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					Missouri Board of Pharmacy


    Practice Act Review
     October 5th, 2004
                             State Statutes

• 338.010: Definition of Practice
  – DUR; Acts, Services, Operations, Transactions
    of a pharmacy
• 338.013: Registration of Technicians
• 338.050: Expiration Dates of Licenses
  – Pharmacist-Pharmacy-Drug Distributor
    >October 31
           338.055: Unprofessional
                          Conduct

• Drug or Alcohol Impairment
• Criminal Prosecution - Guilty or Nolo
  Contendere
• Fraud, Misrepresentation to Secure License
• Obtain Fees or Charges by Fraud
• Incompetency, Misconduct, Gross
  Negligence or Dishonesty……...
           338.055: Unprofessional
                          Conduct
• Violating or Assisting in Violations of
  Chapter 338 and Rules
• Impersonation
• Disciplining Actions from other Agencies
  or States
• Incapacitation
• Failure to Maintain Current License
• Personal Use of C.S. Unless Prescribed,
  Dispensed or Administered by Qualified
  Health Provider…..
            338.055: Unprofessional
                           Conduct

• Mistake of Fact - Issuance of License
• Failure to Display Valid License
• Violation of Professional Trust or
  Confidence
• False or Misleading Advertising
• Violation of Drug Laws (F/S)
• Violation of Drug Substitution Law
                338.056/057: Generic
                     Substitution Law

•   Name of Manufacturer on Rx or Label
•   Two line Blank
•   Actual Name of Drug on Label
•   Procedure for Oral Rx: Document
    Prescriber Approval
                             State Statutes

• 338.059: Rx/Wholesale Labeling
• 338.060: Pharmacist License (Renewal)
  – Exemptions for Military Service
  – Lapsed License
  – CE Requirements
                 338.100: Rx Records

• Total Retention Time: 5 Years
  – 3 Years Hard Copy
  – 2 Years Microfiche or EDP*
• Authority to Inspect
• Copies
• Court Proceedings
                            State Statutes

•   338.110: Board of Pharmacy; Description
•   338.140: Board Authority
•   338.150: Inspection Authority
•   338.155: Immunity
•   338.180/185/190/195: Access to Criminal
    Records; Prosecution Authority; Conviction
    Level (Licensed vs. Unlicensed)
                          State Statutes

• 338.196: Rx Originating from Out-of-State
• 338.210: Definition of a Pharmacy
• 338.220/240/250: Permit Requirements and
  Classes. Consignment Arrangement
• 338.260: Business Name-->Supervised by
  R.Ph.
• 338.300: No Transfer of Permits
                            State Statutes

• 338.315: Receipt of Drugs
• 338.330: Definition of Drug Distributors
• 338.333: Licensing
  – Temporary vs. Permanent
  – Exemption for Consignment Delivery
• 338.337: Out-of-State Distributors
• 338.340: No Distribution w/o License
                           State Statutes

• 338.365: Injunctive Authority
• 338.370: Penalty Provisions
                    Board of Pharmacy

Rules/Regulations




                                   13/75
       2.010-Operational Standards

•   Supervision
•   No Pharmacist on Duty
•   Facility Requirements
•   Warehouses
•   Owner Responsibility
•   Rx Files (Manual vs. EDP); Refills; Three
    File System…….
     2.010-Operational Standards

• Drug/Device Transfer Record Requirements
• Drug Inventories
• Drug Samples
2.015-Termination of Business as
                    a Pharmacy

• Written Notice to the Board----> 15 Days
• Date of Closing
• Disposition of the Inventory and Records
  (Retrievable within 7 Working Days)
• Termination Date--->Inventory of
  Controlled Substances (copies with each
  licensee)…….
2.015-Termination of Business as
                    a Pharmacy

• No transfer of Misbranded or Adulterated
  Drugs
• Return of License (Permit) to the Board
2.018-Prescription Requirements

• Conformance with Two-line Blank or
  Originate form Out of State
• Date, Assigned Unique Readily Retrievable
  Identifier**
• Patient(s)
• Prescriber
• Prescriber Indication of Drug Name,
  Dosage, Directions for Use, Actual Name
  and Dosage…….
2.018-Prescription Requirements

