiDties of continuing education                  I. The title, date and location of the program or course
                      sponsors                                              offering;
       (a) A continuing education sponsor shall receive prior                 2. The name of the program or course presenter;
    Board approval for a program or course if the sponsor pro-
                                                                              3. The name and certificate number of the program or
    vides, in writing on a fonn provided by the Board, infor-
                                                                            course presented;
    mation whicb demonstrates that tbe program or course meets
    the following requirements:                                               4. The number        of continuing     education   credits
                                                                            awarded; and
          1. The program or course is offered in a subject matter
       relevant to tbe practice of pharmacy;                                  5. The name, address, telephone number and signature
                                                                            of the sponsor, or if the sponsor is an association or or-
          2. The program or course is at least one contact hour in          ganization, the signature of an officer or responsible party
       length; and                                                          of the association or organization.
          3. The program or course is conducted by a qualified             (g) The continuing educatioD sponsor sball submit the fee
       instructor or discussion leader who submits a curriculum         set forth at N.J.A.C. 13:39-1.3(a)lxii for each submission of
       vitae and who is:                                                program or course offerings.
            i.  A pharmacist with a B.S. in Phannacy or a                 (h) The continuing education sponsor sball maintain a list
          Pharm.D. with at least five years of experience;              of all attendees who completed each approved program or


                                                                    39-1;                                                 Supp.6-21-10
13:39-3A.6                                                                                            LAW AND PUBLIC SAFETY

CQUlse for a period of five years from the date the program or      (g) Before a permit may be issued to an applicant, the
course was offered.                                               Board shall inspect and approve the premises, fixtures and
                                                                  equipment of the new pharmacy or pharmacy department to
13:39-3A.7     Monitoring of continuing education                 ensure compliance with this subchapter and all relevant stat-
               programs or eourses                                utes, regulations and ordinances.

  A Board member or a Board representative may monitor an           (h) Upon approval of the permit application, the Board
approved program or course without prior notification to the      shall issue a permit number that will allow the applicant to
continuing education sponsor.                                     place prescription legend drugs in stock.
                                                                  Amended by R.1994 d.351, effective July 18, 1994.
                                                                  See: 26 N.I.R. 1596(0),26 NJ.R. 2905(b).
                                                                  Amended by R.1999 d.214, effective1uly 19,1999.
SUBCHAPTER 4. PHARMACY PERMIT                                     See: 31 N.l.R. 1151(0), 31 NJ.R. 1932(3).
    REQUIREMENTS                                                     In (d), substituted a reference to registered pharmacists-in-charge for a
                                                                  referente to pilarmacists-in-charge; inserted a new (g); and recodified
                                                                  fonner (g) as (h).
13:39-4.1    New pharmacies; pharmacy departments;                Recodified from N.IAC. 13:39-4.7 and amended by R.2oo5 d.25,
             eligibility and application                             effective January 18, 2005.
                                                                  See: 36 N.l.R. 3345(0), 37 !'/J.R. 295(0).
   (a) A pennit application shall be submitted to the Board by       Rev.rote the section. Fonner N.lA.C. 13:39-4.1, Issuance of permits,
every individual or business entity desiring to operate a new     recodified to NJ.A.C. 13:39-4.2.
                                                                  Amended by R.2009 d.247, effective August 3, 2009.
pharmacy. Such application shall be made on a furm fur-           See: 41 NJ.R. 371(0),41 NJ.R. 2969(b).
nished by the Board. If the area for which a pharmacy permit         Section was "New pharmacies; eligibility and application", In (a},
is sought is less than the total area of the premises, the area   substituted "individual or business entity" for "person or corporation~
subject to permit shall be known as the "pharmacy depart-         and inserted the last sentence; in (b), inserted "or pbannaey depar1ment",
                                                                  ", including any drive-thru area,"~ and "or oojacenl", and substituted
ment."                                                            "area" for ''premises'' and "proposed pennitted area, and any area where
                                                                  drug,s will be .!<>red andl.". dispensed" fur the I... occurrence of
   (b) The permit application shall indicate the exact intended   "pharmaey"; and in (g). inserted "or pharmacy department".
location and plan or physical arrangement of the proposed         Amended by R.2010 d.09O, effective lune 21, 2010.
                                                                  See: 42 NJ.R. 132(0),42 NJ.R. 1221(a).
pharmacy or pharmacy department area, including any drive-          In (e). substituted "include" for "bear" and <'name(sy' for "ruune"; and
tbm area, and shall indicate any area contiguous or adjacent      in (d), deleted "regiSlered" preceding "pltarmaei.t-in-eharge" and pre-
to but not necessarily a part of the proposed pennitted area,     ceding ~'pharm.acist~·.
and any arca where drugs will be stored andior dispensed.
                                                                  13:39-4.2       Issuance of permits; permit renewals
   (c) The permit application shall include the exact trade
name(s), if any; the corporate names, if any; the name and           (aJ All permits shall be issued by the Board in the name of
addresses of the owners and operators, if a sole propri-          the pharmacy for the operation of which the permit is iSSUed.
etorship, partnership, limited liability partuership or limited
                                                                    (b) A permit holder shall submit to the Board, on an an-
liability company; the names and addresses of all officers and
                                                                  nual basis, within 30 days after the permit expiration, a re-
stockholders and the names and addresses of all principals
                                                                  newal application and the renewal fee set forth in N.J.A.C.
duly licensed to write prescriptions if the pharmacy is not a
                                                                  13:39-1.3(a)2. A permit holder that fails to submit the re-
publicly traded corporation; and the names and addresses of
                                                                  newal application within 30 days after the pennit expiration
the officers, if a publicly traded corporation.
                                                                  shall submit the late renewal fee set forth in N.I.A.C. 13:39-
   (d) 'The pennit application shall include the name of tbe      1.3(a)2 in addition to the renewal fee. A permit holder that
pharmacist-in-charge who shall be a pharmacist in good            continues to engage in the practice of pharmacy with an
standing in the State of New Jersey.                              expired permit shall be deemed to be engaging in the unau-
                                                                  thorized practice of pharmacy and shall be subject to the
   (e) No person, business entity or equity holder of the         penalties set forth in N.J.S.A. 45:1-25 et seq.
business entity shall he eligible for a new permit or a renewal
thereof who is not of high moral character or against whom           (c) The Board shall send a notice of renewal to each
there is pending any indictment or any alleged violation of       permit holder, at least 60 days prior to the expiration of the
local, State or Federal law pertaining to the practice of phar-   permit. If the notice to renew is not sent 60 days prior to the
macy or tbe dispensing of controlled dangerous substances or      expiration date, no monetary penalty or fines shall apply to
any drug under N.J.S.A. 24:21-2.                                  the permit holder for any unauthorized practice during the
                                                                  period following the permit expiration, not to exceed the
   (I) A person submitting an application may be interviewed      number of days short of 60 before the renewal was issued.
by the Board to review his or her qualifications and eligi-
                                                                  Recodified from N.IA-C. 13:39-4.1 and amended by R.2005 d25,
bility.                                                             effective January 18,2005.
                                                                  See: 36 NJ.R. 3345(.), 37 N.1.R. 295(0).



Supp.6-21-10                                                  39-18
    STATE BOARD OF PHARMACY                                                                                                                      13:39-4.6

       Fonner NJAC. 13:39-4.2. Display of permits, rerodified to N.J.A.C.             permit number shall not be issued upon a reallocation of
    13:394.3.
    Amended by R.2007 d.351, effective November 19,2007.
                                                                                      business assets among existing owners; or
    See: 38 NJ.R. 4630(0), 39 NJ.R. 4935(0).
       Section was <4Issuance of permits". Inserted designation (0); and                3. When the existing ownership is changed through the
    added (b) and (e).                                                                addition of a new owner(s) Or Ibe subtraction of an existing
    Amended by R.2010 d.090, effective June 21, 2010.                                 owner, the owners Shall, prior to, or within 10 business
    See: 42 NJ.R. 132(8),42 NJ.R. 1221(.).                                            days of, the addition of the new owner(s), submit to the
       In (a), deleted "or other licensed eSlablishment" followil\!!
    4'pharnuu:y'" .                                                                   Board a new permit application pursuant to N.J.A.C.
                                                                                      13:39-4.1 and the new pennit application fee set forth in
    13:39-4.3      Display of permits                                                 N.l,A,C. 13:39-1.3. A new pharmacy permit number shall
                                                                                      he issued upon request.
       The current permitlssued by the Board for the operation of
    a phannacy shall be conspicuously displayed.                                     (b) Upon a change in ownership pursuant to (a) above, the
                                                                                  new ownership of such entity shall take custodial ownership
    Recodified from N.IAC. 13:394.2 and amended by R.200S d.25, ef·               of the previous five years of prescription and profile records
       recti,,,, January 18,2005.
                                                                                  of the previous pharmacy and shall ensure that the prescrip.
    See: 36 NJ.R. 334S(8), 37 NJ.R. 295(.).
       Fonner NJAC. 13:394.3, Death of owner or partner, reoedifled to            tion and profile records are maintained pursuant to N.J.A.C.
    NJ.A.C. 13:394.4.                                                             13:39·7.6 and 7.19 after the dale of acquisition.
    Amended by R.20to d.090, efrecti,,: June 21, 2010.
    See: 42 NJ.R. 132('),42 NJ.R. 1221(0).                                           (c) Upon the sale, transfer or acquisition of the business
       Substituted "'The current" for "'An and "'deleted "or other licensed
    establishment" following "'pharmacy",                                         assets of a pharmacy, the person or entity acquiring such
                                                                                  assets shall take custodial ownership of the pharmacy's pre-
                                                                                  vious five years of prescription and profile records and shall
    13:39-4.4      Death of oWller or partller
                                                                                  ensure that the prescription and profile records are maintained
       In the case of death of an individual owner or a partner, the              pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of
    permit issued to the deceased owner or to the partnership is                  acquisition.
    terminated and shall be returned to the Board pursuant to
                                                                                  Amended by R.1994 d.351, effective July 18, 1994.
    N.JAc' 13:39-4.8. If the operation or the phannacy is to be                   See: 26 NJ.R. 1596(.),26 NJ.R. 2905(b).
    continued, the estate Or heirs of the deceased partner andlor                 Amended by R.1999 d.214, efleetive July 19,1999.
    the remaining partners shall comply with the requirements set                 See: 31 NJ.R. 1151(3),31 NJ.R. 1932(.).
                                                                                      Rewrote the section.
)   forth at N.l.A.C. 13:394.5.
                                                                                  ReC<Jdilied from NJ.A.C. 13:394.4 and amended by R.2005 d.25,
    Amended by R.1999 d.214. effective July 19, 1999.                                effective January 18,2005.
    See: 31 NJ.R. 1151(.),31 NJ.R. 1932(.).                                       See: 36 NJ.R. 3345(.),37 NJ.R. 295(0).
       Substituted "is terminated and shall be returned to the Board pUl1Ola1l!      Rewrote the section. Former NJ.A.C. B:394.5, Change of corporate
    to NJAC. 13:394.8" for "becomes null and void" at the end of the lirst        officers or sIocldmlders of public companies, recodified to NJ.A.C.
    sentence.                                                                     13:39-4.6.
    Recodified from NJAC. 13:394.3 and amended by R.2005 d.2S,                    Amended by R.2009 d.247, effective August 3, 2009.
       effective January 18,2005.                                                 See: 41 N.I.R. 371(.), 41 NJ.R. 2969(b).
    See: 36 Nl.R. 3345(0), 37 NJ.R. 295(0).                                          Section was "Change of ownership», In (b), substituted "take cus~
       Rewrote the second sentence. Fonner N.J.A.C. 13:394.4, Change of           todiaL owtlC'tShip of the previous five years of' for "ensure that the~' and
    ownership, recodified to N.J.A.C. 13:39-4.5.                                  ~ "and shall ensure that the prescription and profile records"; and
                                                                                  added (c).
                                                                                  Amended by R.20Hld.09O, effeetive June 21, 2010.
    13:39-4.5      Challge of ownership; asset acquisitioll                       Sec: 42 NJ.R. 132(.),42 NJ.R. 1221(.).
                                                                                      Rewrote (a).
      (a) When there is a change in the ownership of the busi·
    ness entity holding a permit to operate a pharmacy, the fol-                  13:39·4.6      Change of corporate officers or sto<\<holders
    lowing requirements shall be satisfied, as applicable:                                       of a publicly traded corporation
         L When a complete change ht ownership occurs and                            If there is a cbange of registered agents or officers or a
      none of the current owners retains any ownership interest,                  change of stock ownership involving 10 percent or more of
      the new owner(s) shall, prior to, or within 10 business days                the outstanding stock of a publicly traded corporation, the
      of, such change, submit to the Board a new permit appli.                    corporation shall file an affidavit with the Board within 30
      cation pursuant to N.JA.C. \3:39-4.1, the new permit                        days indicating the changes that have taken place and any
      application ree set forth in N.l.A.C. 13:39-1.3, and an                     other information requested by the Board.
      inventory of the pharmacy's controlled substances. A new
                                                                                  Recodified from N.IAC. 13:394.5 and amended by R.200S d.25,
      pharmacy permit number shall be issued upon request;
                                                                                     effeetive January 18,2005.
          2. When a reallocation of ownership interests occurs                    See: 36 N.I.R. 3345(0), 37 NJ.R. 295(.).
                                                                                     Inserted "of 3 publicly traded corporation" preceding ", the corpo-
       among existing owners, the owners shall, prior to, or within               ration shall file". Fonner NJ.A.C. 13:394.6. Change of location;
       IO business days of, such change, submit to the Board an                   remodeling of premises, recodified 10 NJAC. 13:394.7.
       affidavit explaining the asset reallocation. A new pharmacy


                                                                              39-19                                                         Supp.6-21-10
13:39-4.7                                                                                             LAW AND PUBLIC SAFETY
        -~




13:39-4.7    Change of location andlor address of licensed           of the completion of the remodeling, the Board shall inspeet
             premises                                                and approve the premises, fixtures, equipment and inventory
                                                                     of the remndeled pharmacy to ensure compliance with this
   (a) When a pharmacy permit holder intends to cbange the
                                                                     subchapter and all relevant statutes, regulations and ordi-
physical location and address of tbe permitted premises, the
                                                                     nances.
permit holder shall apply to the Board, at least 30 days prior
to such change, for a new pharmacy pennit. If the change in          New Rule, R.20 10 d.09O, effective lune 21. 2010.
location and address will result in the temporary closing of         See: 42 N.1.R. 132(0),42 N.l.R. 1221(0).
the pharmacy, tile pennit holder shall comply with all re-             Former N.IAC. 13:39-4.8, Discontinued pharmacies, recodified 10
                                                                     NJ.A.C. 13:394.10.
quirements set forth at N.J.A.C. 13:39-4.IO(c) and (d). The
permit holder shall submit a new permit application pursuant
                                                                     13:39-4.9    Change of name
to N.J.A.C. 13:39-4.1 and the new pennit application fee set
forth in N.J.A.C. 13:39-1.3. The Board shall issue an                  (a) When a pharmacy permit holder intends to cbange the
amended pharmacy pennit reflecting the new location and              name of the pharmacy, the permit holder shall apply to the
address of the pharmacy. Before an amended pennit may be             Board, at least 30 days prior to such change, for an amended
issued to the permit holder for the new location, the Board          pennit. The permit bolder shall submit It new permit appli-
shall inspect and approve the premises, fixtures, equipment          cation pursuant to N.J.A.C. 13:39-4.1 and the new permit
and inventory of the new location to ensure compliance with          application fee set forth in N.J.A.C. 13:39-1.3. The Board
this subchapter and all relevant statutes, regulations and           shall issue an amended pharmacy permit reflecting the new
ordinances. The pennit holder shall ensure that the pre-             name oftile pharmacy.
scription and profile records from the pharmacy's previous
location and address are maintained pursuant to N.J.A.C.                (b) The Board shall issue an amended permit bearing the
13:39-7.6 and 7.19 after the location and address change.            new name upon return of the permit bearing the previous
                                                                     name to the Board for cancellation and payment of the permit
   (b) Whenever there is a change in a pharmacy's address            fee as prescribed in N.J.A.C. 13:39-1.3.
but no change in the physical location of the licensed prem-
ises, the permit holder shall, within 10 business days of the          (c) If a change in pharmacy name is associated with It
change in adrlress, submit an affidavit to the Board explaining      change in ownership, the permit holder shall ensure that the
such cbange.                                                         requirements set forth in N.J.A.C. 13:39-4,5 are satisfied.

Amended by R.lm d.214. effective July 19, 1m.                        Recodified fro01 NJAC. 13:39-4.11 and amended by R.2005 d.2S,
See: 31 NJ.R. 1151(3),31 NJ.R. 1932(3).                                 effective lanuary 18,2005.
  Rewrote (a); and in (0), added lite second and litird sentences.   See: 36 N.l.R. 3345(3), 37 NJ.R. 295(0).
Recodified from N.lAC. 13:394.6 and amended by R.2005 d.25,             Rewrote (b). Fonner NJ.A.C. 13:39-4.12, Reproduction of permits,
  effective January 18,2005.                                         recodified to N./.A.C. 13:39-4.13.
See: 36 NJ.R. 3345(3), 37 NJ.R. 295(0).                              Recodified from N.JAC. 13:39-4.12 and amended by R.2010 d.090,
  Fonner NJ.A.C. 13:39-4.7, New pb.mUldes; eligibility and appli-       effeotlve lune 21,2010.
C1ItIon, recodIfied to NJAC. 13:39-4.1.                              See: 42 N.l.R. 132(0),42 NJ.R. 1221(.).
Repeal and New Rule, R.2010 d.09O, effective June 21, 2010.             Rewrote (0); !lIld added (c). Fonner NJ.A,C, 13:394.9, Av.ilability
See: 42 NJ.R. 132(0),42 NJ.R. 1221(6).                               of records upon termination of business, recodified to N.lAC. 13:39-
  Section was «change oflocation; remodeling of premises".           4.11.


13:39-4.8    Remodeli1lg of licensed premises                        13:39-4.10     Discontinued pharmacies

   (a) Prior to the remodeling of a pharmacy or pharmacy                (a) Whenever a pharmacy is to be discontinued and closed
department, where such remndeling entails a change within            for any reason, including suspension or retirement of the
the premises oflbe location or size of the prescription area, or     permit holder, sale or insolvency, the pennit bolder shall im-
a change in the dimensions of the licensed promises, tbe per-        mediately send written notification of tile anticipated c1osi1lg
mit holder shall noti/)' Ibe Board at least 30 days in advance       to the State Board of Pharmacy, the OffICe of Drug Control
on a form prescribed by the Board. The pharmacy permit               and the Drug Enforcement Administration at least 15 days
holder shall submit plans for Ibe continuation of operations         prior to the anticipated closing date. Whenever a pharmacy is
during the remodeling process which the Board shall review           to be discontioued and closed as It result of an unanticipated
and approve, and the anticipated date of completion. The             occurrence, such as the death of the permit holder, the permit
permit holder shall ensure compliance with all requirements          bolder's representative shall send written notification to the
set forth in this chapter while services continue during the         Board, the Office of Drug Control and the Drug Enforcement
remOdeling process, and if Ibe remodeling will result in the         Administration, as soon as possible prior to the actual closing
temporary closing of the pharmacy, the permit holder shall           date. All medications, including prescription legend and con-
comply with all requirements set forth at N.J.A.C. 13:39-            trolled drugs, should be transferred to the holder of a current
4.12(c) and (d).                                                     pharmacy permit; a wholesaler; a reverse distributor; and/or a
                                                                     manufaclW'er. All medications not properly transferred shall
  (b) The pharmacy permit bolder shall noti/)' the Board             remain on the pharmacy premises with all licenses and reg-               i,
upon completion of the remodeling process. Wilbin 60 days            istrations in effect until such medications are disposed of in


Supp.6-21-10                                                     39-20
STATE BOARD OF PHARMACY                                                        __ _-
                                                                               .           ..              -_ -.-   ...             .
                                                                                                                                            13:39·4.13

the manner prescribed by tbe Board, the Office of Drug                      Amended by R.2009 d.305. effecnve October 5, 2009.
                                                                            See: 40 NJ.R. 5170(0), 41 N.J.R. 3840(0).
Control andlor tbe Drug Enforcement Administration.                            In the introductory paragrapb of (a). substituted "that they have !he"
                                                                            for "ofthejr", "obtain copies of" for "retrieve"} and "'patient proftJe tor a
   (h) Witbin 30 days of closing a pharmacy pursuant to (a)                 one-year" for "profile records for • six-month"; in (.)2 and (a)3, sub·
above, the permit holder or his or ber representative shall                 stituted "that they have" lor nof' and "obtain copies of' for "retrieve'1+
remove all drug signs from both the inside and outside of the               and inserted "and patient profile"~ and in (a)2, substituted ~one-.year''' for
                                                                            "six-month",
discontinued pharmacy and shall notifY the Board in writing                 Recodified from NJ.A.C. 13:39-4.9 and amended by R.2010 d.09O.
of tbe location of the previous five years of prescription and                 effective June 21, 2010.
patient profile records, consistent with the requirements of                See: 42 NJ.R, 132(0),42 N.J.R. 1221(a).
N.IAC. 13:39-7.6 and 7.19. The permit holder or his or her                         In the introductory paragraph of (a). substituted "pennit holder" for
                                                                            "licenseel'" and inserted '>and/or copies of their patient profile"; in (a)2
representative shall return the permit to the Board for can-                and (0)3, inserted "and/or patient profite,"; and in (a)2, subatituted
cellation within 30 days of the closing. Prescription records               "geographic area in which the pharmaey is located" for "major area .of
and other information may be requested by the Board as                      the Iicensce's fonner practice". Fonner NJ.A.C. 13:39-4.11, Replace-
outlined in NJ.A.C. 13:39-7.6 and 7.19.                                     mentpennit, recodified l<> NJ.A.C. 13:39-4.13.

Amended by R.1999 d.214, effective July 19, 1999.                           13:39·4,12          Business houf'S; unauthorized closing
See: 31 NJ.R. 1151(0),31 NJ.R. 1932(0).
   In (a), ebanged NJ.A.C. reference.                                         (a) All pharmacies shall be kept open for the transaction of
Amended by R.2oo5 d.25, effective January 18, 2005.                         business at least 40 hours per week and at least five days per
See: 36 NJ.R. 3345(a), 37 NJ.R. 295(.),
   Rewrote the section.                                                     week.
Amended by R.2009 d.247, effective August 3,2009.
See: 41 NJ.R. 371(a), 41 NJ.R. 2969(b).                                        (b) If any permanent cbanges are made in the opening or
   Added new (a); deleted limner (b); recodifted fonner (a) as new (b);     closing hours of a pharmacy, the Board office shall be no-
and rewrote (b).                                                            tified in writing of these changes within 30 days.
Recodified from N.J.A.C. 13:39-4.8 and amended by R.2010 d.09O,
   effective June 21, 2010.                                             '
See: 42 NJ.R. 132(0),42 NJ.R. 122I(a).                                        (c) A notice shall be conspicuously displayed on the
   In (a), deleted "licensed" preceding the fourth occum::nce of            exterior of any pharmacy indicating any temporary changes in
"pharmacy". Fonner N.J.A.C. 13:39-4.10, Business hours; unauthorized        the opening or closing hours of the pharmacy, or indicating a
closing, recodified to N.J.A.C. 13:39-4.12.                                 temporary closing of the pharmacy whenever such changes
                                                                            occur.
13:39-4.11      Availability of records upon termination of
                business                                                       (d) Any temporary closing ofa pharmacy for more than 48
                                                                            hours shall be reported to and approved by the Board.
   (a) When a pharmacy ceases operation as the result of a
                                                                            Notification to tbe Board shall include contingency plans for
suspension, retirement or death of the owner, sale or other
                                                                            accessing patient records. Any temporary closing of more
cause including insolvency, the permit holder, or the One
                                                                            than 48 hours without prior Board approval shaH result in the
responsible for supervising the disposition of the practice,
                                                                            pharmacy being deemed a discontinued pharmacy requiring
shall make every effort to notifY patrons that they have the
                                                                            compliance with the requirements ofN.J.A.C. 13:39-4. \0 and
right to obtain copies of currently valid prescriptions andlor
                                                                            4.11.
copies of their patient profile and the location of the pre-
scriptions and patient profile for a one-year period following              Amended by R. I 994 d.351, effective July 18, 1994,
notice, using all of the following methods:                                 See: 26 NJ.R. 1596(0), 26 NJ.R. 2905(b).
                                                                            Recodified from NJ.A.C. 13:39-4.9 and amended by R.2oo5 d.2S,
      I. Notification in writing to the Board;                                 ellective January 18,2005.
                                                                            See; 36 N.J,R. 3345(0). 37 NJ.R. 295(0).
    2. Publication, once weekly for two successive weeks                       In (0), inserted "permanent" following "If any"; added (c) and (d).
                                                                            Fonner N,J.A.C. 13:39-4.10, Duplicate permi~ recodified to NJAC.
  in a newspaper wbose circulation encompasses the geo-                     13:39-4.1 L
  graphic area in which the phannacy is located, of a notice                Recodified from NJ.A.C. 13:39-4.10 and amended by R.2010 d.090,
  advising patrons that they have the right to obtain copies of                etTeedv. June 21, 2010.
                                                                            See; 42 N.J.R. 132(0),42 NJ.R. 122I(a).
  their prescriptions andlor patient profile, and the location                 In (b), (e) and (d), deleted "or other Board-licensed establishment"
  of the prescriptions and patient profIle for a one-year                   following the first oecurrence of "pharmacy"; in (c), deleted "or establ-
  period following pUblication; and                                         ishment" following the second and third occurrence of ~arrnaci»; and
                                                                            in (d), substituted "4.10 and 4.11" for "4.&". Fonner N.J.A.C 13:39-
     3. A sign placed in the pbarmacy location informing                    4.12, Cbange of name, recodified l<> N.JAC. 13:39-4.9.
  thc patrons that they bave the right to obtain copies of their
  prescriptions andlor patient profile, and Ihc location of the             13:39-4.13          Replacement permit
  prescriptions and patient profile.                                           A replacement pennit may be issued by the Board upon
Recodified from N.).A.C. 13:39·5.7 and amended by R.2oo5 d.2S,              payment of a fce pursuant to N.l.A.C. 13:39-1.3 and submis·
  effective January 18,2005.                                                sion of an affidavit describing the loss or destruction of Ihe
See: 36 NJ.R. 3345(0),37 NJ.R. 295(0).
  Fonner NJAC. 13:39-4.9, Business botu1l, recodified l<> NJAC.             permit originally issued, or upon return of the damaged per-
13:39-4.10.                                                                 mit.


                                                                       39-21                                                            Supp.6-21-10
13:39-4.13                                                                                               LAW AND PUBLIC SAFETY
                                                                                                         --- -- ---  ..       ...

Recodified &om NJ.A.C. 13:394.10 .od amended by R.2oo5 d.25,                  any significant loss of prescription legend drugs and
   etree!ive January 18, 2005.
See: 36 NJ.R. 3345(0), 37 NJ.R, 295(0).                                       devices and controlled substances, to the phannacist-in-
   Substituted "replacement" for "duplicate". Former N.J.A.C. 13:39-          charge or the pharmacy pennit holder upon discovery.
4.1 [, Change of name, rccedified to NJ.A.C. 13:394.12.                       When detennining whether a loss of prescription legend
Recodified from N.lA.C. 13:394.11 by R,2010 d.090, efieetive June             drugs or devices or controlled substances is significant, the
   21,2010.
See: 42 NJ,R. 132{a), 42 NJ,R. 1221(0).                                       following factors shall be considered, consistent with 21
   f'ormer N.1.A.C. 13:394.13, Reproduction of permits, recodified to         CFR 1301.74(c):
N.1.A.C. 13:394.14.
                                                                                   i.   The actual quantity of prescription legend drugs,
13:39-4.14      Reproduction of permits                                         devices or controlled substances missing in relation to
                                                                                the type of business;
   (a) Any pennit issued by the Board for the operation of a
phannacy may be copied only for State agencies and other                          ii. The specific prescription legend drug, device or
business entities with wbom the pennit holder does pharmacy                     controlled substance missing;
related business.                                                                  iii. Whether the loss of the prescription legend drug,
                                                                                device or controlled substance can be associated with ac·
   (b) Any reproduction of a phannacy pennit by a pennit
                                                                                cess to those drugs, devices or controlled substances by
holder for any unlawful purpose shall subject. pennit holder
                                                                                specific individuals, or whether the loss can be attributed
to disciplinary action pursuant to N.J.S.A. 45: 1-21.
                                                                                to unique activities that may take place involving the
Recodified from NJ.A.C. 13:39-4,12 and amended by R,2OOS d25,                   drugs, devices or controlled substances;
   effective January 18, 2005.
See: 36 NJ.R 3345(a), 37 NJ.R 295(3).                                              iv. A pattern of losses over a specific time period,
   Rewrote the section. Fonner NJ.A.C. 13:39-4.13, Certification of             whether the losses appear to be random and the results of
records, repealed.                                                              efforts taken to resolve the losses;
Recodified from N.J.A.C. 13:39-4.13 and amended by R.2010 d.090,
   effective June 21, 2010.
See: 42 N.1.R 132(0),42 N.J.R 122[(8).
                                                                                  v. If known, whether the specific prescription leg-
   In (a), substituted "may be copied only" for "or other boord·licensed        end drugs, devices or controlled substanees are likely
establishment may only be pbotocopied". Former N.J.A.C. 13:39-4.14,             candidates for theft or diversion; and
Security of p _ i e s and pharmacy departments, recodified to
N.J.A.C.13:394.15.                                                                 vi. Local trends and other indicators of the theft or
                                                                                diversion potential of the missing prescription legend
13:39-4.15      Security of pharmacies and pharmacy                             drug, device or controlled substance.
                departments
                                                                             (b) The holder of a pharmacy or pharmacy department
  (a) The phannacist(s) on dnty in all phannacies, including               pennit and the phannacist·in-charge of the pharmacy or
phannaey departments, shall be responsible for:                            phannacy department shall ensure that:

     1. Keeping the phannacy or pharmacy department                              1. All entrances to the phannacy or pharmacy depart-
  dosed and the seeurity system turned on at all times when                   ment are capable of being locked and are connected to a
  he or she is not present within the pennitted premises in the               monitored security system that transmits an audible, visual
  case of a pharmacy, or, in the case of a phann.ey depart.                   or electronic signal warning of intrusion. The security
  ment, when he or she is not present within the department,                  system shall be equipped with a back-up mechanism to
  except as provided in N.J.A.C. 13:39-6.4;                                   ensure notification or continued operation if the security
                                                                              system is tampered with or is disabled. Only the
        i.   In the case of • phannaey or phannacy depart-
                                                                              pharmacist-in·charge shall be responsible for the security
     ment that has been issued an institutional pennit, pharo
                                                                              of the keys and the security system access code to the
     macy technicians may remain within the pennitted
                                                                              pharmacy or phannacy department;
     premises when the phannacy or phannacy department is
     closed and secured, if the pharmacist detennines, based                     2. If a theft or diversion of prescription legend drugs or
     on his or her professional judgment, that the security of                devices or controlled substances, or a significant loss of
     prescription legend drugs, devices and controlled sub-                   prescription legend drugs or devices or controlled sub-
     stances will be maintained in the phann.cist's .bsence;                  stances, as delineated in <a) above, is reported to the
                                                                              phannacist-in-charge, the phannacist·in-charge shall notifY
     2. Ensuring that the security of the prescription dis-                   the holder of the pharmacy or pharmacy department pennit
  pensing area and its contents are maintained at all times,                  of such report. The pharmacist·in-charge and the holder of
  including the restriction of persons unauthorized by the                    the phannacy or pharmacy department pennit shall ensure
  phannacist on duty from being present in the prescription                   that:
  dispensing area; and
                                                                                   i.   A written report is filed with the Board upon
    3. Reporting all thefts or diversions of prescription                       discovery of the theft or diversion or the significant loss
  legend drugs and devices and controlled substances, and                       of prescription legend drugs or devices; and


Supp.6-21-1O                                                          39-22
    STATE BOARD OF PHARMACY                                                                                                                   13:39-4.17

            ii. A written report is filed with the Federal Drug                    Section was "Pennitting ofphannacy department"',
                                                                                Recodifiod &om N.1.A.C. 13:394.14 II11d amended by R.2010 d.090,
         Enfon:ement Administration upon discovery of the theft                    effective June 21, 2010.
         or diversion or any significant loss of controlled sub-
)        stances, consistent with Federal requirements. A copy of
                                                                                See: 42 NJ.R. 132(.),42 N.J.R 122I(a).
                                                                                   In the introduclOry pll1"llgIl!pb of (a), deleted "registered" preceding
         such report shall be filed with the Office of Drug                     "pharmacist(s)"; in (al3.the introductory paragraph or (b), (b)I, (b)2, the
                                                                                introductory paragmph of (e) and (e)4, deleted "registered" preceding
         Control, consistent with State requirements and with tbe               "pharmacjst~in..charge" throughout; in (a)3. substituted "or" fur "and/or"
         Boord;                                                                 preceding "the phannacy pennit"; and in (b) I, deleted "of the pennitted
                                                                                premises or the pharmacy department" preceding "sIlall be respornible".
          3. There is a secure area for receiving packages known                Former N.1.A.C. 13:394.15, Permits; specialized pennits, recodified ID
       to contain prescription legend drugs and devices and con-                N.l.A.C.13:39-4.16.
      trolled substances. No prescription drug shall be accepted
      during the hours the phannacy or pharmacy department is                   13:39-4.16       Permits; specialized permits
      closed unless adequate security for the storage of such                     (a) The Board may issue a special permit, wherein the type
      shipments has been provided; and                                          of service is of a limited nature. The permit SO issued, being
         4. If a drop-off device is utilized for prescriptions, it is           based on special conditions of usc imposed by the Board,
       ofa one-way, irretrievable and secure design.                            may necessitate the waiver of certain rule requirements.
       (c) In addition to the requirements set furth in (b) above,                 (b) Specialized permits shall pertain to pharmacies pro-
    the holder of a pharmacy department permit and the                          viding specific services as may be necessary and proper to
    pharmacist-in-charge of tbe pharmacy department shall also                  efficiently meet a limited public need for pharmaceutical
    ensure that:                                                                services. An applicant for any specialized pharmacy permit
                                                                                shall provide the Board with an application and a policy and
         I. The pharmacy department is constructed so as to                     procedure manual which sets forth a detailed description of
      enable the closing off and securing oftbe department from                 the type of specialized pharmacy services to be provided
      the main store area. The department shall be separated                    withln the pharmacy pmctiee. The policy and procedure man-
      from the main store area by a secured barrier or partition                ual shall also contain detailed provisions which ensure the
      extending from the floor or fixed counter to the ceiling of               protection of the public welfare as detcnnined by the Board.
      either the department or main store and attached thereto;
                                                                                Recodified &om N.1.A.C. 13:394.16 by R2oo5 d.2.'i, effective January
         2. All medications requiring supervision of a phar-                      18,2005.
      macist. including dispensed medication, remain within the                 See: 36 N.1.R 3345(0), 37 N.1.R 29'(8).
      confines of the department when the pharmacist is not in                    Fonner N.1.A.C. 13:394.15, Retail pennit; prescription department or
                                                                                phannaey department, recodified to NJ.A.C. 13:39-4.14.
      the pharmacy department;                                                  Recodified from NJ.A.C. 13:394.15 by R.2010 d.09O, effective June
                                                                                  21,2010.
         3. The pharmacy department has a published telephone                   See: 42 N.1.R 132(a), 42 N.1.R. 1221(0).
      number different from that of the establishment in which                    Fonner NJ.A.C. 13:394.16, Steering prohibited, recodified to
      the department is located. No extensions of this phone shall              NJA.C. 13;394.17.
      be located outside the department; and
                                                                                13:39-4.17       Steering prohibited
        4. The telephone number of the pharmacist-in-charge is
      available in the office of the manager of the establishment.                 It shall be unlawful for a pharmacy permit holder to enter
                                                                                into an arrangement with a practitioner for the purpose of
       (d) The holder of a pharmacy or pharmacy department                      directing or diverting patients to or from a specified phar-
    permit shall comply with any law andlor ordinance of the                    macy for the filling of prescriptions or restraining in any way
    municipality in which the pharmacy or pharmacy department                   a patient's freedom of choice to select a pharmacy.
    is located requiring the placement of a security key box on
    the exterior of the pharmacy or the premises in which the                   Recodified &om N.1.A.C. 13:394.11 and amended by R2005 d.2',
                                                                                   effective January 18, 2005.
    phannacy department is located for purposes of pennitting                   See: 36 NJ.R. 3345(.), 37N.I.R 295(0).
    emergency access to the premises.                                              Rewrote the section. Fonner N.J.A.C. 13:39-4.16, Permits; speeial-
                                                                                ized pennits, recodified to NJ.A.C. 13;394.15.
    Amended by RI994 d.351, effective luly IS, 1994.                            Recodified from N.I.A.C. 13:39-4.16 and amended by R.201Q d.09O,
    See: 26 NJ.R 1596(0),26 NJ.R. 290S(b).                                         effective June 21, 2010.
    Amended by R1999 d.214, efli:<:tive July 19, 1999.                          See: 42 N.1.R 132(0), 42 N.1.R 1221(0).
    See: 31 NJ.R 1151(.),31 NJ.R 1932(0).                                          Substituted ~<practitionerl! for "health care practitioner who is licensed
       In (b), substituted references 10 registered pharmacists-in-charge for   to issue prescriptions" and inserted "for the filing of prescriptions".
    references to pharmacists-in-charge in 2 and 8.                             Former N.JA.C. 13:39-4.17, Responsibilities of pemrit holders,
    Recodified from NJ.A.C. 13:394.15 and amended by R200S d.25,                recodified to N.1.A.C. 13:394.18.
       effective January 18,2005.
    See: 36 N.1.R. 3345(.), 37 N.1.R 295(0).                                                                  Case-Notes
       Rewrote the section. Fonner NJ.A.C. 13:39-4.14, Contract pharm.-
    ceutical serviees. =odified to NJ.A.C. 13:39·9.4.                             Division of Medieal Assistance and Health Services did not present
    Repeal and New Rule. R2009 d.247, effective August 3, 2009.                 any cogent reason for denying an out-of-state pharma"Y" application for
    See: 41 NJ.R 371(0), 41 N.l.R 2969(b).                                      Medieaid provider authorization where the appIicant's 24..hour enter·


