Missouri Board of Pharmacy

1
Missouri Board of Pharmacy

• Practice Act Review
• October 5th, 2004

2
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 gtOctober 31

3
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...

4
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..

5
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

6
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

7
State Statutes

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

8
338.100 Rx Records

• Total Retention Time 5 Years
• 3 Years Hard Copy
• 2 Years Microfiche or EDP
• Authority to Inspect
• Copies
• Court Proceedings

9
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)

10
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--gtSupervised by R.Ph.
• 338.300 No Transfer of Permits

11
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

12
State Statutes

• 338.365 Injunctive Authority
• 338.370 Penalty Provisions

13
Board of Pharmacy

• Rules/Regulations
• 13/75

14
2.010-Operational Standards

• Supervision
• No Pharmacist on Duty
• Facility Requirements
• Warehouses
• Owner Responsibility
• Rx Files (Manual vs. EDP) Refills Three File
  System.

15
2.010-Operational Standards

• Drug/Device Transfer Record Requirements
• Drug Inventories
• Drug Samples

16
2.015-Termination of Business as a Pharmacy

• Written Notice to the Board----gt 15 Days
• Date of Closing
• Disposition of the Inventory and Records
  (Retrievable within 7 Working Days)
• Termination Date---gtInventory of Controlled
  Substances (copies with each licensee).

17
2.015-Termination of Business as a Pharmacy

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

18
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.

19
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.----gtHandwritten Telephone
  Oral Fax Electronic

20
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

21
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

22
2.050-Public Complaint Handling

• Written Complaints
• Log Book
• Communication with Complainant
• Records Release/Confidentiality

23
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

24
2.080-E.D.P.

• (8) Auxiliary Record System Maintained
• (9) Prescription Transfers-Deactivation
• (10) Purge Requirements---Record Production---gt 3
  Business Days
• (13) Drug Utilization Review Requirements

25
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

26
2.090-Pharmacist-in-Charge

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

27
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..

28
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.

29
2.090-Pharmacist-in-Charge

• Compliance with Drug Sample Laws
• Inventory Q/A gtMisbranded Drugs
• gtAdulterated Drugs
• Compliance with Drug Distributor Laws
• Compliance with Patient Counseling Laws
• Compliance with P/P for Proper Registration and
  Supervision of Technicians

30
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

31
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

32
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.

33
2.120-Transfer of Prescription Information

• Recordkeeping (Transferring Pharmacy)
• Indicate transfer Indicate Pharmacy
• Date of Transfer Transferring Pharmacist
• Voiding of Rx.
• Controlled Substances---gtAddress and DEA Number
  of Pharmacy and Pharmacist Receiving Rx. .

34
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.

35
2.120 Transfer of Prescription Information

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

36
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..

37
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

38
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.

39
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. gt

40
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

41
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

42
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 ...

43
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

44
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.

45
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

46
2.190-Patient Counseling

• Maintain and Review of Patient Information
• Minimum Requirement---gtOffer
• Any Pharmacy Employee
• Written Offer When Patient or Caregiver Not
  Available
• Offer Required on All New and Refill Rx.
• Inpatients are Exempt

47
4CSR 220-2.200 Sterile Pharmaceuticals

• Definitionsgt
• 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

48
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 gt 1
  patient)
• Closed System Aseptic Transfers

49
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)

50
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

51
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.

52
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

53
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

54
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

55
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

56
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)

57
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

58
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

59
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

60
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
• gt 30 Days Stability/Potency Tests Required and
  Product Specific/Instrumental Analysis Approved

61
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 gt 30 Days
• Emergency Dispensing of Level 3 Products
• Exemption

62
4CSR 220-2.200 Sterile Pharmaceuticals

• Compare/Contrast with USP Chapter 797
• Defining Risk Levels
• Type of Materials Used (See Handout) (gt)
• Storage Conditions for Final Products (gt)
• Exposure to Inferior Quality Air (Level 3) (gt)
• Clean Rooms
• Physical Characteristics of Construction(gt)
• Environmental Controls (lt)
• Critical Area Requirements (lt)
• Filter Maintenance (lt)

63
4CSR 220-2.200 Sterile Pharmaceuticals

• Gowning
• All Risk Levels (gt)
• Validation Requirements
• Specific Media Fill Requirements (gt)
• Recordkeeping (lt)
• Cytotoxic Drug Controls (lt)

64
2.300-Record Confidentiality

• Patient Care Records--gtCONFIDENTIAL
• 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

65
2.400-Compounding Standards

• Compounding Based on Rx. or Research
• Manufacturing Extraction or Synthesis Promotion
  of Product(s)
• Batch Product Defined
• Specific quantitycompounded in a single,
  discrete process.during one limited time
• Beyond Use Date is Defined

66
2.400-Compounding Standards

• Space and Equipment
• Ingredient and Container Control
• Q/A Procedures
• Safety and Effectiveness
• Recordkeeping Separate Log---gtMethods to insure
  quality and purity date R.Ph. Ingredients
  Process Source/Lot Identifier
• Product Inventory Must be Reflective of Rx.
  History---gt3 Months of Inventory
• External Use Products---gt1 Year...

67
2.400-Compounding Standards

• Q/A (cont.)
• Records Must be Maintained---gt2 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

68
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)

69
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

70
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

71
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

72
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.

73
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

74
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

75
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)

76
Automated Dispensing andStorage 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

77
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

78
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

79
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

80
3.011-Generic Formulary

• For___________________Date_______
• Address___________________________
• Rx
• ______________ _______________
• Substitution Permitted Dispense As Written

81
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

82
3.011-Generic Formulary

• State of Missouri Negative Formulary
• Albuterol Aerosol Armstrong Pharm.
• GenPharm
• Glaxo Smith Kline
• Ivax
• Sidmak
• Chlorpromazine HCL Tablet
• 12/02

83
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

84
3.040 Return and Re-Use of Drugs

• Returns for Re-use Must
• Original Manufacturers 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

85
Drug Distributor 5.020 and 5.025-Licensing
Requirements

• Licensure Same as Pharmacy
• Initial Applications
• Change of Ownership
• Change of Location
• Temporary License Authority---gt 1 Year
• Out-of-State Facilities Domestic/Foreign

86
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.

87
Drug Distributor 5.030 Definitions and Standards

• Recordkeeping
• Source Identity Quantity Dates of Receipt and
  Distribution
• Records Maintained---gt 3 Years
• Account for all Outdated, Damaged, Misbranded or
  Adulterated Articles
• Exemption from Licensure---5 Total Gross Sales
  of the Pharmacy (Rx)

88
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

89
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