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02-392
Department of Professional and Financial Regulation
Maine Board of Pharmacy

2003-2004 Regulatory Agenda

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

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

EMERGENCY RULES ADOPTED SINCE THE LAST REGULATORY AGENDA: None

EXPECTED 2003-2004 RULE-MAKING ACTIVITY: The Board's current rules, Chapters 1 through 7, will be repealed and new rules adopted in their place.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 current laws. The Board may review and amend the chapters listed below as may be necessary for compliance with current and newly enacted laws, and to clarify 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 and update terms used throughout the Board's rules, and amend licensing requirements and procedures all licenses issued by the Board.

The Board may need to amend, but is not limited to, the following: 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 also amend and update rules regarding standards for the use, maintenance, and supervision of automated pharmacy systems, central filling stations, and prescription transfers, the security of the facilities where drugs are kept or stored, including but not limited to, legend drugs, patient records, and all other data in conjunction with the practice of pharmacy. Review and update, as may be necessary, practice setting standards for pharmacists, pharmacy technicians, pharmacy interns, and student pharmacists. Outdated or duplicative rules that may exist in rules established by the Office of Licensing and Registration as authorized by 10 MRSA §8003 will be repealed.

Finally, the 121st Legislature enacted laws that will require the board to review and amend current rules pertaining to disclosure of retail prescription drug prices, substitution of a generic drug and therapeutically equivalent drug, and to adopt new rules on requiring disclosure by participating retail pharmacies to qualified residents of the amount of savings provided as a result of the Maine Rx Program.

STATUTORY AUTHORITY: 10 MRSA §8003-E, 22 MRSA §2681(6), 32 MRSA §§13720, 13721(1)(F) through (H), 13722(1)(A) and (E), 13723(5)(I) and (7), 13751(2), (3), and (3-A), 13752(1) and (4), 13762, 13764, 13781, and 13784 (3)

CHAPTER 1: Computer Regulations
PURPOSE: Establish standards for the use of computers in the practice of pharmacy.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 2: Nuclear Drug Outlet Regulations
PURPOSE: Establish standards for drug outlets in which compounding, dispensing, labeling, and delivery of radioactive drugs occur.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 3: Sterile Pharmaceuticals
PURPOSE: Establish standards for the preparation, labeling, and distribution of sterile pharmaceuticals.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 4: Complaint Handling and Enforcement
PURPOSE: Establish standards and procedures pertaining to complaints and investigations.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 5: Adjudicatory Hearings
PURPOSE: Establish procedures related to adjudicatory proceedings.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 6: Advisory Rulings
PURPOSE: Establish standards the issuance of advisory rulings by the Board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 7: Continuing Education
PURPOSE: Establish requirements and procedures for continuing professional education for license renewal. The Board may need to amend this chapter to conform to recently adopted rules by the Office of Licensing and Registration on substantiation of continuing education by licensed practitioners.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 8: Security
PURPOSE: Establish security standards for drug outlets operating in Maine.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

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 one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

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 one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 11: Generic Substitutions
PURPOSE: Establish standards for the use of generic and therapeutically equivalent drugs.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

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 one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 13: Previous Pharmacy Regulations
PURPOSE: This chapter nullifies all prior rules adopted by the Board prior to February 1, 1990.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 14: Application for the Registration of a Drug Outlet
PURPOSE: Establish application and licensing requirements for registering drug outlets.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 15: Licensure of Wholesale Drug Distributors
PURPOSE: Establish application and licensing requirements, and operation of wholesale drug distributors.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

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 one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 17: Registration of Pharmacy Technicians
PURPOSE: Establish standards for application, training, qualification, and employment of pharmacy technicians.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

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 one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 19: Prescription Drug Orders, Prescription Transfers, Automated Pharmacy Systems, and Central Filling Stations
PURPOSE: Regulates the receipt and handling of prescription drug orders, including, but is not limited to filling the drug order, transferring and transmitting the drug order and maintaining records. Regulates the operation of mechanical systems that perform activities relative to the storage, packaging, labeling, dispensing, or distribution of medications, including systems that collect, control, and maintain transactional information and data.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 20: Issuance of Citations
PURPOSE: This chapter lists the violations for which a citation may be issued, describes the licensee's right to request a hearing, and describes the time and manner in which the fine must be paid or a hearing requested.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 21: Unprofessional Conduct
PURPOSE: This chapter identifies acts that will be viewed by the Board as unprofessional conduct in the practice of pharmacy.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated


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