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