                                                                            39-23                                                          Supp.6-21-10
13:39-4.17                                                                                                   LAW AND PUBLIC SAFETY

geney response arrangement with a New Jersey-based pharmacy re-                      2. A central proeessing pharmacy. which is a pharmacy
solved any question about emergency services. as that arrangement did
not constitute prohibited steering as defined in the regulations,. and the
                                                                                  that engages in prescription review by perfurming func-
Division admitted that (}uiw()f~statemail order services had been author-         tions tbat may include, but arc not limited to, data entry,
ized. 'J'hu$, the Division's decision denying the out-of-state provider's         prospective drug review, refill authorizations, interven-
appJication was arbitrary~ capricious, and unreasonable as  wen   as other-       tions, patient counseling, claims submission, claims resolu-
v.ise not in accordance with law. Phoenix Phannacy, Inc, v. DMAHS,
QAL Dkt. No. lIMA 03266-07. 2007 NJ. AGEN LEXIS 4&9 Initiol                       tion and adjudication;
Decision (July 6. 2007).                                           •
                                                                                     3. A central fill pharmacy, which is a pharmacy en-
                                                                                  gaging in eentral prescription haudling by filling and/or
13:39-4.18      Responsibilities of permit holders                                refilling prescriptions, which includes the preparation and
  (a) All permit holders shall be responsible for complianee                      packaging of the medication; and
with all the rules. regulations and laws governing the practice                      4. A dispensing pharmacy, which is • pharmacy tbat
of pharmacy.                                                                      receives the processed prescription and/or tbe filled or re-
   (b) Any permit holder may be held liable for violations of                     filled prescription for dispensing to the patient or to tbe
the New Jersey Pharmacy Practice Act. NJ.S.A. 45: 14-40 et                        patient's autborized representative and that offers patient
seq., and the rules in this chapter and may be subject to                         counseling regarding tbe dispensed medication.
disciplinary action.                                                            (d) Two or more of the pharmacies delineated in (c) above
Recodir~      from N.l.A.C. 13:39-4.18 and amended by R,2005 d.25.
                                                                              may engage in central prescription handling provided:
   effective January 18, 2005.
See: 36 NJ.R. 3345(0), 37 N .l.R. 295(0).                                            I. Any or aU of the pharmacies participating in central
   Rewrote the section. Fonner NJ.A.C. 13:39-4.17, Steering prohibited,           prescription handling have a contractual agreement to pro-
recodified to NJ.A.C. 13:39-4.16.                                                 vide such services or have the same owner;
Recodified from N.l,A,C. 13;39-4.17 and amended by R,20l0 d.09O,
   effective lune 21. 2010.                                                          2. Prior to engaging in central prescription handling, all
See: 42 NJ.R. 132(a), 42 N.I.R, l221(a).
   In (b). inserted "New 1ersey" and "Practice" and substituted "40" for          pharmacies that are parties to tbe eentral prescription han-
"I". Fonner NJ.A.C. 13:39-4.18, Procedures for centralized preScription           dling obtain Board approval. I f a participating pharmacy is
handling, reoodilied to NJ.A.C. \3;39-4.19.                                       located outside the State of New Jersey, tbe pharmacy shall
                                                                                  have registered with tbe Board pursuant to N.J.A.C. 13:39-
13:39-4.19      Procedures for centralized prescription                           4.19. The pharmacies shall make a single application to the
                bandling                                                          Board, delineating the scope of practice of each pharmacy
                                                                                  and tbe speciftc rules in this chapter with which eacb
   (a) 'The four component functions of handling a prescrip-
tion are intake, processing, fulfillment and dispensing.                          pharmacy shall comply;
                                                                                     3. An audit trail is maintained tbat records and doc-
   (b) Central prescription handling entails two or more                          uments tbe unique and secure user identifier(s) of the
licensed pharmacies sharing responsibility fur performing the                     pharmacist(s), pharmacy technician(s). intern(s) or ex-
four component fimctions of handling a prescription. For pur-                     tern(s) and tbe component function(s) performed by each,
poses of tbis section, tbe term "prescription" shall include                      at the time tbe functions are performed, for each step of
medication orders when a healthcare facility is involved in                       prescription handling tbat is required to be performed by a
any of tbe component fimctions of central prescription han-                       pharmacist, pharmacy technician, intenl or extern pursuant
dling.                                                                            to tbe requirements of tbis chapter. All steps performed by
   (c) The following pharmacies may engage in central                             a pharmacy technician, intern or extern shall be docu-
prescription handling: an intake or originating pharmacy; a                       mented in the audit trall. All entries to the audit trail made
central processing pharmacy; a eentral fill pharmacy; and a                       by a pharmacy technician, intern or extern shall be re-
dispensing pharmacy. The four component functions of han-                         viewed and approved by the pharmacist. When more tban
dling a prescription shall be performed by the following                          one pharmacist is involved in tbe component functions of
pharmacies:                                                                       prescription handling, the unique and secure user iden-
                                                                                  tifier(s) of tbe pharmacist(s) responsible for the accuracy
     I. An intake or originating pharmacy, which is a phar-                       and appropriateness of each component function(s) shall be
  macy tbat reeeived the patient's or prescribing practi-                         recorded in the audit trail. The audit trail and prescription
  tioner's request to fill or refill a prescription. A central                    information shall be maintained or stored in original bard
  processing pharmacy or a central fill pharmacy, as delin-                       copy fonn or in any other media tbat facilitates tbe repro-
  eated in (c)2 and 3 below, may be considered the intake or                      duction of tbe original hard copy and shall be maintained
  originating pharmacy if the prescription was transmilred by                     for not less than five years from the date tbe prescription is
  tbe prescribing practitioner directly to tbe centralized                        filled or refilled. The oldest four years of infurmation shall
  pharmacy as provided in N.S.A.C. 13:39-7.10 and 7.11 or if                      be maintained in such a manner so as to be retrievable and
  tbe patient requested tbe refill from that pharmacy;                            readable within two weeks. The most recent one year of
                                                                                  information shall be retrievable and readable witbin one


Supp.6-21-1O                                                              39-24
STATE BOARD OF PHARMACY                                                                                                       13:39-4.20

 business day. Recorda not currently in use need not be               container, that indicates which pharmacy to contact if the
 stored in the pharmacy, but the off-site facilities used to          patient has any questions about the prescription or the
 store such records shall be secure. Patient records shall be         medication. The written information provided to the patient
 kept confidential, but shall be made available to persons            shall be in bold print, easily read, and shall include the
 authorized to inspect them under State and Federal statutes          bours a pharmacist is available and a telephone number
 and regulations;                                                     where a pharmacist may he reached. The telephone service
                                                                      shall be available at no cost to the pharmacy's primary
   4. The dispensed prescription for any product bears a
                                                                      patient population;
 permanently aft-.xed label witb at least the following infor-
 mation:                                                                 7. All pharmacies that are to engage in central prescrip-
                                                                      tion handling maintain a common policies and procedures
      i.   The brand name, or if a generic, the brand name
                                                                      manual whicb designates who sball be responsible for each
   and the name of the generic in the following form, with
                                                                      of the component functions of handling the prescription
   the generic name and brand name inserted as appro-
                                                                      and for ensuring compliance with the Board rules set fortb
   priate:
                                                                      in this chapter. Tbe policies and procedures manual shall
      ,~-------    Generic for ------~..";                            also include maintenance oftbe audit trail required by (d)3
                                                                      above. The policies and procedures manual shall be made
      ii.     Tbe strength of medication, where applicable;           available to the Board upon request;
      iii.    The quantity dispensed;                                    8. All pharmacies tbat are to engage in central prescrip-
      iv. The date upon which prescription medication is              tion handling share a common electronic file; and
   dispensed;                                                            9. All pharmaCies that are to engage in central prescrip-
      v. A CDS cautionary label, wbere applicable and                 tion handling are responsible for ensuring that the prescrip-
   when permitted by law;                                             tion has been properly filled.

      vi.     Tbe patient name;                                     <e) A prescription for a controlled substance may be filled
                                                                  or refilled by pbarmacies engaging in central prescription
      vii. Tbe practitioner name;                                 handling when permitted by law, consistent with Federal
                                                                  requirements set fortb at 21 erR 1300 et seq.
      viii. The prescription number;
                                                                  New Rule, R2004 d.380, effective October 4, 2004.
      ix.     Directions for use;                                 See: 36 NJ.R t l(a), 36 NJ.R, 448O(a).
      x. The phrase "use by" followed by the product's            Rwldified from N.J.A.C. 13:39-5.10 by Rl005 d.ZS, effective January
                                                                      18,2005.
   use by date, if dispensed in any packaging other than the      See: 36 NJ.R 3345(a), 37 NJ.R 295(a).
   manumclurer's original packaging. For purposes of this           former NJ.A.C 13:39-4.18, Resp<>osibilities of pharmacists and per-
   paragrdpb, "use by date" means the earlier of one year         mit hotders, recodified to NJ.A.C 13:39-4.17.
                                                                  Amended by R,2oo7 d.351. effective November 19. 2007.
   from the date of dispensing or the expiration date on the      See: 38 NJ.R. 4630(0), 39 NJ.R 4935(0).
   manufacturer~s container;                                         In (d)2, inserted Ill. second sentence.
                                                                  Amended by R2009 dJ05, effective October 5,2009.
      xi. All auxiliary labeling as recommended by tbc            See: 40 NJ.R. 5170(0), 41 NJ.R 3840(.).
   manufacturer and/or as deemed appropriate in the pro-             In (b), inserted the second sentenc<; in (e)l, substituted "13:39-7.10
   fessional judgment of the dispensing pharmacist; and           and 7.11" for "13:39-5.8A and 5.8B'·; in (0)4, inserted "and which o!rers
                                                                  palient coonseling regarding the dispensed medieauQn"; in the intro-
                                                                  ductory paragraph of (d), inserted "of the"; and rewrote (d)3.
      xii. The name, address and telephone number of any
                                                                  _lied from NJ.A.C. 13:39-4.18 and amended by R2010 d.09O,
   or all of the following:                                          effective June 21, 2010.
                                                                  See: 42 NJ.R 132(0), 42 NJ.R, 1221(0).
            (I)   Tbe intake pharmacy;                               In (e)l, (e)2, (e)3 and (e)4. deleted "licensed" preceding the second
                                                                  occurrence of "pharmacy"; in (<:)3, inserted a comma following "l!re-
            (2)   The central processing pharmacy;                scriptioos"; in (c)4, substituted the second occurrence of "'1hat" for
                                                                  "v.ilich"; in the introductory paragraph of (d), deleled "licensed" pre-
            (3)   The central fill pharmacy; andlor               ceding "pharmacies"; rewrote (d)4i; in (d}4vii, substituted "practitioner"
                                                                  for "preseriber"; and in (e), schstituled "CFR" for "C.F.R U". Formet
            (4)   Tbe dispensing pharmacy;                        N.J.A.C. 13:39-4.19, Out-of-State pharmllcy registration, recodified to
                                                                  NJAC.13:39-4.20.
    5. The patient name, the brand or generic name of the
 medication, and the directions for use appear in larger type,
                                                                  13:39-4.20      Out-of·State pharmacy registration
 in a different color type, or in bolded type, in comparison
 to the other infonnation required to appear on the label of         (a) Any pharmacy located in a state other than New Jersey
 the dispensed container pursuant to (d)4 above;                  (hercinafter "out-of-State pharmacy") that sltips, mails, dis-
                                                                  tributes or delivers in any manner, legend drugs or devices or
    6. Tbe patient is provided with written information,          controlled dangerous substances pursuant to a prescription
 eitber on the prescription label or with the prescription        into the State, or which participates in a central prescription