• Refills
• Quantity Dispensed and Pharmacist Initials
• Alterations to a Rx. Based on Prescriber
  Contact
• Controlled Substance Information as
  Required by Law
• Required on All Rx.---->Handwritten;
  Telephone; Oral; Fax; Electronic
              2.020-Pharmacy Permits

• Change of Ownership
  –   Business is Sold*
  –   Changes to or Within a Partnership*
  –   Death of an Owner (One year Provision)
  –   Corporate Ownership*
  –   Stock Transfers*
       *30 Day Grace Period
• Change of Location(Application/Inspection)
  vs. Remodeling
                   2.020 - Pharmacy Permits
• Permit Classifications
  –   Class A:   Community/Ambulatory
  –   Class B:   Hospital Outpatient Pharmacy
  –   Class C:   Long Term Care
  –   Class D:   Non-sterile compounding
  –   Class E:   Radiopharmaceutical
  –   Class F:   Renal Dialysis
  –   Class G:   Medical Gas
  –   Class H:   Sterile Product
  –   Class I:   Consultant
  –   Class J:   Shared Service
  –   Class K:   Internet
              2.050-Public Complaint
                            Handling

•   Written Complaints
•   Log Book
•   Communication with Complainant
•   Records Release/Confidentiality
                             2.080-E.D.P.
•   (1)Original Rx. vs. Refill Documentation
•   (2) System Capability Requirements
•   (3) Rx Records Available During Inspection
•   (4) Proof of Refill Information Accuracy
•   (5) Logbook or Separate Signature File
•   (7) On-Line Record Retrieval During
    Inspection
                          2.080-E.D.P.

• (8) Auxiliary Record System Maintained
• (9) Prescription Transfers-Deactivation
• (10) Purge Requirements---Record
  Production---> 3 Business Days
• (13) Drug Utilization Review Requirements
2.085-Electronic Transmission of
              Prescription Data
• Includes both Image and/or Data
  Transmission with Validation Requirements
• Generation of Hard Copies - Security Paper
• Defines Electronic Signature
• Original facsimile of Rx. Must be
  Maintained in Files
• System Must Guard Against and Detect
  Unauthorized Access
• Rx. Alterations Must be Documented and
  Identify Responsible Pharmacist
      2.090-Pharmacist-in-Charge

• Number of Pharmacies is not Restricted
• Change in Status---->P.I.C. is Responsible
• Change in P.I.C. Inventory of Controlled
  Substances……..
• Maintain Compliance with Automated
  Dispensing and Storage System
  Requirements
        2.090-Pharmacist-in-Charge

•   Appropriate and Direct Supervision
•   Maintain Adequate Security
•   “No Pharmacist on Duty” Posted
•   All Licenses Current and Displayed
•   Compliance with Recordkeeping Laws
•   Compliance with Controlled Substance
    Laws………..
      2.090-Pharmacist-in-Charge

• Compliance with Labeling Laws
• Compliance with Generic Substitution Laws
  and Formulary
• Maintenance of Poison Register
• Maintenance of Sanitation
• Maintenance of Equipment
• Inventory Free of Outdated Drugs…….
      2.090-Pharmacist-in-Charge

• Compliance with Drug Sample Laws
• Inventory Q/A >Misbranded Drugs
                   >Adulterated Drugs
• Compliance with Drug Distributor Laws
• Compliance with Patient Counseling Laws
• Compliance with P/P for Proper
  Registration and Supervision of Technicians
       2.100 Continuing Education
• 30 Contact Hours Required - Biennial
  Renewal
• ACPE or Board Approved Programs
• Programs Approved by Other State Boards
  of Pharmacy
• Inactive License
  – No Practice of Pharmacy
  – Makeup of Hours before Reinstatement to
    Active Status
                    2.110-PRN Refills

• 1 Year Limit from Date Rx. is Written
• Assurance that All Rx. have Proper
  Prescriber/Patient Relationship
• Documentation of Authorizations Must
  Appear in Records in Uniform Fashion
    2.120-Transfer of Prescription
                      Information

• Controlled Substances: 1 Transfer and Must
  be Between Two Licensed Pharmacists
• Pharmacies Sharing E.D.P. Database May
  Transfer as long as Refills Available
• Records of Transferred Controlled
  Substances Must Include Dates and
  Locations of all Previous Refills…….
      2.120-Transfer of Prescription
                        Information

