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Drug Enforcement Administration Justice refill

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Drug Enforcement Administration Justice refill

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									                                                                Drug Enforcement Administration, Justice                                                            § 1306.25

                                                                Agent or Diversion Investigator re-                        name and address, the serial number
                                                                quests a copy of such printout from the                    and date of initial filling, the name of
                                                                user pharmacy, it must, if requested to                    the patient, the name of the practi-
                                                                do so by the Agent or Investigator,                        tioner issuing the prescription, and di-
                                                                verify the printout transmittal capa-                      rections for use and cautionary state-
                                                                bility of its system by documentation                      ments, if any, contained in such pre-
                                                                (e.g., postmark).                                          scription as required by law.
                                                                  (5) In the event that a pharmacy                            (b) If the prescription is filled at a
                                                                which employs such a computerized                          central fill pharmacy, the central fill
                                                                system experiences system down-time,                       pharmacy shall affix to the package a
                                                                the pharmacy must have an auxiliary                        label showing the retail pharmacy
                                                                procedure which will be used for docu-                     name and address and a unique identi-
                                                                mentation of refills os Schedule III and                   fier, (i.e. the central fill pharmacy’s
                                                                IV controlled substance prescription                       DEA registration number) indicating
                                                                orders. This auxiliary procedure must                      that the prescription was filled at the
                                                                insure that refills are authorized by                      central fill pharmacy, in addition to
                                                                the original prescription order, that                      the information required under para-
                                                                the maximum number of refills has not                      graph (a) of this section.
                                                                been exceeded, and that all of the ap-                        (c) The requirements of paragraph (a)
                                                                propriate data is retained for on-line                     of this section do not apply when a
                                                                data entry as soon as the computer sys-                    controlled substance listed in Schedule
                                                                tem is available for use again.                            III, IV, or V is prescribed for adminis-
                                                                  (c) When filing refill information for                   tration to an ultimate user who is in-
                                                                original prescription orders for Sched-                    stitutionalized: Provided, That:
                                                                ule III or IV controlled substances, a                        (1) Not more than a 34-day supply or
                                                                pharmacy may use only one of the two                       100 dosage units, whichever is less, of
                                                                systems described in paragraphs (a) or                     the controlled substance listed in
                                                                (b) of this section.                                       Schedule III, IV, or V is dispensed at
                                                                                                                           one time;
                                                                [36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21,
                                                                1971. Redesignated at 38 FR 26609, Sept. 24,                  (2) The controlled substance listed in
                                                                1973, and amended at 42 FR 28878, June 6,                  Schedule III, IV, or V is not in the pos-
                                                                1977; 45 FR 44266, July 1, 1980; 52 FR 3605, Feb.          session of the ultimate user prior to
                                                                5, 1987; 62 FR 13966, Mar. 24, 1997]                       administration;
                                                                                                                              (3) The institution maintains appro-
                                                                § 1306.23 Partial filling of prescrip-                     priate safeguards and records the prop-
                                                                     tions.                                                er administration, control, dispensing,
                                                                   The partial filling of a prescription                   and storage of the controlled substance
                                                                for a controlled substance listed in                       listed in Schedule III, IV, or V; and
                                                                Schedule III, IV, or V is permissible,                        (4) The system employed by the phar-
                                                                provided that:                                             macist in filling a prescription is ade-
                                                                   (a) Each partial filling is recorded in                 quate to identify the supplier, the
                                                                the same manner as a refilling,                            product and the patient, and to set
                                                                   (b) The total quantity dispensed in                     forth the directions for use and cau-
                                                                all partial fillings does not exceed the                   tionary statements, if any, contained
                                                                total quantity prescribed, and                             in the prescription or required by law.
                                                                   (c) No dispensing occurs after 6                           (d) All prescriptions for controlled
                                                                months after the date on which the                         substances listed in Schedules III, IV,
                                                                prescription was issued.                                   and V shall be kept in accordance with
                                                                [36 FR 18733, Sept. 21, 1971. Redesignated at
                                                                                                                           § 1304.04(h) of this chapter.
                                                                38 FR 26609, Sept. 24, 1973, and amended at 51             [62 FR 13965, Mar. 24, 1997, as amended at 68
                                                                FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24,              FR 37411, June 24, 2003]
                                                                1997]
                                                                                                                           § 1306.25 Transfer between pharmacies
                                                                § 1306.24 Labeling of substances and                            of prescription information for
                                                                     filing of prescriptions.                                   Schedules III, IV, and V controlled
                                                                   (a) The pharmacist filling a prescrip-                       substances for refill purposes.
                                                                tion for a controlled substance listed in                     (a) The transfer of original prescrip-
                                                                Schedule III, IV, or V shall affix to the                  tion information for a controlled sub-
ccoleman on PRODPC75 with CFR