                                                              39-25                                                        Supp.6-21·\o
13:39-4.20                                                                                        LAW AND PUBLIC SAFETY
~~~----------------------------------------
handling arrangement pursuant to N.J.A.C. 13:39-4.18, shall        State pharmacy that mils to submit the renewal application
be registered with the Board pursuant to this section.             within 30 days after the registration expiration shall submit
                                                                   the late renewal fee set forth in NJ.A.C. 13:39-1.3(a)4 in
  (b) It shall be unlawful for any outoQf-State pharmacy not       addition to the renewal fee. An out-of-State pharmacy that
registered with the Board pursuant to tbis section to sbip,        continues to ship, mail, distribute or deliver legend drugs or
mail, distribute or deliver in any manner, legend drugs or         devices or controlled dangerous substances into the State, or
devices or controlled dangerous substances pursuant to a           continues to participate in a central prescription handling
prescription into the State of New Jersey, Sucb conduct shall      ammgement pursuant to NJ,A.C, 13:39-4.18, with an expired
be deemed a violation ofN.J.S.A. 45:14-73 and this section.        registration shall be deemed to be engaging in the un-
                                                                   authorized practice of pharmacy and shall be subject to the
   (0) An out-of-State pharmacy seeldng to register with the
                                                                   penalties set forth in N.J.S,A, 45: 1-25 et seq,
Board shall submit a completed application for registration to
the Board, which shall include the following:                        (I) An out-of-State pharmacy registered with the Board
                                                                   shall submit the information set forth in (c)1 though 5 above
     I. The name under which the pbarmacy is to be op-
                                                                   and the fee set forth in N,J,A.C. 13:39-I.3(a)4, if applicable,
  erated, the type of practice in whicb the pharmacy will be
                                                                   within 30 days of the following:
  engaging, the weekly hours of operation for the pharmacy,
  and a copy of the prescription label to be used by the phar-            I. Any change in ownership of the individual equity
   macy;                                                               holder(s) or business entity holding the license, permit or
     2. The location, names and titles of all principal corpo-         registration to operate tbe pharmacy;
  rate officers, if tbe applicant is a corporation, or the loca-          2, A change of registered agents or officers or a change
  tion, names and titles of any individuals in whom                    of stock ownership involving IO percent or more of the
  ownership is or will be vested, if the applicant is not a            outstanding stock of a publicly traded corporation holding
  corporation;                                                         the license, permit or registration to operate the pbarmacy;
     3, The name of the pharmacist-in-charge and his or her               3, A change in the location of the licensed, permitted or
  license number in the state in which the pharmacy is 10-             registered pharmacy;
  cated, and his or her weekly hours of employment;
                                                                         4, A change in the name of the licensed, permitted or
     4, A dated copy of the most recent inspection report              registered pharmacy; or
  resulting from an inspection of the outoQf-St.te pharmacy
  conducted by the regulatory or licensing agency in the state           5. A change in the pharmacist-in-charge.
  in which the pharmacy is located;
                                                                      (g) An out-of-State pharmacy may obtain a replacement
    5. A letter of good standing from the state licensing          registration upon payment of the fee specified in N.J.A.C.
  authority in the state in which the licensed, pennitted or       13:39-1.3(a)4 and upon submission of an affidavit describing
  registered out-of-State pharmacy is located; and                 the loss or destruction of the registration originally issued,. or
                                                                   upon return of the damaged permit.
    6. The application fee specified in N.J.A.C. 13:39-
  1.3(0)4.                                                           (h) An out-of-State pharmacy registered with the Board
                                                                   shall:
   (d) An out-of-State pharmacy registered with the Board
shall maintain, at all times, a valid unexpired license, penmit,          L Inform the Board, upon request, of the results of any
or registration to conduct the pharmacy in compliance with             inspections or investigations conducted by the regulatory
the laws and regulations of the state in which it is located,          or licensing agency of the state in which the pharmacy is
The pharmacy shall notify the Board inunediately upon the              licensed, permitted or registered or by a Federal agency,
permanent closing of the pharmacy or upon the commence-                including tbe filing of any action against the pharmacy by
ment of any action by the licensing authority in the state in          the agency;
which it is located concerning its license, permit or registra-
tion to conduct the pharmacy. Suspension or revocation of a               2. Inform the Board, upon request, of any directions to,
pharmacy's license, permit or registration in the state in             and requests for information from, the pharmacy issued by
whicb it is located shall result in the immediate commence-            the regulatory or licensing agency of the state in which the
ment of proceedings by the Board to suspend or revoke the              pharmacy is licensed, permitted or registered or by a Fed·
out-of-State pharmacy's registration in New Jersey,                    eral agency; and
                                                                          3. Comply with directions concerning compliance with
   (eJ An out-of-State pharmacy registered with the Board
                                                                       this section and any requests for information issued by the
shall submit on an annual basis, prior to the expiration of the
registration, a renewal application which shall contain the in-        Board.
furmation set forth in (c) I through 5 above, and the renewal        (i) An out-of-State pharmacy registered with the Board
fee set forth in N.J.A.C. 13:39-L3{a)4, A registered out-of-       shall maintain its record of prescriptiOns for patients in the


Supp.6-21-IO                                                   39-26
    STATE BOARD OF PHARMACY                                                                                                        13:39-4.21

    State of New Jersey for a period of not less than five years.                    3. In immunization programs sponsored by government
    The oldest four years of record information shall be main-                     ageneies that are not patient specific.
    tained in such a manner so as to be retrievable and readable
)   within two weeks. The most recent one year of record infor-                   (b) In order to administer vaccines and related emergency
    mation shall be retrievable and readable within one business               medications pursuant to this section, a licensed pharmaCist
    day.                                                                       shall be pre.approved by the Board to perform such functions.
                                                                               In order to obtain such prior Board approval, a pharmacist
       G) An out-of-State pharmacy registe~ with the Board                     shall submit documentation to the Board which establishes
    shall, during its regular hours of operation, but not less than            that he or she has satisfied tbe fullowing education and train·
    five days per week, and for a minimum of 4Q hours per week,                ing requirements:
    provide a toll-free telephone service to fu.cilitate communica-
    tion between patients in the State of New Jersey and a                            I. Completion of an academic and practical curriculum
                                                                                   that includes instruction in Centers for Disease Control and
    pbarmacist wbo has access to the patients' records. This toll-
    free number sball be disclosed on a label affixed to eacb con-                 Prevention (CDC) guidelines for vaccine administrations,
    tainer of drugs dispensed to patients in the State of New                      set forth in Appendix D of "Epidemiology and Prevention
    Jersey or the out-of-State phannacy shall meet the require-                    of Vaccine-Preventable Diseases (The Pink Book: Course
    ments set forth in N.J.A.C. 13:39-4. I 8(d)6.                                  Texlbook)," updated lOth edition, February 2007. The
                                                                                   CDC vaccine administration guidelines are incorporated
       (k) The Board may forward a complaint against any out-                      herein by reference, as amended and supplemented, and
    of-State phannacy registered with the Board for alleged                        can be found at the CDC website, www.cdc.gov,
    violations of any New Jersey or Federal law or regulation, or                  specifically, l!!!p;liwww.cdc.goyiyaccinesipubslpinkbookl
    any information concerning alleged violations of New Jersey                    downloadsiappendiceslawdx-full-<l.pdf. The instruction
    or Federal law by the phannacy, to the regulatory Or licensing                 shall be offered by a provider accredited by the Ac-
    agency in the state in which the pharmacy is located, or the                   creditation Council for Pharmacy Education (ACPE). The
    Board may institute disciplinary proceedings in New Jersey                     curriculum sball include tbe following subjects:
    pursuant to N.J.S.A. 45: 1-21 et seq., to resolve the complaint                     i. The Occupational Exposure to Bloodbome Path-
    or alleged violation.                                                            ogens standard of the Occupational Health and Sarety
    New Rule, R.2007 d.351, elfu:tive November 19,2007.                              Administration (OSHA), set forth at 29 C.F.R.
    See: 38 NJ.R. 4630(8), 39N.I.R. 4935(0).                                         §191O.1030, and the New Jersey Public Employees
    Recodified from N.1.A.C. 13:39-4.19 and amended by R.2010 d.090,                 Occupational Safety and Health (PEOSH) Act, set fortb
       effective June 21, 2010.
    See: 42 N.1.R. 132(0),42 N.l.R. 1221(0).                                         at N.J's.A. 34:6A-25 et seq., incorporated herein by
       In the inttoductory paragraph of (e), inserted a comma follOWing the          reference;
    second occurence of "Board"; in (c)5, inserted ""licensed, permitted or
    registered" and substituted "located'; for "Iice~ permitted or                      ii.   CDC Guideline for Infection Control in Health
    registered"; and in (1)5, deleted "registered" preceding "phannacist-in-         Care Pernonnel (1998). The CDC Guideline for Infection
    charge". Fonner N.I.A.C. 13:39-4.20, Proeedures for physician ordered            Control in Health Care Personnel (1998) are incorporated
    or g~errunent sponsored immunizations perfonned by phamwcists.
    reeod.fied to N.1.A.C. 13:39-4.21.                                               berein by rererence, as amended and supplemented, and
                                                                                     can be found at the CDC website, www.cdc.gov, spe-
    13:39-4.Zl      Procedures for physician ordered or                              cifically, h!tjl;lIwww.cdc.govlncidodldhaolpdflWidelincsi
                    government sponsored immunizations                               InfectControl98. pdf,
                    performed by phannacists                                            iii. Basic immunology;
       (a) The provisions of this section set forth the require-                       iv. Communicable or vaccine preventable disease
    ments for licensed phannacists authorized to administer vac-                     epidemiology;
    cines and related emergency medications, which shall be
    limited to dipbenhydramine and epinephrine, to eligible pa-                         v. Vaccine characteristics, contraindications, mon-
    tients who are 18 years of age and older, consistent with the                    itoring, proper storage and proper handling;
    requirements of N.J.S.A. 45: 14-63, under the following
                                                                                        vi.   Informed consent;
    circumstances:
                                                                                       vii. Pre- and post-vaccine assessment and counsel-
        I. Pursuant to a prescription by a New Jersey licensed                       ing;
      physician for a vaccine, related emergency medications,
      and pharmaCist administration of the vaccine that is patient                      viii. Immunization record management;
      specific;                                                                         ix. Immunization schedules established pursuant to
         2. In immunization programs implemented pursuant to                         "General Recommendations on Immunization" of the
      a New Jersey licensed physician's standing order for the                       CDC AdVisory Committee on Immunization Practices
      vaccine, related emergency medications, and administra-                        (ACIP) (December I, 2006), incorporated herein by
      tion instructions that are not patient specific; andlor                        reference, as amended and supplemented. The ACIP


                                                                           39-27                                                 Supp.6-2HO
13:39-4.21                                                                                       LAW AND PUBLIC SAFETY
                                                                                    -~--




     recommendations can be found at the CDC website,              (g) Before administration of a vaccine, the licensed phar-
     www.cdc.gov, specifically, hqp:llwww.cdc.gov!mmwrl           macist shall:
     preview/mmwrhlmVrr55ISal.htm;
                                                                        L Screen the patient using CDC established criteria for
       x.    Injection techniques;                                    each speeific vaccine to be administered;
       xi    Emergency responses to adverse events;                      2. Counsel the patient andlor the patient's represen-
                                                                      tative about contraindications, proper care of the injection
       "ii. Medical waste disposal; and
                                                                      site, and instructions to contact a physician or emergency
       "iii Reporting adverse events;                                 care fucility in tbe event of any adverse reaction;
     2. Current certification in the American Heart Associa-             3. Inform the patient andlor the patient's representative
  tion Basic Life Support (BLS) protoco~ the Red Cross Adult          in writing, in specific and readily understood terms, about
  Cardiac Pulmonary Resuscitation (CPR) protocol for health           the risks and benefits of the vaccine and provide the patient
  care providers or in a course that complies with guidelines         with a vaccine information sbeet published by the CDC;
  created by the International Uaison Committee on Resuscita-         and
  tion (ILCCR). The ILCOR guidelines, 2005 International
  Consensus on Cardiopulmonary Resuscitation (CPR) and                  4. Obtain a signed informed consent form, which com-
  Emergency Cardiovascular Care (ECC) Science with Treat-             plies with the requirements of (h) below, from the patient
  ment Recommendations, are incorporated herein by refer-             or the patient's representative wbich shall be maintained at
  ence, as amended and supplemented, and can be found at the          the pharmacy practice site. If the immunization program is
  American Heart Association website, http://americanheart.           to talce place somewhere other than the pharmacy practice
  org!presenter.jhtml7identifieF}Q225 12, specifically, http;11       site, the signed informed consent forms shall be maintained
                                                                      in the licensed pharmacist's possession at the immuni-
  circ.ahajournals.orglcontent!voIl12I2:Lsuppll; and
                                                                      zation location. The signed informed consent foons shall
    3. At least two hours of continuing education in im-              be maintained in either hard copy or electronic form as
  munizations, consistent with the requirements of N.J.A.C.           provided in (l) below.
  13:39-3A.l, in each biennial renewal period.
                                                                     (h) The informed consent form provided by a licensed
   (c) Documentation which establishes that a licensed phar-      pharmacist to a patient shall contain a check-off bo" which
macist has satisfied the education and training requirements      authorizes the pharmacist to send copies of the patient's vac-
of (b) above shall be maintained at the pharmacy practice site.   cine documentation to the patient's primary care provider,
If the immunization program is to take place somewhere            and another check-{)ff box which prohibits the pharmacist
other than the pharmacy practice site, the documemation shall     from sending copies of the patient's vaccine documentation to
be maintained in the licensed pharmacist's possession at the      the patient's primary care provider. The informed consent
immunization location. Such documentation shall be made           form shall speciry that a patient's failure to select one of the
available for inspection by tbe Board.                            two check-off boxes shall result in the patient's vaccine doc-
                                                                  umentation being sent to the patient's primary care provider,
  (d) Board approval granted pursuant to this section shall be    if identified.
renewed on a biennial basis. A pharmacist seeking such
renewal shall submit documentation which establishes that he         (i) The licensed pharmacist shall document all immuni-
or sbe has satisfied the requirements of (b)2 and 3 above.        zations he or she performs and such documentation shall be
                                                                  maintained at the pharmacy practice site. If the immunization
  (e) A physician's standing order shall speciry the pro-         program is to talce place somewhere other than the pharmacy
cedures that shall be followed for the reporting of adverse       practice site, the documentation shall be maintained in the
events. The licensed pharmacist shan maintain and adhere to       licensed pharmacist'S possession at the immunization loca-
a manual of policies and procedures for dealing with acute        tion, and then transferred to the pharmacy practice site. Such
adverse events. The policies and procedures manual shall          documentation shall be retained in either hard copy or elee-
require, at a minimum, that the pharmacist immediately notiry     tranic form, consistent with (l) below, and shall be made
emergency medical personnel and obtain assistance for the         available for inspection by the Board. Such documentation
patient when an adverse event requiring the administration of     shall include:
emergency medications occurs. The policies and procedures
manual shall be reviewed annually by the licensed pharmacist             I. The patient's name, address, telephone number, date
and such review shall be documented.                                  of birth, allergies and gender;

   (f) Pbysicians' standing orders shall he maintained in                2. The vaccine administered, the manufacturer, expira-
either hard copy or electronic form as provided in (l) below,         tion dale, lot number, site of administration, and dose ad·
and shall be available for inspection by the Board at the             ministered;
pharmacy practice site and, if applicable, at the immunization           3. The date of original order and the date of admIn-
location.                                                             istration(s);


Supp.6-21-1O                                                  39-28
      STATE BOARD OF PHARMACY                                                                                                          13:39-5.3

           4, The name and address of the delegating physician,        Recodified from NJAC, 13:39-4.20 by R,20tO d.09O, effective June
                                                                         21,2010,
        and the name and address of the licensed pharmacist ad-        See: 42 NJ,R, 132(.),42 N.l.R, 1221(0),
        ministering the dose, and the immunization location, if
        different from the pharmacy practice site; and
           5, The name and address of the patient's primary care
         provider, ifprovided,                                         SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS

        (j) The licensed pharmacist shall document in detail and       13:39-5,1      Purpose and scope
      immediately report aU clinically significant adverse events to
      the delegating physician, and to the primary care provider, if     The rules in this subchapter shall apply to all retail
      identified and if authorized on the infonned consent fonn        pharmacies, retail pharmacy departments and all institutional
      consistent with (b) above. The licensed pharmacist shall,        pharmacies filling prescriptions for outpatient use. For pur-
      within 72 hours, report such events to the appropriate gov-      poses of this subchapter, "pharmacy" means a retail pbar-
      ernment reporting system.                                        macy, retail pharmacy department or an institutional phar-
                                                                       macy filling prescriptions for outpatient lISe.
         (k) The licensed pbarmacist shall provide a copy of all
                                                                       New Rule, R.2005 d.25, effective January 18,2005,
      patient related documentation and a copy of the signed           S«, 36 N.l.R. 3345(8), 37 N.l.R. 295(0),
      informed consent fonn to each patient receiving an immu-           Former N.J.A.c' 13:39-5.1, Imprinted prescription blanks, repealed,
      nization, Or to the patient's representative, to the patient's   Amended by R.2010 d.09O, effective June 21, 2010.
      primary care provider, if provided and if authorized on the      See: 42 N.1,R, 132(0),42 NJ.R. 1221(a),
                                                                         Rewrote the section.
      infonned consent form consistent with (h) ahove, and if
      applicable, to the appropriate government reponing system.                                        Case Notes

         (l) All documentation and records required to be main-           Out..,f-stare applicant could not be deemed an institutional pharmaey
                                                                       because: (I) the applicant's Wisconsin license stated only that it was a
      tained by this section shall be maintained in either hard copy   "phartllllC)''' and did oot further describe the licensee as either retail or
      or electronic form for a period of not less than seven years     instituti011llI; (2) the Jus-nce D e p _ regislrlltion recognized peti-
      from the date of most recent entry and shall be supplied to      tiooer as a retail pbannacy; (3) an ~institutiooal pbannacy" under New
                                                                       Jersey regulations must be within a bealthcare facility or system licensed
      any physician or health care provider upon receipt of a signed   as such by the Board; and (4) the New Jersey regulations also 'tate dJat
      patient release of health information form, All records shall    the term "pharmacy" standing alone indicates a retail pharmacy. Becalm
"\,   be made available to persons authorized to inspect them          the applicant was not deemed an institutional phmmacy. its authorization
      under State and Federal smootes and regulations. The oldest      as • Medicaid provider W8l! not proscribed under N.l.A.c' 10:51-
                                                                       2.2(bJI. Phoenix Pharmacy, Inc, v. DMAHS, OAL Dkt. No, HMA
      six years of information shall be maintained in such a manner    03266-07,2007 N.J. AGEN LEXIS 439, Initial Decision (July 6, 2(07).
      so as to be retrievable and readable within two weeks. The
      most recent one year of information shall be retrievable and     13:39-5.2      Pharmacy access and egress
      readable within one business day. Records not currently in
      use need not be stored in tbe pharmacy, but the storage             Pharmacies shall mainlllin entrances which are easily and
      facilities shall be secure. Patient records shall be kept con-   safely accessible to !he general public. Access to and egress
      fidentiaL                                                        from the pharmacy shall not be such that the public must
                                                                       traverse or traffic through any area in which prescriptions are
         (m) In the case of immunization programs implemented          prepared.
      pursuant to a physician's standing order, a licensed pbarma-
      cis! shall be supervised by the delegating physician. Super-     Rcccdified from N.l.A.C. 13:39-7.1 and amended by R.2005 d.25,
                                                                         effective 1anuary 18,2005.
      vision by the delegating physician shall be deemed adequate      See: 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
      ifthe delegating physician:                                        Rewrote the section. Fonner NJAC, 13:39-5.2, Lack of directions
                                                                       on original prescriplion, reccdified to NJAC. 13:39-72.
           l. Is responsible for fonnulating or approving a stand-
        ing order, periodically reviewing the order and the services   13:39-5,3      Pbarmacy signs
        provided to patienls under the order;
                                                                         (a) Pharmacies shall post a sign on the exterior of the
          2. Is geographically located to be easily accessible to      building or a sign which is otherwise visible from a public
        the pharmacy practice site and, if applicable, to the im-      roadway, conspicuously identiJYing the existence of a phar-
        munization location.                                           macy on the premises, unless prohibited hy lease agreement
                                                                       or municipal ordinance. In such case, a copy of the lease or
          3. Is available through direct telecommunication for         ordinance shall be furnished to the Board.
        consultation, assistance, and direction; and
          4. Receives annual smoos reports on !he immunization            (b) Pharmacies shall post the hours that the pharmacy is
                                                                       open and the name of the pharmaclst-m-charge in plain view
        program as administered by the pharmacist.
                                                                       at all consumer entrances and COnsumer access points to the
      New 1!JJIe, IU009 dJ04, effective April 6, 2009,                 pharmacy, including drive-thru windows and drop-off boxes,
      See, 40N.1.R.I072(a),41 N.J,R.1493(a).

                                                                   39-29                                                          Supp, 6-21-10
13:39-5.3                                                                                                        LAW AND PUBLIC SAFETY

   (c) In the case of a pharmacy department, the hours that                      Inserted "or counters" following "counter", and substituted "total" for
                                                                             "continuous'" following "12;',
the department is open and the name of the pharmacist-in-                    Recodified from N.J.A.C. 13:39-7.4 and amended by R.2005 d.2S,
charge shall be posted in plain view at the entrance to the                     effective January 18. 2005.
department and at all consumer entrances and consumer                        See: 36 N.J.R. 3345(0), 37 N.J.R. 29S(o).
access points to the premises, including drive-thru windows                     Rewrote the section. Former N.J.A.C. 13:39-5.5, Copies of prescrip-
                                                                             tions; transfers, recodified II.> N.J.A.C. 13:39-7.7.
and drop-off boxes. When the premises in which the
pharmacy department is located maintains different hours of
operation from the pharmacy department, all advertising,                     13:39-5.6       Prescription area sink
announcements, signs and statements indiCating hours of                        An adequate sink with hot and cold running water shall be
operation and the presence of the pharmacy department shall                  provided in the prescription area, easily accessible to the
clearly and distinctly indicate the bours that the pharmacy                  prescription counter.
department is open.
                                                                             Amended by R.1999 d.214, effective July 19, 1999.
Recodified from NJ.A.C. 13:39-7.2 .od amended by R.2005 d.25,                See: 31 NJ.R. 1151(.),31 NJ.R. 1932(0).
   effective January IS, 2005.                                                  Substituted a reference to anterooms for 8 reference to rooms.
See: 36 NJ.R. 3345(8), 37 NJ.R. 295(8).                                      Recodified from N.J.A.C. 13:39-7.5 and amended by R.2005 d.25,
    Rewrote (a); added (b). Fonner NJ.A.C. 13:39-5.3, Authorization for         effective January IS. 2005.
renew.1 of prescriptions, recodified II.> NJ.A.C. 13:39-7.3.                 See: 36 N.J.R. 3345(8), 37 NJ.R. 295(0).
Amended by R.2009 d.247, effective August 3, 2009.                              Deleted "of retail and institutional pharmacies,'~ preceding "easily
See: 41 NJ.R. 371(.), 41 N.J.R. 2969(b).                                     accessibte~ in the first sentence, deleted the seoond sentence. Fonner
    In (b), inserted "hours thllt the pharmacy is opcn and the", and sub-    N.1.A.C. 13:39-5.6, Record of pharmacist filling prescription. recodified
stituted "in plain view at aU consumer entrances and consumer access         to N.J.A.C. 13:39-7.6.
paints to the phannacy~ including drive..thru windows and dropo()ff
boxes" for "'00 the entrance to the pharmacy in such a way as to be
visible to tbe public"; and added (c).
                                                                             13:39-5.7       Adequate storage
Amended by R.2010 d.090, effective June 21, 2010.                               There shall be sufficient shelf, drawer or cabinet space
See: 42 NJ.R. 132(0),42 N.J.R. 1221(0).
    In (b) aod (cJ, deleted "registered" preeeding "pbarmacist-in-cbarge".   within the prescription area for proper storage of prescription
                                                                             drugs and chemicals and the minimum equipment required
13:39-5.4     Spatial requirement of pharmacy prescription                   pursuant to N.J.A.C. 13:39-5.8. All prescription drugs and
              area                                                           chemicals shall be maintained under adequate storage condi-
                                                                             tions, including proper lighting, ventilation and temperature
   (a) For pharmacies in operation prior to July I, 1963, the                control, as recommended by the drug manufucturer.
space devoted to tbe prescription area and laboratory shall not
be less tban 10 percenl of the main floor area of Ihe phar-                  Recodified from NJ.A.C. 13:39-7.6 and amended by R.200S d.25.
                                                                                effective January 18, 200S.
macy, and in no instance sball it be less than 50 square feel. If            See: 36 N.1.R. 3345(0),37 NJ.R. 295(0).
the main floor area of such pharmacy exceeds 1,200 square                       Rewrote the section. Fonner NJ.A.C. 13:39-5.7 Availability of
feel, the 10 percent requirement does not apply and Ihe min-                 reoords upon termination of business, recodified to NJ.A.C. 13:39-4.9.
                                                                             Amended by R.2010 d.090, effective June 21, 2010.
imum requirement for the prescription area shall nol be less                 See: 42 NJ.R. 132(0),42 NJ.R. 1221(0).
than 120 square feet.                                                           Seetion was ·Storage IUld adequate stocle". Inserted the IllS! sentence.

   (b) For all other pharmacies including pharmacies subjecl
                                                                             13:39-5.8       Minimum equipment and supplies; cleanliness
to Ihe provisions of (a) above which are moving to a neW
location, the ptescription area must occupy exclusively a min-                 (a) All prescription areas shall contain the following mini-
imum of 150 square feel.                                                     mum equipment and supplies, which shall be stored, so as to
                                                                             be readily accessible:
Recodified from N.J.A.C. 13:39-7.3 and amended by R.2005 d.25,
   effeetive January 18,2005.
See: 36 N.J.R. 3345(0), 31 NJ.R. 295{a).
                                                                                    l. An up-to-date, comprehensive pharmaceutical refer-
   In (a), deleted "or drugstore" foll"",ng "floor area of the pharmacy";        ence text(s) and suitable current reference texts encom-
in (h), deleted "retail" preceding "pharmacies". Former N.J.A.C. 13:39-          passing the pharmaceutical services provided by the phar-
5.4. Approval of FDA necessary, recodifted 10 N.J.A.C. 13:39-7.5.                macy, drug interactions, drug product composition and
                                                                                 patient counseling. Unabridged electronic versions of such
13:39-5.5     Preseription counter                                               reference texts shall be acceplllble;
   Pharmacies shall contain a prescription counler or counlers                      2. Over the counter Scbedule V Record Book or an
On which to work, and the free working space shall not be                        electronic recording system, as permitted by Federal law
less tban 18 inches in width and not less than 12 lolal feel in                  pursuant to 21 CPR 1306.26 and 1304.04, to maintain all
length. This minimum working surface shall be kept clear at                      required information consistent with N.J.A.C. 8:65-
all times for the processing andlor compounding of pre-                          7. I9(a)5, if Schedule V controlled substances are sold
scriptions.                                                                      without a prescription;
Amended by R.1999 d.214, effective July 19, 1999.                                   3. Permanent prescription filing device and patient pro-
See: 31 NJ.R. 1151(8),31 NJ.R.1932(a).
                                                                                 file record system;


Supp.6-21-1O                                                             39-30
    STATE BOARD OF PHARMACY                                                                                                                13:39-5.10

         4, Storage place of substantial construction. which is                 Amended by R1999d.214, effeetlveJuly 19, 1999.
                                                                                See: 31 NJ.R 1151(0),31 NJ.R. 1932(a).
       capable of being securely locked when the pharmacist is                     In (a), rewrote I, 2 and 13,
       not present in the prescription dispensing atea, for Sched-              Recodified from NJ.A.C. 13:39-7.7 and amended by R.200S d.21,
)      ule II controlled substances, if not dispersed;                             effective January 18, 2OOS.
                                                                                See: 36 N.J.R. 3345(a), 37 NJ.R. 295(0).
          5, Suitable volumetric devices;                                          Rewrote the section. Former RJ.A.C. 13;39-S.8 Prescriptions and
                                                                                medication orders transmitted by technological devices in an institution,
         6, A steel spatula and a spatula of rubber or com-                     recodified to NJAC. 13:39·9.27,
       position;                                                                Amended by R.2009 d.247, effective August 3, 2009.
                                                                                See: 41 RJ.R. 371(a), 41 N.I.R. 2969(b).
         7, Refrigerator, as required by United States Pharma-                     In (0)4, substitured "Storage place of substantial construction, whidl
       copoeia Standards, to be used only for the storage of phat-              is capable ofbeing securely locked when the pharmacist is not present in
       maceuticals;                                                             the prescription dispensing area." for "Securely locked. substantially
                                                                                «mstructed storage place", and inserted a comma following "sub-
          8, Suitable counting trays or approved counting device;               stances'",
                                                                                Amended by R.2010 d.09O, eflectiveJune 21, 2010.
          9, Labels;                                                            s..: 42 N.I.R 132(0), 42NJ.R 1221(0).
                                                                                    Seetion was   ~Minimum    equipment and facilities", Rewrote the
          10. Auxiliary labels;                                                 introductory paragraph of (a), (a)l, (a)2 and (0)5; delele<l fanner (oj<i
                                                                                through (0)9; recodified (a)IO as (0)6; deleted former (a)lI; recodified
         II. Two Drug Utilization Review Council Placards and                   fonner (8)12 through (a)IS as (a)7 through (.)10; in (0)10, deleted ",
      the 29th edition of the list of "Approved Drug Products                   inc10ding poison labels" !rom the end; deletod (8)16; recodified (a)17
      with Therapeutic Equivalence Evaluations," commonly                       and (.)18 as (a)1I and (a)12; rewrote (a)1I and (a) I 2; and added (a)l3,
                                                                                (b), and (c).
      known as the "Orange Book," incorporated herein by refer·
      ence, as amended and supplemented, consistent with
      Department of Health and Senior Services rules set forth at               13:39-5.9     Prescription balances, scales, weights and
      N.J.A.C. 8:71-1. The Orange Book can be obtained by                                     automatic counting devices
      contacting the Superintendent of Documents, Government                      (a) All pharmacies shall have all halances, scales, weights
      Printing Office, PO Box 371954, PittsbW'gh, PA 15250-                     and automatic counting devices inspected every 12 months by
      7954, (202) 512-1800 or toll free (866) 512-1800, and is                  the Depatttnent of Weights and Measures of the municipality
      available on-line at http://www.f<ta.gov/cder/orangei                     or county in which the pharmacy is located, and such
      default.htm and at ht\p:llwww.fda.govIcder/ob/default.htm;                balances, scales, weights and automatic counting devices
          12. Assorted stock of prescription containers and child               shall be properly sealed by the applicable authority.
       safery closures or caps that meet United States Pharma·
                                                                                  (b) Counting trays Or counting devices that meet the
       copoeiaINational Fonnulary standards on light resistance                 requirements of (a) above shall be used to count oral, solid
       and tightness; and
                                                                                drugs or medications.
         13. Copies of, or access to, current State statutes and
                                                                                Thefollowmg annotations apply to N.J.A.C. 13:39-5.9 prior to its repeal
      rules relating to the practice of pharmacy.                                 by R10 10 d.09():
       (b) All prescription areas where non-sterile compounding                 Recodified from NJ.A.C. 13:39-7.8 by R.2005 d.25, effcotiv. January
    is performed shall contain the following minimum equipment                     18,200S.
                                                                                See: 36 N.J.R. 3345(0), 37 N.I.R. 295(0~
    and supplies, which shall be stored, so as to be readily                    Fonner NJ.A.C. 13:39-S.9, Labeling, recodified to NJ.A.C. 13:39-7.12.
    accessible:                                                                 The following annotations apply to N.J.A.C. 13;39-5.9 subsequent to irs
                                                                                   recodificationfrom N,J.A.C. 13:39·5.11 by R.20JOd09():
        I. Class A prescription balance with a complete set of
                                                                                Amended by R.1994 d.3ll, effeetive July 18, 1994.
      metric weights or equivalent electronic weighing device;                  See: 26 N.l.R. 1596(0),26 N.J.R. 290S(b).
         2. A glass morlat and pestle;                                          Recodified from N.J.A.C. 13:39-7,11 end amended by R.2005 d.25,
                                                                                   effe<:tive January 18,2005.
         3. GIa'lS funnels;                                                     See; 36 N.I.R 3345(0), 37 NJ.R. 295(8).
                                                                                Recodified !rom N.I.A.C. 13:39-S.11 and ameoded by R.2010 d.090,
         4. Stirring rods;                                                         effective June 21, 2010.
                                                                                See: 42 NJ.R. 132(a), 42 N.I.R. 1221(.),
         5. Ointment tile or patehment paper; and                                  Inserted designation (0); in (a), deleled "or other Board-licensed
                                                                                establishment" following "pharmacy"; and added (b). Former N.I.A.C
          6. Suppository mold.                                                  13;39-S.9, Cleanliness, orderliness and sanitation, repealed,
       (c) The prescription area and all related equipment and
    supplies shall be kept in a clean, orderly and sanitary con·                13:39-5.10        Restriction on storage of prescription legend
    <Iition at all times,                                                                         drugs and controlled dangerous substances

    Amended by RI994 d.3SI, effective July 18, 1994.                              (a) Prescription legend drugs, devices and controlled dan·
    See: 26 NJ.R 1596(0),26 NJ.R 290S(b).                                       gerous substances shall not be stored in the phannacy or phar-
    Amended by RI999 d.l96 eflectiveJune 21, 1999.                              macy department in such a manner as to be accessible 10 the
    See: 30 NJ.R 4113(0), 31 NJ.R 253(0), 31 NJ.R. 1618(0).
       In (3), added a reference to equivalent electronic weighing devices at   public.
    the end of 5, end rewrote IS.


                                                                            39-31                                                       Supp.6-21-10
13:39-5.10                                                                                                LAW AND PUBLIC SAFETY
----~------~--------~------------------------

   (b) Prescription legend drugs. devices and controlled dan-              pharmacy department, an institutional pharmacy or a nuclear
gerous substances shall be stored only in areas of the prem-               pharmacy.
ises that are part of the pharmacy or pharmacy department,
                                                                           New Rule, R.2005 d.2S, effective January 18,2005.
except that in a health care facility, prescription legend drugs,          See, 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
devices and controlled dangerous substances shall be stored                  Fonmer N.J.A.C. 13:39-6.1, Professioual judgment in dispensing
consistent with the requirements ofN.J.A.C. 13:39-9.23.                    drugs, recodified to N.l.A.C. 13:39-7.13.

   (c) Prescription legend drugs, devices and controlled dan-              13:39-6_2     Pharmacist-in-charge
gerous substances that are received during hours the phar-
macy or pharmacy department is closed shall be stored cOll-                   (a) Every pharmacy shaU name a pharmacist whose license
sistent with the requirements ofN.l.A.C. 13:39-4.15(b)3.                   is in good standing in New Jersey as tbe phannaeist-in-eharge
                                                                           of the pharmacy. No pharmacy shall operate without a
 The following annolalio", apply to N.J.A.C. 13:39-5.10 prior 10 its       pharmacist-in-charge for longer than 30 days.
   repeal by R.2010d.090:
Amended by R.1999 d.214, effective July 19, 1999.                             (b) Wbenever the pharmacist-in-charge is absent from the
See: 31 N.J.R.lISI(a), 31 N.l.R. 1932(0).                                  pharmacy for more than 30 days, the pharmacist-in-charge
   1nS<rted references to pharmacy training and patient counseling.
 Re<:odified from N.l.A..C. 13:39-7.9 by R.200S d.25, effective Januory    and the permit holder shall notify the Board of the name of
   18,2005.                                                                the pharmacist who shall act as the interim pharmacist-in-
See: 36 N.l.R. 3345(0), 37 N.J.R. 295(.).                                  charge.
   Former N.J.A.C. 13:39-5.10, Procedures fur Cenlnilized Prescription
Handling, recodified to N.J.A.C. 13:39-4.18.                                 (c) A pharmacist shall not assume the responsibilities ofa
ThefoJ/owing GnMtotions <T/'Ply 10 N.J.A.C. 13:39-5.10 subseqoent to its   pharrnacist-in-<:harge of more than one pharmacy or phar-
   recodificatwnfrom N.J.A.C 13:39-5.12 by R,2010d.09Q:
                                                                           macy department simultaneously, except as provided in (c)1
Recodified from NJ.A.C. 13:39-6.5 and amended by R.2005 d.2"
   effective January 18,2005.                                              below.
See: 36 N.J.R. 3345(.), 37 N.l.R. 295(0).
   Substituted "stored" for "displayed" following "sball not be" ond             I. If an area within a health care facility is permitted as
substituted '''pharmacy'' for "licensed establisrunent" ~jng "in such          both an institutional pharmacy and a retail pharmacy, the
a manner....                                                                   health care facility may employ one individual to act as the
Amended by R.2009 d.247, effective August 3. 2009.
See: 41 N.J.R. 371(0), 41 NJ.R. 2969(b).                                       pharmacist-in-<:harge for both the institutional pharmacy
   Inserted designation (0); in (a). inserted "or pluirmlley department"       and the retail pharmacy.
and substiture.l"as to" fur "!hat they can"; and added (b).
Re<:odifoed from N.l.A.C. 13:39-5.12 and amended by R.2010 d.09O,            (d) Whenever there is a change of a pharmacist-in-charge
   effective June 21. 2010.                                                of a pharmacy, an inventory of aD controlled dangerous
See: 42 NJ.R. \32(0),42 N.J.R. 1221(a).                                    substances as defmed in N.J.A.C. 8:65-10.1 through 10.5
   Rewrote (b); and added (cJ. Former N.J.A.C. 13:39-S.10, Television
in prescriptioo area prohibited, repealed.                                 shall be performed consistent with the requirements of
                                                                           N.l.A.C. 8:65-5.4 and 5.5.
13:39-5.11      (Reserved)                                                   (e) Whenever a pharmacist assumes or terminates the
Recodified to N.J.A.C. 13:39-5.9 by R.2010 d.090. effective June 21,       duties as a pharmaeist-in-charge of a pharmacy. the
  2010.                                                                    pharrnaeist-in-charge and the pennit holder shall so advise the
Soo: 42 NJ.R. 132(0),42 NJ.R. 1221(a).
  Section was "Prescription balances. scales, weights and automatic        Board in writing within 30 days by completing a fonn
counting devices·~.                                                        provided by the Board.

13:39-5_12      (Reserved)                                                   (I) A pharmacist-in-charge shall be a full-time employee,
                                                                           employed for a minimum of 35 hours par week and shaD be
Reoodified to N.l.A.C. 13:39-5.10 by R.2010 d.090, effective June 21,      physically present in the pharmacy or pharmacy department
  2010.
See: 42 N.J.R. 132(.),42 NJ.R. 1221(0).                                    for that amount of time necessary to supervise and ensure
  Section was "Restrietion on storage of prescription legend drugs and     that:
controllod dongerous substance".
                                                                                  I. The pbarmacy is staffed by sufficient, competent
                                                                               personnel in keeping with the size, scope and complexity
                                                                               of the pharmaceutical services provided by tbe pharmacy;
SUBCHAPTER 6. PHARMACIST-IN-CHARGE;
    PHARMACY PERSONNEL
                                                                                 2. Accurate records of all prescription medication re-
                                                                               ceived and dispensed are maintained;
13:39-6.1     Purpose and scope                                                  3. Policies are in place regarding accurate dispensing
                                                                               and labeling of prescriptions and that such policies are
  The rules in this subehapter shall apply to all pharmacies
                                                                               followed;
and pharmacy departments in the State. For purposes of this
subchapter, "pharmacy" means a retail pharmacy or a retail



Supp.6-21-10                                                           39-32
            STATE BOARD OF PHARMACY                                                                                                                    13:39-6.5

                 4. Security of the prescription area and its contents are               Repealed by R.I994 d.351, effective July \8, 1994.
                                                                                         See: 26 NJ,R. 1596(0),26 N.l.R. 2905(1)),
               maintained at all times consistent with the requirements set                 Section was "Sale of eootrolled dangerous substances and prescription
               forth in N,J.A,C. 13:39-4,14;                                             legend drugs by other than a registered pharmacist in a Board..licensed
        )         5. Only pharmacists and interns or externs under im-
                                                                                         establishtnent"'.
                                                                                         New Rule, R.l998 <1.166, effective April 6, 1998.
               mediate personal supervision provide professional con·                    See: 29 NJ.R, 5051(.), 30 N.J.R. \297(1)).
               sultation with patients and physicians;                                   Amended by R.2005 d,25, effective January 18, 2005.
                                                                                         See: 36 NJ,R. 3345(0), 37 NJ.R. 295(0).
                 6. Only phannacists, interns or externs accept telephone                   Rewrote the section.
                                                                                         Amended by R.2007 d.283,effi:ctive September 4, 2007,
               prescriptions and only phannacists, interns or extems, or                 See: 38 N.J.R. 3137(a), 39 NJ.R. 3774(b).
               phannacy technicians consistent with the requirements of                     Inserted the final senten<X!.
               N,I.A.C. 13:39-<i.6(b), aceeptrenewnl authori711tions;                    Amended by R.2010 d.09O, effective June 21, 2010.
                                                                                         See: 42 NJ.R. l32(a), 42 N.J,R. 1221(.).
                  7. No misbranded, deteriorated, adulterated, improperly                   Rewrote the _tion.
               stored or outdated drugs or any drugs marked "sample" or
               with any like designation or meaning are dispensed or                     13:39-<i.4    Mealor restroom breaks
               present in the active stock in the pharmacy;
                                                                                           (a) A sole phannacist on duty may take restroom breaks
                 8, The prescription area is maintained in an orderly and                and 30-minute meal breaks while working in a pharmacy
               sanitary manner; and                                                      consistent with the following requirements:

                  9. The pharmacy and all phannacy personnel provide                            L The pharmacist shall remain in the pbanoacy or, in
               pharmaceutical services in accordance with acceplable pro-                    the case of a pharmacy department, in the pharmacy de-
               fessional standards and comply with all Federal and Slate                     partment building, and shall be accessible for emergencies
               SIaNtes, rules and regulations governing the practice of                      or for counseling, if requested;
               pharmacy.
                                                                                               2. The phannacy shall remain open during the restroom
            Amended by R.1994 <1.351, effective July 18, 1994,                               or meal breaks, provided a pharmacy employee remains
            See: 26 NJ.R. 1596(0),26 N.I,R. 2905(1)).
            Amended by R.1m d.214, effective July 19, 1999.                                  present in the pharmacy, for patient related services, which
            See: 31 NJ,R. 1151(.),31 NJ.R. 1932(0),                                          include, but are not limited to, the following:
               In (c~ through (e), substitu!ed references to registered pharmacist-in.
            charge for refereru:.es to pharmaeist-in--charge.                                     i.    The receipt of new written prescriptions; and
        \   Amended by R,2004 <1.380, effective October 4,2004.
            See: 36 N.I.R. 11(0),36 N.J,R. 4480(0).                                              ii. The dispensing of prescription medications which
               In (e), deleted existing 8, recodified former 9 to 14 !IS 8to 13.               bave been checked by the pbanoacist; and
            Recodified from N.J.A.C. 13:39-3.18 and amended by R.2005 d.2'.
               effe<tive January 18,2005.                                            .         3, A sign shall be posted in the prescription dispensing
            See: 36 NJ.R. 334'(0), 37 NJ.R. 295(a).                                          area Slating "Phannacist on break, but available for emer-
               Rewrote the section. Former N.J.A.C. 13:39-6,2, Prescription p.....
            pared, compounded or dispensed by pharmacy externs or interns, ....              gencies and counseling."
            codified to NJ.A.C. 13:39.{;.5,                                              New Rule, R.2005 d,25, effective January 18, 2005.
            Amended by R.2009 d.247, effective August 3, 2009.                           See: 36 NJ.R. 3345(.),37 N.J.R. 295(0),