• Recordkeeping (Transferring Pharmacy)
  –   Indicate transfer; Indicate Pharmacy
  –   Date of Transfer; Transferring Pharmacist
  –   Voiding of Rx.
  –   Controlled Substances--->Address and DEA
      Number of Pharmacy and Pharmacist
      Receiving Rx. ……….
   2.120-Transfer of Prescription
                     Information

• Receiving Pharmacy
  – Rx. Information; Indicate Transfer and the
    Name of the Original Pharmacy and
    Transferring Pharmacist
  – Original Rx. Date; Original Dispensing Date (if
    different)
  – Original Number of Refills; Remaining Refills;
    Date of Last Refill; Original Rx. Number…….
    2.120 Transfer of Prescription
                      Information

• Receiving Pharmacy (cont.)
  – Controlled Substance Rx.- Address and DEA
    Number from all Previous Transferring
    Pharmacies
           2.130-Drug Repackaging

• Pre-Packs
• Pharmacies that Repackage or Relabel for
  Outside Distribution to Other Facilities or
  Practitioners Must:
  – Register with FDA as Repackager and be
    Subject to GMP Inspections
  – Annual Listing of All Drugs Repackaged…..
             2.130-Drug Repackaging

• Standards for Pre-packs
  – Minimum USP Requirements
  – Expiration Date: Manufacturers Expiration or
    12 Months, Whichever is Less.**
  – Labeling: Name and Strength of Drug, Name of
    Manufacturer or Distributor, Expiration Date
    and Assigned Lot Number
  – Containers: Class “B” Minimum

     37/75
                2.140-Long Term Care

• Policy and Procedure Manual Required
  – Dispensing Procedures
  – Notification to Institution of Unavailability of
    Drug
  – Labeling
  – Drug Returns/Destruction
     • Disposition of Controlled Substances
  – Direction Change Labels: Temporary Labels
    Used by LTC Staff.
               2.140- Long Term Care

• Definitions:
  – Long Term Care Facility: Nursing home,
    retirement care, mental care or other facility or
    institution which provides extended health care
    to resident patients.
  – Remote Dispensing System: Any system of an
    automated or manual design that is used to
    provide doses of medication for immediate
    administration by authorized health care
    personnel and is not licensed as a pharmacy. >
              2.140-Long Term Care
  – Pharmacist Must Supervise Restocking of
    System.
  – Repackaging Requirements
  – Security - P/P
• Prescription Drug Order Defined
  – Exception to Rx Two Line Blank
  – Separate Rx File is Allowed
  – Meds. That Leave the Facility
    2.145 - Standards for Multi-Med
             Dispensing (Packaging)
• Customized Packaging with Proper Consent
• Solid Oral Dosage Forms
• Patient Package Insert for Each Drug
• Packaging Must Meet Board Requirements
  or Manufacturer if More Stringent
• Packaging Can Show Evidence of
  Tampering
• Child Resistant Packaging Standards
  Required
           Standards for Multi-Med
             Dispensing (Labeling)

• Each Container Labeled for Time of
  Administration
• Label Must Include: Patient Name; Med
  Pack Serial Number (Additional to Rx);
  Name, Strength, Physical Description/ID,
  Quantity of Each Product; Directions for
  Use/Caution Statements for Each Product;
  Storage Requirements; Prescriber for Each
  Product; …………...
           Standards for Multi-Med
             Dispensing (Labeling)

Date of Preparation; Beyond Use Date (No
  More than 60 Days Beyond Preparation
  Date); Name/Address/Telephone of the
  Pharmacy; All Other Required Statements
  of Manufacturer or USP
• Each Separate Container Must ID Drug
  Products Contained Therein
            Standards for Multi-Med
                  Dispensing (Files)

• Maintain Separate Record for Med-Packs.
  Each Record Contains:
  – Name and Address of the Patient
  – Rx. Number for Each Drug Contained Therein
  – Identity of Manufacturer/Labeler and Lot
    Number for Each Product
  – Description of Med-Pack Sufficient to Provide
    Patient with Duplicate Med-Pack for Future
    Refills……………….
            Standards for Multi-Med
                  Dispensing (Files)
  – Preparation Date and Beyond Use Date
  – Special Labeling Instructions
  – Initials of the Dispensing Pharmacist
• Custom Packaging Restrictions
  – No Return and Reuse Allowed
  – No Custom Packaging of Controlled
    Substances Allowed
           2.190-Patient Counseling