                                                                package a label showing the pharmacy                       stance listed in Schedules III, IV or V

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                                                                § 1306.26                                                              21 CFR Ch. II (4–1–08 Edition)

                                                                for the purpose of refill dispensing is                    a manual mode for prescription
                                                                permissible between pharmacies on a                        transferral.
                                                                one time basis only. However, phar-                           (d) The procedure allowing the trans-
                                                                macies electronically sharing a real-                      fer of prescription information for re-
                                                                time, on-line database may transfer up                     fill purposes is permissible only if al-
                                                                to the maximum refills permitted by                        lowable under existing state or other
                                                                law and the prescriber’s authorization.                    applicable law.
                                                                Transfers are subject to the following                     [46 FR 48919, Oct. 5, 1981. Redesignated and
                                                                requirements:                                              amended at 62 FR 13966, Mar. 24, 1997]
                                                                  (1) The transfer is communicated di-
                                                                rectly between two licensed phar-                          § 1306.26 Dispensing without prescrip-
                                                                macists and the transferring phar-                              tion.
                                                                macist records the following informa-                         A controlled substance listed in
                                                                tion:                                                      Schedules II, III, IV, or V which is not
                                                                  (i) Write the word ‘‘VOID’’ on the                       a prescription drug as determined
                                                                face of the invalidated prescription.                      under the Federal Food, Drug, and Cos-
                                                                  (ii) Record on the reverse of the in-                    metic Act, may be dispensed by a phar-
                                                                validated prescription the name, ad-                       macist without a prescription to a pur-
                                                                dress and DEA registration number of                       chaser at retail, provided that:
                                                                the pharmacy to which it was trans-                           (a) Such dispensing is made only by a
                                                                ferred and the name of the pharmacist                      pharmacist (as defined in part 1300 of
                                                                receiving the prescription information.                    this chapter), and not by a nonphar-
                                                                  (iii) Record the date of the transfer                    macist employee even if under the su-
                                                                and the name of the pharmacist trans-                      pervision of a pharmacist (although
                                                                ferring the information.                                   after the pharmacist has fulfilled his
                                                                  (b) The pharmacist receiving the                         professional and legal responsibilities
                                                                transferred prescription information                       set forth in this section, the actual
                                                                shall reduce to writing the following:                     cash, credit transaction, or delivery,
                                                                  (1) Write the word ‘‘transfer’’ on the                   may be completed by a nonphar-
                                                                face of the transferred prescription.                      macist);
                                                                  (2) Provide all information required                        (b) Not more than 240 cc. (8 ounces) of
                                                                to be on a prescription pursuant to 21                     any such controlled substance con-
                                                                CFR 1306.05 and include:                                   taining opium, nor more than 120 cc. (4
                                                                                                                           ounces) of any other such controlled
                                                                  (i) Date of issuance of original pre-
                                                                                                                           substance nor more than 48 dosage
                                                                scription;
                                                                                                                           units of any such controlled substance
                                                                  (ii) Original number of refills author-
                                                                                                                           containing opium, nor more than 24
                                                                ized on original prescription;
                                                                                                                           dosage units of any other such con-
                                                                  (iii) Date of original dispensing;                       trolled substance may be dispensed at
                                                                  (iv) Number of valid refills remaining                   retail to the same purchaser in any
                                                                and date(s) and locations of previous                      given 48-hour period;
                                                                refill(s);                                                    (c) The purchaser is at least 18 years
                                                                  (v) Pharmacy’s name, address, DEA                        of age;
                                                                registration number and prescription                          (d) The pharmacist requires every
                                                                number from which the prescription in-                     purchaser of a controlled substance
                                                                formation was transferred;                                 under this section not known to him to
                                                                  (vi) Name of pharmacist who trans-                       furnish suitable identification (includ-
                                                                ferred the prescription.                                   ing proof of age where appropriate);
                                                                  (vii) Pharmacy’s name, address, DEA                         (e) A bound record book for dis-
                                                                registration number and prescription                       pensing of controlled substances under
                                                                number from which the prescription                         this section is maintained by the phar-
                                                                was originally filled;                                     macist, which book shall contain the
                                                                  (3) The original and transferred pre-                    name and address of the purchaser, the
                                                                scription(s) must be maintained for a                      name and quantity of controlled sub-
                                                                period of two years from the date of                       stance purchased, the date of each pur-
                                                                last refill.                                               chase, and the name or initials of the
                                                                  (c) Pharmacies electronically access-                    pharmacist who dispensed the sub-
                                                                ing the same prescription record must                      stance to the purchaser (the book shall
ccoleman on PRODPC75 with CFR




                                                                satisfy all information requirements of                    be maintained in accordance with the

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