            See: 41 N.I.R. 371(0), 41 NJ.R. 2969(b).                                         Former NJ,A,C. 13:39"().4, Direct supervision of dispensing and
               Rewrote (l}4.                                                             compounding, repealed.
            Amended by R.2010 d,09O, effective June 21, 2010.                            Amended by R.2009 d.247, effective August 3, 2009.
            See: 42 N.J.R. 132(.),42 N.J.R. 1221(0).                                     See: 41 N.l.R. 371(.~ 41 N,J,R. 2969(1)).
               Section was '~gistered pharmacist-m..charge". Deleted "registered'~           Secti... was "Meal break,". In the introductory paragraph of (aj, sub-
            preceding "pbannacist-in-cbarge" throughout; in (.), substituted "whose      stituted <"restroom breaks and" for the first occurrence of "a" and stJb..
            license is" for "licensed and"; in (1)), !be introductory paragraph of (c)   stituted "meal breaks" fur <-<meal break"; in the introductory paragraph of
            and In (e). deleted "registered" preceding ;'phannacist"; in the intro-      (0)2, inserted "restroom or" and ,ubstitu!ed "breaks, provided 0 phar-
            ductory paragraph of (eJ, inserted ", except as provided in (e)1 below";     macy employee remains present in the pharmacy.... for "break"; and in
            added (e)l; in (d) and (e~ deleted "0< other Board·ficensed estab-           (a)), substituted "prescription dispensing area" for ""pharmacy" and de-
            IishmenC following "pharmacy"; rewrote (1)1; and in (1)9, inserted"pro-      leted "meal" preceding "break".
            vide pharmaceutical services in accoo:iance v.ith acceptable professional
            standards and·~.
                                                                                         13:39-6,5      Prescription handling by pharmacy externs,
            13:39-6.3      Identification tag                                                           interns or pbarmacy tecbnlcians

               All personnel working in the pharmacy, except personnel                      A phannacy intern, extern or technician in any pharmacy
            engaging in the compounding of sterile preparations con-                     may perform the component functions of prescription han-
            sistent with the requirements ofN.l.A.C. 13:39-11, shaH wear                 dling described in N.J.A.C. 13:39-4,18, consistent with the
            an identification tag, which sball include at least the person's             requirements of this chapter, On or after April 5, 2011, all
            TITSt name, fITSt initial of their last name and job title, The              steps perfonned by a phannacy technician, intern or extern
            identification tag of any employee in training shall reflect the             shall be documented in the pharmacy audit trail consistent
            staNs of the employee as a trainee,                                          with the requirements ofN.J.A.C. 13:39-7.6.
\   .

                                                                                     39·33                                                         Supp.6·21·10
13:39-6.5                                                                                              LAW AND PUBLIC SAFETY
                                                                            --------
_lied from NJAC. 13:39-6.2 and amended by R200S d.25. effee·                 pertaining to the practice of pharmacy, and that the ap-
   live January 18,2005.                                                     plicant is not currently under suspension or revocation.
See: 36 N.J.R. 334S(0), 37 NJ.R 295(0).
   Rewrote the section. Former N.lAC. 13:39-6.5 Restriction on
display of prescription legend drugs and, recodifted to N.lAC. 13:39-     (b) By March 2, 2008, a pharmacy         shall only employ a
5.12.                                                                   person registered with tbe Board as a      pbarmacy technician
Amended by R2009 d.293, effective October 5,2009.                       pursuant to (a) above, or a pharmacy       technician applicant,
See: 41 NJ.R. 1637(.),41 NJ.R. 3840(0).                                 consistent with (c) below, to perform      pharmacy technician
   Section was "Prescription prepared or compoonded by phartl13CJ'
extems, interns or pharmacy technicians". Rewrote the section,          functions.
Amended by R.20lQ d.09O, effective June 21, 2010.
See: 42 N.J.R. 132(8),42 NJ.R. 1221(s).                                    (c) By March 2, 2008, any person who is hired as a
   Rewrote the section.                                                 pharmacy technician who is not registered with tbe Board
                                                                        shall be designated a pharmacy technician applicant. A per-
13:39-6.6     Pbarmacy tecbnidan registration and                       son may only be considered a pharmacy technician applicant
              pbarmacy tecbnidan applicants                             one time and only for a maximum of 180 consecutive days.
                                                                        During the first 10 days of employment, the pbarmacy tech·
  (a) A person wishing to be registered witb tbe Board as a
                                                                        nician applicant sball file an application with tbe Board to
pharmacy technician sball:
                                                                        begin the pharmacy technician registration process. The
     I. Be 18 years of age or older;                                    applicant sball retain proof of filing the application until he or
                                                                        she receives his or her registration. If at the conclusion of tbe
     2. Possess a higb school diploma or its eqUivalent;                180 day period, the pharmacy technician applicant has not
                                                                        completed the pbarmacy technician registration process, con-
    3. Submit a certification attesting to !be fact !bat he or
                                                                        sistent witb (a) above, tbe applicant sball cease performing
  she is proficient in written and spoken English;
                                                                        pharmacy technician functions in the pharmacy.
    4. Apply to tbe Board for registration and submit the
  application fee set forth in N.J.A.C. 13:39-1.3;                        (d) All persons who are employed as pbarmacy technicians
                                                                        on September 4, 2007 shall be registered witb the Board by
     5. Submit his or her name, address and fingerprints for            Marcb 2, 2008. Such persons shall satislY tbe requirements
  purposes of a criminal history background check pursuant              set forth in (a) above, except that such persons shall be ex-
  to NJ.S.A. 45:1-28 et seq., (P.L. 2002, c. 104) to determine          empt from satislYing tbe requirement established in (a)2
  whether criminal history record information exists which              above. Sucb persons sball present proof of employment to tbe
  may disqualilY tbe applicant from being registered by tbe             Board which establishes tbat they bave been practicing as
  Board; and                                                            pharmacy technicians prior to Septemher 4, 2007.
    6. Submit, as part of tbe application for registration,                (e) If an applicant for registration as a pharmacy tech-
  evidence of good moral character which is an ongoing re-              nician is being investigated for any alleged violation of the
  quirement for registration, and evidence that he or she:              New Jersey Pharmacy Practice Act, N.J.S.A. 45: 14-40 et seq.,
        i.   Is not presently engaged in drug or alcohol use            or tbe pharmacy laws, rules or regulations of any other juris-
     that is likely to impair the ability to practice as a phar-        diction, the Board in its discretion may deny the applicant the
     macy technician with reasonable skill and safety. For              opportunity to register as a pharmacy technician.
     purposes of this section, the term "presently" means at
                                                                          (f) A pharmacy sball not employ as a pharmacy technician
     the time of application or any time witbin tbe previous
                                                                        applicant any person wbo was previously employed as a phar-
     365 days;
                                                                        macy technician applicant at a pharmacy in tbe State and who
        ii. Has not been convicted of violating any law of              fuiled to complete tbe pharmacy technician registration proc-
     tbis State or any otber state of tbe United States relating        ess or any person who bas been tbe subject of disciplinary
     to controlled dangerous substances or other habit-form-            action by the Board.
     ing drugs;
                                                                        New Rule, R.2007 d.23S, effective September 4,2007.
        iii. Has not been convicted of violating any law re-            See; 38 N.l.R 3137(0), 39 NJ.R. 3774(b).
                                                                          Fonner NJ.A.C. 13:39-6.6. Ph8f11lacy !e<:hnicians, recodified to
     lating to the practice of pharmacy;                                N.lAC.13:39-6.15.
                                                                        Public Notice: Board of Pharmacy: Extension of Deadline for Regis-
       iv. Has not been convicted of a crime involving                    tration as 8 Pharmacy Technician.
     moral turpitude; and                                               Sec: 40 NJ.R 900(0), 7005(0).
                                                                        Amended by R.2010 d.09O, effective June 21, 2010.
        v. Has not had his or her autbority to engage in !be            Sec: 42 NJ.R. 132(0), 42 N.l.R. 1221(8).
     activity regulated by tbe Board suspended or revoked as              In (e), updated the N.l.SA reference.
     a result of any administrative or disciplinary proceedings
     in this or any other jurisdiction which determined tbe ap-
     plicant to be in violation of any laws, rules or regulations




Supp.6-21-10                                                        39-34
    STATE BOARD OF PHARMACY                                                                                                       13:39-6,13

    I3:39-<i.7    Authorization to practice as a pharmacy               13:39-6.10     Technician change of address of record:
                  technician; display of registration                                  service of process

)      (a) Ao applicant for registration as • pharmacy technician
    wbo has successfully satisfied all Board requirements for reg-
                                                                          (a) A registered pharmacy technician shall notilY the
                                                                        Board in writing of any change in bis or her address of record
    istration and has heen approved by the Board to he registered       within 30 days of sucb change.
    shall, upon payment of the initial registration fee set forth in
    N.J,A,C, 13:39-1.3. receive an authorization signed by the             (b) Failure to nOlilY the Board of any change in a regis-
    Executive Director of the Board granting the applicant the          tered pharmacy technician's address of record pursuant to (a)
    right to practice as a pharmacy tecbnician in the State of New      above may result in disciplinary action in accordance with
    Jersey until sucb time as an initial registration may he issued.    NJ.S.A. 45:1-21(h) and N.J.A,C. 13:45C-L3, and the im-
    The registrant shan maintain sucb authorization on his or her       position of penalties set forth in N.J.S.A. 45:1-25,
    person .t all times while engaging in the practice of phannacy
                                                                           (c) Service of any administrative complaint or other
    as a pharmacy technician until the initial registration is is-      Board-initiated process at a registered pbarmacy technician's
    sued.
                                                                        address of record shall he deemed adequate notice for the
       (b) Upon issuance, the current biennial renewal regis-           purposes ofN.JAC, 1:1-7.1 and the commencement of any
    tration shall be conspicuously displayed in the registered          disciplinary proceedings,
    pharmacy technician's principal place of employment,                New Rule, R.2007 <1.283, effective September 4, 2007,
                                                                        See: 38 NJ,R. 3137(a), 39 NJ.R. 3774(b).
      (c) A registered pharmacy technician who is employed by
    more than one pharmacy in the State sball maintain the              13:39-6.11     Verification of technician registration
    wallet-sized registration issued by the Board on his or her
    person when be or she is working at a location where his or            A verification that tbe registration of a pharmacy tech-
    her current biennial renewal registration is not on display,        nician is in good standing sbalJ be supplied by the Board
                                                                        upon written request and upon payment of the tee set !brth in
    New Rule, R.2007 d.283, effective September 4, 2007,                N.J.A.c' 13:39-1.3,
    See: 38 NJ.R. 3137(.), 39 NJ,R. 3774(b).
    Amended by R.20JO <1.090, efTeetive June 21, 2010,                  New Rule, R.2007 <1.283, effeetive September 4, 2007.
    See, 42 NJ,R, I 32(a), 42 N,J,R. 1221(3).                           See: 38 NJ.R. 3137(a), 39NJ,R. 3774(b).
      In (e). deleted "licensed" prece<ling the second occurrence of
    "pharmacy".
                                                                        13:39-6.12     Reproduction ortcchnieian registration
    13:39-6.8     Replacement of technician registration                               prohibited

       A replacement initial registration or renewal registration          The initial registration, biennial registration or wallet-sized
    shall be issued by the Board upon payment of a ree as               registration issued by the Board to any pharmacy technician
    prescribed in N.J.A.c' 13:39-1.3 and upon submission of             shall not he reprinted, photographed, photostated, duplicated
    proof of the applicant's identity and reasonable proof of the       or reproduced by any other means either in whole or in part,
    loss or destruction of the initial registration or renewal regis-   except as provided in NJAC. 13:39-<i.8,
    tration, or upon return of the damaged initial registration or      New Rule, R.2007 d,283, effective September 4, 2007,
    renewal registration to the Board.                                  See: 38 NJ.R. 3137(3), 39 NJ.R. 3774(b),
    New Rule, R.2007 d,283, effective September 4, 2007,
    Sec: 38 NJ.R, 3137(a). 39 NJ.R. 3714(b).                            13:39-6.13      Biennialtecbnician registration renewal;
                                                                                        administrative suspension
    13:39-6.9    Techoician cbange of name                                 (a) A pharmacy technician shall renew his or her regis-
       If a registered pharmacy technician legally changes the          tration for a period of two years from the last expiration date.
    name under wbich be or she has been practicing as a phar-           The pharmacy technician shall submit a renewal application
    macy technician, the pharmacy technician shall notilY tbe           to the Board, along with the renewal fee set forth in N.J.A.c'
    Board within 30 days of sucb change, The registered phar-           13:39-1.3, prior to the date of registration expiration. A phar-
    macy technician sball submit original proof of the cbange of        macy technician who submits a renewal application within 30
    name or a certified copy of the court order or marriage certif-     days following the date of registration expiration sball submit
    icate whIcb sball be retained by the Board. When a replace-         the renewal fee, as well as the late fee set forth in NJ.A.c'
    ment registration is issued, the initial registration shall he      13:39-1.3, A pharmacy technician who fails to submit a re-
    returned for cancellation and the pharmacy technician shall         newal application within 30 days of registration expiration
    remit the requi.red fee as preSCribed in N.J.A.C, 13:39-1.3.        shall have his or her registration suspended without a hearing.
                                                                        Such suspension shall be deemed an administrative suspen-
    New Rule, R.2007 d.283, effective September 4,2007,                 sion.
    See: 38 NJ.R. 3137(.), 39 NJ,R. 3774(b).




                                                                    39-35                                                       Supp, 6-21-10
13:39-6.13                                                                                         LAW AND PUBLIC SAFI':TY

   (b) A pbmnacy technician wbo continues to perfonn the           13:39-6.15     Pbarmacy tecbnician duties and pbarmacist-
functions of a pbmnacy technician witb a suspended regis-                         tecbnician ratios
tration sball be deemed to be engaging in unautborized
                                                                     (a) In addition to externs and interns, only pharmacy tech-
practice as a pbannacy technician and sball be subject to the
                                                                   nicians and pbarmacy technician applicants may assist the
penalties set forth in N,j,S.A. 45:1-25 et seq,
                                                                   pharmacist in performing tbe following task:s:
   (c) The Board sball send a notice of renewal to each phar-
                                                                           1. Retrieval of prescription files, patient files and pro-
macy technician, at least 60 days prior to the expiration of his
                                                                       files and otber such records pertaining to the practice of
or ber registration, If the notice to renew is not sent 60 days
                                                                       pbmnacy;
prior to the expiration date, no monetary penalty or fines shall
apply to the pharmacy technician for any unautborized prac-              2, Data eorry;
tice during tbe period following the registration expiration,
not to exceed the number of days short of 60 before the                  3. Label preparation;
renewal was issued.                                                      4. The counting, weighing, measuring, pouring and
New Rule, R.2007 d,283, effective September 4, 2007.                   compounding of prescription medication or stock legend
See: 38 NJ.R 3137(0), 39 NJ.R. 3774(b),                                drugs and controlled substances, including the filling of an
                                                                       automated medication system; and
13:39-6.14     Reinstatement from administrative and                      5. Accepting authorization from a patient for a pre-
               disciplinary suspensions of a pharmacy                  scription refill, or wm a practitioner or his or her agent for
               technician'. registration                               a prescription renewal, provided that the prescription re-
   (a) A pbarmacy technician who bas had his or her reg-               mains unchanged, consistent with (a)5; below:
istration administratively suspended pursuant to N.1,A,C,                    i   The pbmnacy technician or pharmacy tecbnician
13:39-6.13 may apply to tbe Board for reinstatement fol-                 applicant sball identif'y bimself or berself as a pbarmacy
lowing the date of registration expiration. A pbannacy tech-             tecbnician when accepting authorization from a prac-
nician applying for reinstatement shall submit:                          titioner or bis or ber agent. For purposes of this section,
     1. A reinstatement application, including an affidavit of           "prescription refill" means the dispensing of medications
  employment listing eacb job beld during the period of                  pursuant to a practitioner's authorization provided on tbe
  registration suspension, including the names, addresses,               original prescription. For purposes of this section, "pre-
  and telepbone numbers of eacb employer;                                scription renewal" means the dispensing of medications
                                                                         pursuant to a practitioner's authorization to fill an ex-
     2. All past due renewal fees set forth in N.S,A.C.                  isting prescription that has no refills remaining.
   13:39-1.3;
                                                                      (b) Pbarmacy technicians and pbmnacy technician ap-
    3. A reinstatement fee set forth in NJ,A.C, 13:39-1.3;         plicants sball not:
  and
                                                                          I. Receive new verbal prescriptions;
     4. Any outstanding penalties imposed by the Board,
                                                                         2, Interpret a prescription or medication order for thera-
   (b) A plwmacy technician who has had bis or ber regis-              peutic acceptability and appropriateness;
tration suspended pursuant to disciplinary action taken by the
Board may apply to the Board for reinstatement of his or her             3. VerilY dosage and directions;
registration at the conclusion of the suspension period, A               4. Engage in prospective drug review;
pharmacy technician applying for reinstatement wm a disci-
plinary suspension shall submit:                                         5, Provide patient counseling;
     1. A renewal application, including an affidavit of em-             6, Monitor prescription usage;
  ployment listing each job beld during the period of regis-             7, Override computer alerts witbout first notif'ying the
  tration suspension, inCluding the names, addresses, and              pbarmacist;
  telephone numbers of each employer;
                                                                         8. Transfer prescriptions from one pbarmacy to another
     2. A reinstatement fee set forth in NJ.A.C. 13:39-1.3;            pharmacy; or
     3, The applicable renewal fee(s) set fortb in N.J.A,C.
                                                                         9,   Violate patient confidentiality.
   13:39-1.3; and
    4. Evidence of having met all conditions imposed by               (c) A pbarmacy shall require all plwmacy technicians and
  the Board pursuant to tbe disciplinary andlor reinstatement      pbmnacy technician applicants employed by tbe pharmacy to
  order(s).                                                        sign a patient confidentiality statement. Such statements shall
                                                                   be maintained on-site by the pharmacy,
New Rule, R.2007 d.283, effective September 4, 2007.                                                                                    ,
                                                                                                                                        i
                                                                                                                                            ,

See: 38 NJ,R, 3137(_), 39 NJ,R, 3774(b).


Supp, 6-21-10                                                  39-36
         STATE BOARD OF PHARMACY                                                                                               13:39-6.15

             (d) Except as provided in (e) below. a phannacist shall not       more than two persons receiving in-service training at tbe
         supervise more than two pharmacy technicians at any given             same time;
         time. The pharmacist shall provide immediate personal super-
     )   vision, as defined in NJ.A.C. 13:39-1.2, of all pharmacy
                                                                                  6. Provide immediate personal supervision as defined
                                                                               in N.J.A.C. 13:39-1.2; and
         technicians he or she supervises. Those personnel who do
         computer processing of prescriptions are to be included in the           7. Provide the Board, upon request, with a copy of the
          I to 2 ratio. A registered phannacy technician or a pharmacy         established job descriptions, task protocols, and policies
         technician applicant who is receiving in-service training,            and procedures for all phannacy technician duties.
         which shall not exceed 2 \0 days, shall be excluded from the I       (f) If the phannacist to pharmacy technician ratio exceeds
         to 2 ratio during such training. A pharmacist shall not super-    I :2, the pharmacy shall maintain a policy and procedure
         vise more than two persons receiving in-service training at       manual with regard to phannacy technicians, which shall
         the same time.                                                    include the following:
            (e) A pharmacy that employs a pharmacist to pharmacy                  I. Supervision by a phannacist;
         technician ratio greater than 1:2 shall:
                                                                                 2. Confidentiality safeguards of patient information;
              I. Establish written job descriptions. task protocols,
           and policies and procedures that pertain to the duties per-           3. Minimum qualifications;
           fonned by the pl1annacy technicians;                                   4. Documentation of in-service education and/or on-
             2. Ensure and document that all phannacy technicians              going training and demonstration of competency, specific
           who are working when the ratio exceeds 1:2 have:                    to practice site and job function;

                 i. Passed the Phannacy Technician Certification                  5. General duties and responsibilities of phannacy
                                                                               technicians;
              Board's Pharmacy Technician Certification Examination
              and have fulfilled the requirements to maintain this               6. Retrieval of prescription flies, patient flies, patient
              status;                                                          profile information and other records pertaining to the
                 ii. Passed a Board-approved certification program             practice of pharmacy;
              and have fulfilled the requirements to maintain this               7. All functions related to prescription ptocessing:
              status; or
                                                                                 8. All functions related to prescription legend drug and
                iii. Completed a program that includes a testing               controlled substance ordering and inventory control;
             component, which has been approved by the Board as
                                                                                 9. Prescription refill and renewal authorization;
             satistying the criteria set furth in (f) below. Completion
             of a ptogram with a Board-approved testing component                 10. Procedures dealing with documentation and records
             shall quality the pharmacy technician to work only for            required for controlled drug substance and prescription
             the specific pharmacy and/or corporation for which the            legend drugs:
             pharmacy technician was employed when the training                   II. Procedures dealing with medication errors, including
             was obtained. If the pharmacy technician becomes                  classifICation of medication errors;
             employed by another phannacy and/or cotporation, the
             pharmacy technician shall be required to complete the                12. Pharmacy technician functions related to automated
             new employer's training ptogram;                                  systems;
              3. Ensure that all pharmacy technicians are knowledge-              13. Functions tbat may not be performed by pharmacy
           able in the established job descriptions, task ptotocols, and       technicians, including at a minimum those functions listed
           policies and procedures in lbe pharmacy setting in which            in (b) above; and
           the technicians are to perform their duties;                          14. A form signed by the pharmacy technician which
              4. Ensure that the duties assigned to any phannacy               verifies that the manual has been reviewed by the tech-
           technician do not exceed the established job descriptions.          nician.
           task protocols and policies and procedures, nor involve any        (g) The phannacist-in-charge shall review at least every
           of the prohibited lasks in (b) above;                           two years and, if necessary, amend tbe policy and procedure
              5. Ensure that all phannacy technicians receive in-          manual. Documentation of the review shall be made available
           service training before the pharmacy technicians assume         to the Board upon request.
           their responsibilities and maintain documentation thereof.        (h) When pharmacy technicians and pharmacy technician
           A registered pharmacy technician or a pharmacy technician       applicants are engaged in any permitted activities, the phar-
           applicant who is receiving in-service training, which shall     macist(s) shall be responsible fur all the activities of the
           nOI exceed 210 days, shall be excluded from the I to 2 ratio    pharmacy technicians and the pharmacy technician appli-
           during such training. A pharmacist shall not supervise          cants.
\.

                                                                       39-37                                                Supp.6-21-1O
13:39-6.15                                                                                                         LAW AND PUBLIC SAFETY

Amended by R.1994 d.351, effective July 18,1994.                                  (c) Prescriptions, other than those listed in (a) and (b)
See: 26 N.l.R. 1596(3),26 NJ.R. 2905(h).                                        above, shall not be filled by a pbarmacy in New Jersey.
Amended by R.1997 d.502. effective December I, 1997.
See: 28 NJ.R. 5048(0), 29 N.J.R. 5072(a).                                       New Rule. R.2005 d.25, effective JllIluary 1g, 2005.
    Added (d) through (I).                                                      See: 36 N.J.R. 3345(.), 37 NJ.R. 295(a).
Ameoded by R.1999 d.214, effective July 19, 1999.                                  Former N.J.A.C. 13:39-7.1, Retail pharmacy access and egress,
See: 31 N.J.R. 1151(0), 31 N.l.R. 1932(a).                                      recodified to N.J.A.C. 13:39-5.2.
   In (t), substituted a reference to supervising registered pharmacist<; for   Amended by R.2009 d.247. effective Augn,t 3, 2009.
a reference to a registered pharmacJsts-in..charge.                             See: 41 N.1.R. 371(a), 41 N.1.R. 2969(b).
Recodified from N.I.A.C. 13:39--6.7 and amended by R.2005 d.25,                    In (a), deleted "written'" preceding the ftrSt occu.rrence of "prescrip-
    effective January 18, 2005.                                                 tion" and inserted "by a practitioner licensed to "'Tite prescriptions» and
See: 36 NJ.R. 3345(3), 37 NJ.R. 295(8).                                         "and prncticing in New Jersey"; and rewrote (b).
   Rewrote the section. Former N.J.A.C. 13:39--6.6, Foreign prescrip-           Amended by R.2010 d.090, effective June 21, 2010.
tions, repealed.                                                                See: 42 NJ.R. 132(8),42 N.I.R. 1221(a).
Recodified from N.J.A.C. 13:39--6.6 and amended by R.2007 d.283,                   Section was "Valid prescriptions; out"Of-State prescriptionsn, In (a).
   effective September 4, 2007.                                                 substituted "issue" for "write" and updated the NJ.SA reference: and in
See: 38 N.l.R. 3137(.), 39 N.l.R. 3774(b).                                      (b), substituted "practitioner authorized to issue" for "prescriber licensed
   Section was "Pharmacy technicians". Rewrote the introductory para-           to write'.
graph of (a); in (b), inserted "and pharmacy technician applicants" and
inserted the second sentence; in Ibe inlroductory paragraph of (e). in-
serted "and pharmacy technician applicants"; added new (d); recodified          13:39-7.2      Laekorinrormation on original prescription
former (d) through (g) as (e) through (h); rewrote (e) and (I); deleted
fonner (h); and in (i), inserted "and pharmacy tecbnicinn applicants" and          (a) If a practitioner fails to include on the original pre-
"and the pharmacy technician applicants".                                       scription any information that he or she is required to include
Amended by R.2010 d.090, effective June 21, 2010.                               pursuant to rules governing the practitioner's professional
See: 42 N.J.R. 132(a), 42 N.I.R. 1221(a).                                       practice, including New Jersey Uniform Prescription Blanks
   In the introductory paragraph of (aJ, deleted "",gistered" preceding
"pharmacist"; in (a)3, deleted "and" from Ibe end; in (0)4, substituted ";      rules set forth at N.J.A.C. 13:45A-27, tbe pharmacist shall
aod" fur a period at the end; recodified the [lISt sentence of former (h) as    obtain such information.
(a)5; in (h)5, substituted "Accepting" for "Pharmacy technicians and
phannacy tecbnkian applicants may accept", "practitioner- for "phy-                    I. If the practitioner has failed to include directions for
sichm"" and '\ consistent with {a)5i below:" for a period at the end; Ie"'          use and the practitioner cannot be contacted, the pharma-
codified the second through foorth sentences of furmer (h) as (a)5i; in
(a)54 substituted ''practitioner'' for "physicianu aod «practitioner's" for«        cist shall indicate on the prescription label the words "use
prescriber's"; recodified (c) tbrough (i)     a., (b) through (h): in (d),          as directed" or "as ordered by the physician" or similar
substituted "(e)" for "(1)"; in Ibe introductory parngrnph of (e), deleted          words to the same effect.
"regist.ered" preceding "phannacisf"; in (e)2iii, substituted «that" for the
flfSt occurrence of '''oVhich'' and Hor' for "(g)" and inserted a comma            (b) All information required for a valid prescription s!tall
fullowing "component"; in (e)4 and (1)13, substituted "(bY' for "(e)"; in       be recorded on the prescription, or in the patient profile
(e)4, deleted 0 comma following "protocols"; in (I), inserted a comma
following "technicians"; in (g), substituted "pharmacist-in-cl!arge" fur        record system maintained pursuant to N.J.A.C. 13:39-7.19, or
"phannacist in charge"; and in (h), deleted "registered" preceding              in the phannacy's other manual or electronic fdes.
"pharmacist(s)".
                                                                                Amended by R.1999 d.214, effective July 19, 1999.
                                                                                See: 31 N.I.R. 1151(a), 31 N.I.R. 1932(a).
                                                                                  Rewrote (a).
                                                                                Recodified frmn N.JAC. 13:39-5.2 and amended by R.2005 d.25,
SUBCHAPTER 7. DRUG DISPENSING AND                                                 effective January 18,2005.
    PRESCRIPTION RECORDS                                                        See: 36 N.I.R. 3345(0), 37 NJ.R. 295(0).
                                                                                  Undesignated (a) and deleted (b). Former N.J.A.C. 13:39-7.2, Retail
                                                                                pharmacy signs, recodified to NJA.C. 13:39-5.3.
13:39-7.1      Valid prescriptions                                              Repeal and New Rule, R.201Qd.09O, effuctive June 21, 2010.
                                                                                Sec: 42 N.J.R. 132(a), 42 N.J.R. 1221(0).
   (a) A phannacist shall only fill a prescription issued by a                    Section was "Lack of directions on original prescription"',
practitioner licensed to issue prescriptions in New Jersey and
practicing in New Jersey if the prescription is on a New                        13:39-7.3      Authorization for renewal of prescriptions;
Jersey Uniform Prescription Blank pursuant to N.J.S.A.                                         new prescriptions
45:14-55 and N.J.A.C. 13:45A-27, except as provided in
                                                                                   (a) A prescription for medication or devices, which pur-
NJ.A.C. 13:39-7.10 and 7.1 I.
                                                                                suant to State or Federal law may be sold, dispensed or fur-
    (b) A pharmacist shall fill a prescription issued by a prac-                nished only upon prescription, shall not be renewed without
titioner authorized to issue prescriptions in another state,                    specific authorization of the practitioner or the practitioner's
territory or possession of the United States, including pre-                    authorized agent, and the prescription may not be filled or
scriptions issued at facilities within or outside of New Jersey                 refilled after one year from the date the original prescription
that are regulated by the United Slates Department of Vet-                      was iSSUed. A pharmacist obtaining authorization from a
erans Affairs andIor the Department of Defense. Such pre-                       practitioner's authorized agent shall document tbe name and
scriptions shall be filled pursuant to New Jersey law. Such                     title of the agent
prescriptions shall not be required to be issued on a New
                                                                                      1. Prescriptions marked "PRN" or other letters or
Jersey Uniform Prescription Blank.
                                                                                    words meaning refill as needed shall not be renewed



Supp.6-21-IO                                                                39-38
        STATE BOARD OF PHARMACY                                                                                                                 13:39-7.6

           beyond one year past the date the original prescription was                In the introductory paragraph of (a), substituted "Except as provided
                                                                                   in (b) below, in" for "In" and deleted "(except controlled dangerous
           issued                                                                  substan~)"' foUowing "'drug'~; in (3)1, substituted "practitioner" for
                                                                                   "licensed practitioner; and" and inserted the second and third sentences;
    )     (b) When the renewals listed on the original prescription
        have been depleted, no additional renewals may be added to
                                                                                   rewrote (a)2; and odded (b),

        the original prescription. For additional dispensing, a new
                                                                                   13:39-7.5     Approval of FDA necessary
        prescription must be authorized by the practitioner,
                                                                                      (.) No drug or medicinc other than a compounded pre-
           (c) Prescription information obtained from a practitioner               scription order shall be sold or dispensed in any pharmacy
        shall be documented at the time of receipt as a new pre-                   within the State of New Jersey until such drug or medicine
        scription in hard copy form or by direct entry into the elec-              has received New Drug Application (NDA), Abbreviated
        tronic prescription records system.                                        New Drug Application (ANDA), Investigational New Drug
        Amended by RI994 d.351, elIedive luly 18, 1994,                            Application (INDA) or uther Federal Food and Drug Admin-
        See; 26 NJ,R 1596(.),26 NJ,R 290S(b),                                      istration approval, where required,
        RecodifIed fi'0I11 NJ.A.C, 13;39-5,3 and amended by R200S d.2S,
           elIective lanuary 18,2005,                                                 (b) Tbe storage, labeling and dispensing of all Investi-
        See; 36 NJ,R 3345(8), 37 NJ,R 29S(0).                                      gational New Drugs sball be a pharmaceutical service pro-
           Former NJ.A.C, 13;39·7.3, Spatial requin:ment of. retail pharmacy
        prescription area, recodifIed '" N.1.A.C, 13:39-5.4.                       vided in cooperntion with, and in support of the principal
        Amended by R2010 d,09O, effective JWle 21, 2010,                           investigator. Under these parameters the dispensing of such
        See: 42 NJ.R 132(0), 42 N.J.R 1221(0).                                     drugs shall not be construed to be a violation of (a) above. A
           Section W1t.S "Autbmization for renewal of prescriptions'". In the
        inlroduClory paragraph of (a) and in (a)l, substituted "the" for "of'
                                                                                   pharmacy participating in experimental research shall comply
        p~eding ";OOginol'" and inserted '''was issued'~ ; in the introductory     with Federal Department of Health and Human Services
        paragraph of (a), inserted a comma following udeviccs'\ inserted "fllled   regulations set forth at 45 CFR Part 46, Protection of Human
        or", insened the last sentence, and substituted "practitioner or the       Subjects of Research, incorporated by reference herein, as
        practitioner's authorized agent" for "prescriber"; rewrote (b) and odded
        (e).                                                                       amended and supplemented and with the New Jersey Depart-
                                                                                   ment of Health and Senior Servioes' Policy on the Protection
        13:39-7.4     Emergency dispensing                                         of Human Research Subjects, incorporated by reference
                                                                                   herein, as amended and supplemented, and which is available
           (a) Except as provided in (b) below, in the absence of a                at ht!p;llwww.state.nj."slbea1th!irb/oolicies.shtrnL
        cwrent, valid prescription, a pharmacist may dispense an
        emergency supply (no more than a 72-hour quantity) of a                    Recodified !i'OI11 N.1.A.C, 13;39-5.4 and amended by R.2oo5 d.25,
                                                                                     effectiv" January 18,2005.
        chronic maintenance drug or device if, in his or her pro-                  See; 36 NJ.R 3345(0), 37 N.1.R 295(a),
        fessional judgment, refusal would endanger the health or                     Rewrote (a) and added (b). Fonner N.1.A.C. 13;39-7.5, Prescription
        welfare of the patient, provided the following conditions are              are. sink, reeodifled to N.1.A.C, 13:39-5.6,
        satisfied:                                                                 Amended by R.2010 d,090. effective JWIC 21, 2010.
                                                                                   See: 42 N.1.R. 132(.),42 NJ.R 1221(0),
             I. The pbarmacist first ascertains to the best of bis or                Rewrote (b).
          her ability, by direct communication with the patient or
                                                                                   13:39-7.6     Required records and documents
          caregiver, that sucb a medication or device was prescribed
          for that patient by order of a practitioner. The pharmacist                 (a) On or after April 5, 20 II, a pharmacy sball maintain an
          shall require the patient or caregiver to provide suitable               audit trail that records and documents the unique and secure
          identification. Such communication shall be documented in                user identifier(s) of tbe pharmacist(s), pharmacy techni·
          the patient proftJe record system maintained pursuant to                 cian(s), intern(s) or extern(s) performing the component func-
          N.J.A,C. 13:39-7.19 or in the phannacy's other manual or                 tions of each step of prescription handling, as defined in
          electronic files; and                                                    N,],A.C. 13:39-4,18, which are required to be perfonned by a
                                                                                   pharmacist, pharmacy technician, intern or extern pursuant to
            2. The pharmacist documents the dispensing of the
                                                                                   the requirements of this chapter. All steps performed by a
          emergency supply in the prescription record system.
                                                                                   phannacy technician, intern or extern shall be documented in
           (b) A phannacist may dispense an emergency supply of a                  the audit trail. AD entries to the audit trail made by a
        Schedule II controlled dangerous substance in the absence of               pharmacy technician, intern or extern shall be reviewed and
        a current, valid prescription upon receipt of oral authorization           approved by the phannacist. When more than one pharmaCist
        from a practitioner as provided under Federallaw pursuant to               is involved in the component functions of· prescription
        21 CFR 1306.11, consistent with the requirements of                        handling, the unique and secure user identifier(s) of the phar-
        N.J.A.C.8:65-7.8,                                                          macist(s) responsible for the accuracy and appropriateness of
        New RnJe, R2005 d.25, effective January IS, 2005,
                                                                                   each component function(s) shall be recorded in the audit
        See; 36 NJ.R 3345(0),37 NJ.R. 295(a).                                      trail. Audit trail documentation shall be generated at the time
          Former NJAC. 13:39-7.4, Prescription counter, ....odified to             each component function(s) is perfonned.
        N.J.A.C. 13:39-5,5.
        Amended by R.2010 d,09O, effective June 21, 2010.                             (b) Computer systems employed for audit trail documen-
\       See; 42 NJ.R 132(0), 42 NJ.R 1221(a).                                      tation shall be designed to identify and document the unique


                                                                               39·39                                                       Supp.6-2l-10
13:39-7.6                                                                                                     LAW AND PUBLIC SAFETY
       .~--              --------------------~                                                                                    --.--
                                                                                                                                 ..

and secure identifier for all pharmacists. pharmacy techni-                  13:39-7.7     Copies of prescriptions andlor patient profile
cians, interns and externs wbo utilize tbe system. Computer                     (a) A pbarmru;y sball immediately comply with tbe pa-
systems that automatically generate the unique and secure                    tient's request for copies of prescriptions and/or patient pro-
user identifier of a pbnrmacisl, pbarmacy technician, intern or              file. Copies of prescriptions issued directly to the patient shall
extern witbout requiring an enlfy by the responsible party are
                                                                             Slate in letters at least equal in size to those describing the
prohibited,
                                                                             medication dispensed, the underlined statement: "COPY-
   (c) Appropriate documentation identifYing Ibe unique and                  FOR INFORMATION ONLY."
secure user identifier of all pharmacists, pbnrmacy techni-
                                                                                (b) Presentation of a prescription marked "COPY-FOR
cians, interns and externs employed by the pbnrmacy shall be
                                                                             INFORMATION ONLY" or a labeled prescription container
mainlained by tbe pharmacy for a period of nol less than five
                                                                             sball be for information purposes only and sball have no legal
year.;; after the last date of employment. If a pbnrmacy utilizes
                                                                             status as a valid prescription order, The pbarmacist in receipt
a manual system, appropriate documentalion identifYing the
                                                                             of sucb copy or labeled prescription container shall contact
bandwritten initials with the handwritten signature and
                                                                             the prescribing practitioner for a new prescription or the last
printed name of all pharmacists, pbarmacy technicians, in-
                                                                             dispensing pharmacy to transfer the prescription pursuant To
terns and externs employed by the pharmacy shall be main-
                                                                             N.JAC 13:39-7.8,
tained for a period of not less than five year.;; after tbe last
date of employment, The oldest four year.;; of record infor-                 Amended by RI997 d.S02, effective D«:ember I, 1997,
mation shall be maintained in such a manner so as to be                      See: 28 N.J.R 5048(a), 29 NJ,R, 5072(a).
                                                                               In (e), added "or electronic transfer"; and in (d), added the second
retrievable and readable within two wee"", The most recent                   sentence.
one year of a record infurmation shall be retrievable and                    Amended by RI999 d.214,effedive luly 19, 1999.
readable within one business day, Records not currently in                   See: 3t N.J.RllSI(a),31 N,J,R 1932(a).
                                                                               In (a), added Ibe last sentence; and added (e).
use need not be stored in tbe pbarmacy, but otT-site facilities              Recodified !rom NJAC 13:39-5.5 and amended by R200s d.2S,
used to sTore sucb records shall be secure.                                    efli:ctive IanWIt)' 18,2005,
                                                                             See: 36 NJ.R 3345(a), 37 NJ,R 295(a),
   (d) All audit trail and prescription information shall be                   Rewrote the section. FonnerNJ.A.C 13:39-7.7, Minimum equipment
maintained or stor<:d in original hard copy furm or in any                   and facilities, recodified to NJAC 13:39-5,8.
other media that facilitates the reproduction of the original                Amended by R2010 d.09O, efli:ctive June 21, 2010,
                                                                             See: 42 N,IK 132(.),42 NJ,R. 1221(a).
hard copy and sball be maintained for a period of not less                     Section was "Copies of presaiptioos". In (a), inserred "and/or patient
than five years, The oldest four years of record information                 profile"; aad in (b), inserted "prescription marked 'COPY-FOR
shall be maintained in such a manner so as to be retrievable                 INFORMA nON ONLY' or a" and deleted "or a prescription mazked
                                                                             'COPY-FOR iNFORMATION ONLY'" following the first oC<1l!Tellee
and readable within two weeks, The most recent one year of a                 Qf""oontainer",
record information shall be retrievable and readable within
one business day, Records not currently in use need not be                   13:39-7.8     Transfer of prescriptions between pharmacies
stored in the pbnrmacy, but olI-site fllcilities used to store
such records shall be secure. Patient records shall be kept                    (a) When a patient, the patient's caregiver, or a pbnrmacy
confidential, but shall be made available to persons au-                     acting on behalf of a patient or caregiver requests tbe trunsfer
tborized to inspect them under State and Federal statutes and                of a valid prescription between pharmacies, a pbnrmacy shall
regulations,                                                                 immediately comply witb the patient's request.

   (oj Notwithstanding the requirements of (d) above, a phar-                   (b) Except as provided in (c) and (d) below, a prescription
macy shall maintain prescription records for controlled dan-                 may be transferred between pbarmacies, consistent with this
gerous substances as required by Federal law consistent with                 section, for one year from the date the prescription was writ-
the provisions of21 CFR 1304.04,                                             ten. provided refills of the prescription are available,

Amended by R1991 d.355, effeotiveJuly 15, 1991.                               (c) A prescription for a Scbedule II controlled substances
See: 22 NJ.R, 1866(1)),23 NJ.R, 2161(0).                                     may not be transferred.
   Added new (d) through (I).
  Redesignated existing (d)-(g) as (g)-fj).                                     (d) A prescription for a Schedule III, IV or V controlled
Amended by R.l994 d.351, efli:c<iveJuly 18, 1994.                            substance may be tranSferred between pharmacies pursuant to
See: 26 N.J.R. IS%{a), 26 NJ.R 2905(b).
Recodified from NJAC 13:39-5.6 IItld amended by R200S d.25, ef-              N.JAC 8:65-7,14(b) and 7.18(d), A prescription for a
   fective JanWIt)' 18,2005,                                                 Scbedule III, IV or V controlled substance that bas been
See: 36 NJ,R. 3345(3),37 NJ.R 295(a).                                        transferred shall not be transferred a second time. This pro-
   Rewrote the section. Former NJ.A,C 13:39-7.6, Scornse and ade-
quate stock, recodified to N.J.A,C, 13:39-5,7,
                                                                             hibition sball not apply To the trunsfer of such prescriptions
Amended by R,2009 d.293, elIective October 5, 2009.                          between pharmacies engaged in centrul prescription handling
See: 41 NJ,R 1637(0), 41 NJ.R 3840(3).                                       pursuant to N,JAC 13:39-4.I8(e) and 10 pharmacies that
   Section was "Reoor<I of pharmacist filling prescripti()fl". Rewrote the   share a real-time, on-line database consistent with the require-
section.
Ameeded by R2010 d.09O, elIective June 21,2010.                              ments of 21 CFR 1306.25.
See: 42 NJ,R, 132(a),42NJ,RI22J(a),
   Added (e).
                                                                                                                                                        (

Supp.6-21-10                                                             39-40
        STATE BOARD OF PHARMACY                                                                                                                        13:39-7.10

          (e) A prescription may be lraIlsferred between pbarmacies                      former (e)2iii(3) as (e)2iii(2): deleted fOllller (e)2iii(4); recodifIed
                                                                                         former (e)2iii(5) as (e)21il(3); and added new (e)2iii(4).
        for the purpose of refill dispensing by telephone, or by fac-
        simile or electronic means as provided in N.J.A.C. 13:39-7.10
    )   and 7.11, provided that:                                                         13:39-7.9      Filing and storage of controlled substance
                                                                                                        prescriptions
              I. The sending pharmacy invalidates the prescription
                                                                                           (a) Prescriptions for all controlled substances listed in
           on file as of the date the prescription is transferred and