• Maintain and Review of Patient Information
• Minimum Requirement--->Offer
  – Any Pharmacy Employee
  – Written Offer When Patient or Caregiver Not
    Available
  – “Offer” Required on All New and Refill Rx.
  – Inpatients are Exempt
               4CSR 220-2.200 Sterile
                    Pharmaceuticals
• Definitions>
  – Batch: Compounding of multiple units within a
    single discrete process by the same
    individual(s)…..one limited time period.
  – Beyond Use Date: Date After Which a Product
    Should not be Used. Assignment Based on
    Immediate/Short Term Use.
  – Emergency Dispensing: High Risk Level
    Product Needed Prior to Appropriate Testing.
    Documentation - Need/Prescriber Approval
     • Separate Authorizations Required
                  4CSR 220-2.200 Sterile
                       Pharmaceuticals
  – Validation: Documentation that can show
    consistent Quality Assurance that Processes
    Used will Produce Products Meeting
    Predetermined Specifications and Quality.
• Risk Levels
  – 1: Stored at Room Temperature (48 Hours)
     •   Stored under Refrigeration (7 Days)
     •   Stored Frozen (30 Days)
     •   Unpreserved Product (Administered to 1 patient)
     •   Preserved Product (Batch Prepared for > 1 patient)
     •   Closed System Aseptic Transfers
            4 CSR 220-2.200 Sterile
                  Pharmaceuticals
– 2: In Addition to Level 1 Requirements:
   • Must Use Closed System Transfer Methods
   • Products Are Stored Beyond Level 1 Requirements
     or;
   • Batch Prepared Products (w out) Preservatives for
     More than one patient or;
   • Compounding by Numerous/Complex
     Manipulations Using a Closed System Transfer
     Method (Manufactured Container e.g., Automated
     Compounder)
                4CSR 220-2.200 Sterile
                     Pharmaceuticals
  – 3: Use of Non-Sterile Ingredients/Containers
    or Equipment Before Terminal Sterilization or;
     • Compounding Using an Open System of Transfer
       Before Terminal Sterilization (Sterile or Non-Sterile
       Ingredients)


• Policy and Procedure Manual
  – Completed for All Risk Levels Provided
  – Annual Review
                4CSR 220-2.200 Sterile
                     Pharmaceuticals

• Personnel Education and Training
  – Level 1: Experiential Training
  – Level 2: Risk Level 1 + Competency via
    Process Simulation
  – Level 3: Risk Level 1 and 2 Requirements +
     • Specific Product Preparation Training
        – Q/A - End Product Testing; Sterilization; Selection of
          Containers, Equipment and Closures
        – Specific Training on Aseptic procedures for the Specific
          Product and Processes.
                4CSR 220-2.200 Sterile
                     Pharmaceuticals

• Facilities
  – Level 1: Separate Area
     • Class 100 Environment for Critical Area
        – Disinfected Prior to Each Use
        – Re-Certified every 6 Months/When Moved; Pre-Filters
          Changed According to Manufacturer Directions
        – Pumps Recalibrated According to Manufacturer
          (Documented)
     • Separate Area for Hot/Cold Water and for Labeling,
       Order Entry and Recordkeeping
              4CSR 220-2.200 Sterile
                    Pharmaceutical
• Level 2: In Addition to Risk Level 1:
  – Controlled Area Must Meet Class 10,000
    Standards;
  – Floors Disinfected Daily; Equipment Surfaces
    Daily and Walls Monthly
  – Environmental Monitoring of Air and Surfaces
  – Critical Area Cleaned Between Batches
  – Automated Compounders: Calibrated and
    Accuracy Verified According to Manufacturer
    Requirements
              4CSR 220-2.200 Sterile
                   Pharmaceuticals
• Level 3: In Addition to Risk Level 1 and 2;
  – Compounding in a Class 100 Workbench
    Within a Class 10,000 Clean Room
  – Compounding in a Class 100 Clean Room
  – Compounding Within a Positive Pressure
    Barrier Isolator
  – Walls and Ceilings Disinfected Weekly
  – Sterilized Equipment Only in Contact with
    Sterile Products
                4CSR 220-2.200 Sterile
                     Pharmaceuticals

