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AGENCY UMBRELLA-UNIT NUMBER: 02-392
AGENCY NAME: Department of Professional & Financial Regulation, Office of Licensing & Registration, Board of Pharmacy

CONTACT PERSON: Geraldine L. Betts, Board Administrator, 35 State House Station, Augusta, ME 04333-0035. Tel. (207) 624-8625

EMERGENCY RULES ADOPTED SINCE THE LAST REGULATORY AGENDA: None

EXPECTED 2002-2003 RULE-MAKING ACTIVITY: The Board's current rules, Chapters 1 through 7 will be repealed and new rules adopted in their place. The Board expects to reorganize the structure of the rules and update all rules for compliance with laws currently in place. The Board may review and amend the chapters listed below as may be necessary for compliance with current laws, references to state and federal codes, and other national standards of practice. The Board may review and revise all rules with the intent to clarify terms used throughout the Board's rules, and amend licensing requirements and procedures for licensing and registration of drug outlets, mail order entities, manufacturers, wholesalers, pharmacists, and pharmacy technicians. The Board may review existing rules and adopt new rules for standards pertaining to: sterile drug outlets, store closing protocols, emergency dispensing and refill protocols, internet and telepharmacy practices, storage and usage of emergency kits containing controlled substances in Long Term Care facilities and other facilities that may apply, and the duties and responsibilities for a Pharmacist-in-Charge.

The Board may set standards for the use, maintenance, and supervision of automated pharmacy systems, central fill stations, and prescription transfers; for the security of the facilities where drugs are kept or stored; and for legend drugs, patient records, and all other documents in conjunction with the practice of pharmacy. The Board may evaluate the standards of practice for the sale and dispensing of medication and professional responsibilities in the conduct of any drug outlet with employees or personnel engaged in the practice of pharmacy. Outdated or duplicative rules that may exist in rules established by the Office of Licensing and Registration as authorized by 10 MRSA §8003 will be repealed.

STATUTORY AUTHORITY: 32 MRSA §§13720, 13722(A)(E), 13723, 13751(3),(3-A)(F), 13752(1)(4), 13762, and 13764

CHAPTER 1: Computer Regulations
PURPOSE: Establish standards for the use of computers in the practice of pharmacy.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 2: Nuclear Drug Outlet Regulations
PURPOSE: Establish standards for drug outlets in which compounding, dispensing, labeling, and delivery of radioactive drugs occurs.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 3: Sterile Pharmaceuticals
PURPOSE: Establish standards for the preparation, labeling, and distribution of sterile pharmaceuticals.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 4: Complaint Handling and Enforcement
PURPOSE: Establish standards and procedures pertaining to complaints and investigations.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 5: Adjudicatory Hearings
PURPOSE: Establish procedures related to adjudicatory proceedings.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 6: Advisory Rulings
PURPOSE: Establish standards the issuance of advisory rulings by the Board.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 7: Continuing Education
PURPOSE: Establish requirements and procedures for continuing professional education for license renewal.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 8: Security
PURPOSE: Establish security standards for drug outlets operating in Maine.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 9: Out of State Mail Order Companies
PURPOSE: Establish requirements for registration and standards for mail order companies who fill and mail drugs to Maine consumers.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 10: General Rules
PURPOSE: Establish standards for the sale of Schedule V Controlled Substances, services at rural health centers, examination score transfers, construction, operation, and licensing of retail drug outlets, "PRN" refills, pre-printed, telephone, validity, and faxed prescriptions, death or sudden removal of a pharmacist, pharmacist-in-charge, disposal of drugs, perpetual inventory, reporting loss of controlled substances, unprofessional conduct, signs, notification requirements, record security and retention, and permanent closing of a drug outlet. This chapter also sets licensing eligibility requirements and application procedures for pharmacists.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 11: Generic Substitutions
PURPOSE: Establish standards for the use of generic and therapeutically equivalent drugs.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 12: Adoption of Federal Regulations
PURPOSE: This chapter adopts and reserves the right for the Board to enforce all federal laws and rules pertaining to pharmacy.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 13: Previous Pharmacy Regulations
PURPOSE: This chapter nullifies all prior rules adopted by the Board prior to February 1, 1990.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 14: Application for the Registration of a Drug Outlet
PURPOSE: Establish application and licensing requirements for registering drug outlets.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 15: Registration of Wholesale Drug Distributors
PURPOSE: Establish application and licensing requirements, and operation of wholesale drug distributors.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 16: Patient Counseling Requirements
PURPOSE: Establish standards for the purpose of conducting and recording patient counseling in conjunction with dispensing drugs.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 17: Registration of Pharmacy Technicians
PURPOSE: Establish standards for application, training, qualification, and employment of pharmacy technicians.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

CHAPTER 18: Noncontrolled Prescription Drug Administration
PURPOSE: Establish a list of type of noncontrolled prescription drugs that a Registered Nurse or Advanced Practice Registered Nurse may carry in the course of practicing their profession.
ANTICIPATED SCHEDULE: Within 180 days
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Under Consideration

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