                                                                                         Schedule 11 shall be mainmined in a separate prescription file.
           records on the back of the invalidated prescription order or
           in the electronic system the following:                                          (b) Prescriptions for all controlled substances listed in
                1. That the prescription has been transferred and the                    Schedules III, IV and V shall be maintained in a separate
              date of transfer;                                                          prescription file for such controDed substances only or in
                                                                                         such form that they are readily retrievable from other pre-
                ii. Tbe name and nddress or store identifier of the                      scription records of the pharmacy. Prescriptions will he
              pharrna<:y to which the prescription was transferred;                      deemed readily retrievable if, at the time they are initially
                                                                                         filed, the face of the prescription is stamped in red ink in the
                 iii. The name or personal identifier of the pharma-
                                                                                         lower right comer with the leiter "C" no less than one-inch
              cist, intern or extern to whom the prescription was trans-
                                                                                         high and filed either in the prescription file for controlled
              ferred; and
                                                                                         substances listed in Schedule II or in the prescription ftle for
                 iv. Tbe initials or personal identifier of the pharma,                  non-controlled substances. If a pbarmacy employs an elec-
              cist, intern, or extern issuing the tnlnsterred prescription               tronic recordkeeping system for prescriptions that permits
              order;                                                                     identifICation by prescription numher and retrieval of original
                                                                                         documents by the practitioner's name, patient's name, dmg
             2. The receiving pharmacy, upon receiving sucb pre'                         dispensed and date filled, then the requirement to mark the
           scription directly from another pharmacy, records the fol,                    hard copy prescription with a red "c" shall he waived.
           lowing:
                                                                                         New Rule, R.2005 d.25, effective Janumy 18,2005.
                 i.   The name and address or store identifier and                       See: 36 N.J.R. 3345(0), 37 N.l.R. 295(0).
              original prescription numher of the pharmacy from                            Fonner N.J.A.C. 13:39~7 .9, Television in prescription area prohibited..
              which the prescription was transferred;                                    recodified to N.l.A.C. 13:39-5.10.
                                                                                         Amended by R.2009 d.247, effective August 3, 2009.
                ii. The Dame or personal identifier of the sending                       See: 41 NJ.R. 371(0), 41 NJ.R. 2969(b).
                                                                                            In (b)~ substituted "Schedule" for «schedule", deleted '''usual consec-
              pharmacist. intern or extern;                                              utively numbere<f' prec:eding the fifth occurrence of ""prescription''', and
                                                                                         inserted 1he last sentence.
                 iii. All information constituting a preSCription order,                 Amended by R.2010 d.090, effendve June 21, 2010.
              as well as the following:                                                  Sec: 42 NJ.R. 132(0),42 NJ.R. 1221(0).
                                                                                            10 (b). substituted "that" for '''which'' preceding "pennits" and
                    (I)    Date of issuance of original prescription;                    upractitioJler's'~ for «prescrjber~s".


                    (2)    Original numher of refills authorized on orig,
                                                                                         13:39-7.10       Prescriptions transmitted by facsimile
                 inaI prescription;
                                                                                           (a) A pbarmacist may accept for dispensing a facsimile
                    (3)    Number of valid refills remaining; and
                                                                                         prescription, consistent with the requirements of this section.
                    (4)    Date the prescription was last filled; and                    For purposes of this section, "fucsimile prescription" means a
                                                                                         prescription wbich is transmitted by a device which sends an
              3. The pharmacist. intern, extern, or technician at the                    exact image to the receiver.
           receiving pharmacy informs the patient or caregiver that
           the original prescription has been cancelled at the sending                      (b) A pharmacist shall not fill a fucsirnile prescription
           pharmacy.                                                                     transmitted by anyone other than a practitioner authorized to
                                                                                         prescrihe medications pursuant to N.J.S.A. 45: 14-40, or the
        New Rule, R.2005 d.25, effective January IS, 2005.
        See: 36 NJ.R. 3345(0), 37 NJ.R. 295(.).                                          prescribing practitioner's authorized agent.
           Former NJ.A.C. 13:39-7.8, Cleanliness, orderliness and sanitation,
        recodified to N.JA.C. 13:39-5.9.                                                   (c) The fucsirnile machine used to receive prescriptiOllS
        Amended by R.2007 d.283, effective September 4, 2007.                            shall be located within the pharmacy prescription area.
        See: 38 N.J.R. 3137(0). 39 NJ.R. 3774(b).
           In (1)3, deleted "receiving" preceding "phannacist" and inserted "at             (d) A facsimile prescription shall contain all information
        the receiving pharmacy",                                                         required to he included on a "'Tilten prescription pursuant to
        Amended by R.20IOd.09O, effediveJune 21, 2010.
        See, 42 NJ.R. 132(.),42 N.l.R. 1221(0).                                          New Jersey State Board of Medical Examiners rule N.J.A.C.
           In (d), deleted ", consistent with this section, one time onh:'                13:35-7.2(d), except that an NJPB shall not be required for
        following 1he fm;! occurrence of "pbannacies" and inserted serond and            the prescription.
        third sentences: deleted former (e); recodified former (I) as (e); rewrore
        the introductory paragrapb of (e); in (e) Iii, inserted "and address {)f ,tore     (e) The fucsimile Iransmission of the prescription shall
\       identifier"; in (e )2i. substituted "and" fot a comma fonowing "name'"
        and inserted "or store identifier"; deleted form .... (e)2iii(2); reeodified
                                                                                         contain the following:


                                                                                     39-41                                                         Supp.6-21-1O
13:39-7.10                                                                                         LAW AND PUBLIC SAFETY

    1. The identification number of the facsimile machine             the patient is a hospice patient. The facsimile shall serve as
  which is used to transmit the prescription;                         the original written prescriptioo and shall be maintained
                                                                      pursuant to the requirements of (g) ahove.
     2. The date and time of the prescription transmission;                                                                                 ,
                                                                                                                                            \
                                                                     (i) A pharmacist may fill a prescription for a Schedule Ill,
    3. The name, address, telephone number and facsimile
                                                                  IV or V controlled substance transmitted by facsimile con-
  number of the phannacy; and
                                                                  sistent with the requirements of this section. The facsimile
    4. If an authorized agent transmits the facsimile pre-        prescription shall serve as the original written prescription.
  scription, the full name and title of the transmitting agent.
                                                                     0) A pharmacist shan not enter into any agreement with a
   (I) A phannacist shall seek verbal verification of a fucsim-   prescribing practitioner that requires that fucsimile prescrip-
ile prescription from the prescribing practitioner whenever       tions be transmitted to a patticular pharmacy or in any way
the pbarmacist has reason to question the authenticity, ac-       denies a patient the right to have his or her prescription trans-
curacy or appropriateness of the prescription. A pharmacist       mitted by facsimile to a pharmacy orthe patient's choice.
may accept verbal verification regarding the authenticity or
legibility of a facsimile prescription from a prescribing prac-      (k) Nothing in this section shall be construed to preclude
titioner's authorized agent. A pharmacist shall not fill a fac-   the fucsimile transfer of infonnation between pharmacies for
simile prescription wbere there is a question regarding au-       purposes of transfurring prescriptions pursuant to N.J.A.C.
thenticity, accuracy or appropriateness if such verification is   13:39-7.8.
not provided.
                                                                     (l) A pharmacist shall not use a technological device in
  (g) A pharmacist shall retain a printed copy of a fucsimile     order to circumvent his or ber responsibilities with regard to
prescription, or an electronic reproductioo of the fucsimile      verifYing the validity of prescriptions or in order to
prescription that is readily retrievahle and printable, for a     circumvent other standards of pharmacy practice.
minimum of five years. The printed copy shall be of non-          New Rule, R.2003 d.373, effective September IS, 2003.
fading legibility.                                                See: 34 N.I.R. 3064(0), 35 NJ.R. 4290(0).
                                                                  Administrative correction.
  (b) A pharmacist may fill a prescription for a Schedule II      See: 3S NJ.R. 4724(0).
controlled substance transmitted by facsintile provided that      Recodified from N.J.A.C. 13:39-S.8A by R.2oo5 d.2S. effi:ctive January
                                                                    18,2005.
the original signed prescription is presented to the pharmacist   See: 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
prior to the dispensing of the controlled substance, except as        Fonner N.J.A.C. 13:39-1.l0, Return of prescription medication,
provided in (b)l, 2 and 3 below.                                  recodified to NJ.A.C. 13:39-7.16.
                                                                  Amended by R.2010 d.09O, effective June 21, 2010.
     \. A prescription for a Schedule II narcotic substance       See: 42 NJ.R. 132(.),42 NJ.R. 1221(0).
                                                                     In (b), updated the N.J.S.A. reference; in (g), deleted "p","uanl to
  prescribed for pain management to he compounded for the         N.J.S.A. 45: 14-IS" following "'five years"; and added (k) and (f).
  direct administration to a patient by parenteral, intrave-
  nous, intramuscular, subcutaneous or intraspinal infusion       13:39-7.11      Electronieally transmitted prescriptions
  may he transmitted by the practitioner or the practitioner's
  agent to the dispensing pharmacy by facsintile. Tbe fuc-           (a) A phannacist may aceept for dispensing an electronic
  simile shall serve as the original written prescription and     prescription, consistent with the requirements of this section.
  shall he maintained pursuant to the requirements of (g)         For purposes of this section, "electronic prescription" means
  ahove.                                                          a prescription which is transmitted by a computer device in a
                                                                  secure manner, including computar to computer and c.omputer
      2. A prescription for a Scbedule II substance prescribed    to facsimile transmissions.
  for pain management for a resident of a long-term care
  facility may be transmitted by the practitioner or the prac-       (b) A pharmacist shall not fill an electronic prescription
  titioner'S agent to the dispensing pharmacy by facsimile.       transmitted by anyone other than a practitioner authorized to
  The facsimile shall serve as the original wrinen prescrip-      prescribe medications pursuant to N.J.S.A. 45: 14-40, or the
  tion and shall be maintained pursuant to the requirements       prescribing practitioner's authorized agent. If the electronic
  of (g) above.                                                   prescription is transmitted by the practitioner's authorized
                                                                  agent, the transmission shall include the full name and title of
     3. A prescription for a Schedule II narcotic substance
                                                                  the agent.
  prescribed fur pain management for a patient receiving
  services from a hospice certified by Medicare under Title          Cc) The permitholder shall ensure that the electronic sys-
  XVIII or licensed by the State may be transmitted by the        tem utilized to receive prescriptions shall have adequate secu-
  practitioner or the practitioner's agent to the dispensing      rity and system safeguards designed to prevent and detect
  pharmacy by facsimile. The practitioner or the practi-          unauthorized access, modification or manipulation of the pre-
  tioner's agent shall nnte on the fucsimile prescription that    scriptions.




Supp.6-21-10                                                  39-42                                             Next Page is 39-42.1
STA TE BOARD OF PHARMACY                                                                                                       13:39-7.12

   (d) The computer or device used to receive electronically          (k) Two or more permit holders may establish a common
transmitted prescriptions shall be located within the pharmacy     electronic tiling system to maintain required dispensing infor-
prescription area.                                                 mation.

   (e) An electronic prescription shall contain all information       (f) Nothing in this section shall be c",nstrued to preclude
required to be included on a written prescription pursuant to      the electronic transfer of information between pharmacies for
New Jersey State Board of Medical EXllI1liners rule N.J.A.C.       purposes of transrerring prescriptions pursuant to N.J.A.C.
13:35-7.2(d), except that a handwritten original signature and     13:39-7.8.
an NJPB sball not be required for the prescription. Consistent
with the requirements of N.J.A.C. 13:35-7.4A, the practi-            (m)A pharmacist shall not use a technological device in
tioner's electronic signature Or other secure method of valida-    order to circumvent his or her responsibilities with regard In
tion shall be provided with the electronic prescription unless     verifying the validity of prescriptions or in order to circum-
the prescription is transmitted by the practitioner's authorized   vent other standards of pbarmacy practice.
agent. If transmitted by an authorized agent, the fuji name and    New Rule, R.2003 d.373, effective September 15,2003.
title of the agent shall be included on the transmission and the   See: 34 NJ.R. 3064(a), 35 N.1.R. 429O(a).
agent shall not sign the prescription.                             Reoodified from N.J.A.C. 13:39-5.8B and amended by R,2005 d.25,
                                                                      effective January 18,2005.
   (I) A pharmacist shall seek verbal verification of an elec-     See: 36 NJ.R. 3345(a), 37 NJ.R. 295(a).
                                                                      Added (k) and (/). Former NJ.A.C. 13;39-7.11, Prescription balanoes,
tronic prescription from the prescribing practitioner whenever     scales, weights and automatic counIing devi<t:S, recodified to N.l.A.C.
the pharmacist has reason to question tbe authenticity, ac-        13:39-5.11.
curacy or appropriateness of the prescription. A pharmacist        Amended by R.201 0 d.090, effective June 21, 201 O.
                                                                   See; 42 NJ.R. 132(0),42 N.J.R. 1221(.).
may accept verbal verification regarding the authenticity or          ht (b), updated the NJ.S.A. reference; in (e), inserted the seoond and
legibility of an electronic prescription from a prescribing        third senten<es; in (g), deleted "punruant to N.J.S.A. 45;14-15" follow-
practitioner's authorized agent. A pharmacist shall not fill the   ing "live years"; and added (m).
electronic prescription where there is a question regarding
authenticity, accuracy or appropriateness if such verification     13:39-7.12         Labeling
is not provided.
                                                                     (a) The dispensed container for any product shall bear a
   (g) A pharmacist shall retain a printed copy of an elec-        permanently affixed label with at least the following infor-
tronic prescription, or a record of an electronic prescription     mation:
that is readily retrievable and printable, for a minimum of five
                                                                           I. The pharmacy name and address;
years. The printed copy shall be of non-fading legibility.
                                                                          2. The phannacy telephone number;
   (h) A pharmacist may fill a prescription for a Schedule II
controlled substance transmitted electronically, provided that             3. The brand name, or if a generic, the brand name and
the original signed prescription is presented to the pharmacist         the name of the generic in the following form, with the
prior to the dispensing of tbe controlled substance. If per-            generic name and brand name inserted as appropriate:
mitted by Federal law, and in accordance with Federal re-               U _______   Generic for _______..";
quirements, an electronic prescription shall serve as the orig-
                                                                          4. The strength of medication, where applicable;
inal signed prescription.
                                                                          5. The quantity dispensed;
   (i) A pharmacist may fill a prescription for a Schedule III,
TV or V controlled substance transmitted electronically, pro-             6. The date upon which prescription medication is dis·
vided that the pharmacist has obtained the original signed              pensed;
prescription, an oral prescription, or a facsimile prescription           7. A CDS cautionary label, where applicable;
from the prescribing practitioner or the prescribing practi-
tioner's authorized agent prior to the dispensing. Ifpermitted            8. The patient name;
by Federal law, and in accordance with Federal requirements,
                                                                          9. The practitioner's name;
an electronic prescription shall serve as the original signed
prescription.                                                              10. The prescription number;
   (j) A pharmacist sball not enter inln any agreement with a              II. Directions for use; and
prescribing practitioner that requires that electronic prescrip-
                                                                           12. The phrase "use by" followed by the product's use
tions be transmitted to a particular pharmacy or in any way             by date, if dispensed in any packaging other than the manu-
denies a patient the right to have his or her prescription
                                                                        facturer's original packaging.
transmitted electronically to a pharmacy of the patient's
choice.                                                                      i.   For purposes of this paragraph, "use by date"
                                                                          means the earlier of one year from the date of dispensing
                                                                          or the expiration date on the manufacturer's container.


                                                              39-42,1                                                      Supp.6-21·1O
13:39-7.12                                                                                                       LAW AND PUBLIC SAFETY

  (b) The patient name, the brand or generic name of the                      penaJty and attorney fees. In re Suspension or Revocation of License of
                                                                              Sort, OAL Dkt. No. BDS 10231-05,2007 N.J. AGEN LEXIS 884, Final
medication, and the directions for use shall appear in larger                 Deeision (June 18, 20(7).
type, in a different color type, or in bolded type, in com-
parison to tbe other information required to appear on the                       Iloard of Pharmacy adopted the Initial Deeision (2006 NJ. AGEN
label of the dispensed container pursuant to (a) ahove.                       l.EXIS 1077), which c.oncluded thot a pharmacist railed to use pro-
                                                                              fessional judgment when fimng 104 prescriptions delivered by a phar..
                                                                              maceutical sales representative; the State's expert opinion that any
  (0) In addition to the requirements set forth in (a) and (b)                reasonable phannacist wouJd have noticed and questioned the drastically
ahove, the dispensed container for any product shall bear all                 similar handwriting on the face of prescriptions that supposedly were
auxiliary labeling as recommended by the manufacturer.                        'hTitten by different physicians, coupled with the fact that so many pa~
                                                                              tients would be suffering from concurrent infections covered by the
   (d) When, in the judgment of the pharmacist. directions to                 products made by the same pharmaceutical company, and the faet that
                                                                              the drugs prescribed posed potential interactions that the pharmacist
the patient or cautionary messages are necessary, eitber for                  never questioned, demonstrated that the pharmacist had sufficient reason
clarification or to ensure proper administration, storage or use              to question the validity of the prescriptions aru:l failed to do so. In re
of the medication, the pharmacist may add sucb directions or                  Suspension or Revocation of License of       SOrT,   OAL Dkt No. 80S
cautionary messages 10 those indicated by the practitioner on                 10231-05,2007 N.J. AGEN LEXIS 884, Final Decision (June 18,2007).
the original prescription.                                                       Board of Pharmacy adopted the Initial Deeision (2006 NJ. AGEN
                                                                              l.EXIS 1077), which oonclnded that the staru:lard of care applicable to a
New Rule, R.1999 d. 196 effective June 21, 1999.                              licensed pharmacist who filled bundled prescriptions delivered by 0
See: 30 NJ.R. 4113(.), 31 NJ.R. 253(8), 31 N.J.R. 1618(8).                    phannaceutical sales representative was that of a pharmacist, not a
Recodified rrom NJ.A.C. 13:39·5.9 aru:l amended by R.2005 d.25,               pharmaceutical representative delivering samples. In re Suspension or
  effective January 18, 2005.                                                 Revocation of License of Soo, OIlL Dkt. No. BDS 10231-05, 2007 N.J.
See: 36 N.J.R. 3345(0),37 NJ.R. 295(a).                                       AGEN l.EXIS 884, Final DecisiOn (Iune 18,2007).
  Rewrote (b) aru:l added (c). Fonner NJ.A.C. 13:39-7.12, Disposal of
unwanted drugs, NCOdified 00 N.JAC. 13:39-7.17.
Amended by R.2004 d.380, effective October 4, 2004 (operative April 2,        13:39-7,14      Advertising and sale or prescription drugs
  20(5).
See: 36 NJ.R. Il(a), 36 N.J.R. 4480(a).                                          (a) "Advertisement" means any attempl directly or indi-
  Rewrote the section.                                                        rectly by poblication, dissemination, or circulation in print or
Administrative correction.                                                    electronic media which directly or indirectly induces or at-
See: 37 N.I.R. 1535(0).
Amended by R.2009 d.305, effective Detober 5,2009.                            tempts to induce any person or entity to pun::base or enter inlo
See: 40 NJ.R. 5170(.), 41 NJ.R. 3840(.).                                      an agreemenl to purchase services or goods from a Board
   Deleted fonner (0)9; and NCOdified fonner (a)1O through (a)l3 as (0)9      licensee.
throagh (a)12.
Amended by R.2010 d.09O, etreetive June 21, 2010.                                                                                                          i
See: 42 N.I.R. 132(0), 42 NJ.R. 1221(0).
                                                                                 (b) Price quotations for prescription drugs appearing in any              .
   Rewrote (a)3; in (8)9, substituted "practitioner's" for "p",scrib.,.";     advertisement shall stipulate the strength and quanlity re-
and in (d). substituted "practitioner" for "prescriber',                      quired to be pun::hased for the offered cost. Price quotations
                                                                              shall include tbe usual and customary prescription cost. All
13:39-7.13       Professional judgment in dispensing drags                    services including, bul not limiled to, delivery cbarges ren-
                                                                              dered by the pharmacy whicb will add additional costs 10 the
   The pharmacist shall bave the right 10 refuse 10 fill a pre-               price quoted, must be set forth in the advertisement.
scription if, in his or her professional judgment, the prescrip-
tion is outside the scope of practice of the practitioner; or if                ( c) Any reference in any form of advertisement 10 the
the pharmacist has sufficient reason to question the validity of              quality of a drug or its benelicial use is prohibited.
the prescription; or to protect the health and welfare of the
patient.                                                                       (d) Price quotntions for drugs appearing in any advertise-
                                                                              ment shall stipulate the effective period of price quotation.
Recodified from NJ.A.C. 13:39-6.1 aru:l amended by R.2005 d.25,
  effective lanuary 18, 20OS.                                                   (oj Upon request by any consumer, the pharmacist shall
See; 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
  Undesignated (a) aru:l deleted (b). f'ormer N.J.A.C. 13:39.7.13,            give usual and cuslomary price infurmation for a non-third
Outdated drugs O£ drugs marked "sample", recodified 00 NJ.A.C. 13:39-         party paying customer over the telephone and sball stipulate
7.18.                                                                         the effective period orthe price quotntion.
Amended by R.2010 d.09O, effeedveJuneZl, 2010.
See: 42 NJ.R. 132(0),42 NJ.R. 1221(a).                                           (t) All advertisements shall be predominantly informa-
  Substituted "practitioner" for "prescriber".
                                                                              tional and shall not be misleading, confusing or false. Any
                               Case Notes                                     advertisement demeaning the quality of protessional services
                                                                              rendered by another licensee or permittee shall be prohibited.
   Board of Pharnutey adopted the Initial Deeision (2006 N.J. AGEN
tEXIS 1071) that a pharmacist engaged in dishonesty, fraud. de<eptiOll,       Recodified from N.J.A.C. 13:39-6.8 and amended by R.200S d.25,
or misrepresentation, aru:l gross neg/igence, by accepting boodled pre-          elfective January 18,2005.
scriptions delivered by a sales representative, filling those prescriptions   See: 36 NJ.R. 3345(0), 37 NJ.R. 295(a).
without question, dispensing medications in bulk to an ~ end                     Rewrote (e); in (l), deleted the second sent<:nce. Fonner NJ.A.C.
user~ and tben coUecting S901000 in reimbursement; the pharmacist's           13:39-7.14, Patient profile record system, NCOdified to NJ.A.C. 13:39-
.ctions posed a risk to the public at large, aru:l the Board suspended the    7.19.
pharmacist's license for five yearS and ordered paymenl of a civil



Supp.6-21-IO                                                            39-42.2
    STATE BOARD OF PHARMACY                                                                                                         13:39-7.16
                                               ----~----------------------

                                 Case Notes                                        the purchaser to consult a physician if the condition for
      Prohibition against tertain premiums or rebates was unconstitutional.        which the substance is being used does not improve.
    Matter of CVS Pharmacy, Wayne, 224 N.J.Super. 631, 541 A.2d 242
)   (A.D.l98l!) reverred 116 N.J. 490, 561 A.2d 1160, O<rtioran denied 110
    S.C!. 841. 493 U.S. 1045.107 L.Ed.2d 836.
                                                                                      6. Upon an individual'S fourth request for a Schedule V
                                                                                   substance within a short period of time (two to four days
                                                                                   subsequent to the third purchase), the pharmacist shall de-
    13:39-7,15      Restriction OD sale of Scbedule Vover-the-                     termine, through direct communication with the purchaser,
                    counter controlled substances                                  how many people are using the substance, whether con tin-
       (a) It shall be considered unprofessional conduct for a                     ned use will be therapeutic, whether the purchaser is treat-
    pharmacist to dispense a Schedule V over-the-counter cOD-                      ing a condition which requires a physician's consultation,
    trolled substance when:                                                        whether the purchaser is exhibiting signs of drug abuse and
                                                                                   whether the purchaser is making similar requests of other
         I . The phannacist, in his or her professional judgment,                  local pharmacies.
      knows or reasonably should know that the requested sub-
      stance will be used for unauthorized or illicit consumption
                                                                                       7. If a pharmacist determines that an individual's re-
                                                                                   quest for a Schedule V substance within a short period of
      or distribution; or
                                                                                   time (two to four days) subsequent to his or her fourth
          2. The phannacist, in his or ber professional judgment,                  purchase is warranted, the pharmacist shall document in
      knows or reasonably should know that the person request-                     the Over-th.-Counter Schedule V Record Book the jus-
      ing the substance previously used it for unauthorized or                     tification for such sale. In addition, the pharmacist shall
      illicit consumption or distribution.                                         recommend that the purchaser consult with a physician for
                                                                                   medical evaluation due to the substance's abuse potential
       (b) The standard of professional judgment and care that                     as well as the potential itazard presented by the substance's
    attends the sale of a Schedule V over-the-counter controlled                   continued use.
    substance shall conform to the following:
                                                                                      8. If any Schedule V substance is dispensed to one in-
         I. All phannacists shall comply with NJ.A.C. 8:65-                        dividual more than five times within any 12-month period,
      7.19, which requires that the sale of specified controlled                   the pharmacist shall obtain oral or written conftrmation
      substances be limited in quantity during any 48-hour pe-                     from the purchaser's physician as to the continued need for
      riod, that the purchaser be at least 18 years of age, and that               the substance and shall document such conftnnation in the
      the phannacist obtain suitable identification (including                     Over-the-Counter Schedule V Record Book.
      proof of age where appropriate) from every purchaser not
      known to the phannacist.                                                New Rule, R 1990 d.418, eff.dive October 1, 1990.
                                                                              See: 22 NJ.R. \329(01. 22 NJ.R. 31S3(b).
        2. In all instances, any doubts regarding the propriety               Recodified from N.J.A.C. 13:39-6.8 by R2005 d25, effective January
                                                                                   18,20OS.
      of a sale of a Schedule V substance shall be resolved                   See: 36 NJ.R. 3345(.), 31 NJ.R 295(.).
      against making the sale.
         3. The phannacist shall enter every sale of a Schedule               13:39-7.16      Return of prescription medication
      V substance in the Over-the-Counter Schedule V Record                     (a) Prescription medication correctly dispensed to a patient
      Book pursuant to NJ.A.C. 8:65-7.19. The infurrnation to                 may be aceepted for return by the pharmacist but shall not be
      be recorded shall include the purchaser's fll'St and last               placed in stock for reuse or resale, except as provided in
      name, street address, city and state, the name and quantity             N.J.A.c' 13:39-9.18(0)2.
      ofthe Schedule V substance sold, the date of each sale, and
      the name or initials of the pharmacist making the sale.                    (b) Prescription medication incorrectly dispensed to a pa-
                                                                              tient shall be accepted for return by the phannacist and shall
         4. Upon an individual's second request for a Schedule                not be placed back in stock for reuse or resale.
      V substance within a short period of time (two to four
      days), the pharmacist shall determine, through direct com-                ( c) Prescription mediCation that has been prepared for a
      munication with the purchaser, whether the substance is                 patient, but which has not been dispensed to the patient. may
      being used correctly. In that regard, the phannacist shall              be placed back in stock for reuse or resale provided that:
      ascertain how many people are using the substance and
      whether the condition which the substance is being used to                      I. In the professional judgment of the pharmacist, the
      treat is improving.                                                          prescription mediCation is eligible for re-dispensing. El-
                                                                                   igible medications are those medications tbat are able to be
         5. Upon an individual's third request for a Schedule V                    consumed by a patient within the original time frame estab-
      substance within a short period of time relative to the                      lished for the medication'S stability and expiration. Prod-
      number of persons using it (two to four days subsequent to                   ucts that have a limited shelf life and/or that have not been
      the second purchase), the phannacist shall advise the pur-                   stornd consistent with manufacturers' storage requirements
      chaser of the substance's abuse potential and shall caution                  may not be re-dispensed;



                                                                         39-42.3                                                 Supp.6-21-1O
13:39-7.16                                                                                                   LAW AND PUBLIC SAFETY

     2. The prescription medication shall not be placed in                   13:39-7.19      Patient profile record system
   manufucturers' stock containers of different lot numbers
                                                                                (a) A patient profile system must be maintained by all
   andior with different expiration dates;
                                                                             pharmacies for persons for whom prcscriptions are dispensed.          )
       3. Manufucturcrs' stock containers shall not be over-                 The Patient Profile Record System (PPRS) may be a manual
   filled;                                                                   or electronic system and shall be devised, so as to enable the
                                                                             immediate retrieval of information necessary to enable the
      4. In those circumstances in which prescription medi-                  dispensing pharmacist to identifY previously dispensed medi-
   cations cannot be properly returned to the original manu-                 cation and patient specific information at the time a prescrip-
   facturers' stock containers, the medication shall be held in              tion is presented for dispensing. One profile record may be
   the pharmacy in the labeled container in which it has been                maintained for members of a family living at the sarne ad-
   repackaged. Prior to redispensing. such medications shall                 dress and possessing the same fumily name.
   be placed in a new container with a new label or the
   original label shall be removed and the container shall be                  (b) The following information shall be recorded in the
   relabeled;                                                                PPRS:
      5. If the manufucturer or the FDA orders a recall of a                        I. The family name and the first narne of the person for
   drug product, the pharmacist shall assume products held in                     whom the medication is intended (the patient);
   labeled containers without lot numbers are included in the
   recall and proceed accordingly; and                                              2. The address and telephone number of the patient;
     6. Medications held for re-dispensing shall be used as                         3. Indication of the patient's age, birth date or age
   soon as possible. Such medications, lacking original lot                       group (infant, child, adult) and geoder;
   numbers and expiration dates. shall not be dispensed to                          4. The original or refill date the medication is dis-
   patients beyond six months from the date the medications
                                                                                  pensed;
   were originally prepared for dispensing. Re-dispensed
   medications shall be marked with the sarne use by date as                         5. The number or designation identifYing the prescrip-
   the medication which was originally prepared for dis-                          tion;
   pensing.
                                                                                    6. The practitioner's name;
Amended by R.199S d.167, effective Apri16, I99S.
See: 29 N.J.R. 474O(b), 30 NJ.R. 1298(0).                                           7. The name, strength and quantity of the drug dis-
   Amended NJ.A.C. reference.                                                     pensed;
Amended by R.1999 d.214, effe<:tive July 19, 1999.
See: 31 NJ.R. 1151(8),31 NJ.R. 1932(0).                                              8. Pharmacist's comments relevant to the patient's drug
   Rewrote the section.
RecOOified from N.IAC. 13:39-7.10 and amended by R.2005 d.2"
                                                                                  therapy; and
   effective January IS. 2005.                                                      9. Any allergies and idiosyncrasies of the patient and
See: 36 NJ.R. 3345(0), 37 N.J.R. 295(0).
   Rewrote the section.                                                           any medical conditions that may relate to drug utilization,
Amended by R.2010d.090, effuctive June 21, 2010.                                  as communicated by the patient or the patient's repre-
Sec: 42 N.J.R. 132(0),42 N.J.R. 1221(0).                                          sentative.
   In the introductory paragraph of (e), substituted ''that'' for ''which~
following "medication"; and in (0)4, inserted the last sentence.                      i.    If there are no patient allergies, idiosyncrasies or
                                                                                    medical conditions that may relate to drug utilization,
13:39-7.17      Disposal of unwaoted drugs                                          such information shall be documented in the patient
  Unwanted drugs shall be disposed of in a manner that does                         profile record system.
not cause them to become a health hazard, and in accordance                    (c) The pharmacist shall use professional judgment to
with all local, State, and Federal codes.                                    review and monitor the patient profile, determine if there
Recodified from N.IAC. 13:39-7.12 by 11..2005 d.25, errective January
                                                                             should be any adjustment in the original patient information
   18,2005.                                                                  and so indicate the appropriate change in the patient profile
See: 36 NJ.R. 3345(0), 37 NJ.R. 295(.).                                      record.

13:39-7.18      Outdated drugs or drugs marked "sampleH                        (d) All prescription patients who patronize a pharmacy
                                                                             shall have a profile record as specified by this section, and the
  No outdated, misbranded, deteriorated, improperly stored                   pharmacist shall inquire as to whether other prescription
or adulterated drugs, or any drugs marked "sample" or with                   drugs are being concomitantly utilized in order to establish a
any like designation or meaning shall be dispensed or placed                 current drug history for the patient.
or maintained in active stock for use or sale.
                                                                                (e) A patient profile record shall be maintained or stored in
R£<odified from N.J.A.C. 13:39-7.13 and amended by R.2005 d.25.              original hard copy form or in any other media that facilitates
  effective January IS, 2005.
See: 36 N.J.R. 3345(0), 37 NJ.R. 295(0).                                     the reproduction of the original hard copy and shall be main-
                                                                             tained for a period of not less than five years from the date of

Supp.6-21-1O                                                            39-42.4
    STATE BOARD OF PHARMACY                                                                                                                    13:39-7.21

    the last entry in the profile record. In using an electronic data               (h); in (e), substituted "practitioner" for "ptCscriber" and deleted   "a"
                                                                                    preceding the fourth OCCutrellce o["record"; and deleted (j).
    processing system, the system shall have the capability of
    producing retrievable and readable documents of aU original                                                   Case Notes
    and reftlled prescription data for a period of not less than five
                                                                                        Board of Phannacy adopted the Initial Decision (2006 N], AGEN
    years, includlng the number of refills authorized by the                        LEXlS 1077) that a phannacist engaged in dishonesty, fraud, deceptioll,
    practitioner, The oldest four years of record information shall                 or IllISrepresentation. gross n<+:ligence, and violated NJ.A,C. 13:39·
    be maintained in such a manner so as to be retrievable and                      7. ~9(b) by .accepting bundled p,:"scriptions de~v~ by a sales represen-
    readable within two weeks. The most recent one year of                          tatiV~, ~II~ those presmptJons WIthout questlon, and dispensing
                                                                                    medications 10 bulk: to an unknov.n end user; the patient's telephone
    record information shall be retrievable and readable within                     number and gender mU!'t be listed in the patient prolile s)'Stem. In re
    one business day. Records not currently in use need not be                      Suspension or Revocation of License of Sorr. OAL Dkt No. BDS
    stored in the pharmacy, but off-site facilities used to store                   102314)5,2007 N.J. AGEN LEXlS 884, Final Decision (June 18, 2007).
    such records shall be secure. Patient reccrds shall be kept
    confidential, but shall be made available to persons author-                    13:39-7.20      Drug utilization review
    ized to inspect them under State and Federal statutes and                          (a) Upon receipt of a new or refill prescription, a pharma-
    regulations,
                                                                                    cist shall examine the patient's profile record before dispens-
       (f) If the pharmacy uses an electronic data processing sys-                  ing the medication, to determine the possibility of a poten.
    tern, an auxiliary recordkeeping system shall be established                    tially siguificant drug interaction, reaction or misutilization of
    when the electronic data processing system is inoperative for                   the prescription. Upon determining a potentially significant
    any reason, When the electronic data processing system is re-                   drug interaction, reaction or misutilization, the pharmacist
    stored to operation, the patient profile information and num-                   shall take the appropriate action to avoid or minimize the
    ber of refills authorized during the time the electronic system                 problem, which shall, if necessary, include consultation with
    was inoperative shall be entered into the electronic data proc-                 the patient and/or the practitioner.
    essing system within 72 hours,                                                     (b) Upon receipt of a refill prescription, a pharmacist shall
       (g) If an electronic data processing system is used, tbe                     determine if a substantial time, as is appropriate for that drug
    system shall provide adequate safeguards against manipu-                        in the pharmacist's professional judgment, has elapsed from
    lation and alteration of records and to protect confidentiality                 the last filling, When necessary, the pharmacist shall consult
    of the information contained in the data hank,                                  with the practitioner and/or the patient to ensure that
                                                                                    continued use of the medication is appropriate,
       (h) The hOlder of the pharmacy permit shall make arrange·
    ments with the supplier of data processing services or mate-                       (c) When patient profile records indicate sporadic, erratic
    rials to ensure that the pharmacy will continue to have ade-                    or irrational use of medication by • patient, the phannacist
    quate and complete prescription and dispensing records if the                   shall consult with the patient and/or the practitioner to de-
    relationsnip with such supplier terminates for any reason,                      termine if continued use of the medication is appropriate.

    Amended by R.I993 d,307, etrwive June 21, 1993.                                 New Rule, R20JO d.090, e!feetive JWle 21, 2010,
                                                                                    See: 42 NJ,R 132(,), U NJ.R 1221(a),
    See: 24 N.J,R. 266(8), 2S NJ.R. 2697(8).
    Amended by RI994 d.351, eITeetiveIuly IS, 1994.
    See: 26 NJ.R. 1596(0),26 N.J.R, 2905(b).                                        13:39-7.21      Patient counseling
    Recodified from N.l.A.C, 13:39-7.14 and amended by R.2005 d,25,
      effective January IS} 2005.                                                      (a) Except as provided in (a)5 belOW, before dispensing a
    See: 36 NJ1l3345(0), 37 NJ,R. 295(0).                                           new medication, a pharmacist shall make reasonable efforts
    Amended by R.2009 d.305, eITective October 5, 2009.
    See; 40 NJ.R. 5170(0), 41 N,J.R 3840(a),                                        to counsel the patient or the patient's caregiver, Counseling
        In (b)4, deleted "and the initials of Ibe dispensing phannacist, if said    may include the following:
    initials and such date are not recorded on the back of the original
    prescription or in any other Board~approved record" from the end; and in              I, The name and description of the medication;
    (t)! inserted "or stored in original bard copy fonn or in any other media
    that facilitates the reproduction of the original hard copy and shall be              2. The dosage form, dosage, route of administration,
    maintained", deleted "immediately" preceding the third oc<urrence of                and duration of drug therapy;
    "retrievable"" inserted ~thin one business day.'\ and inserted the last
    twosentences.                                                                         3. Special directions and precautions for preparation,
    Amended by R,20 10 d.09O, effective June 21, 201 O.
    See: 42 N.Jll132(a), 42 NJ,R 1221(.),                                               administration and use by the patient;
       In (a), inserted "may be. manual or electronie system and", • comma
    following "devised"~ and "and patient specific infonnation"; in (b)6~                  4, Common adverse or severe side effects or interac-
    substituted "pracriti~er's"" for "prescriber's"; in (b)7 deleted 14and" from        tions and contraindications that may be encountered, in·
    the end; in (b)8, substituted u; and" for a period at the end; recodified the       eluding how to avoid such side effects, interactions and
    former introductory paragraph of (c) !IS Ibe introductory paragraph of
    (b)9; rewrote the introductory paragraph of (h)9; recodified fonner (e) I
                                                                                        contraindicatiolll!, and the action required if they occur;
    as (b)9i; reVlTOte (b)9i; recodified former (d) !IS (e); deleted the                  5. Techniques for self·monitoring drug therapy;
,
;
    introductory paragraph of (e) and (e)l through (e)7; recodified fonner
    (e)8!1S (dl; deleted (e)9; re<:odified fonner (f) through (i) as (e) through
                                                                                          6, Proper storage;


                                                                              39-42.5                                                       Supp.6-21-1O
13:39-7.21 _ _                                                                                             LAW AND PUBLIC SAFETY

       7. Prescription refill information; and                                                         Case Noles
                                                                           Out..of..state applicant could not be deemed an institutional pharmacy
       8. Action to be taken in the event ofa missed dose.              because: (I) the applicant's Wisconsin license stated only that it was 8
                                                                        "pharmacy" and did not further describe the licensee as either retail or
  (b) The offer to counsel may be made by pharmacy                      institutional; (2) the Justice Department registration recognized peti.
personnel. However, counseling shall be perfonned only by a             tioner as a retail pharmacy; (3) an 4'institutionaJ phannacy" under New
pharmacist, or by a pharmacy intern or pharmacy extern                  Jersey regulations mlLst be within a healthcare facility or system lieensed
                                                                        as such by the Board; and (4) the New Jersey regulations also state that
under the immediate personal supervision of a pharmacist                the term "pharmacy" standing alone indicates 8 retail pharmacy. Because
consistent with the requirements ofN.J.A.C. J3:39-6.2(f)5.              the applicant was not deemed an institutional phannacy~ its authorization
                                                                        as 0 Medicaid provider was not proscribed under N.l.A.C. 10:51·
   (c) A phannacist shall not be required to counsel a patient          2.2(b)1. Phoenix Pharmacy, Inc. v. DMAHS, OAL Dkt. No. HMA
or caregiver when the patient or caregiver refuses such                 03266·07,2007 N.J. AGEN LEXIS 489, Initial Decis;on (July 6, 2007).
counseling. The absence of any record of a fuilure to accept
the pharmacist's offer to counsel shall be presumed to signilY          13:39·9,2      Definitions
that the offer was accepted and that the counseling was                   The following words and terms, as used in this subchapter,
provided.                                                               shall have the following meanings, un!ess the context clearly
                                                                        indicates otherwise.
   (d) If the patient or caregiver is not physically present, the
offer to counsel sball be made by telephone or in writing on a            "Drug administration" means a procedure in which a pre-
separate document accompanying the prescription. A written              scribed drug is given to a patient by an authorized person in
offer to counsel shall be in bold print, easily read, and shall         accordance with aU laws and rules governing such proce-
include the hours a phannacist is available and a telephone             dures.
number where a pharmacist may be reached. The telephone
service must be available at no cost to the pharmacy's                    "Fonnulary" means a continually revised compilation of
primary patient population.                                             pharmaceuticals available in the pharmacy for use in tbe
                                                                        facility developed by the Pharmacy and Therapeutics Com·
  (e) The requirements of this section shaU not apply to a              mittee,
pharmacist who dispenses any drug to an inpatient at a
hospital or a long term care facility in which the resident is            "Health care fucility" means a faci!ity or institution li-
provided with 24-hour nursing care.                                     censed by the Department of Health and Senior Services pur·
                                                                        suant to N.J.S.A. 26:2H·1 et seq.
New Rule, R.2010 d.09O, effective June 21, 2010.
See: 42 N.I.R. 132(0), 42 NJ.R. 1221(8).
