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02-392
Department of Professional and Financial Regulation
Maine Board of Pharmacy
2001-2002 Regulatory Agenda
UMBRELLA-UNIT NUMBER: 02-392
AGENCY NAME: Department of Professional & Financial Regulation, Office
of Licensing & Registration, Board of Pharmacy
CONTACT PERSON:
Geraldine L. Betts, 35 State House Station, Augusta, ME 04333-0035.
(207) 624-8625. Email: jeri.l.betts@state.me.us
EMERGENCY RULES
ADOPTED SINCE THE LAST REGULATORY AGENDA: NONE
EXPECTED 2001-2002
RULE-MAKING ACTIVITY: 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, manufacturer, 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 Outdated or duplicative rules that may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as authorized by 10 MRSA §8003 will be repealed.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
© Department of the Secretary of State
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