• Apparel
  – Risk Level 1: No Requirements
  – Risk Level 2: Low Particulate Clothing covers;
    Head and Facial Hair covered (Gowns/Mask)
     • Gloves Maintained
  – Risk Level 3: Level 2 Requirements + Shoe
    Covers
     • Exemption for Positive Pressure Barrier Isolator
       Box
                4CSR 220-2.200 Sterile
                     Pharmaceuticals

• Product Preparation and Validation
  – Risk Level 1:
     • Work Environment
     • Ingredients and Closures
        – Essential Materials Only: Arranged for Proper Air Flow
        – Disinfect all Surfaces, Equipment and Containers
     • Aseptic Technique/Validation
        – Scrub
        – Restrict Extemporaneous Activities
        – Technique Validation Annually (Additional Validation)
               4CSR 220-2.200 Sterile
                    Pharmaceuticals
– Risk Level 2: (In addition to Risk Level 1)
   •   File for Product Batch Information
   •   Verification of Calculations
   •   Accuracy of Automated Compounders
   •   Validation: Process Simulation
               4CSR 220-2.200 Sterile
                    Pharmaceuticals
– Risk Level 3: (In Addition to Risk Level 1 & 2)
   • Standards for Non-Sterile Components
      – Certificate of Analysis
   • Batch Preparation Files to Include Yield vs. Actual
     Information
   • Sterilization/Quarantine Specifications
   • Final Container Capabilities Ie. Sterility
   • Validation: Written Policies/Procedures on
     Procedures, Equipment and Techniques
                 4CSR 220-2.200 Sterile
                      Pharmaceuticals

• Records
  – Risk Level 1
     •   Training/Competency Evaluations
     •   Temperature Logs
     •   Certification of Workbenches
     •   Copies of Any Manufacturer Standards
     •   Maintenance/Calibration
  – Risk Level 2 (In Addition to Risk Level 1)
     • Batch Preparation/End Product Testing
                  4CSR 220-2.200 Sterile
                       Pharmaceuticals
  – Risk Level 3 ( In Addition to Levels 1 & 2)
     •   Preparation Work Sheet
     •   Sterilization Records
     •   Quarantine records (if applicable)
     •   End Product Evaluation/Testing
     •   Ingredient Validation Records
• Records Must Be Maintained for 2 Years
• Beyond Use Dating
  – Risk Level 1 & 2: Stability/Sterility Data
  – Risk Level 3: Same as Risk Level 1 & 2
     • > 30 Days: Stability/Potency Tests Required and
       Product Specific/Instrumental Analysis Approved
                4CSR 220-2.200 Sterile
                     Pharmaceuticals
• End Product Evaluation
  – Risk Level 1 & 2 Require Visual Inspection
  – Risk Level 3 Requires a Statistically Valid
    Sampling Plan for:
     • Sterility Testing
     • Parenteral Products - Pyrogenicity
     • Non-Sterile to Sterile Products: Quarantined
       Pending Tests for Sterility and Pyrogenicity;
       Potency Confirmation if Stored for > 30 Days
• Emergency Dispensing of Level 3 Products
• Exemption
                  4CSR 220-2.200 Sterile
                       Pharmaceuticals
• Compare/Contrast with USP Chapter 797
  – Defining Risk Levels
     • Type of Materials Used (See Handout) (>)
     • Storage Conditions for Final Products (>)
     • Exposure to Inferior Quality Air (Level 3) (>)
  – Clean Rooms
     •   Physical Characteristics of Construction(>)
     •   Environmental Controls (<)
     •   Critical Area Requirements (<)
     •   Filter Maintenance (<)
              4CSR 220-2.200 Sterile
                   Pharmaceuticals
– Gowning
   • All Risk Levels (>)
– Validation Requirements
   • Specific Media Fill Requirements (>)
– Recordkeeping (<)
– Cytotoxic Drug Controls (<)
     2.300-Record Confidentiality
• Patient Care Records-->CONFIDENTIAL
  – Rx., Rx. Orders, Patient Profiles,
  – Must Maintain Adequate Security
  – Records Released to: Patient, Prescriber or
    Current Practitioner, Requests or Subpoenas
    from a Lawful Court, Person Authorized by
    Court Order, Patient Authorized Access,
    Pharmacist/Pharmacist, As Authorized Under
    HIPPA
  – Board Rep.: Authority to Inspect and Copy
   2.400-Compounding Standards