                                                                           "Health care system" means one or more bealth care fitcili-
                                                                        ties which are owned or controlled by the same legal entity.

                                                                          "Institutional pbalTllllCy" means the area in a health care
SUBCHAPTER 8. (RESERVED)                                                fucility or a health care system licensed by the Board as a
                                                                        pharmacy that maintains an institntional permit. "Institutiona!
                                                                        pharmacy" includes any areas of the health care facility or the
                                                                        health care system where pharmaceuticals are stored, com·
SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR                               pounded or dispensed.
    HEALTH CARE FACILITIES
                                                                           "Medication order" means a written request for medication
13:39-9.1     Purpose alld scope                                        originated by a practitioner and intended for patient use in the
                                                                        health care fucility, and not for use of the institution's
   (a) The rules in this subehapter shall apply to all retail
                                                                        employees or their dependents or outpatients of the facility's
pharmacies which contract to provide phannaceutical services
                                                                        clinics. A valid medication order contains the date ordered,
for healthcare facilities and to all institutional pharmacies
                                                                        the patient's name and location within the fitcility, the name,
which provide pharmaceutical services for their own health
                                                                        dose, route, and frequency of administration of the medica-
care system.
                                                                        tion, and any additional instructions. Computer-generated
  (b) An institutional pharmacy filling prescriptions for out-          medication orders within an institutional setting, utilizing the
patient use shall comply with all retail pharmacy require-              practitioner's electronic signature or password will meet legal
ments of this chapter.                                                  requirements for a practitioner's original handwritten signa·
                                                                        ture on medication orders. Computerized signatures or pass·
New Rule, R.200S d.2S. cffective January 18, 2005.                      words will be accepted provided that the fucility has adequate
See: 36NJ.R. 334S(a),37 N.J.R. 295(0).                                  safeguards which assure the confidentiality of each electronic
  Former N.J.A.C. 13:39·9.1, Definitions, recodified to N.JAC. 13:39·
9.2.                                                                    signature or password and which prohibit their improper or
                                                                        unauthorized use.




Snpp.6·2HO                                                         39-42.6
STATE BOARD OF PHARMACY                                                                                                                          13:39-9.6
                                                                                                            --~--~--



   "Phannacy and Therapeutics Committee" means the active                           uously displayed in the facility's pharmacy. The institutional
standing committee of tbe institution or health care facility                       pharmacy is subject 10 and shall be cooducted in accordance
which is the organizational line of communication and liaison                       with all existing State and Federal rules and regulations.
between the medical service and pharmacists and which acl,
to review and promote rational drug therapy and utilization in                         (b) An institutional pharmacy that is part of a bealth care
the facility.                                                                       system may fill medication orders for health care facilities
                                                                                    that are part of the health care system and that provide phar-
  "Unit dose packaging" means a single unit use non·                                maceutical services directly to the patients of the health care
parenteral medication provided in packaging which contains                          system.
the fuUowing information for each unit in the package:
                                                                                    Amended by R.2000 d.4S7, effective November 20, 2000.
       J. Product name;                                                             See: 31 NJ.R. 3044(a),32 NJ.R. 4123(a).
                                                                                      Designated existing section as (a); and added (b).
     2. Strength and/or quantity and/or volume, where ap-                           Recodified from N.J.A.C. 13:39-9.2 and amended by R.200S d.2S,
                                                                                      efTecU\-'e January 18. 2005.
   propriate;                                                                       See: 36 NJ.R. 3345(a), 37 N.J.R. 295(0).
                                                                                      In (0), amended lhr N.J.A.C. reference. Former N.l.A.C. 13:39-93,
      3. Lot number;                                                                Control ofinstitutional pharmaceutical, recodified to NJ.A.C. 13:39-9.8
     4. The phrase "use by" followed by the product's use
   by date.                                                                         13:39-9.4     Contract pharmaceutical serVices;
                                                                                                  Institutional permit required
         i.   For purposes of this paragraph, "use by date"
      means tbe earlier of one year from the date of packaging                         An institutional permit is required for any area within an
      or the expiration date on the manufacturer's container;                       institution s.r;iced by an outside vendor that performs on-site
                                                                                    pharmaceutical services as defmed in N.J.A.C. 13:39-1.2.
      5. Manufacturer or repackager; and
                                                                                    Amended by R.1994 d.351, effective July 18, 1994.
     6. If there is more than one product in the single unit, a                     See: 26 NJ.R. 1596(0),26 NJ.R. 2905(b).
   pbysical description of each medication in the single unit.                      Recodined from N.I.A.C. 13:39-4.14 and amended by R.200S <1.25,
                                                                                      effective January 18,2005.
Amended by R.1994 d.351, ctTective July 18, 1994.                                   See: 36 N.l.R. 334S(0), 37 NJ.R. 29S(a).
See: 26 NJ.R. 1596(0),26 NJ.R 2905(b).                                                Delated "where drugs are stored, manufactured or compoooded and
Amended by R. t998 d.167, <fleetiv. April 6, 1998.                                  which is" following ''within an institution" and inserted "oo~site" pre..
See: 29 N.J.R. 4740(b), 30 NJ.R. 1298(a).                                           ceding "pharmaceutical services". former N.I.A.C. 13:39-9.4, Pharma-
  Amended N.J.A.C. reference in "Phannacy and Therapeutics Com·                     ceutical services, recodified to N.J.A.C. 13:39-9.9.
mil1>:e" defmition.
Amended by Rim d.214, effective July 19, 1999.                                      13:39-9.5     Advisory committees
See: 31 NJ.R. 1151(a), 31 NJ.R.1932(0).
   Deleted "Authorized prescriber" and "Direct supervision"; in "Health               The pharmacist·in-charge, or designee, shall be an actively
care facility¥>+ substituted a. refereru:e to patients and residents fOT a refer-
ence to the sick and injured; in "'Unit dose drug distribution S}"Stem"~            participating member on any committees of tbe facility that
deleted a reference 10 biologicals; and added ~Unil use packaging".                 may be concerned with drugs and their utilization.
Amended by R.2000 d.457, elTective November 20, WOO.
S..: 31 NJ.R. 3044(a), 32 NJ.R. 4123(0).                                            Recodified from 13:39-9.10 by R.I994 d.3S1, effective July IS, 1994.
   Inserted "Health care system"; in '<lnstitutional pharmacy". inserted            See: 26 N.J.R. 1596(0),26 NJ.R. 2905(b).
references to heallb care systems throughout substituted "a!1JI" for                Amended by RI999d.214, effective July 19, 1999.
"other'" following "incJudcs"'~ and deleted Ilmanufactured,"" following             See: 31 N.J.R.1151(a),31 NJ.R.1932(a).
"stared.'1.                                                                            Substituted a reference to registered phannacist-in..(;harge for a
Recodified from NJ.A.C. 13:39-9.1 and amended by R.200s d.2S,                       reference to pharmacist-in--cbarge.
   effective January 18, 200S.                                                      Recodified from N.l.A.C.13:39-9.19 by R.2005 d.25, effective January
See: 36 N.J.R. 3345(a), 37 NJ.R. 295(0).                                               18,2005.
   Rcmute "Health care facitity"; in "Phannacy and Therapeutics Com-                See; 36 N.l.R. 3345(.~ 37 NJ.R. 295(0).
mittee"', substituted "medical service and pharmacists" for "medical and               Former NJ.A.C. 13:39-9.5, Pharmaceuticals, recodifJCd to NJ.A.C.
pharmacy staff' and deleted lhr last sentence; rewrole "Unit use                    13:39-9.1 O.
packaging". Former NJ.A.C. 13:39-9.2, Licensure of institutional pbar-              Amended by R.2010 <1.090, effective June 21, 2QIO.
maeies, recodified to N.I.A.C. 13:39-9.3.                                           See: 42 NJ.R. 132(0),42 N.I.R. 1221(a).
Amended by R.2010 d.09O, effective June 21, 2010.                                      Deleted "registered" preceding "pharmacist-in--charge".
See: 42 NJ.R. 132(0),42 NJ.R. 1221(a).
   In definition "Medication order"> substituted "a pr3ctitiooer" fur '~an          13:39-9_6     Pharmacy and Therapeutics Committee;
authori7.ed prescriber"" and ''practitioner's" for "prescribcr's~' twice;
deleted dermition hUnit dose drug distribution system"; substituted                               applicability; polices and procedures
definitioo "Unit dose paetaging" for definition "Unit use packaging');
and re\Vrote defInition ;<Unit dose packaging".                                        (a) In all health care facilities providing pharmaceutical
                                                                                    ser;ices to patients, an active standing committee of the in·
13:39-9,3       Licensure of institutional pharmacies                               stitution entitled the Pharmacy and Therapeutics Comntittee
                                                                                    or other appropriate name shall be established if required pur-
  (a) Any institutional pharmacy as defined under N.J.A.C.                          suant to Department of Health and Senior Ser;ices rules. A
13:39-9.2 shall be registered with and possess an institutional                     Pharmacy and Therapeutics Committee shan be multidisci.
permit issued by the Board. The permit shall be conspic·                            plinary and include a pharmacist.


                                                                              39-42,7                                                       Supp.6·21-1O
13:39-9.6                                                                                                       LAW AND PUBLIC SAFETY
----------------------------------------------~

   (b) [n all health care facilities providing phannaceutical                 Substituted referen<:es lo registered pbarmacists-in""-Charge for ref·
                                                                           erenccs to phannacists~in-cbarge throughout.
services to patients that are not required to maintain a Pbar-             Recodified from 13:39-9,6 and amended by IU994 d.351, effective July
macy and Therapeutics Committee pursuant to Department of                     18,1994,
Health and Senior Services rules, the pharmacist-in-charge of              See: 26 NJ,R. 1596(.).26 N.1,R 2905(b).
the provider pharmacy, in cooperation with the health care                 Amended by RI999d,214, effective July 19. 1999.
                                                                           See: 31 N.J.R, 1151(0),31 NJ.R 1932(a),
facility. shall create policies and procedures as needed to                Rt=difred from N,J,A.C. 13:39-9.3 and amended by R200S d.25,
provide pharmaceutical services to the health care facility.                  effective January 18, 2005.
Copies ofth. policies and procedures shall be made available               See: 36 NJ.R 3345(0), 37 N.l.R 295(0).
to the Board upon request.                                                    Rewrote lIle seclion. Fonner N,JAC. 13:39-9.8, Compounding,
                                                                           repealed,
Recodified from 13:39-9.11 by R1994 d.351, effective July 18, 1994.        Ameuded by R2010 d,09O, effective Joue 21, 2010.
See: 26 N.1.R 1596(0).26 NJ.R. 2905(b).                                    See: 42 NJ.R. 132(.).42 N.1,R 1221(a).
Recodified from NJAC. 13:39-9,20 and llJllended by R2005 d.25.                Section was «Control of health care pbarmaceuticaJ services; re.-
   effective January 18.2005.                                              sponsibilities of the registered pharmacisl-in..clJarge of the provider
See: 36 NJ,R 3345(0), 37 NJ,R 295('),                                      phannacy)t. Deleted "registered" preceding "pharmacist.in-<:harge"
   Rewrote the section, Fonner N.1.A.C. 13:39-9,6. Drug disbursement;      throughout
written order.;; outpatient prescriptions, recodified to N.J,A.C. 13:39-
9.11.                                                                      13:39-9.9        (Reserved)
Amended by R2010 d,09O. effective June 21. 2010.
See: 42 NJ,R 132(0), 42 N.J.R 1221(0),                                     Amended by R1994 d.351. effeetiveluly 18, 1994,
   In (b), substilulud "Copies of the" for "The written" and inserted      Sec: 26 NJ,R 1596(0).26 NJ.R, 2905(b),
"made" and nupon request".                                                 RecodifJed from NJAC, 13:39·9.4 by RZ005 d.25. effective January
                                                                              18.2005,
                                                                           See, 36 NJ.R. 3345(8). 37 N.1.R, 295(0),
13:39-9.7     (Reserved)                                                      Former NJAC. 13:39-9.9, Monitoring of patient drug therapy,
                                                                           recodified to NJAC. 13:39-9.13,
Recodified from 13:39·9.12 by RI994 d.351, effective luly 18, 1994,        Repealed by R2010 d,09O. effective June 21, 2010,
See: 26 N,J.R. 15%(0).26 NJ,R, 2905(b).                                    See: 42 NJ.R 132(0),42 N,J.R 1221(0).
Recodified from NJ,A.C. 13:39-9.21 and anreuded by R2005 d.25,                  Section was ~'Phannaceulieal servicesn •
   effective lanuary 18.2005,
See: 36 NJ,R 3345(0), 37 NJ,R, 295(0).
   Inserted "ccosi'tent willl lIle requirements ofN.1,A.C 13:39~.2(f)J·    13:39-9.10        Pharmaceuticals; drug supply;
alllle end of lIle p!lI'lIgnIph, Former NJAC, 13:39-9.7, Drug disburse-                      investigational drugs; controlled dangerous
ment; oral orders, recodified to NJAC 13:39·9.12,
Repealed by R,2010 d.090, effective lune 21, 2010.                                           substances
See: 42 NJ.R. 132(0).42 NJ.R.l22l(o).
   Section was '~Institutlonal pharmacy staff",                               (a) The pharmacist-in-charge shall be responsible for de-
                                                                           termining the specifications for drugs and pharmaceutical
13:39-9.8     Control or health care pharmaceutical                        preparations used in the treatment of patients of the facility as
                                                                           to quality, quantity and source of supply. An authorized
              services; responsibilities orthe plumoacist-ill-
              charge althe provider pharmacy                               purchasing agent andlor materials manager andlor pharmacy
                                                                           buyer of the facility may perfonn the actual procurement, All
   (a) The pharmaceutical services of the health care facility             purchases shall be reviewed by the pharmacist-in-charge or
shall be the responsibility of and under the coolrol, super-               his or her designee. who shall be a pharmacist.
vision, and direction of the pharmacist·in-charge of the
provider pharmacy.                                                           (b) Written policies and procedures for the maintenance.
                                                                           content, control and accountability of drugs supplied and
   (b) If a health care facility does not have an institutional            located throughout the facility sball be developed by the
pharmacy on its premises or cbooses to utilize the services of             phannacist-in-charge and approved by the Pharmacy and
a phannacy outside the heallh care system, it may enter into               Therapeutics Committee.
an agreement with a retail pbarmacy licensed by tbe Board.
The pharmacist-in-charge of the retail pharmacy sball direct,                 (c) Written policies and procedures for the control, use and
control, supervise and be responsible for the pharmaceutical               accounlability of Investigational New Drugs shall be de-
services provided to the facility.                                         veloped by the pharmacist-In-charge and Ihe Pharmacy and
                                                                           Therapeutics Committee. The storage, labeling and dispens-
  (c) The phannacist-in-charge of the provider pharmacy.                   ing of aU Investigational New Drugs shall be a phanna-
with the cooperation oflbe Phannacy and Therapeutics Com-                  ceutical service provided in cooperation with, and in support
mittee, shall develop written policies and procedures as                   of the principal investigator. Under these parameters, the
needed to provide pharmaceutical services to the facility. The             dispensing of these drugs shall not be construed to be a
written policies and procedures shall be available to the                  violation ofN.J.A.c' 13:39-75(a). A facility participating in
Board,                                                                     experimental research involving residents shall comply with
                                                                           Federal Department of Health and Human Services regu-
Amended by R, 1994 d,351, effective July 18, 1994,
See: 26 NJ,R. 15%(.), 26 N.1,R 2905(b).                                    lations, set forth at 45 CPR Part 46, Protection of Human
                                                                           Subjects of Research, which is incorporated by reterence
Amended by R,1999 d,214, effective July 19, 1999.
See: 31 NJ,R, 1151(.),31 NJ,R, 1932(.).                                    herein, as amended and supplemented and with the New
                                                                                                                                                       (


Supp.6-2)-10                                                          39-42.8
STATE BOARD OF PHARMACY                                                                                                                   13:39-9.12

Jersey Department of Health and Senior Services' Policy on                     Amended by R.1994 d.351, effective July 18. 1994.
                                                                               See: 26 NJ.R. 1596(.),26 NJ.R. 2905(b).
the Protection of Human Research Subjects, which is incor-                     Recudified from NJ.A.C 13:39-9.6 and amended by R.2005 d.25.
porated by reference herein, as amended and supplemented,                         effective January 18, 2005.
and which is available at http://www.state.nj.uslhealthlirbl                   See: 36 N.l.R. 3345(.), 37 N.J.R. 295(0).
policies.shlmL                                                                    In (0), substituted "a" for "an electro·mechanlc81" preceding
                                                                               "facsimile" 8JJd ameuded N.lAC reference; rewrote (e) and (d); deleted
                                                                               (e). Former NJ.A.C 13:39-9.11, Drvg labeliug, recodified to N.JAC
  (d) Written policies and procedures for the control, use and                 13:39·9.15.
accountability of controlled dangerous substances shall be                     Amended by R.2009 d.293, effective October 5, 2009.
developed by the pharmacist-in-charge and the Pharmacy and                     See: 41 N.l.R. 1637(a), 41 N.l.R. 3840(0).
Therapeutics Committee. Controlled dangerous substances                           Section was IIDrug disbursement; written orders; outpatient prescrip-
                                                                               tions".
shall be purchased received, stored, dispensed, administered,                  Amended by R.2010 d.09O, effective June 2t. 2010.
recorded and controlled in accordance with State and Federal                   See: 42 NJ.R. 132(a), 42 NJ.R. 1221(.).
laws and regulations.                                                            Rewrole (a).

Amended by R.1994 d.351, effective July IS, 1994.                                                            Csse Noles
Soc: 26 NJ.R. 1596(.),26 NJ.R. 2905(b).
Amended by R.I999 d.l96 effective June 21,1999.                                     Violation not found due to faiJure of Board to prove phannacist's
See: 30 NJ.R. 4113(8), 31 NJ.R. 253(.), 31 NJ.R. 1618(a).                      knowledge or receipt of equipment and test requirements. NC\V Jersey
    In (e), deleted "by • phannaeist" following "conducted" in the seeond      State Bd. ofPhannaey v. Y'lIUZZi, 4 N.l.A.R. 489 (1981).
sentence, added "or by supportive personnel and co-signed by the super-
vising pharmacist" at the end of the fourth senlence, and inserted a new       13:39-9.12       Drug disbursement; oral orden<
fifth seruroce.
Recodified from N.JAC 13:39-9.5 and amended by R.2oo5 d.25,                      (8) The provisions of this section shall be implemented in
    e!Tective January 18,2005.
See: 36 N.l.R. 3345(.), 37 N.l.R. 295(a).                                      accordance with the policies and procedures of, and protocols
    In (a), substituted "supervised" for '~approved'" following uthe pur..     of the Pharmacy and Therapeutics Committee.
ellase sban be"; rewrote (c); in (d)' amended N.JAC reference and
inserted ", which is incorporated by reference berein. as amended and             (b) A pharmacist shall =eive oral orders only from an
supplemented"; deleled exisHug (e); added a new (e) and (I). Fonner            authorized practitioner. Such orders shall be immediately
N.J.A.C \3:39-9. to, MediCalion nol dispensed in finished form.                recorded and signed by the person receiving the order on the
recodifted 10 NJ.A.C \3:39-9.14.
Amended by R.2010 d.09O, effective June 21, 2010.                              medication order sheet or into the electronic data processing
Soe: 42 NJ.R. 132(0),42 NJ.R. 1221(0).                                         system.
    In (a)J substituted "AU purchases"' for "In such a case, the" and
"reviewed" for "supervlsed"; deleted fanner (b); recodified former (c)           (c) Oral orders for Schedule II controlled substances shall
lI1ld (d) as (b) and (e); in (b), deleted the frn;t and second senlenoes and   be pennitted only in the case of a bona fide emergency
deleted   ~'registered"   preceding   "pharmaeisl~irH;harge";   rewrole (e);
deleted (e); recodified former (I) as (d); and in (d), inser1ed the first      situation.
sentence and deleted the last sentence.
                                                                                   (d) Oral orders received consistent with the requirements
                                                                               of (b) and (c) above shall be countersigned by the prac-
13:39-9.11        Drug disbllrsement; written orders
                                                                               titioner.
  (a) The phannacist shall review the practitioner's original
order or a copy of the original order generated by any media                      (e) The pharmacist may release to the patient at discharge
that mcilimtes the reproduction of the original order before                   any remaining medication in a multiple dose container (for
                                                                               example, inhalers, multiple dose injectable medications, such
any initial dose of medication is dispensed, except as
provided for in NJ.A.C. 13:39-9. B.                                            as insulin. topical preparation, drops, ointments and topical
                                                                               irrigation solutions), and a limited supply of other medica-
  (b) Drugs not specifically limited as to time or number of                   tions, provided that the pharmacist:
doses when ordered shall be controlled by the automatic stop
                                                                                       I. Labels the medications for out-patient use pursuanl
order procedure or other methods in accordance with written
                                                                                    to labeling requirements set forth in NJ.A.C. 13:39-7.12;
policies of the facility.
                                                                                       2. Counsels the patient prior to discharge from tbe
  (c) The Pharmacy and Therapeutics Committee shall de-                             hospitat or medical mcility pursuant to N.JAC. 13:39-
velop a list of unapproved or unacceptable abbreviations and                        7.21; and
symbols which shall not he used in tbe mcility. Orders in-
volving symbols or abbreviations shall only be dispensed                              3. Ensures that discharge orders contain the attending
consistent with this list.                                                          physician's authorizations to dispense tbe remaining doses
                                                                                    of tbe prescription or the limited supply of other medi-
   (d) When appropriate, the phannacist shall make necessary                        cations to the patient or guardian.
entries into the patient medical record relative to drug use in                Recodified from 13:39-9.6 and ameoded by R.1994 d.35t, effective July
accordance with health care mcility policies and, where ap-                      18,1994.
plicable, pursuant to regulations of the Department of Health                  See: 26 NJ.R. 1596(a), 26 NJ.R. 2905(1)).
and Senior Services andlor Centers for Medicare and Medi-                      Amended by R.I997 d.502, effec.ive December 1, 1997.
                                                                               See: 28 NJ.R. 5048(.), 29 N.!.R. 5072(a).
caid Services.


                                                                          39-42.9                                                     Supp.6-21-1O
13:39-9.12                                                                                                        LAW AND PUBLIC SAFETY
                                                           ------------------                          .. ~--~

    Inserted new (a); recodified existing (a) through (e) as (b) through (d);   13:39-9.15      Drug labeling
and added ( e).
Amended by IU999 d.214. effective July 19,1999.                                   Labeling of medications, other than intravenous solutions,
See: 31 N.J.R. 1151(a), 31 NJ.R. 1932(0).
    In (d), deleted "as requited by 42 CPR 463" at the end.
                                                                                shall be in conformance with written policies and procedures                    )
Recodified from N.J AC. 13:39-9.7 and amended by R.2005 d.25,                   controlling the drug distribution system in use within the
    effective Januaxy 18, 2005.                                                 facillty and in accord with currenl acceptable standards of
See: 36 NJ.R. 3345{a), 37 NJ.R. 295(a).                                         pbannaceutical practice. Labeling of intravenous solutions
    In (a). substituted "provisions'· for "mandatory requirements" follow-
 ing "The~; in (b), substituted «medication" for "prescriber's" preceding       shall be consistent with the labeling requirements set forth in
~'order sheet ; in (e)t amended the NJ,A.C. reference in 2. Former
                 U
                                                                                NJ.A.C.13:39-11.
NJAC. 13:39-9.12, Use of patient's own medication, recodified to
NJ.A.C. 13:39-9.16.                                                             Recndifled from 13:39-9_6 and amended by R.1994 d.351, effeetiveJuly
Amended by R.2010 d.09O, effi:ctiveJWlC 21, 2010.                                 18,1994.
See: 42 NJ.R. 132(.)' 42 N.J.R. 1221(a).                                        See: 26 NJ.R. 15%(0).26 NJ.R. 290S(b).
    In (8), substituted "policies and procedures of,'" for "policy"; in (b)     Amended by R.l999 d.214, effeetiveJuly 19, 1999.
and (d), substituted "pcactitioner" for "prescriber"; in (d) inserled           See: 31 N.J.R.llSI(.),31 N.J.R. 1932(.).
:"eceived consistent with Ibe requirements of (b) and (e) abo';""; in Ibe         Deleted a fonner (a); and deleted. former (b) designation.
mtroductory p8l'l!gT3ph of (e). inserted 8 comma follOwing Ibe first            Recodified from N.J.A.C. 13:39-9.11 and amended by R.2OOS d.2S,
occw:rmce of "medications'" deleted a comma following "'ointments't,              effective Januaxy 18,200S.
and Inserted "and a limited supply of other mediartions.n • in (e)l             See: 36 NJ.R. 3345(a), 37 NJ.R. 295(3).
substituted "NJ.A.C. 13:39-7.12" for "NJ.S.A. 4S:14-24"; in (e)2:                 Deleted the last sentence. Former N.lA.C. 13:39-9.15, Disposal of
updated Ibe N.J.A.C. reference; and in (e)3, substituted "dispense" for         unused nledications, reendified to N.J.A.C. 13:39-9.18.
''release'''' and inserted «-or the limited supply of other medicatioos"",      Amended by R.20 10 d.09O, effective June 21, 2010.
                                                                                See: 42 N.J.R. 132(8), 42 N.J.R. 1221(0).
                                                                                  Inserted the last sentence.
13:39-9.13       Monitoring of patient drug tberapy
   (a) The phannacist shall be responsible for monitoring                       13:39-9,16      Use of patient's own medication
drug therapy of patients in the facility. This shall include, bUI                  (a) No drugs sball be administered to a patient except
is not limited to, maintaining and reviewing the patient                        those provided through the pharmacy or as provided by
medication profile prior to the dispensing of medications.                      "'Titten policies and procedures developed by the pharmacist-
  (b) In instances involving Ihe issuance and administration                    in-charge or, where applicable, the director of pharmaceutical
of STAT orders (orders requiring immediate attention) these                     services and approved by the Pharmacy and Therapeutics
drugs shall be documented on the patient's medication profile                   Committee.
immediately after dispensing.                                                      (b) Although the use of patient's own medications may be
  (c) When the pharmacy is closed, these drugs shall be doc-                    warranted in certain situations, it should be discouraged as a
umented on the patient's medication profile immediately after                   general or routine practice. If a patient's previously acquired
the pharmacy is reopened.                                                       medication is to be used, a written order to this effect shall be
                                                                                signed and dated by the patient's physician. Such medications
ReCodified from 13:39-9.6 and amended by R.I994 d.351, effective July           shall be identified by the pharmacist lIS to contents and dis-
   18, 1994.                                                             .
See: 26 N.J.R. IS%(.), 26 N.J.R. 2905(b).
                                                                                pensing origin. Also, these medications shaD be documented
Reendified from N.JAC. 13:39-9.9 by R.2oo5 d.2S, effi:ctive January             as part nfthe pharmacy's patient profile record system.
   18,2005.
See: 36 NJ.R. 3345(.), 37 NJ.R. 295(8).                                         Recodified from 13:39-9.6 and amended by R.1994 d.351, effective July
  Fonner NJ.A.C.13:39-9.l3, Im.... ngatioruil drugs; removal of out-              18,1994.
dated and recalled drugs; eJIleI1!1lIlcy drug supply; cootrolled dangerous      See: 26 NJ.R. 1596(a), 26 NJ.R. 290S(b).
substanees, repealed.                                                           Amended by R.1999 d.214, effi:ctiveJuly 19, 1999.
                                                                                See: 31 N.J.R.1I51(.),31 NJ.R.1932(.).
                                                                                  In (a), substituted "and except as provided" fur". Any exception to
13:39-9.14       Medication Dot dispensed in finished form                      this rule must be governed'" following I·phannacy"', and substituted a
                                                                                reference to registered phannacists~inrcharge fur a reference to phar~
   The pharmacist shall be responsible for providing medica-                    macistg...m..charge.
tion in a form that requires little or no further alterations,                  Recodified from N.JA-C. 13:39-9.12 and amended by R.200S d. 25,
                                                                                   effectiveJanuaxy 18, 2005.
preparation, reconstimtion, dilution or labeling by other li-                   See: 36 NJ.R. 3345(.),37 NJ.R 29S(0).
censed personnel. The pharmacist shall provide adequate in-                        In (a), substituted "or" for ~~and except" preceding "as provided" and
structions for those products that are not dispensed in finished                inserted "Of, where applicable, the director of pharmaceutical servjces'~
form.                                                                           following "pharmaelst-in-charge". FormerNJA.C. 13:39-9.16, Records
                                                                                and reports, recodified 10 NJ.A.C. 13:39-9.19.
Reoodified from 13:39-9.6 and amended by R.1994 d.351, effective July           Amended by R.2010 d.090, e!rective June 21, 2010.
  18,1994.                                                                      See; 42 N.J.R. 132(a), 42 NJ.R. 1221(a).
See: 26 NJ.R. 1596(a), 26 NJ.R. 2905(b).                                           In (a). deleted "registered" precoding "phonnacist-in~arge".
Reoodified from N.J.A.C. 13:39-9.10 by R.2005 d.25, effective Januaxy
  18, 2005.                                                                                                 Case Not..
See: 36 NJ.R. 3345(.), 37 NJ.R. 295(a).                                           Violation found due to baving outdated medicalion and "Not to be
  Former NJ.A.C. 13:39-9.14, Drug-dispensing devices, recodified to
N.J.A.C. 13:39-9.17.                                                            Sold" sample medications in prescription area; penalties (also cited as
                                                                                NJA-C. 13:39-9.2). New Jersey State Bd. of Phannacy v. Yanuzzi, 4           (
                                                                                NJ.A.R. 489 (1981).


Supp.6-21-1O                                                              39-42,10
         STATE BOARD OF PHARMACY                                                                                                                 13:39-9.18
                                            ------------~-----

         13:39-9.17     Drug-dispensing devices                                  Amended by R.1999 d.214. elfective July 19, 1999.
                                                                                 See: 31 N.J.R. 1151(a), 31 NJ.R. 1932(3).
            (a) Where the use of a drug-dispensing device is approved              Rewrote the section.
     )   as an integral part of the drug distribution system by the
         filcility, the pharmacist-in-charge and the Pharmacy and Ther-
                                                                                 Recodified from NJ.A.C. 13:39-9.14 and amended by R.2005 d.2',
                                                                                    effective January 18.2005.
                                                                                 See: 36 NJ.R. 3345(a), 37 NJ.R. 295(a).
         apentics Committee, the device may be used when the phar-                  In (b), substituted "immediate personal" for Hdired" preceding "su..
         macist is not on duty (absent during either the day or night),          pervisor of a pharnlllJ:ist"; in (c) and (d), deleted '"direct" preceding
                                                                                 "supervision of a pharmacist"; in (e), substituted "technicians, interns
         provided that any absence of the phannacist does not exceed             and extems" lOr "supportive personnel" following "'authorized pre..
         24 hours, or when the phannadst is on duty, provided that               scriber.; or designated pharmacy": deleted (II). Fonner NJ.A.C. 13:39-
         proper review of the use of the drug-dispensiog device can be           9.17, Drug information and education, recodified to N.I.A.C. 13:39-
         ascertained. The supervision of any drug dispensing device so           9.20.
                                                                                 Amended byR2010 d.090, effective June 21, 2010,
         utilized shall be the responsibility of the pharmacist-in-charge        See: 42 NJ.R. 132(8),42 NJ.R. 1221(a).
         servicing the health care facility. The drug-dispensing device              In (a), (eJ and (S), deleted "registered" preceding "pharmacist-in-
         data shall be checked for accuracy every 24 hours by a phar-            cbarge" throughout; in (b), substituted "by the phartl1ll<:y" for '"in the
                                                                                 fll(;i1itv"· in (e) inserted "health care" and substituted "practitioners n for
         madst and so documented.                                                "physid:m.<:j, a:nhorized prescribers or designated"; in (f1 substi'tuted
                                                                                 "practitioner" for "prescriber"; and in (g), deleted "licensed" preceding
           (b) Packaging and labeling of medication for drug-dis-                "pharmacy'».
         pensing devices, when done by the phannacy, sball be
         performed under the inunediate personal supervision of a                13:39-9.18           Disposal of unused medications
         pharmacist in the employ of or under contract to the facility.
                                                                                   (a) Written policies and procedures governing unused
           (c) Stocking ofthe drug-dispensing devices with prepack-              medications shall be established and implemented by the
         aged medications shall be performed by or under the super-              pharmacist-in<harge and shall comply with the fullowing
         vision of a phannacist.                                                 requirements;

            (d) The cleanliness of the drug dispensing devices shall be                  l. All medications where the drug souree, lot or control
         maintained by a phannacist or by a person under the super-                   number, Or expiration or use by date are missing, shall be
         vision of a phannacist.                                                      sent to the phannacy for fmal disposition, or shall he
                                                                                      dispused of by the health care filcility accordiog to its
             (e) Controlled substances and other medications to which,                written protocol.
         in the professional judgment of the pharmacist-in-charge,
         access should be limited, shall be secured within the drug                      2. If a unit dose packaged medication has been stored
         dispensing device to limit access to single medications only                 in a medication room or secure area in the institution and
         and shall be checked and documented by the pharmacist or                     the medication seal and control number are intact, the
         his or her designee who shall be a licensed health care                      medication may be recycled and redispensed.
         professiona~ every 24 hours. Other than a pharmacist, only
                                                                                         3. Any and all medication returned by out-patients of
         authorized registered nurses, licensed practical nurses, prac-               the facility sball not be redispensed.
         titioners, pharmacy technicians, interns and externs shall have
         access to the medication in each drug-dispensing device. The                    4. The record of disposal of unused or nonadministered
         activity regarding all medication, including the identity of the             dispensed conITolled dangerous substances expended or
         person accessing the medication, shall be recorded and                       wasted either by accident or intent shall be signed and co-
         available to the phannacist.                                                 signed and witnessed by a licensed nurse, physician, or
                                                                                      phannacist, or where allowed by Department of Health and
             (t) All medications withdrawn from a drug dispensing                     Senior Services rules an administrator of the health care
         device require a medication order by an authorized pmc-                      facility, and disposed of by the health care facility accord-
         titioner. All such medication orders shall be checked by the                 ing tu its written protocol and consistent with all local,
         pharmacist within 24 hours from the time of the original order               State and Federal laws and regulations.
         and so noted on the pharmacy's patieut medication profile.
                                                                                 Rec<>d.ified from 13:39-9.6 and amended by R. 1994 d.351. effective July
            (g) Wben there is no pharmacy on the premises and when                  18,1994.
                                                                                 See: 26NJ.R. 15%(8),26 NJ.R. 2905(b).
         the drug-dispensing devices are an integral part of the                 Amended by R. I 999 d.214, effective July 19, 1999.
         approved drug disITibution system of the facility, the devices          See: 31 NJ.R. 1151(8),31 NJ.R.1932(8).
         shall be controlled by the pharmacist-in-charge who is re-                 In (a), substituted a reference ro registeted pharmacists-in-charge for a
                                                                                 reference to pbarmaeists-in-oharge in the introoucrory paragrapb, and
         sponsible for the pharmaceutical services of the institution.           rewrote   I and 4.
         Under these circumstances, the time between medication                  Recodified from NJ.A.C. 13:39-9.15 and amended by R.2005 d.l',
         order checks shall not exceed 24 hours.                                   effective January 18,2005.
                                                                                 See: 36NJ.R. 334'(8), 37 NJ.R. 295(a).
         Recodified from 13:39-9.6 and amended by R.1994 d.351, effective July      In (al, inserted "lot or' following "drug soorce" and inserted "oc use
           18,1994.                                                              by" following «expiration't~ in I and rewrote 4. Former N.J.A.C. 13:39-
,        See: 26 N.1.R. 1596(0),26 NJ.R. 2905(b).                                9.18, After boUTS access to the institutional pharmacy, recodified to
\.                                                                               N.J.A.C. 13:39-9.21.


                                                                           39-42.11                                                           Supp.6-21-10
13:39-9.18                                                                                                   LAW AND PUBLIC SAFETY

Amended by R,2010 d,09O, effective June 21, 2010,                           most recent one year of infono.tion shall be relnevable
See: 42 N,J,R. 132(a142 NJ.R. 1221(0).
  In the introdu<tory pIlragraph of (a), deleted "registered" preceding
                                                                            and readable within one business day.
"phannacist-in-ch"'ll"".                                                     (c) All outpatient prescriptions dispensed and outpatient
                                                                          profile records in the institutional phannacy shall confono to
13:39-9.19      Records and reports                                       the requirements set forth in N.J.A.C. 13:39·7.6,
   (a) Records of the pharmaceutical services of the provider
                                                                             (d) Records for receipt, use and final disposition of con·
pharmacy for the facility shall be the responsibility of the
                                                                          trolled dangerous substances shall be maintained by the insti-
pharmacist-in-charge. On or after April 5, 20 II, a pharmacy
                                                                          tutional pharmacy in compliance with the requirements of
shall maintain an audit trail that records and documents the
                                                                          Federal and State controlled dangerous substances laws and
unique and secure user identifier(s) of the pharmacist(s),
                                                                          regulations. Nursing administration and audit records for COn-
pharmacy technician(s), intem(s) or extem(s) performing the
                                                                          trolled dangerous substances shall be available for review by
component functions of prescription handling, as dermed in
                                                                          the pharmacy.
N.J.A.C. 13:39-4.18, which are required to be performed by a
pharmacist, pharmacy technician, intern or extern pursuant to                (e) Records of the receipt, dispensing and disposal of in-
the requirements of this chapter, All steps perfunoed by a                vestigational drugs shall be maintained by the institutional
pharmacy technician, intern or extern shall be documented in              pharmacy in compliance with Federal and State laws and
the audit trail. All entries to the audit trail made by a                 regUlations.
pharmacy technician, inlern or extern shall be reviewed and
approved by the pharmacist. When more than one pharmacist                    (t) The phanuacist-in-charge shall be responsible for
is involved in the component functions of prescription                    maintaining a system by which all reported adverse drug
handling. the unique and secure user identifier(s) of the pharo           reactions are recorded and reviewed by the Pharmacy and
macist(s) responsible for the accuracy and appropriateness of             Therapeutics Committee, where applicable, and are submitted
each component function(s) shall be recorded in an audit trail.           to all appropriate State and local agencies consistent with
Audit trail documentation shall be generated at the lime the              State and local laws and regulations.
component function(s) is perfonned, All audit trail and medi-
                                                                          Recodified from 13:39-9.7 and amended by R.1994 d.35 t, effective July
cation order infonnation shall be maintained or stored in                    18,1994,
original hard copy fono or in any other media that filcilitates           See: 26 NJ.R. 1596(.),26 N.l.R. 2905(b),
the reproduction of the original hard copy and shall be                   Amended by R.1999d.214, effective July 19, 1999.
maintained for a period of not less than five years. The oldest           See: 31 N,J,R. 1151(.),31 Nl.R. 1932(0).
                                                                             In (a) and (I), substitured references to registered phannacists-in-
four years of infonnation shall be maintained in such a                   ch"'ll" for rel\lrences 10 phanllllci,ts-in-charge; in (-1 substituted •
manner so as to be retrievable and readable witbin two weeks.             reference to statutes and regulations for a reference to la\\'S; and in (f)~
The most recent one year of information shall be retrievable              deleted a fanner second sentence.
                                                                          Recodified from NJ.A.C, 13:39-9,16 and .mended by R,2oo5 d.2S,
and readable within one business day. Records not currently                  effective January 18,2005,
in use need not be stored in the phannacy, but off·site                   See: 36 NJ,R. 3345(0), 37 N.l.R. 295(0).
facilities used to store such records shall be secure. Patient               Rev.rote (0), (b), (I), Fonner N.J,A.c' 13:39-9.19, Advisory com-
records shall be kept confidential, but shall he made available           minees, recodified 10N.l,A.C, 13:39-9,5.
                                                                          Amended by R.2009 <1.305, effective October 5, 2009,
to persons authorized to inspect them under State and Federal             See: 40 N.l.R. 5170(0), 41 N.l.R. 3840(0).
statutes and regulations,                                                    Rewrote (a) and (e); in (b)I, delered "the initials of the phannacisl
                                                                          performing the dispensing or supervising;" preceding tithe reportetf', and
  (b) The pharmacy shall maintain a patient profile record                inserted H comma following "diagnosisll ; and in (b)3. deleted "imme-
for each patient receiving drug therapy in accordance with                diately" preceding the last occurrence of "retrievable", and inserted
                                                                          "within one business day"',
N.J.A.C. 13:39-7.19 and as follows:                                       Amended by R.2010 d,09O, effective June 2t, 2010.
                                                                          See: 42 NJ.R. 132(0), 42 NJ,R, 1221(0),
     I , The profile records for inpatients shall contain: the               In (0) ecti (I), delered "registered" preceding "phannacist·in-cl!arge",
  date of eacb entry; the name; sex; age or birlhdate; location
  of the patient; the drug narne, dose, route of administration           13:39·9.20       Drug information and education
  and quantity dispensed; the reported diagnosis, allergies
                                                                             (a) The pharmacist-in-charge shall be responsible for
  and chronic condition(s) of the patient.
                                                                          maintaining drug standards, references and sources of drug
     2. All notations made on the inpatients' profile records             information current and adequate to meet the needs of the
  by pharmacy technicians, interns and externs shall be veri-             pharmacists, physicians, nurses, other health care personnel,
  fied and countersigned, either manually or electronically.              and patients of the facility. Reference texts shall include, but
  by the supervising phannacist.                                          not be limited to, those required by the Board under N.J.A.C.
                                                                          13:39-5.8.
     3. The inpatient profile record shall be filed and stored
  for five years following patient discharge, The oldest four               (b) On each patient care unit, the phannacist shall maintain
  years of infonnation shall be maintained in such a manner               the following:
  so as to be retrievable and readable within two weeks. The


Supp.6-21-1O                                                        39-42.12
STATE BOARD OF PHARMACY                                                                                                                      13:39-9.22

       I. A copy of the current institutional fonnulary;                             6. The signature of the nurse.
      2. A reference drug compendium which will give basic                       (e) The phannacist-in-charge shall obtain with the record
   information concerning drugs approved by the Phannacy                       in (d) above the container from which the required dose{s)
   and Therapeutics Committee; and                                             was taken for drug administration purposes in order that it
     3. The telephone number of either the local or regional                   may be properly checked by a phannacist.
   poison control center.                                                         (1) All records in (d) above shall be maintained or stored
  (c) The pharmacist shall participate in the drug education                   in original hard copy form or in any other media that fa-
programs of the fucility.                                                      cilitates tbe reproduction of the original hard copy, and shall
Recodified from 13:39-9.8 by R.1994 d.3SI. effective July 18, 1994.
                                                                               be kept by the phannacy for five years. The oldest four years
See; 26 N.J.R. 1596(0), 26 NJ.R. 2905(b).                                      of infonnation shall be maintained in such a manner so as to
Amended by R.1999 d.214, effective July 19, 1999.                              be retrievable and readable within two weeks. The most re-
See: 31 NJ.R.IISI(a),31 NJ.R.1932(0).                                          cent one year of information shall be retrievable and readable
   In (8), substituted a reference to registered pharmacists-in-cbarge for a
reference to pharmacists-in-<harge; and in (b), deleted a former I, •          within one business day. Records not currently in use need
recodified former 2 illrough 4 as I illrough 3.                                not be stored in the phannacy, but off-site facilities used to
Recodified from N.l.A.C. 13:39-9.17 and amended by R.200S d.25.                store such records shall be secure. Patient records shall be
   effective lanuary 18, 200S.                                                 kept confidential, but shall be made available to persons
See: 36 NJ.R. 3345(0), 37 Nl.R. 295(a).
   In (a), amended the Nl.A.C. reference. Fonner NJ.A.C. 13:39-9.20,           authorized to inspect them under State and Federal statures
Pharmacy and 1'hcrapeutics Committee, recodified to N.1.A.C. 13:39-            and regulations.
9.6.
Amended by R.20JO d.090, effective JWlC 21, 2010.                              Recodified from 13:39-9.9 and amended by R.1994 d.351. effe<tive July
See: 42 N.J.1t 132(0),42 N.J.1t 1221(a).                                          IS, 1994.
  In (a), deleted "registered" preceding ''pbarmaeist-in-<harge''.             See; 26 Nl.R. 1596(8),26 N.1.1t 2905(b).
                                                                               Amended by 11.1999 d.214, effeeliveJuly 19, 1999.
                                                                               See: 31 Nl.R. 1151(8),31 NJK 1932(0).
13:39-9.21       After hours access to the institutional                          Rewrote (b) and (e); in (d) and (e), substituted references to registered
                 pharmacy                                                      pbatmacists-in.-ch.arge for references to phannaeists~jn~cbarge~ and in
