Transcript Missouri Board of Pharmacy

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
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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
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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
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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
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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
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Class A:
Class B:
Class C:
Class D:
Class E:
Class F:
Class G:
Class H:
Class I:
Class J:
Class K:
Community/Ambulatory
Hospital Outpatient Pharmacy
Long Term Care
Non-sterile compounding
Radiopharmaceutical
Renal Dialysis
Medical Gas
Sterile Product
Consultant
Shared Service
Internet
2.050-Public Complaint
Handling
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Written Complaints
Log Book
Communication with Complainant
Records Release/Confidentiality
2.080-E.D.P.
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(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
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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)
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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)
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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)
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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)
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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
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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)
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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
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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
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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:
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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.
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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
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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
AB
AB
BN
AB
AB
Armstrong
0.09mg./INH
GenPharm
0.09mg./INH
Glaxo Smith Kline (Ventolin)
0.09mg./INH
Schering
0.09mg./INH
Ivax
0.09mg./INH
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