• Compounding: Based on Rx. or Research
• Manufacturing: Extraction or Synthesis;
  Promotion of Product(s)……
• Batch Product Defined*
  – “Specific quantity…compounded in a single,
    discrete process….during one limited time…”
• Beyond Use Date is Defined*
   2.400-Compounding Standards

• Space and Equipment
• Ingredient and Container Control
• Q/A Procedures
  – Safety and Effectiveness
  – Recordkeeping: Separate Log*--->Methods to
    insure quality and purity; date; R.Ph.;
    Ingredients; Process; Source/Lot #; Identifier
  – Product Inventory Must be Reflective of Rx.
    History--->3 Months of Inventory
   External Use Products--->1 Year…...
   2.400-Compounding Standards

• Q/A (cont.)
  – Records Must be Maintained--->2 Years
  – Actual Name of Each Therapeutic Ingredient on
    Label to Consumer*
  – Illness or Lesions Must be Excluded from
    Contact with Product or Equipment
  – No Solicitation of Business for Specific
    Products
2.400 - Compounding Standards
• Management of Compounding*
  – Pharmacist Responsibility (Identity; Quality;
    Purity) Assure that Processes Are Completed
  – Drugs Must Meet Compendial Standards-C/A
  – Drug Monitoring Systems
     •   Infection Rates
     •   Adverse Drug Reactions
     •   Incidence of Recalls
     •   Complaints from Patients and Prescribers
  – Recall Standards (Physicians/Patients/Board)
2.400 - Compounding Standards

• Compounding of Commercial Products is
  Prohibited*
  – Products Withdrawn or are Unavailable
  – Clinical Necessity
• Modification of OTC Products is By Rx.
  Only*
• Authority to Compound a Drug: By Patient
  Specific Rx. Only
         2.600-Standards for Class F
            Renal Dialysis Pharmacy

• Limited to Dispensing Pre-packaged Drugs
  to Patients at Residence or Dialysis Clinic
  and Directly Related to Dialysis.
• P.I.C.-Consultant
  – Weekly Review of Operations:
     •   Appropriate Supervision
     •   Only Formulary Drugs Provided
     •   Patients Adequately Trained
     •   Approve all Drug Related P/P
      2.650 Standards for Class J
      Pharmacy: Shared Services

• Shared Service: Processing by one
  pharmacy of a request from another
  pharmacy.
  –   Dispensing
  –   DUR
  –   Claims Adjudication
  –   Refill Authorizations
  –   Therapeutic Interventions
 2.650 - Class J: Shared Service
          Pharmacies
• Requirements
  – Same Ownership or Contract that provides for
    services provided; Responsibilities of each
    licensee; Accountability for services provided
  – Maintain separate licenses at each location
    involved
  – Share EDP or Sufficient Information Necessary
    to Fill or Refill a Rx. That is Real Time/On-line
    Access.
2.650 - Class J: Shared Service
          Pharmacy
– P/P Manual
  • Methods of Compliance with State and Federal
    Drug Laws
  • Maintenance of Records that can Identify the
    Pharmacist Responsible for Dispensing and
    Counseling
  • Rx. Order Processing
  • Adequate Protections for Confidentiality and
    Integrity of Patient Records
  • Quality Assurance Program that Monitors for Proper
    Patient Outcomes
   2.700 Pharmacy Technician
          Registration

• Registration Completed and Mailed to
  Board of Pharmacy Upon Employment
• Registration or Copy of Application On Site
• Disqualification List:
  – Barred from Employment
  – Conditional Employment
• Persons Assisting in the Practice of
  Pharmacy
 2.800 - Vacuum Tube Systems

• Ensure Security
  –   Right Drug to the Right Patient
  –   Secure System from Tampering
  –   Multiple or Switchable Systems are Prohibited
  –   No R.Ph. On Duty - System Must not be in
      Operation
• No Direct Line of Sight Then Must Use
  Video and Audio Systems. (12” Wide
  Video Minimum)
          Automated Dispensing and
                   Storage Systems
• Mechanical Systems Used to Store, Distribute
  and Account for All Drug Transactions
• Documentation Requirements: Locations;
  System Events; P/P on System Operations,
  Waste and Security Measures Used
• Pharmacist Supervises Technicians that
  Restock
• No Return and Reuse of Drugs
    4CSR 220-2.900 Automated
 Dispensing and Storage Systems