                                                                               (e), substituted a reference to required doses for a reference to single
   (a) Only a phannaeist shall have access to the phannacy                     doses.
stock of controlled dangerous substances in Schedules II                       Reoodified from NJ.A.C. 13:39-9.18 and amended by R.2005 d25,
through V.                                                                        effective January 18, 2OOS.
                                                                               See: 36 N.J.R. 3345(a), 37 NJ.R. 295(0).
   (b) Only a phannacist shall have access to the institutional                   Rewrote (t). Fonner N.J.A.C. 13:39-9.21, Institutional pharmacy
                                                                               stall; recodifled to NJ.A.C. 13:39·9.7.
phannacy except that in a phannacist's absence from an insti·                  Amended by R.2oo9 d.305, effective Oetober S, 2009.
tution, a registered nurse designated by the registered phar-                  See: 40 N.J.R. 5170(a), 41 N.J.1t 384O(a).
macist-in-charge may obtain medication from the hospital                          Rewrote (I).
                                                                               Amended by R.2010 d.09O, effective June 21, 2010.
phannacy as needed in an emergency and not available as                        See: 42 N.J.R. 132(a), 42 NJ.R. 1221(a).
floor stock.                                                                      In the inttOOuctory paragrapb of (d) and in (0), substituted
                                                                               '"phannaejst~in*'Charge" for "registered pharmacist in charge".
   (c) A designated registered nurse shall remove only those
medication doses which shall be administered prior to the                      13:39-9.22       Pharmacy facilities; space
opening of the phannacy. The designated registered nurse
may remove the following from the phannacy stock of drugs                        (a) Adequate filcilities (space, lighting, equipment, temper-
or automated dispensing device:                                                ature control and supplies) shall be provided for the control of
                                                                               the professional, techoical and administrative funetions of the
    L A drug in its original container or a drug pre-                          institutional pharmacy as needed for the effective and effi-
  packaged by the phannacy for use in the institution;                         cient assurance of patient safety through proper purchasing,
    2. The required dose(s) of a drug from the original                        receipt, storage, dispensing, administration and control of
  container for a specific patient.                                            drugs.
   (d) The phannacist·in-charge shall obtain from the reg-                       (b) The fucilities shall include, but are not limited to, those
istered nurse on a suitable fonn a record of any drugs re-                     requirements provided in N.J.A.C. 13:39-5.4 through 5.&.
moved showing the following:
                                                                               Recodified from 13:39-9.15 by R.1994 d.351, effective July 18, 1994.
       L   The name of the drug;                                               See; 26 NJ.R. 1596(a), 26 NJ.R. 2905(b).
                                                                                  In (a), substiMed references to registered phannacists-in",harge for
       2. The dosage size;                                                     references to pharm~"in~charge in I and 2, substituted a reference to
                                                                               certified preceptors for a reference to qualified preceptors and inserted •
       3. The amoUllt taken;                                                   refen:nc<l to faculty preceptors in 3, and added 4.
                                                                               Recodified from N.I.A.C. 13:39-9.24 and amended by R.2OOS d25,
       4. The date;                                                               effective 1anuary 18,2005.
                                                                               See: 36 N.J.1t 3345(8),37 NJ.R. 295(0).
       5. The patient's name and location; and                                    In (b), amended N.J.A.C. reference. Fonner NJ.A.C. 13:39-9.22,
                                                                               Pharmacist stall; repealed.


                                                                         39-42.13                                                         Supp.6-21-1O
13:39-9.22                                                                                                           LAW AND PUBLIC SAFETY

Amended by R20 10 d.09O. effective June 21, 20 10.                              Recodified from N.lAC. 13;39-9.25 and amended by R2005 d.25,
See; 42 Nl.R 132(a). 42 NJ.R. 1221(a),                                             effective January 18,2005.
  Deleted (e).                                                                  See: 36 N.l.R 3345(0), 37 NJ.R 295(a}.
                                                                                   In (a), rewrote 3, substituted "drug ll1lIllufacturer" for "United States
                                                                                PharmacopoeiallNational Fonnulory" in 4, and deleled 5; added (b) and
13:39-9.23       Storage and seeurity                                           (e). Former N.l.A.C. 13:39-9,23, "Supportive personnel statrlllg was
                                                                                rosen,ed.
  (a) Provisions shall be made for adequate safe storage of                     Amended by R201 0 d.09O, effective June 21, 2010.
drugs wherever they are stored in the health care facility.                     See: 42 NJ.R 132(a), 42 NJR 122I(a).
                                                                                   In (a)3 and (e), deleted "registered" preceding "pbarmacist-in-
      I. All drugs shall be secured for safe use and protected                  charge"; in (a)3, deleted ", that is, tile drugs in tile pbarmacy orea, drugs
   against illicit diversion. Controlled dangerous substances in                in transit. and the drugs in the patient C8J"e areas~' following "'facilitytt-;
                                                                                and in (b), inserted "proper storage,". deleted "dispensed for use"
   !be institutional pharmacy and throughout tbe facility shall                 foHQwing the 5e\:':ond occurrence of ""drugs" und substituted "or'! for ",
   he stored and protected in conformance with State and                        except fOf hospitals, where tIley can also be prepared and signed"
   Federal laws and regulations,                                                following "inspecting phannacist".

     2. Supplies of external preparations stored in patient                     13:39-9.24       Equipment
   care areas shall he kept separate from internal medications.
                                                                                  Adequate equipment shall be provided for the compound-
     3, The phannacist-in-charge or, where provided for in                      ing, packaging, labeling, refrigeration, sterilization, testing
   Department of Health and Senior Services rules, the                          and sare distribution of drugs and other functions.
   director of phannaceutical services shall be responsible for
   all the medications in the facility.                                         R<=dified from 13;39-9.17 by R.1994 d,351, effective July 18, 1994.
                                                                                s.:e: 26 NJ.R 15%(0),26 NJ.R. 2905(b).
     4. The drugs throughout the facility shall be maintained                   Amended by RI999 d.214, effective July 19, 1999.
                                                                                See: 31 NJ.R 1151(.),31 NJ.R 1932(.).
   under adequate storage conditions including proper light-                       Deleted 3 reference to biologicals.
   ing, ventilation and temperature control as required by the                  Recodified from NJ.A.C. 13:39-9,26 by R,200S d.25, effective January
   drug manufacturer.                                                              18,2005.
                                                                                See; 36 NJ.R, 3345(a). 37 NJ.R 295(3).
   (b) The phannacist-in-charge or, where provided for in                          Fonner NJAC. 13:39-9.24, Pbarmacy facilities; space, reoodified 10
Department of Health and Senior Services rules, the director                    NJ.A.C. 13:39-9.22.
                                                                                Amended by R2010 d.090, effective lund I , 2010.
of pharmaceutical services shall establish a system of control                  See: 42N.J.R 132(a),42N.J.R, 1221(a).
for all drugs dispensed for use in the drug therapy of patients                    Deleted tbe last sentence.
of the facility. Inspections shall be conducted of all medi-
cation areas located in the facility or any other service area of               13:39-9.25       Institutional decentralized pharmacies
the facility at least once every two months to check for
expiration or use by dates, proper storage, misbranding,                          (a) An institutional decentralized pharmacy or a "satellite
physical integrity, security and accountability of all drugs.                   pharmacy", means an area within a health care system that
These inspections shall be fully documented. Written inspec-                    has been issued an institotional pennit and is in a location
tion reports shall he prepared and signed by the inspecting                     other than the original permitted location, where the prep-
pharmacist or by the pharmacy technician, intern or extern                      aration or dispensing or compounding of medications is
and co-signed by his or her supervising pharmacist. The                         performed.
phannacist-in-charge shalJ he responsible for ensuring that,                      (b) Medication shall not be dispensed from a decentralized
prior to performing any inspections pursuant to this subsec-                    pharmacy without a phannacist present, except that, when the
tion, pharmacy technicians, interns and externs are trained                     decentralized pharmacy is closed, a licensed nurse may
and can successfully demonstrate competency. Procedures for                     dispense medication in accordance with the written policies
the review of these reports shall be developed and instituted                   and procedures of the institution.
by the pharmaeist-in-cbarge and can be incorporated into the
overall quality assurance program of !be health care facility.                     (c) Institutions operating decentralized pharmacies shall
                                                                                notifY the Board, in writing, of the existence of, and Ihe
  (c) Procedures shall be established to assure the immediate                   discontinuation of, each decentralized pharmacy location.
and efficient removal of aU outdated and recalled drugs from
patient care areas and from the active stock of the phannaey.                      (d) Institutional decentralized pharmaCies sball be subject
The phannacist-in-charge shall develop written policies and                     to normal Board inspections.
procedures governing the removal from the liIcility of
outdated or recalled drugs.                                                        (e) Inspections of all medications in a decentralized insti-
                                                                                tutional pharmacy sball be performed consistent with the
ReCodified from \3;39·9.16 by R.1994 d.351, effective July 18, 1994.            requirements ofN.I,A.C. 13:39-9.23,
See: 26 Nl.R, 1596(.), 26 Nl.R 2905(b).
Amended byR,1999 d214,effective July 19, 1999.                                    (f) Institutional decentralized pharmacies shall comply
See: 31 NJ.RI151(a).31 N.J,RI932(a).
    In (a)3. substituted a reference to registered pharmacists~in--charge for   with all requirements in Ibis subchapter applicable to the
8: reference to pharmacists ..ln-charge.                                                                                                                          \.


Supp.6-21-IO                                                              39-42.14
    STATE BOARD OF PHARMACY                                                                                                                  13:39·10.2
                                          ----~-



    pharmaceutical services provided by the decentralized phar-                  (e) It shall be deemed professional misconduct for a phar-
    macy, as determined by the pharmacist-in-charge.                          macist to use a technologic",l device in order to circumvent
                                                                              his or her responsibilities with regard to documenting, au-
)   Recodified from 13;39-9.18 by R.1994 d.351, effective July 18, 1994.
    See: 26 NJ.R. 1596(0).26 NJ.R. 2905{b).                                   thenticating and verifying medication orders and prescriptions
    Amended by R.1999 d.214, effective July 19, 1999.                         or in order to circumvent other standards of pharmacy
    See: 31 NJ.R 1151(0),31 NJ.R. 1932(0).                                    practice.
       Rewrote (d)!.
    RecudirJed from N.J.A.C 13:39-9.27 and amended by R.200S d.2S,              (I) No licensee or permit holder registered under N.l.SA
       effuctive January 18, 2OOS.
    See; 36 N.J.R. 3345(0), 37 N.l.R. 295(0).                                 45: 14-40 et seq. shall under any circumstances provide a
       Rewrote the section. Former N.J.A.C. 13:39-9.25. Storage and           technological device to, or accept a technological device
    securily, recudified to NJ.A.C. 13:39-9.23.                               from, any practitioner licensed to write prescriptions.
    Amended by R.2010 d.09O, effective June 21, 2010.
    See: 42 NJ.R. 132(0), 42 N.J.R. 1221(0).                                     (g) No licensee or permit holder shall enter into any
       In (f), deleted "registered" preceding "phannaci,t-in-<:harge".
                                                                              agreement with an authorized practitioner which denies the
                                                                              patient the right to bave his or ber prescription transmitted by
    13:39·9.26      Valid medication orders; out-of-State
                                                                              technological device to a pharmacy of the patient's choice.
                    medication orders
                                                                              New Rule, R.I992 d.I66, elTective April 6, 1992.
       (a) Only medication orders issued by a practitioner li-                See; 23 N.l.R. 2469(0), 24 N.J.R. 1371(0).
    censed to write medication orders in the United States or any             Amended by RI999 d.214, effi:ctive July 19, 1999.
    territory of the United States shall be considered valid medi-            Sec: 31 NJ.R.lISI(a). 31 N.l.R. 1932(0).
    cation orders and such medication orders shall be filled                     In (c), ndded the last sentence.
                                                                              Amended by R.2003 d.373. effective September 15, 2003.
    pursuant to New Jersey law.                                               Sec: 34 N.l.R. 3064(.), 35 NJ.R. 4290(0).
                                                                                 In (b), del.led "at 0 retail pharmacy and • registered pharmacist"
      (b) Medication orders, other than those listed in (a) ahove,            preceding "flUing prescriptions".
    shall not be filled by a pharmacy in New Jersey.                          Reendified Cram NJ.A.C 13:39-5.8 and amended by R.2005 d.25.
                                                                                 effective January 18,2005.
    New Rule, R200S d.25, effective January 18.2005.                          See: 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
    See: 36 N.J.R. 3345(0), 37 N.l.R. 295(0).                                    In (b), substituted "eligible outpatients" for "out-patients who arc
      Fonner N.l.A.C. 13:39-9.26, Equipmen~ recodified to N.J.A.C.            treated by staiT members of the institution in their respective clinics, as
    13:39-9.24.                                                               pennitled p\llll\lll!lt to N.l.S.A.4S;14-32" following "institution and their
    Amended by R.2010 d.090, effective June 21, 2010.                         dependents and for" in the introductory p'ragnlph and amended the
    See: 42 NJ.R. 132(0), 42 N.J.R. 1221(0).                                  N.J.A.C. reference in I; in (e). amended the N.J.A.C. referen<... and
      In (a). substituted "a practitioner" ror "'an authorized prescriber",   inserted "or fur direct administration to patients by parental. intrnven~
                                                                              intnunuscul8J'+ subcutaneous or intraspinal infusion" fbllowing'1\ospice
                                                                              patients". Former NJ.A.C. 13:39·9.27, Institutional decentraltred phar-
    13:39-9.2.7    Prescription. and medication orde ...                      macies, recodified to NJ.A.C 13:39-9.25.
                   transmitted by technological devices in an                 Amended by R2010 d.09O, effective June 21, 2010.
                   institution                                                See: 42 NJ.R. 132(0), 42 N.J.R. 1221(a).
                                                                                 Rewrote (b); in (c), deleted "registered" pr«eding "pharmacist", and
       (a) A pharmacist may, subject to the conditions set forth in           deleted the last sentence; and in (I), updated the N.l.S.A. reference.
    this section, accept for dispensing a prescription or a medi-
    cation order transmitted by a fu.csimile (FAX) machine or
    other technological device as approved by the Board.
                                                                              SUBCHAPTER 10. AUTOMATED MEDICATION
      (b) A pharmacist filling prescriptions under an institutional               SYSTEMS
    permit for employees of the institution and their dependents
    and for eligible outpatients may accept for dispensing pre-               13:39-10.1       Purpose and scope
    scriptions for all substances consistent with the requirements               The rules in this subchapter establish standards applicable
    ofN.J.A.C. 13:39-7.10 and 7.11.                                           to all pharmacies and/or facilities that utilize automated medi-
       (c) A pharmacist who is authorized to fill inpatient medi-             cation systems to store, package, dispense and distribute pre-
    cation orders, as defIned in NJ.A.C. 13:39-9.2, in an insti-              scriptions or medication orders.
    tutional pharmacy may accept all inpatient medication orders.
    including orders for Schedule Il substances, which have been              13:39-10.2       "Automated medication system" definition
    transmitted by technological device.                                         As used in this subchapter, "automated medication system"
                                                                              means any process that performs operations or activities,
        (d) Whenever a pharmacist has reason to question the
                                                                              other than compounding or administration, relative to the
    accuracy or authenticity of a prescription or medication order
                                                                              storage, packaging, dispensing and distribution of medica-
    transmitted by technological device, the pharmacist shall
                                                                              tions, and which collects, controls and maintains all transac-
    verify the transmission directly with the prescribing prac-
                                                                              tion information. "Automated medication system" does not
    titioner.
                                                                              mean an automatic counting device operated purS\Jllllt to



                                                                        3942.15                                                          Supp.6-21-1O
13:39-10.2                                                                                               LAW AND PUBLIC SAFETY
                                                                ---------------------
N.JAC. 13:39-5.9 or a mechanical drug dispensing device                    5. Ensuring compliance witb all applicable provisions
operated pursuant to N .J.A. C. 13 :39-9.17.                             ofN.J.A.C. 13:39.
Amended by R,2009 d.305, effective October 5,2009.                    Amended by R.200S d.25, effective Januasy 18, 2005.
See: 40 NJ.R. 5110(8), 41 NJ.R, 384O(a).                              See: 36 N.J.R. 3345(a), 37 NJ.R. 295(0).
  Substituted "automated" for the fIrst occurrence of «Automated"'.      In (b), inserted "or use by" followlng "for expiratioo" in 2.
"NJ.A.C. 13:39-5.11" ror "N.JAC. 13:39-7.11", and "NJ.A.C. 13:39-     Amended by R,2010 d.09O, effective June 21,2010.
9.17" for "N.JAC. 13:39-9.14".                                        See: 42 NJ.R. 132(a),42 N.J.R, 1221(3).
Amended by R,20 10 d.09O, effective June 21, 2010.                       Rewrote {.)I and (a)2 and the introduCWry paragrapb of (b); in (8)4,
See: 42 NJ.R. 132(8),42 N.J.R, 1221(8).                               inserted "'self..jns~tion and/or the"; and in (b)2, substituted ~once every
   UpdaJed the r""t NJ AC. reference.                                 tw1) months" fur 'monthly" twice.



13:39-10.3     Authority to use automated medication                  13:39-10.4      Written policies and procedures of operation
               system                                                   (a) When an automated medication system is used to fill
   (a) A phannacy may use an automated medication system              prescriptions or medication orders, it shall be operated ac-
to fill prescriptions or medication orders provided that:             cording to written policies and procedures of operation. The
                                                                      policies and procedures of opcration sball:
     I. The pharmacist·in·charge shall be responsible for
  the supervision of the operation of tbe system, or in the                  1. Include a table of contents;
  case of an automated medication system utilized at a                       2. Include a description of all procedures of operation;
  location with no on-site pbannacy, the pharmacist-in-
  eharge of the provider phannacy shall be responsible for                  3. Set forth methods that shall ensure retention of each
  the supervision ofth. operation ofthe system;                          amendment, addition, deletion or other change to the
                                                                         policies and procedures of operation for at least two years
     2. The pharmacy has conducted a self-inspection of the              after the change is made. Each such change shall be signed
  automated medication system documented on a furm pro·                  or initialed by the phannacist·in-charge and shall include
  vided by the Board and has submitted the self-inspection to            the date on which the pharmacist-in-charge approved the
  the Board;                                                             change;
     3. The automated medication system has heen tested by                  4. Set forth methods that shall ensure that a phannacist
  the pharmacy and fOWid to dispense accurately. The phar-               currently licensed in the transmitting jurisdiction reviews
  macy shall make the results of such testing available to the           and approves the transmission of each original or new
  Board upon request; and                                                prescription or medication order to the automated medica-
     4. The pharmacy has made the automated medication                   tion system before the transmission is made;
  system available to the Board for the purpose of inspection,                5. Set forth methods to identify the quality control
  whereby the Board may validate the accuracy of the self·                 measures in place to ensure the accuracy of the final
  inspection and/or of the system.                                         dispensed product;
   (b) The pharmacist-in-eharge shall be responsible for the                6. Set furth methods that sball ensure that access to the
following:                                                               records of medications and otber medical information of
                                                                         the patients mainlained by the pharmacy is limited to
     1. Reviewing and approving all policies and procedures
                                                                         licensed practitioners or personnel approved to have access
  for system operation, safety, security, accuracy and access,
                                                                         to the records, fur the purpose of complying with N.J.A.C.
  patient confidentiality and prevention of unauthorized ac-
                                                                         13:39-7.19;
  cess and malfunction;
                                                                             7. Set forth methods that shall ensure that access to the
     2. Ensuring that medications in the automated medica-
                                                                           automated medication system for stockiog and retrieval of
  tion system are inspected, at least once every two months,
                                                                           medications is limited to licensed practitioners or qualified
  for expiration or use by date, misbranding and physical
                                                                           pharmacy technicians, interns and externs Wider the super-
  integrity, and ensuring that the automated medication
                                                                           vision of a pharmacist. An accountability record, which
  system is inspected, at least once every two months, fur
                                                                           documents all transactions relative to stocking and remov·
  security and accountability;
                                                                           ing medications from the automated medication system
    3. Assigning, discontinuing or changing personnel ac-                  shall be maintained; and
  cess to the automated medication system;
                                                                              8. Identify the circumstances under which medications
     4. Ensuring that the automated medication system is                   may be removed from the automated medication system by
  stocked accurately and an accounlability record is main-                 a licensed practitioner for distribution to a patient without
  tained in accordance with tbe written policies and pro-                  prior order review by a pharmacist
  cedures of operation; and
                                                                         (b) A phannacy whicb uses an automated medication sys-                     i,
                                                                      tern to fill prescriptions or medication orders shall, at least


Supp.6-21-10                                                    39-42.16
    STATE BOARD OF PHARMACY                                                                                                          13:39-11.1

    annually, review its written policies and procedures of oper-                   4. Requires the plumnacy to report to the Board each
    ation and revise !hem ifneeessary.                                           recurring error of the automated medication system. A "re-
                                                                                 curring error," for purposes of this section, means any spe-
)      (c) A copy of !he written policies and procedures of oper-                cific type of inaccuracy within the automated medication
    ation adopted pursuant to this section shall be retained at the              system that occurs more than twice within a 14 day period;
    plumnacy and at the healthcare facility where the automated                  and
    medication system is utilized. Upon request, the pharmacy
    shall provide to the Board a copy of the written policies and                   5. Requires Ibe plumnacy to maintain all documen-
    procedures of operation for inspection and review.                           tation relating to the written program for quality assurance
                                                                                 for at least two years.
    Amended by R.2009 d.305, elrective October 5, 2009.
    See: 40NJ.R 5170(0), 41 NJ.R.3840(0).
       In (a)5, substituted "NJ.A.c. 13:39-7.19" for "NJ.A.C. 13:39-           13:39-10.7    Written plan for recovery
    7.14(h)".
    Amended by R.2010 d.09O, effective June 21, 2010.                             (a) A pharmacy which mes an automated medication sys-
    See: 42 N.I.RI32(a),42 N.J.R. 1221(0).                                     tem to fill prescriptions or medication orders shall maintain a
       In (a)3, substituted "phwmacis.-in-<harge" for "registered pbsnnacist   written plan for recovery from a disaster which interrupts the
    in cbarge" twice; added new (0)5; recedified former (a)5 through (a)7 as
    (0)6 through (0)8; in (a)7 and (.)8, deleted "registered" preceding
                                                                               ability of the pharmacy to provide services. The written plan
    "pharmacist"; and in (a)7, substituted "pbwmacy technicians, interns and   for reeovery shall include:
    extems" for "support petSOnDel acting'" and inserted a comma follov.-ing
    "record".                                                                       I. Planning and preparation for a disaster;
                                                                                    2. Procedures for response to a disaster;
    13:39-10.5      Personnel training requirements
       The pharmacist-in-<:harge sball be responsible for ensuring
                                                                                   3. Procedures for the maintenance and testing of the
                                                                                 written plan for recovery; and
    that, prior to performing any services in conneetion with an
    automated medication system, all pharmacists and pharmacy                       4. A procedure to notify the Board, each organization
    teebnicians, interns and externs are trained in the pharmacy's               which has contracted with the pbarmacy, each patient of
    standard operating procedures with regard to automated med-                  the pharmacy, and other appropriate agencies, of a disaster
    ication systems as set forth in the written policies and                     and the date on wbich the pharmacy expects to reeom·
    procedures of operation maintained pursuant to N.J.A.C.                      menee the provision of service.
    13:39-10.4.
    Amended by R.2005 d.2S, eifedive January 18,2005.                          13:39-10.8    Written program for preventative
    See: 36 NJ.R. 334S(a), 37 NJ.R. 295(8).                                                  maintenance of automated medication
      Substituted "pharmacy technicians, interns and extems" for '"'-sup..                   system
    portive persoll.llel".
    Amended by R.2010 d.09O, effective lune 21, 2010.                            A pharmacy which uses an automated medication system
    See: 42 N.J.R. 132(.),42 N.I.R. 1221(0).                                   to fill prescriptions or medication orders shall maintain a
      Substituted "phannacist-in-charge" for "registered pbwmacis' in
    cbargeu and ~pharmac.ists·' for "licensed practitioners",                  written program for preventative maintenance of the system.

    13:39-10.6      Written program (or quality assurance
      (a) A pharmacy which uses an automated medication sys-                   SUBCHAPTER II. COMPOUNDING IN RETAIL AND
    tem to fill prescriptions or medication orders shall operate                   INSTITUTIONAL PHARMACIES FOR STERILE
    according to a written program for quality assurance of the                    AND/OR NON-STERILE PREPARATIONS
    automated medication system which:
                                                                               13:39-11.1    Purpose and scope
        I. Requires continuous monitoring of the automated
      medication system;                                                          This subchapter shall apply to all retail and institutional
                                                                               pharmacies which compound and dispense sterile and/or non-
         2. Establishes mechanisms and procedures to tes! the                  sterile preparations.
      accuracy of the automated medication system at least every
      six months and whenever any upgrade or cbange is made to                 Amended by RI998 d.297, effective Iune 15, 1998.
      the system;                                                              See: 29 N.1.R. 2246(0), 30 NJ.R. 2255(0).
                                                                                 Rewrote the section.
                                                                               Amended by R2005 d.25, etrective January 18,2005.
         3. Establishes a protocol for measuring the effective-                See: 36 N.J.R. 3345(8),37 N.J.R. 295(0).
       ness ofthe automated medication system;                                   Rewrote the section.




    Nelt Page is 39-43                                                   39-42.17                                                  Supp.6-21-10
        STATE BOARD OF PHARMACY                                                                                                 13:39-11.5

        13:39-11.2 DellnltioDS                                                 Former NJ.A.C. 13;39-11.5, Information required 10 appear 00
                                                                             prescription label, was rerodiJied to NJAC. 13:39-11.11.
          The following words and terms, when used in this sub-
    )   chapter. shall have the following meanings:
                                                                             Reoodif1ed from NJAC. 13:39-11.5 and amended by R.2OO5 d.25,
                                                                               effective January 19~ 2005.
                                                                             See: 36 NJ.R 3345(0).37 NJ.R. 295(0).
          "ISO class 5 air quality conditions" means conditions in             Rewrote the section. Former NJ.A.C. 11:39-11.4, Complialla; re-
                                                                             pealed.
        which the air particle count is no greater than a total of
        3,520 particles of 0.5 micrometers and larger per cubic
        meter of air (100 particles per cubic foot).                         13:39-11.5   Pharmacist in charge and permitbolders'
                                                                                          responsibilities
          "ISO class 6 air quality conditinns" means conditions in
                                                                                (a) The pbarmacist-in-charge shan supervise all sterile
        which the air particle count is no greater than a total of
                                                                             and/or non-sterile compounding. For purposes of supervis-
        35,200 particles of 0.5 micrometers and larger per cubic
                                                                             ing sterile compounding, the pharmacist-in-dlarge shaJl be
        meter of air (1,000 particles per cubic foot).
                                                                             trained in aseptic manipulation skills.
          "ISO class 7 air quality conditions" means conditions in
        which the air particle count is no greater than a total of              (b) The pharmacist in charge shall bave the responsibility,
        352,000 particles of 0.5 micrometers and larger per cubic            in tbat section of tbe pharmacy where sterile andlor non·
        meter of air (10,000 panicles per cubic foot).                       sterile preparations are compounded, for, at a minimum, the
                                                                             following:
        New Rule, RI998 d.297, effective June 15, 1998.
        See: 29 N.J.R. 2246(0), 30 NJ.R. 2255(0).                                  1. Compounding of an preparatinns within the phar·
          Former NJAC. 13:39-11.2, Training requ.uements, was reoodiIied        macy or pharmacy satellite, including compounding of
        10 NJAC. 13:39-11.7.
        Amended by RZOO5 d.25, effective Jannary 18, 2005.                      individual medication orders or prescriptions, tbe fOrDm-
        See: 36 NJ.R. 3345(0), 37 NJ.R 295(0).                                  lation of products in response to special drug needs and
          Rewrote the .ection.                                                  batch compounding;

        13:39-11.3 Sterile and non-llterile preparation servK:es;                 2. Storage of all materials pertinent to tbe compound-
                   environment                                                  ing of preparations, including d.rugs, chemicals and bio-
           (a) A sterile preparation service is ODe specializing in the         logicals, and the establishment of specifications for pro-
(       compounding and dispensing of sterile preparations upon                 curement of tbe materials in accordance with State and
                                                                                Federal laws and regulatinns;
        receipt of a valid prescription or medication order. Such
        compounding shall take place in the confines of a controUed                3. Ensuring that an packaging and labeling of aU
        environment as required by N.J.A.C 13:39-11.16; or when                 drugs compounded with the pharmacy are performed
        circumstances permit as set forth in NJ.AC. 13:39-11.1l(c),             under tbe immediate personal supervision of a pharma-
        in a laminar bood, as provided bY N.I.AC. 13:39-11.22, or               cist;
        in a glove box, as provided by N.J.AC. 13:39-11.23.
                                                                                  4. Recording aU transactinns of the pharmacy as may
          (b) Compounding of non-sterile preparations shali take                he applicable to State, Federal and local laws and rules, lUI
        place in a compounding environment designated specificany               may be necessary to maintain accurate control over, and
        for that purpose.                                                       accountability for, all pharmaceutical materials;
        Amended by RI995 d.WI, effe<tive June 5, 1995.
        See: ZI NJ.R 43(8), ZI NJ.R. 2239(.).
                                                                                   5. Ensuring that preparation and compounding of
        New Rule, R.1998 d.297, effective 1 _ 15, 1998.                         sterile preparations is performed only by licensed pharma·
        See; 29 N.J.R. 2246(0). 30 NJ.R 2255(0).                                cists who have been trained in aseptic manipulation skills,
           Former NJAC. 13:39-11.3, Supp<>rtWe personnel; required supern-      or by pbarmacy technicians, interns or externs wbo have
        sion, was re<:odified to NJ.A.C. 13:39-IIA
        Amended by R.2OO5 d.25, effe<tive January 18, 2005.                     been trained in aseptic manipulation skills working under
        See: 36 NJ.R 3345(0), 37 NJ.R 295(.).                                   the immediate personal supervision of a licensed pharma-
          Rewrote the.ection.                                                   cist Irained in aseptic manipulation skills;

        13:39-11.4 General requirement for compounded sterile                      6. Ensuring that preparatinn and compounding of
                   preparations; pre·approval                                   non-sterile preparations is performed only bY licensed
                                                                                pharmacists or bY pharmacy technicians, intern or externs
        . An applicant or permitholder wbo wishes to compound
        sterile preparations shall notify the Board at least 60 days            working Wlder tbe immediate personal supervision of a
        prior to commencement and shaJl receive approval from the               linensed pharmacist; and
        Board before commencing compounding of sterile prepara-                    7. Establishing procedures for maintaining tbe integri-
        tions.                                                                  ty and manufaclurer's control identity of packaged materi-
        New Rule, RI998 d.297, effective June IS, 1998.                         al. The packaging records shall be initialed by tbe super-
        See: 29 NJ.R 2246(0),30 NJ.R. 2255(0).                                  vising pbarmacist.


                                                                         3943                                                  Supp. 1-18-05
13:39-11.5                                                                              DEPT. OF IAW AND PUBUC SAFElY

New Rule. R1998 d.297, effective lune 15,1998.                                1. Comprehensive knowledge of the pharmacy's stan-
See: 29 NJ.R. 2l46(a), 30 N.I.R 2lSS(a).
  Former N.J.A.C. 13:39-11.6. Expiration date of sterile preparation,      dard operating procedures with regard to compounding
WllS recodified to NJ.A.C. 13:39-11.12.                                    sterile preparations as set forth in the policy and proce-
Reoodified from NJ.A.C. 13:39-11.6 oed amended by R.200S d.2S,             dure manual required to be maintained pursuant to
  effective lanuary 18, 200S.
See: 36 NJ.R. 3345(0). 37 NJ.R. 295(a).                                    N.J.A.C.13:39-11.13;
  Rewrote the section.. Former NJA.c' 13:39-11.5, General require--
men4 recodified to NJAC. 13:39-11.4.                                         2. FamiliaritY with the necess81)1 compounding tech-
                                                                           niques; and
13:39-11.6    Phannacy technicians, interns aDd externs;                     3. Appropriate aseptic technique, which shall be prov-
              requi~ supervision                                           en by means of a test batch of culture media, media fill Or
  (a) Dispensing pharmacists shall provide immediate per-                  the equivalent.
sonal supervision to pharmacy technicians, interns or externs
who are perionning delegated sterile and non-sterile prepa-                (c) At least annually, the pharmacist in charge shall be
ration compounding. The ratio of dispensing pharmacists to              responsible for testing the aseptic technique of aU personnel
pharmacy teclmicians shaH not e=ed 1:2 at any given time                involved in compounding sterile preparations by means of a
unless all of the reqwrements of N.J.AC. 13;39-6.6(d) and               test batch of culture media, media fill or the equivalent.
(e) are met.                                                            Test results shall be maintained for five years, and shall be
                                                                        made available for the Board's inspection upon request.
    1. Supervision shall include, but is not limited to, the
                                                                        Individuals who fail to demonstrate acceptable aseptic tech-
  checking of each ingredient used, the quantitY of each
                                                                        nique shall be prohibited from engaging in sterile prepara-
  ingredient whether weighed, measured or counted, and
                                                                        tion compounding until demonstrating acceptable technique
  the finished label.
                                                                        by means of a test batch of culture media, media fill or the
                                                                        equivaJel'\t.
  (b) The dispellBing pharmacist may delegate to pharmacy
technicians, interns or externs only the foUowing tasks:                Reoodifled from NJ.A.C. 13:39-11.2 and amended by R.I998 d.297,
recording of the prescription, selection of the drugs, con·               effective June lSI 1998.
tainer and diluent, tYPing of labels and compounding of                 See: 29 NJ.R. 2l46(')' 30 NJ.R. 2lS5(.).                                ,
preparations. The dispensing pharmacist shall ensure that                 Rewrote the section. Former NJAC. 13:39-11.7, Handling. po<k-             )
each task has been performed correctly in the dispensing                aging oed delivery, was recodified to N.JAC. 13:39-11.13.
                                                                        Amended by RlOOS d.2S, effecti.e lanuary 18, 2005.
process.                                                                See: 36 NJ.R. 3345(0), 37 N.1.R. 295(a).
                                                                          Rewrote the section.
Reeodified from NJAC. 13:39-11.3 and amended by R.1998 d.297,
   effective June 15t 1998.
See: 29 NJ.R 2246(a), 30 NJ.R 2lS5(.).                                  13:39-11.8 Batch preparation
   Rewrote !he =tio... Fonner NJAC. 13:39-11.8, Policy and proce-
dure manual was recodified to NJ.A.C. 13:39-11.14.                         Pharmacists and pharmacy technicians, interns and ex·
Reeodified from NJAC. 11:39-11.8 oed amended by R.200S d.2S,            terns may compound sterile and non-sterile preparatiollB
  effective January 18, 2005.
See: 36 NJ.R. 3345(.), 37 NJ.R. 295(a).                                 consistent with the provisions of NJ.AC. 13:39-11.6 in a
   Rewrote !he section. Former NJAC. 11:39-11.6, Pharmacist in          quantitY that is supported by prior valid prescription or
charge and pennitholdef1i' responsibilities. reeodified to NJAC.        medication orders before receiving a valid written prescrip-
11 :39-11.5.
                                                                        tion or medication order, provided the pharmacist can doeu-
                                                                        ment a history of valid prescriptions subsequently received
13:39-11.7 Trainiog reqnirements for romptlQDdiog sterile               shortly thereafter or medicatinn nrders that have been
           preparatioos                                                 generated solely within an established professional prescri·
   (a) The pharmacist in charge and aU personnel involved               ber.patient-pharmacist relationship, and provided they
in compounding sterile preparations shall have practical or             maintain the prescription on file for all such products
academic training in sterile preparation compounding, clean             dispensed at the pharmacy as required by state law. The
room technolOgy, laminar flow technology, and quality as-               pharmacist shall document the batch preparation process in
surance techniques. Such training shall be documented for               accordance with NJ.A.C. 13:39-11.9(d).
each person before that individual begins to compound
                                                                        New Rule, R.I998 d.297, effective June 15, 1998.
sterile preparatiollB and annually thereafter. That documen·            See: 29 NJ.R 2l46(a), 30 NJ./l.. 2lS5(a).
tation shall be maintained by the permitbolder for five years              Former NJAC. 13:39-11.9, Quality ...uranee progr.un. was recodi·
and made available to the Board upon request.                           fied to NJAC. 13:39-11.15.

  (b) The pharmacist in charge shall be responsible for
                                                                        Reoodified from NJAC. 13:39-11.9 and amended by R.200S d.25,
                                                                           effective January 18, 200S.
                                                                        See: 36 N.1.R. 3345(.), 37 NJ.R. 295(aj.
                                                                                                                                              (".
ensuring that, prinr to compounding sterile preparations, all              Rewrote !he =tinn. Former NJAC. 13:39-11.8, Supportive per-
personnel are trained and can successfully demollBtrate:                sonne~ required supervision, recodified to NJ.A.C. 11:39-11.6.




Supp. 1-1S-05                                                       3944
         STATE BOARD OF PHARMACY                                                                                                     13:39-11.10
         -----------~----~~--~----.----------~------------.----
         13:39-11.9    Documentation                                        be maintained for not less than five years from the date of the
                                                                            last entry in the record. The oldest four years of record
     )      (a) Consistent with tbe provisions ofN.l.A.C. 13;39·11.5,
         the dispensing pbannacist shall ensure tbat compounded
                                                                            infonnation shall be maintained in such a manner so as to be
                                                                            retrievable and readable within two weeks. The most recent
         preparations bave been properly prepared, labeled, controlled,
                                                                            one year of a record shall be retrievable and readable within
         stored, dispensed and distributed in accordanee with the pro-
                                                                            one business day. Records not currently in use need not be
         visions of tbis subcbapter.
                                                                            stored in the pbarmacy, bnt off·site facilities used to store
           (b) The pbarmacist in cbarge shall be responsible for            such records shall be secure. Patient records sball be kepI
         ensuring that policies and procedures exist so that all aspects    confidential, but shall be made available to persons author-
         of tbe dispensing process set out in (d) below are documented      ized to inspect them under State and Federal statutes and
         and that the pbarmacist responsible for each preparation can       regulations.
         be identified.                                                     Recodified from N.IA.C. 13:39·11.4 and amended by R,l99B d.297,
                                                                               effective June 15, 1998,
            (c) On or after April 5,2011, a pbarmacy sban maintain an       See: 29 N.J.R. 2246(0),30 NJ.R, 2155(0).
         audit trail tbat records and documents the unique and secure          Rewrote the seetion, Former NJA.C. 13:39·1I.IQ, Patienl profile
         user identifier(s) of the pharmacist(s), pbarmacy techni-          reconis, was recodifie<l to N.IA.C. 13:39-11.16.
                                                                            Recodifie<l from NJAC. 13:39·11.10 and amende<l by R,200S d.15,
         cian(s), itrtern(s) or extern(s) involved, consistent with the        effeclivelanuary 18,2005.
         requirements of this chapter, in the steps of the compounding      See: 36 NJ.R. 3345(0), 37 N.I.R. 295(0).
         process set out in (d) below. All steps perfonned by a phar-          Rewrote tile section. Former N.IAC. 13:39.11.9, Batch ~on,
         macy technician, intern or extern shall be documented in the       recodified 10 NJ.A.C. 13:39-11.8.
                                                                            Amended by R.2009 d.305, effective October 5. 2009.
         audit trail. All entries to the audit trail made by a phannacy     See: 40 NJ.R. 5170(0), 41 NJ.R, 384O{a),
         technician, intern or extern shall be reviewed and approved           Rewrote (e) and (e).
         by the pbarmacist. When more than one pbarmacist is in-
         volved in the steps of the compounding process, the unique         13:39-11.10      Information required to appear on
         and secure user identifier(s) of the phannacist(s) responsible                      pres<:ription label
         for the accuracy and appropriateness of eacb step sball be
                                                                              (a) The dispensed container fur any compounded prep-
         recorded in the audit trail. Audit trail documentation shall be
                                                                            aration shall bear a pennanently affixed label with at least the
         generated at the time eacb step is perfonned.
                                                                            fullowing information:
            (d) Compounding steps wbich shall be docwoented       are as
         follows;
                                                                                  I. The date and, for sterile preparations, the time pre-
                                                                                pared;
              I. Receipt of prescription or medication order;                      2. In the retail pbarmacy only, the name of the pre-
              2. Recording of prescription or medication order in the           scriber;
           patient record profile system, pursuant to NJ.A.C. 13:39·              3. The name of the patient;
           11.15;
                                                                                  4. Directions for use;
              3. Correct selection of the drugs, container, and diluent
           prior to their being compounded;                                       5. 111e name and quantity of all active ingredients;
              4. Verification that all pharmacy sterile preparation               6. The name, address, and telepbone number of the
           compounding is perfonned within a ISO class 5 laminar air            pbarmacy;
           flow hood or ISO class 5 clean room and that proper
                                                                                  7. The use by date and, for sterile preparations, the use
           aseptic procedures are being used at all times to prevent
                                                                                by time (If no time is stated, it is presumed to be 11 :59
           bacterial contamination of this product;
                                                                                P.M. of the stated use by date).
              5. Verification that ingredients comply with the pre-               8. Any ancillary and cautionary inslruCtions as needed;
           scription or medication order;
                                                                                  9. As pertinent, a warning consistent with applicable
             6. Verification that the prescription or medication order
                                                                                Federal and State law that cytotoxic products are biohaz-
           label complies with the requirements of N.l.A.C. 13:39-
                                                                                ardou.; and
           11.10; and
                                                                                  10. As pertinent, the requirements for proper storage.
              7. Verification that the prescription or medication order
           is complete and ready to be dispensed, including any             Reoodifie<l from N.l.A.C. 13:39-11.5 and amended by R.1998 d.297.
           necessary ancillary supplies.                                      etrective June 15, 1998.
                                                                            See: 29 N.l.R, 2246(8), 30 N.l.R. 2255(8).
                                                                              In (a), inserted. reference to time in I, and rewrole 2 and 10. Former
            (c) The audit trail information shall be maintained or          N.l.A.C. 13:39-11.11, ControIle<l envirooment entry, was reoodifie<l to
\.       stored in original hard copy form Or in any other media that
         facilitates tbe reproduction of the original bard copy and shall
                                                                            NJ.A.C.I3:39·ILl7.
                                                                            Recodifie<l from N.J.A.C. 13:39·11. and amended by IU005 d.15,