• Supervision by Pharmacist Electronically
• Health Facilities
  – First Dose Release
• Ambulatory Care Setting
  – Input of Rx.
  – Limited to Prescribers at Specific Location
  – Pharmacist Available at All Times for
    Counseling
   4CSR 220-2.900 Automated
Dispensing and Storage Systems
 – Labeling in Compliance with 338.059
        • Label Application: Prior to Release
 – Records of Transactions Must be Maintained
   Separate for Each Remote Site
 – Perpetual Inventory of Controlled Substances
 – Location: Private and within Same Area Used
   for Clinical Services
 – Required Audio and Video Systems
65/75
    4CSR 220-2.900 Automated
 Dispensing and Storage Systems

• All Automated Systems
  – Tests of the System: 6 months or with any
    Upgrade
  – Loading of Machines
• Each Remote Licensed as Class J: Shared
  Service
• Supervisor Pharmacist: Restricted to 3
  Sites Simultaneously/Exceptions
                   3.011-Generic Formulary

For___________________Date_______
Address___________________________
Rx



______________            _______________
Substitution Permitted        Dispense As Written
          3.011-Generic Formulary

Albuterol
Aerosol, Metered; Inhalation
AB        Armstrong                0.09mg./INH
AB        GenPharm                 0.09mg./INH
AB        Glaxo Smith Kline (Ventolin)     0.09mg./INH
BN        Schering                0.09mg./INH
AB        Ivax                     0.09mg./INH
AB        Pliva                    0.09mg./INH
                                                   12/02
                3.011-Generic Formulary

• State of Missouri Negative Formulary
 Albuterol Aerosol           Armstrong Pharm.
                             GenPharm
                             Glaxo Smith Kline
                             Ivax
                             Sidmak



Chlorpromazine HCL; Tablet

                                                 12/02
3.040-Return and Reuse of Drugs
• Accepted from Institutions Only
  – Hospitals
  – LTC Facilities
  – Hospice Facilities
• Assurance of Storage Requirements
  – Manufacturer/USP
  – Pharmacy Originally Dispensed Drug
• Lot Number and Expiration Date Traceable
  3.040 Return and Re-Use of Drugs

• Returns for Re-use Must:
  – Original Manufacturer’s Packaging with T-ES
  – Federal Registered Repackagers with T-ES*
  – Licensed Pharmacy Products that are Un-used
    with T-ES*
  – Licensed Pharmacy Products where Un-used
    Portion can be separated and Re-used*
  NO PRODUCTS CAN BE REPACKAGED*
  AND RE-USED MORE THAN ONE TIME
      Drug Distributor: 5.020 and
    5.025-Licensing Requirements

• Licensure: Same as Pharmacy
  – Initial Applications
  – Change of Ownership
  – Change of Location
• Temporary License Authority---> 1 Year
• Out-of-State Facilities: Domestic/Foreign
           Drug Distributor: 5.030
          Definitions and Standards

• Personnel
• Facility: Size, Temp., Sanitation,
  Segregation of Distressed Drugs
• Security: Facility and Records
• Drug Storage
• P/P Manual Required: Drug Handling,
  Recalls, Stock Rotation, Loss Reports,
  Disasters…….
           Drug Distributor: 5.030
          Definitions and Standards

• Recordkeeping
  – Source; Identity; Quantity; Dates of Receipt
    and Distribution
  – Records Maintained---> 3 Years
  – Account for all Outdated, Damaged,
    Misbranded or Adulterated Articles
• Exemption from Licensure---5% Total
  Gross Sales of the Pharmacy (Rx)
 Medical Gas Distributor - 5.070
• Defined: Compressed/Liquid - Labeled for
  Medical Use
• Exemptions: Temperature/Humidity; Floor
  Pallets; Separate Inventory for Vet. Use;
  Water Supply; Outdated Drugs;
  Refrigeration; Exterior Lighting*; Alarm
  Systems*; Secure Storage Area*
• Federal Registration: Transfilling
          • *Nitrous Oxide
            6.030-Drug and Medical
                       Information

• Transfers Between Pharmacists or from
  Pharmacists to Other Health Care
  Practitioners is Now “Recognized.”
  – Initial Rx. Transfers (Recordkeeping)
  – Verbal Orders from Prescribers Noted by
    Pharmacists in Patient Records

				
DOCUMENT INFO
Description: Blank Registration Form from a Licensed Child Care Facility document sample