                                                                              effectlveJanuary IB, 2005,


                                                                        39-45                                                      Supp. 10-5-09
13:39·11.10                                                                                                     LAW AND PUBLIC SAFETY

See: 36 N.1.R. 3345(0), 37 N.1.R. 295(0).                                    sterility, of these preparations. The pharmacist in charge shall
   Rewrote (a). Fonner NJ.A.C. 13:39-11.10, Ilocumentation, recod-
ified to N.l.A.C. 13:39-11.9.                                                ensure that:
Amended by R.2009 d.305, effi:ctive October 5, 2009.
See: 40 NJ.R. 5170(a), 41 NJ.R. 384O(a).                                            L A reasonable effort is made to provide tamper-
   Deleted form ... (a)6; and recodified fonner (a)7 through (a)11 as (a)6       evident packing;
through (a)IO.
                                                                                   2. Retail delivery is made from the pharmacy to the
                                                                                 patient within a reasonable time; and
13:39-11.11      Use by date of sterile preparation
                                                                                   3. Propar in-transit storage is provided consistent with
  (3) The use by date of a sterile compounded preparation                        product labeling.
shall be 24 hours or as otherwise staled by the manufacturer
                                                                             Recodified from N.J.A.C. 13:39-11.7 and amended by R.1998 d.297.
or current literature at the time of preparation, but shall not                 effective Jwte 15. 1998.
exceed 30 days after preparation.                                            See: 29 NJ.R. 2246(8). 30 NJ.R. 2255(8).
                                                                                In (a). inserted a new fIrst sentence in the introductory paragraph and
   (b) Any use by date that extends beyond 24 hours or the                   changed "Delivery" to "Retail delivery" in 2. Former NJAC. 13:39-
manufacturer's expiration date shall be substantiated by doc·                 11.13, Controlled environment: slocking, was recodified to NJ.A.C.
umentation satisfactory to the Board. Satisfactory documen·                  13:39-1 L19.
                                                                             Recodified from NJAC. 13:39-11.13 and .mended by R.2005 d.25,
tation shall include, but not be limited to:                                    err""tive January 18,2005.
                                                                             See: 36 NJ.R. 3345(0), 37 NJ.R. 295(0).
         I. Manufacturer's criteria on extending beyond use                     Rewrote the section. Former NJ.A.C. 13:39-11.12, Expiration date of
   dates;                                                                    .terilepreparatlon, recodified to N.J.A.C. 13:39-11.11.

      2. Appropriate literature; and
                                                                             13:39-11.13      Policy and procedure manual for
      3. Direct testing.                                                                      compounded sterile preparations
   (c) In an institutional pharmacy, any sterile compounded                     (a) The phannacist in charge shall maintain a policy and
preparation which is prepared Wlder the pharmacy's control                   procedure manual which shall set forth in detail the licensee's
in a ISO class 5 laminar air flow hond which is not in a clean               standard operating procedures with regard to compoWlded
room and which meets the requirements of N.J.A.C. 13:39-                     sterile preparations.
11.22, shall be labeled to indicate that administration to a
patient shall be initiated and completed within 28 hours of the                (b) The policy and procedure manual shall include policies
beginning of the preparation time. If such a compounded                      and procedures governing the following:
preparation is preparod by closed-system aseptic transfer of a
                                                                                    I. A risk-management program (including, but not lim·
single, sterile. nonpyrogenic, finisbed medication obtained
                                                                                 lted to, incident report procedures, an adverse drug reaction
from licensed manufacturers into sterile fmal containers (for
                                                                                 system, and a product contamination system);
example, syringes, minibags, portable infusion-device cas·
settes), then the compoWlded preparation shall be labeled to                       2. Security measures ensuring that the premises where
indicate that administration to a patient shall be completed                     compounded sterile drugs are present are secured, SO as to
within the time recommended by the manufucturer but not                          prevent access by unauthorized personnel;
exceeding 30 days after preparation. A closed system aseptic                       3, Equipment;
transfer is one which does not penni! exposure of the phar-
maceutical components to the environment, and shall be                                i.    Procedures for use; and
prepared in a ISO class 5 laminar air flow hood.                                      ii.   Documentation of appropriate certifications;
Recodified from N.J.A.C. 13:39-11.6 and amended by R.l998 d.297,                   4. Sanitation standards and procedures;
   effective Juoe 15, 1998.
See: 29 NJ.R. 2246(0),30 NJ.R. 2255(0).                                            5. Reference materials as set out in N.JA.C. 13:39-5.8
  In (a), added "or current literature at the time ofpreparatioo" at the         and 11.24;
end of the senrenee; and inserted • new (e). Former NJ.A.C. 13:39-
11.12, Controlled environment: construction, was recodified to N.JAC.              6. Information concerning drug:
13:39-11.18.
Recodified from N.J.A.C. 13:39-11.12 and amended by R.2oo5 d.25,                      I.    Preparation;
   effective Jan1ll1l'y 18, 200S.
See: 36 NJ.R. 3345(0). 37 NJ.R. 295(0).                                               it    Storage and handling;
   Rewrote the section. Former N.J.A.C. 13:39-11.11, Information
required to appear On prescription label, n:oodified to NJAC. 13:39-                  ill. Dispensing;
11.10.                                                                                Iv.   Labeling;

13:39-11.12      HondHng, packaging and delivery                                      v.    Delivery; and

   (a) The pharmacy shall be responsible for the proper han-                          vi.   Destruction, recalls and returns;
dling and packaging of compounded preparations for delivery                        7. Palient recordkeeping as set forth in N.l.A.C. 13:39-               ~
from the pharmacy to the patient in order to assure and                          ILl5;
maintain integrity, efficacy, stability, and, where applicable,

Supp. 10-5-09                                                            39-46                                               Next Page Is 39-46.1
    STATE BOARD OF PHARMACY                                                                                          13:39-11.13
                          '---

         8. Handling, dispensing and documentation of inves-             12. Documentation as set forth in N.J.A.C. 13:39-11.9;
      tigational new drugs;
)       9. A quality assurance program as set forth in N.J.A.C.
                                                                         13. Description of appropriate garb;
                                                                         14. Conduct guidelines for personnel in the controlled
      13:39-11.14;
                                                                       areas;
         10. Verification of training and competency guidelines
      as set forth in N.J.A.C. 13:39-11.7;
                                                                         15. Personnel responsibilities;
                                                                         16. Patient education (retail patients);
        II. Compounding process validation;




)




    Next Page is 39-47                                       39-46.l                                                Supp. 10-S-09
STATE BOARD OF PHARMACY                                                                                                             13:39-11.15

    17. Protoool and procedures to maintain the integrity                        tribution, storage, administration, and directions for use
  of the interior work area of the laminar air /low hoods;                       for eacb type of product dispensed;
  and
                                                                                   3. All compounding processes representative of all
     18. Written procedures in compliance with the Occu-                         types of manipulations, products and batcbes must be
   pational Safety and Health Administration standards for                       sterile tested and validated at least every 12 months.
   handling small and large spiUs of antineoplastic agents
   and other hazardous substances.                                                 4. Air and sudace sampling for microbial organisms in
                                                                                 ISO class 5 laminar air flow hoods and ISO class 6 clean
  (c) The pharmacist in cbarge shall review at least every                       rooms is done twice annually and at any time wben
two years and, if _ary, amend the policy and procedure                           microbial contamination is suspected pursuant to Uuited
manual as needed Documentation of the review shall be                            States Pharmacopoeia/National Formulary guidelines;
made available to tbe Board upon request.                                          5. Laminar air /low hoods shall be certified every six
Rerodified from N.JAC 13:39-11.8 and amended by Rim d.297,
                                                                                 months, and every time they are moved, by an indepen-
  effective June 15, 1m.                                                         dent certification company;
See: 29 NJ.R. 2246(a), 30 NJ.R 2255(0).
  Rewrote (1)). Former NJAC 13:39-11.14, Controlled enviroomen~                    6. The ISO class 6 clean room and ISO class 7
maintenance and supplies, was recodified to NJAC. 13:39-1J.I9(c)                 anteroom shall be certified every six months by an inde-
lbrougll (e).                                                                    pendent certification company; and
Amended by R.I999 d.l96 effecti", June 21, 1999.
See: 30 NJ.R. 4113(0), 31 NJ.R 253(0), 31 NJ.R 1618(0).                            7. All unused drugs and materials used in the com-
  In (1)), added 18.
Reoodi!ied from N.1AC 13:39-11.14 and amended by R2005 d.25,                     pounding of sterile preparations, including antineoplastic
  effective J.nu.". 18. 2005.                                                    agents, are disposed of properly in accordance with ac-
See: 36 NJ.R. 3345(0), 37 NJ.R 295(0).                                           cepted professional standards and applicable laws, includ-
  In (a), substituted "with regard to compounded sterile preparations"           ing the Medical Waste Act (NJ.SA 13:1E-48.1 et seq.,
fur "with regard   '0  sterile .dmixture oemces"; in (1)), substituted
                                                                                 P.L 1989, c.34).
"where compounded stenle drugs are presenl'~ for "when: !:>1erile
admixture drugs are presen'" followiJ!s   ".ba.  the premi.es" in 2 and
amended the NJ.A.C references in 5, 7, 9 and 12; in (c), inserted 'fat       Recodified from NJAC 13:39-11.9 and amended by RI998 d.297,
least every two years" following "in charge shall review", subSlituted "as     effective June 15, 1998.
needed" for "on a' leas. an annual basis" followiJ!s "policy and             See: 29NJ.R 2246(a), 30 NJ.R 2255(a).
procedure manual" and deleted ~'annual" following "Documentation of            In (a), substituted Hsten1en for ~i:njectable" followiol "available";
the". Former NJAC 13:39-11.13, Haudling. paclclging and delivery,            and rewrole (b). Former NJ.A.C 13:39-11.15, Clean room, was
recodified to NJAC 13:39-11.12.                                                        '0
                                                                             recodified NJ AC. 13:39-11.20.
                                                                             Recodified from NJAC. 13:39-11.15 and amended by R.2005 d.25,
                                                                               eflectj", Jan..". 18. 2005.
13:39-U.14 Quality assurance program for compounded                          See: 36 NJ.R. 3345(.), 37 NJ.R 295(a).
           sterile preparations                                                Rewrote the section. Former NJAC 13:39-11.14, Policy and pro-
                                                                             cedure manual, recodified.o NJAC 13:39-lIJ3.
  (a) This section sbaII apply both to commercially aVail-
able sterile drug products that are dispensed to patients
                                                                             13:39-11.15     Patient profile records for compounded sterile
without compounding or other manipulation, and to sterile
                                                                                             preparations
preparations which, prior to dispensing, have been in any
way repackaged, reconstituted, diluted, admixed, blended, or                    ( a) The pharmacist in charge sball ensure that a patient
olberwise manipulated (collectively referred to as "com-                     profile record is maintained and mouitored for eacb patient.
pouoded").                                                                   The patient profile record shall include, but is not limited
                                                                             to, !be following:
  (b) The dispensing pharmacist shall ensure that !be com-
                                                                                   1. Available medical information consistent with
pounded sterile preparation retains its quality attributes
                                                                                 N.J.A.C. 13:39-7.19; and
within acceptable limits through a written quality assurance
program. The quality assurance program shall require at                            2. All medication orders for institutional patients.
least that:
                                                                                (b) The pharmacist in cbarge shall ensure that a reason-
     1.   A reasonable effort sball be made by tbe dispensing                able, documented attempt is made to include in the record
  pharmacist to assure that compounded sterile prepara-                      over-the-counter and horne remedies used by noninstitution-
  tions sball be kept under appropriate controlled condi-                    al patients.
  tions at the location of use by providing adequate labeling
  and verbal or written instructions regarding proper stor·                    (c) The pharmacist in charge sbaII ensure Ibat initial and
  age and administration as set forth by the product man....                 ongoing multidisciplinary clinical mouitoring and compre-
  facturer, wilb each compotmded sterile preparation dis-                    hensive care plans are maintained and readily available.
  pensed;
                                                                             Recudilied from NJAC 13:39-11.10 and amended by RIm d.291,
    2. The quality assurance program encompasses all                           effective June IS, 1998.
  phases of sterile compounding, including preparation, dis-                 See: 29 NJ.R. 2246(a), 30 NJ.R. 2255(.).


                                                                         39-47                                                      Supp. 1-18-05
13:39-11.15                                                                                 DEPT. OF LAW AND PUBUC SAFETY

  Rewrote (a) and (b) and inserted a new (c). Fotmer NJAC                    (d) Ceilings which coDsist of inlaid panels shall be im-
13:39-11.16, Anteroom, was recodified In NJ.A.C 13:39-11.21.
Recedified from NJAC 13:39-11.16 and amended by R2OO5 d.2S,
                                                                          pregnated with a polymer to render them impervious and
  effective January 18, 2005.                                             hydrophobic and shall either be caulked or weighted and
See: 36 NJ.R. 3345(0), 37 NJ.R 295(0).                                    clipped.
  In (a), amended tlle NJAC. reference in 1. Former NJAC
13:3911.15, Quality assurance program, recedified to NJAC.
13:39-11.14.
                                                                            (e) Solid walls shall consist either of panels locked to-
                                                                          gether and sealed, or of epoxy-coated gypsum board.
13:J')..U.16 ControUed environment Cor compounded                            (f) Floors shall have vinyl floor covering and sball be
             sterile preparations: use, access, location;                 seamless or have heat-welded seams and caving to the
                temperature                                               sidewall.
  (0) The pbarmacy shall have a designated area for sterile
                                                                            (g) There sball be no dust-collection overhangs (such as
preparation compounding, known as the "controlled envi·
                                                                          ceiling utility pipes) or ledges (such as window sills). All
ronmen!," consisting of a clean room and an anteroom
                                                                          sprinkler beads shall be flush with the ceiling.
unless the pharmacy meets the requirements of NJ.AC.
13:39-11,22 or 11.23.                                                       (h) Ceiling lighting fixtures shall have exterior lens sur·
                                                                          faces which are smooth, mounted f1usb, and air tight.
  (b) A controlled environment shall be:
                                                                            (i) All areas in ceilings and walls where the surface has
     1.   Accessible only to designated personnel:                        been penetrated shall be sealed.
     2. Used only for the compounding of sterile prepara-                   (j) Any clean room construction other than that specified
  tions, or such other tasks rhat require a controlled envi-              in (3) through (i) above (for example, softwaU, prefabri.
  ronment;                                                                cated, modular, portable clean rooms) shall be approved by
    3. Structurally isolated from other areas witbin the                  !be Board prior to installation and use.
  pharmacy by means of restricted entry or access; and                    Recedified from NJAC. 13;39-11.12 aod amended by R199!! d.297,
                                                                            effectjve June lSf 1998.
    4. Air conditioned to maintain a temperature of 59 to                 See: 29 NJ.R. 2246(a), 3() NJ.R. 2255(0).
  77 degrees Fahrenheit.                                                     In (b), inserted "damage from"; in (e), substituted "Solid walls" for   "
                                                                          "Walls": rewrot<: (g) and (i); and added 8 new (j).
                                                                          Amended by Rim d.196 effective June 21, 1m.
Recedified from NJAC 13:39-11.11 aad amended by RI998 d.m,                See: 30 NJ.R 4113(8), 31 NJ.R. 253(0). 31 NJ.R. 1618(0).
   effective June 15, 1998.                                                  In (d), substituted "either he caulked or weighted and dipped" for
See: 29 NJ.R 2246(0), 3() NJ.R. 2255(0).                                  "also be caulked around each perimeter to seal them to the support
   Rewrote (a); and in (b). substituted "sterile" for "parenteral" in 2   frame" at the end.
and added a new 4.                                                        Recodified from NJ.A.C. 13:39-11.18 by R2005 <1.25, e!fecti": 1anuary
Recodified from NJ.A.C. 13:39-11.17 aad amended by R.2OO5 d.25,              18,2005.
   effective January 18, 2005.                                            See; 36 NJ.R 3345(0), 37 N.1.R 295(0).
See: 36 NJ.R. 3345(.), 37 NJ.R 295(a).                                      Former NJ.A.C. 13:39-11.17, ControUed environment: use, access,
   In (a), substituted "sterile preporaUnn compounding, known" for        location; temperature, recedified to NJAC. 13:39-11.16.
~·steri1e product preparation, known" and amended the NJ,AC. reee ....
ences in the introductory paragraph, aad substituted "for the com·
pounding of sterile prepamions" for "fur the preparation of sterile       13:39-11.18 Controlled environment tor compounded
prnducls" in 2. Fonner NJAC 13:39-11.16, Patient prome rcootds,                       sterile preparatiDII5: stocking, maintenance
recedified to NJ.A.C. 13:39-11.15.
                                                                                      and supplies
                                                                            (a) The controlled environment shan contain only the
13:39-11.17 Controlled environment lOr compounded
                                                                          foHowing:
            sterile preparations: construction
                                                                                1. Items such as furniture, equipment, supplies, and
  (a) The surfaces of ceilil]gs, walls, floors, fixtures, sbelv-              other goods wbich are required for the tasks to be
ing, counters, and cabinets in the controlled environment                     perfonned there;
sball be smooth, impervious, free from cracks and crevices,
and nonshedding, thereby minimizing spaces in which mi·                         2. Items wbich are nonpermeable, nonsbedding, and
croorganisms and other contaminants may accumulate.                           resistant to disinfectants: and
                                                                                3. Items whicb have been cleaned and sanitized imme-
  (b) All surfaces sball be resistant to damage from sanitiz-                 diately prior to their being placed in the clean room.
ing agents.
                                                                            (b) Whenever possible, equipment and other items used                    t.··
  (c) Junctures where ceilings meet wall sball be covered,                in the controlled environment should Dot be taken from                     \
caulked or sealed to avoid cracks and crevices where dirt                 these rooms except for calibration, servicing, or other activi-
can accumulate.                                                           ty associated with tbe proper maintenance of tbe item.


Supp. 1-18-05                                                         39-48
        STATE BOARD OF PHARMACY
                                                                         -------------_._--_13:39-11.2'
                                                                                             _--                                                  ..

           (e) The controlled environment shall be kept clean and                  Recodified from N.J .A.C. 13:39-11.15 and amended by R.1998 d.297,
                                                                                     effective June 15. 1998.
        arranged in an orderly fashion. AU required equipment shall
    ,   be maintained in good operating condition.
                                                                                   See: 29 NJJL 22%(0), 30 Nl.R. 2255(a).
                                                                                      Rewrote (d); and in (e), deleted former 2 and recodified fonner 3 and
    )                                                                              4 a<; 2 and 3.
           (d) The controlled environment shall not be used fur bulk               R£oodified from N.J.A.C. 13:39-11.20 and amended by R.2oo5 d.25,
        storage, warehousing, or clerical and secretarial functions.                   e!Tective January 18,2005.
                                                                                   See: 36 NJ.R. 3345(0), 37 NJ.R. 295(a).
           (e) The controlled environment area shall contain the                       In (d)~ substituted "ISO class 6" for "class 1,000"'; in   (e)~   rewrote L
                                                                                   Former N.J.A.C. 13:39-11.19, Controlled environment: stocking,
        fullowing supplies:                                                        maintenance and supplies, recodified lO N.J.A.C. 13:39-11.18.
             I. Gloves, masks, gowns, and other personal protective
                                                                                   13:39-11.20        Controlled environment Cor compounded
           equipment;
                                                                                                      .terile preparations: anteroom
             2. Needles and syringes of various sizes;
                                                                                     (a) The anteroom shall have an air quality of ISO class 7
             3. Di.infecllmt cleaning agents;                                      or better.

             4. Clean towels;                                                          (h) The anteroom shall contain the following equipment:
             5. Hand-washing materials, including antimicrobial                           I. A sink with hot and cold running water;
          skin cleaner; and
                                                                                         2. Waste containers for all personal protective equip-
            6. Any and all supplies necessary for the aseptic                          ment;
          compounding of sterile preparations.
                                                                                          3. An eyewash station; and
        Recodified from NJAC. 13:39-11.13 and 13:39-11.14 and amended by
           IU998 d.297, e!Tective JWle 15, 1998.                                          4. A hazardous waste spill kit.
        See: 29 Nl.R. 22%(8), 30 NJ.R. 2255(a).
           Rewrote (a)3.                                                             (c) A refrigerator, as required by United States Pharma-
        R£oodifled from NJ.A.C. 13:39-11.19 and amended by R.2005 d.25,
           e!Tective January 18,2005.
                                                                                   copoeia Sllmdards, shall be reasonably accessible to the
        See: 36 Nl.R. 3345(a~ 37 NJ.R. 295(a}.                                     anteroom io ensure the integrity of the compounded sterile
           In (e), substituted "ascepdc compounding of sterile preparations" for   preparations, but shall not be located within the controlled
        "ascoptic preparation of sterile admixture preducls" in 6. Former          environment.
        NJ.A.C. 13:39-11.18, Controlled environment; construction. recodifIed
        to NJAC. 13:39-11.17.                                                      Rc:<:odified from N.J.A.C. 13:39-11.16 and amended by R.1998 d.297.
                                                                                      effective June IS, 1998.
        13:39-1   '.'9   Controlled environment for compounded
                         sterile preparations: dean room
                                                                                   Sec: 29 NJ.R. 22%(a), 30 Nl.R. 2255(0).
                                                                                      In (b), dele!ed former 2 and recodified fonner 3 through 5 as 2
                                                                                   through 4; ....d deleted (d).
                                                                                   R<codifIed from NJAC. 13:39-11.21 and amended by R.2oo5 d.25,
          (a) Tbe clean room shall contain no sinks or floor drains.                  effective January 18, 2005.
                                                                                   Sec: 36 NJ.R 3345(8), 37 NJ.R. 295(8).
           (h) Work surfaces shall be constructed of smooth, imper-                   In (a), substituted "ISO class 7" for "C!a<;s 10,000"; in (c), substituted
        vious materials, sueh as stainless steel or molded plastic, so             "integrity of the compounded sterile preparations, but sh.II" for "in-
        that the work surfaces niay be readily cleaned and sanitized.              legrity of the stenle admixture product, but sballn • Former N.JAC.
                                                                                   13:39-11.20, Controlled environment: clean room, recodifIed to NJAC.
                                                                                   13:39-11.19.
          (c) The clean room shall be a minimum of 100 square feet
        in size and shall be compatible with the volume of com-
        pounding being conducted.                                                  13:39-11.11        Vertical air laminar Dow hoods for
                                                                                                      compoullded sterile preparations
          (d) Appropriate environmental control devices capable of                   (a) Pharmacies shall compound antineoplastic agents and
        maintaining ISO class 6 air-quaUty conditions during normal                other hazardous substances in an ISO class 5 vertical air
        activity shall be in place.                                                laminar flow hood.
          (e) Tbe clean room shall contain the fonowing equipment:                   (b) Personnel who compound and dispense antineoplastic
             I. An ISO class 5 or better laminar airflow hood or a                 agents and other hazardous substances shall adhere to OSHA
          suitable ISO class 5 or better HEPA filter system;                       Work Practice Guidelines, as set forth in CPL 2-2.20B CH-4,
                                                                                   Chapter 21, incorporated herein by reference, as amended and
            2. Waste containers in compliance with Occupational                    supplemented.
          Safety and Health Administration (OSHA) sllmdards for
                                                                                   New Rule, R.1998 d.297, e!Tective JWle 15, 1998.
          used needles and syringes, and for chemotherapy waste;                   Sec: 29 NJ.R. 2246(0), 30 NJ.R. 2255(8).
          and                                                                      Recodified from N.J.A.C. 13:39-11.22 and amended by R.2005 d.2S,
                                                                                     effective January 18~ 2005.
             3. Ancillary supplies required for proper compounding.                See: 36 N.J.R. 3345(0), 37 N.J.R. 295(a).
\

                                                                               39-49                                                          Supp.6-21-10
13:39-11.21                                                                                                   LAW AND PUBLIC SAFETY

  In{a), substituted "an ISO class 5" fur ''a class 100", Fonner NJAC       13:39-11.25      Disposal of drugs and materials
13:39-11.21, Controlled environment: anteroom, recodified to NJAC
13:39-11.20.                                                                   All unused drugs and materials used in the compounding of
                                                                            preparations, including antineoplastic agents, shall bo dis-
13:39-11.22      Laminar air flow hoods not in a clean room                 posed of properly in accordance with accepted professional
                 for compounded sterile preparations                        standards and applicable laws, including the Medical Waste
                                                                            Act (NJ,S.A. 13:IE-48.1 et seq., P.L. 1989, c.34), so as not
  Institutional phannacy ISO class 5 laminar air flow hoods
                                                                            to endanger the public health.
not located in a clean room may only he located in an area
which is maintained under sanitary conditions and traveled by               New Rule, R.1998 d.297, effective June IS, 1998.
persons engaging in the compounding of sterile preparations.                See: 29 NJ.R. 2246(8), 30 N.J.R. 2255(.).
                                                                            Recodified from N.JAC. 13:39-11.26 and amended by R.2005 d.25,
Such hoods shall he certified by an independent certification                 effective January 18,2005.
company prior to use when first installed or after being                    See: 36 NJ-R. 3345(0), 37 NJ.R. 295(0).
moved and at six-month intervals,                                             Substituted "'compounding of preparations" for "preparation of sterile
                                                                            admixture products" preceding ~ncluding antineoplastic agents", for-
New Rule, R.1998 d.297,effectiveJune 15,1998.                               mer N.JAC. 13:39·11.25, Library references, recodified to N.J.A.C.
See: 29 NJ.R. 2246(a), 3il NJ.R. 2255(a),                                   13:39·11.24.
Recodified from NJAC. 13:39-11.23 and amended by R.2005 d.25,
  effective January 18, 2005,
See: 36 NJ.R. 3345(.), 37 NJ.R. 295(a).                                     13:39-11.26      Security
   Substituled "ISO class 5" for "class I 00" and "engaging in the
compounding of sterile preparations" for "engaging in sterile product
                                                                               The compounding area and its contents and otber areas
preparation". Fonner NJ.A.C. 13:39-11.22, Vertic.1 air lantinar tlow        where compounded preparations are present shall be secured,
hoods, recodifted to NJAC 13:39-11.21.                                      so as to prevent access by unauthorized personnel.
                                                                            New Rule, R.I998 d.297, effiective Jlllltl 15, 1998.
13:39-11.23      Controlled environment for compounded                      See: 29 N.I.R. 2246(0), 30 NJ.R. 2255(.),
                 sterUe preparations: self-contained sterile                Recodified from N.I.A.C. 13:39-tl27 and amended by R.2005 d.25,
                 glove boxes                                                  effiective January 18,2005.
                                                                            See: 36 NJ.R. 3345(0), 37 NJ,R. 295(a),
   Self-contained ISO class 5 glove boxes, barrier isolation                  Substituled "compounding" for "sterile admixture" following "The"
technology or the equivalent not located in a clean room may                and "compounded preparations" for ""'sterile admixture drugs" following
                                                                            I'area and its contents and other areas where". Fonner NJ.AC. 13:39-
only be located in an area which is maintained under sanitary               1L26, Disposal of drugs and malerials, recodified to NJ.A.C. 13:39-
conditions and traveled by persons engaging in the com-                     1L25.
pounding of sterile preparations. Such boxes shall be certified
by an independent certification company prior to use when                   13:39-11.27      Reserved
first installed or after being moved and at six·month intervals.
                                                                            Recodified to NJAC. 13:39-11.26 by R.2005 d.25, effective January
New Rule, R.1998 d.297, effective JWle 15, 1998.                              18,2005.
See: 29 N.J.R. 2246(.), 3il N.1.R. 2255(a).                                 See: 36 NJ.R, 3345(0). 37 N.J.R. 295(0).
Recodified from N.J.A.C 13:39·11.24 and amended by R.2005 d.25,               Section was "Security".
   effective Jllnuary \8,2005,
See: 36 NJ.R. 3345(a), 37 NJ.R. 295(8).
   Substitnted "ISO class 5" for "class \ 0 10 class 100" following "Self
contained" Wld "engaging in the cmnpounding of sterile preparations"
for "engaging in sterile product preparation". Fonner NJAC. 13:39-
                                                                            SUBCHAPTER 12. NUCLEAR PHARMACIES
11.23, Laminar air flow hoods not in a dean room, recodified to
NJ,A.C.13:39-1I.22.                                                         13:39-l2.1      Definitions
                                                                               The following words and terms when used in this sub-
13:39-11.24      Library references
                                                                            chapter shall have the tbllowing meanings, unless the context
  In addition to the minimum reference library mandated in                  clearly indicates otherwise.
N.J.A.C. 13:39-5.8, each phannacy engaged in compounding
shall contain recognized references pertinent to specialized                   "Authentication of product history" includes, but is not
compounding preparations.                                                   limited to, identifying the purchase source, the ultimate use or
                                                                            disposition and any intennediate handling of any components
New Rule, R.1998 d.297, effective June IS, 1998.                            of a radiopharmaceuticaL
See: 29 NJ-R. 2246(8),30 NJ-R. 2255(a),
Recodified from NJ,A.C. 13:39-11.25 and amended by R.2005 d,25,               "Authorized practitioner" means a practitioner duly au-
   effective January 18, 2005,
See: 36 N,l.R. 3345(.), 37 NJ-R. 295(a).                                    thorized by applicable Federal and State law to possess, use
   Rewrote the sectino. Former N.J,A.C. 13:39-11.24. Contrnlled en-         and administer radiopharmaceuticals.
vironment: self-contained sterile glove boxes, recodified to N.JAC.
13:39-1 L23,                                                                  "Designated agent" means an individual under the direct
                                                                            supervision of a practitioner authorized to communicate the
                                                                            practitioner's instructions to the nuclear pharmacy.



Supp.6-21-10
STATE BOARD OF PHARMACY                                                                                                       13:39-12.2

   "Immediate personal supervision" means that the pharma-                and distribution of drugs shall be under the immediate per-
cist is physically present in the compoundingfdispensing area             sonal supervision of the nuclear pharmacist who shall be
when interns, extems and pharmacy technicians are per-                    responsible for all nuclear operations of the licensed area and
fonning delegated duties, and the pharmacist conducts any                 shall be in personal attendance at all times when the nuclear
necessary in-process checks and the final check in preparation            pbarmacy is open fur business. On or after AprilS, 2() II,
and compounding of medications, including the checking of                 nuclear pharmacies shall maintain an audit trail that records
each ingredient used, the quantity of each ingredient whether             and documents the unique and secure user identifier(s) of the
weighed. measured or counted, and the finished label.                     pharmacist(s), pharmacy technician(s), intern(s) or extern(s)
                                                                          performing the radiopharmaceutical services, which are re-
   "Internal test assessment" includes, but is not limited to,            quired to be performed by a pbarmacist, pharmacy technician,
conducting those tests necessary to insure the integrity of the           intern Or extern pursuant to the requirements of this chapter.
test.                                                                     All steps performed by a pharmacy technician, intern or ex-
                                                                          tern shall be documented in the audit trail. All entries to the
   "Radiopharmaceutical" means any substance defined as a
                                                                          audit lTail made by a pharmacy technician, intern or extern
drug in Section 201(gXI) of the Federal Food, Drug and
                                                                          shall he reviewed and approved by the pharmacist. When
Cosmetic Act or in the FDA's Nuclear Pharmacy Guidelines
                                                                          more than one pharmacist is involved in performing radio-
and which exhibits spontaneous disintegration of unstable
                                                                          pharmaceutical services pursuant to this subchapter, the
nuclei with the emission of nuclear particles or photons and
                                                                          unique and secure user identifier(s) of the pharmacist(s) re-
includes any such drug which is intended to be made radio-
                                                                          sponsible for the accuracy and appropriateness of the services
active. This definition includes nuclide generators which are
                                                                          performed shall be recorded in the audit trail. Audit trail
intended to be used in the preperation of any such substance
                                                                          documentation shall be generated at the time each service is
but does not include drugs such as carbon-containing com-
                                                                          performed. Such documentation shall be maintained or stored
pounds or potassium-containing compounds or potassium-
                                                                          in original hard copy form Or in any other media that fa-
containing salts which contain trace quantities of naturally
                                                                          cilitates the reproduction of the original hard copy and shall
occurring radionuclides.
                                                                          be kept by the pharmacy for five yeMS. The oldest four years
   "Radiopharmaceutical quality assurance" includes, but is               of infurmation shall be maintained in such a manner so as to
not limited to, the performance of appropriate chemical,                  be retrievable and readable within two weeks. The most re-
biological and physical tests on radiopharmaceuticals and the             cent one year of information shall be retrievable and readable
interpretation of the resulting data to determine their suita-            within one business day. Records not currently in use need
bility for use in humans and animals, including internal test             not be stored in the pharmacy, but off-site facilities used to
assessment, authentication of product history and the keeping             store such records shall be secure. Patient records shall be
of proper records.                                                        kept confidential, but shall be made available to persons
                                                                          authorized to inspect them under State and Federal statutes
   "Radiopharmaceutical service" includes, but is not limited             and regulations.
to, the compounding, dispensing, labeling and delivery of ra-
diopharmaceuticals; the participation in radiopharmaceutical                 (b) Nuclear pharmacies shall have adequate space, com-
utilization reviews; the proper and safe storage and distri-              mensurate with the scope of services required and provided,
bution of radiophannaceuticals; the maintenance of radio-                 meeting minimal United States Nuclear Regulatory Com-
pharmaceutical quality assurance; and the offering of those               mission or its successor's requirements and the requirements
acts, services, operations or transactions necessary in the               established by the State of New Jersey Bureau of Radiation
conduct, operation, management and conlTol of a nuclear                   Protection. The nuclear pharmacy sball be seperate from the
pharmacy.                                                                 pharmacy areas for non-radioactive drugs and shall be inac-
                                                                          cessible to all unautborized personnel. All pharmacies han-
Ameoded by R.I994 d.351, effective July IB, 1994.                         dling radiopharmaceuticals shall be provided with a radio-
See: 26 N.J.R. 1596(0),26 N.J.R. 290S(b).
Amended by R.2ooS d.25, effective January 18,2005.                        active storage and decay area. A nuclear pharmacy dispensing
See: 36 N.J.R. 3345(0), 37 N.J.R. 295{a).                                 radioactive drugs may be exempted from the general space
   DeJeted "Dil'eQ. supervisioo"; IKided "Immediate personal supet~       requirements for pharmacies.
vision",
Amended by R.2010 d.09O, effuctive June 21, 20tO.                            (c) The process used for handling radioactive materials by
See: 42 NJ.R. 132(a), 42 N.J.R. 1221(6).
   In defInition "Immediate persooal supervision". deleted "registered"   any license holder must involve appropriate procedures fur
preooding the first OCCUJTeJlce of"'phamtaeisf'.                          the purchase, receipt, storage, manipulation, compounding,
                                                                          distribution, and disposal of radioactive materials. In order to
13:39-12.2      General requirements for pbarmacies                       ensure the public health, safety, and welfare, a nuclear phar-
                providing radiopharmaceutical service                     macy sball fll'Sl meet the following general requirements:
  (a) The application for a specialized retail permit to                        I. The environment where the handling of radioactive
operate a pharmacy providing radiopharmaceutical services                     materials takes place shall be properly ventilated so that
shall only be issued to a site employing a qualified nuclear
pharmacist. All personnel performing tasks in the preparing

                                                                      39-51                                                Supp.6-21-10
13:39-12.2                                                                                          LAW AND PUBLIC SAFETY

  radioactive materials cannot be airborne from that environ-    sor. A nuclear pharmacy may furnish radiopharmaceuticals to
  ment to other non-occupationally unrestricted areas;           these practitioners for patient use.
     2. The environment sball be properly located so that           (i) Nuclear pharmacies shall comply with all applicable
  the receipt and dispersal of radioactive materials does not    laws and regnlations of Federal and State agencies including
  result in inadvertent and undesired contamination of other     those laws and regulations governing non-radioactive drugs.
  non-occupationally labeled areas; and                          For nuclear pharmacies handling radiopharmaceuticals exclu-
    3. The area sball be designed in sucb a manner that          sively, the Board of Pharmacy may waive rules pertaining to
  radIoactive materials can be contained in given areas to       pharmacy permits for nonradiopharmaceuticals wbich re-
  ensure adequate safety and protection to personnel working     quirements do not pertain to the practice ofnuc1ear pharmacy.
  in or near tbem and to insure proper operation of the             (j) Radioactive drugs are to be dispensed only upon a non-
  corresponding assay equipment.                                 refillable prescription order from a United States Nuclear
    (d) Nuclear pbarmacies shall maintain records of acqui-      Regulatory Commission licensed medical practitioner (or the
sitiOll and disposition of all radioactive drugs in accordance   designatad agent) authorized to possess, use and administer
with rules and regulations of the United States Nuclear Reg-     radiopharmaceuticals.
ulatory Commission.
                                                                    (Ie) Prescription orders for delivery of radioactive drugs for
  (e) The immediate outer container of a radioactive drug to     use in the medical practice of a United States Nuclear Reg-
be dispensed shall be labeled with the following:                ulatory Commission licensed medical practitioner may be
                                                                 placed on a telephone answering and rec<:>rding device, only if
     1. The standard radiation symbol;                           the practitioner (or the designated agent) is identified in such
                                                                 a manner that is clearly recognized by the nuclear pharmacist
    2. The words, "CAUTION-RADIOACTIVE MATE-
                                                                 dispensing the radioactive drug.
  RIAL";
     3. The radionuclide;                                           (I) A qualified nuclear pharmacist shall have the authority
                                                                 to delegate to any qualified and properly rrained person or
     4. The chemical form;                                       persons, acting under his or ber immediate personal super-
                                                                 vision, any nuclear pharmacy act whicb a reasonable and
    5. The amount of radioactive material contained in
                                                                 prudent pharmacist would find is within the scope of sound
  millicuries or microcuries;
                                                                 pharmaceutical judgment to delegate. Such delegation may
     6. If a liquid, the volume in milliliters;                  only occur if, in the professional opinion of the qualified
                                                                 nuclear pharmacist, the act may be properly and safely
    7. The requested calibration time for the radioactivity      performed by the person to whom the pharmacy act is
  contained;                                                     delegated. The delegated act may only be performed in its
    8. The name, address, and telephone nwnber of the            customary manner, not in violation of other statutes. The
  nuclear pharmacy;                                              person to whom a nuclear pharmacy act is delegated sball not
                                                                 hold himself or berself out to the public as being authorized
     9. The prescription nmnber; and                             to practice pharmacy.
     10. The date and patient's name, if available.              Amended by R.2005 d.25, effective January 18,2005.
                                                                 Sec: 36 NJ.R. 3345(0), 37 NJ.R. 295(a).
   (I) The immediate container shall be labeled with the           In (a) and (I), substituted "immediate personal" for«direct".
following:                                                       Amended by R.2009 d.305. effective October 5, 2009.
                                                                 See: 40 N.J.R. 5170(a), 41 NJ.R. 3840(.).
     1. The standard radiation symbol;                             Remote (a).

    2. The words, "CAUTION-RADIOACTIVE MATE-                     13:39-12,3      General requirements for a nuclear
  RIAL";                                                                         pbarmacist
     3. The name ofthe radiopharmaceutical.                        (a) A qualified nuclear pharmacist shall meet the following
  (g) Nuclear pharmacies shall only dispense radiopharma-        requirements:
ceuticals which comply with acceptable professional stan-
                                                                        L He or she is a pharmacist licensed to practice in the
dards of radiopharmaceutical quality assurance.
                                                                     State of New Jersey; and
   (h) A nuclear pharmacist may transfer to authorized                 2. He or she meets minimal standards of rraining and
persons and United States Nuclear Regulatory Commission              experience in the handling of radioactive materials in ac-
licensed medical practitioners radioactive materials not in-         cordance witb the requirements of the United States Nu-
tended for drug use, in accordance with tbe regulations of the
United States Nuclear Regulatory Commission or its sueees-                                                                           (.


Supp.6-21-1O                                                 39-52
STATE BOARD OF PHARMACY                                                                                                   13:39-12.5

  clear Regulatory Commission or its successor and the State          pensed as may be determined by the United States Nuclear
  of New Jersey Bureau of Radiation Protection.                       Regulatory Commission or its successor and the State of
                                                                      New Jersey Bureau of Radiation Protection.
J3:39-J2.4      Minimum requirements for 'pace,
                                                                     (c) Eacb nuclear pharmacy sball have on the premises the
                equipment, supplies, and library
                                                                  following, up-to-date reference books:
  (a) Each nuclear phannacy must meet the following re-
quirements for space:                                                    I. An up-to-date, comprehensive phannaceutical ref-
                                                                      erence text(s) and suitable reference texts encompassing
     l. The area for the storage, compounding and dis-                the general practice of pharmacy, drug interactions. drag
  pensing of radioactive drugs shall be completely separate           product composition and patient counseling. Unabridged
  from pharmacy areas for non-radioactive drugs;                      computerized versions of these reference texts shall be
                                                                      acceptable;
    2. Hot lah and storage area shall be a minimum of 120
  square feet; and                                                      2. State statutes and rules relating to phanuacy;
    3. The compounding and dispensing area shall be a                   3. State and Federal regulations governing tbe use of
  minimum of 300 square feet.                                         applicable radioactive materials; and
  (b) Eacb nuclear pharmacy sball be equipped with at least             4. Text relating to the practice of nuclear phannacy and
the following items of equipment:                                     radiation safety.
                                                                  Amettdedby IU999 d.214, effective July 19, 1999.
     i. Dose calibrator;                                          See: 31 N.J.R. IIS1(0). 31 NJ.R. 1932(0).
    2. Refrigerator;                                                In (e). rewrote Ibe introductory paragraph and I.

    3. Drawing station;                                           13:39-12.5      Quality control
    4. Well scintillation counter;                                   The holder of a nuclear pharmacy permit shall be re-
                                                                  sponsible for the radioactive quality control of all drugs,
    5. Microscope;                                                including biologicals, dispensed or manufactured. Radio-
     6. Chromatographic apparatus or comparable means of          active pbarmaceutical quality controls include, but are not
  effectively assuring tagging efficiency;                        limited to, the carrying out and interpretation of data resulting
                                                                  from chemical. biological and pbysical teSts on potentially
    7. Radiation survey equipment of the appropriate type         radioactive pharmaceuticals to determine the suitability for
  and calibration to detect quantities of radioactive materials   use in bumans and other animals, including internal test
  as prescribed in the appropriate radioactive material li-       assessment and authentication of product history.
  censes; and
    8. Other equipment deemed necessary for radiopharma-
  ceutical quality control for products compounded or dis-




                                                              39-53                                                     Supp. 10-5-09

				
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