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Home > Agendas > 2007-2008 > P&FR > Board of Pharmacy

2007-2008 Regulatory Agendas

02-392
Board of Pharmacy

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, tel. (207) 624-8625

EMERGENCY RULES ADOPTED SINCE THE LAST REGULATORY AGENDA: None

EXPECTED 2007-2008 RULE-MAKING ACTIVITY: The Board may consider updating rules as may be necessary and to clarify or correct any errors or omissions from the comprehensive rules update of November 8, 2004. Particular focus will be given to, but not limited to; registration requirements for wholesale distributors, pharmacy technician requirements and practice areas, internet pharmacies, pharmacist in charge registration and responsibilities, and destruction of prescription drugs. Outdated or duplicative rules that may exist in 10 MRSA, Part 9, Chapter 901 and rules established by the Office of Licensing and Registration as authorized by 10 MRSA §8003 will be updated or repealed.

CHAPTER 1: Definitions
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13723
PURPOSE: This chapter defines certain specialized terms used throughout all rules adopted by the board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 2: Advisory Rulings
STATUTORY AUTHORITY: 5 MRSA §§ 8051, 9001(4)
PURPOSE: This chapter provides for the discretionary issuance of advisory rulings by the board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 3: Applicability of Rules to Unregistered Facilities
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(D), 13723
PURPOSE: This chapter provides for the applicability of the board’s rules to the facilities identified in 32 MRSA §13721(1)(D)
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 4: Licensure of Pharmacists
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13723, 13732, 13733, 13734
PURPOSE: This chapter sets forth the application procedure for persons applying for licensure as a pharmacist pursuant to 32 MRSA §§ 13732 and 13733
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 5: Continuing Pharmacy Education
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13723, 13735
PURPOSE: This chapter implements the requirement in 32 MRSA §13735 that each pharmacist complete 15 hours of continuing pharmacy education annually as a condition of license renewal.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 6: Pharmacy Student Internship Programs
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(G), 13723, 13732(3)
PURPOSE: This chapter sets forth requirements of the pharmacy student internship required for licensure by chapter 4, section 1(4)(B) of the board’s rules.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 7: Registration and Employment of Pharmacy Technicians
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(I)(H), 13723
PURPOSE: This chapter sets forth the qualifications, permissible duties and supervision responsibilities of the pharmacist in charge with respect to registered pharmacy technicians.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 8: Registration of Retail Drug Outlets
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(E), 13723, 13751, 13752, 13752-A
PURPOSE: This chapter sets forth registration requirements for retain drug outlets.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 9: Registration of Rural Health Centers
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(E), 13723, 13751, 13762, 13763, 13764
PURPOSE: This chapter sets forth registration requirements for rural health centers.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 10: Registration of Free Clinics
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(E), 13723, 13751, 13752, 13752-A, 13753
PURPOSE: This chapter sets forth registration requirements for free clinics.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 11: Registration of Mail Order Prescription Pharmacies and Licensure of Mail Order Contact Lens Suppliers
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(E), 13723, 13751, 13752, 13752-A, 13753
PURPOSE: This chapter sets forth registration requirements for mail order prescription pharmacies and license requirements for mail order contact lens suppliers. This chapter also contains enforcement provisions unique to these two types of drug outlet.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 12: Registration of Manufacturers and Wholesale Drug Outlets
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(E), 13723, 13751, 13758
PURPOSE: This chapter sets forth registration requirements for wholesale drug outlets, also known as wholesalers or wholesale drug distributors, and manufacturers.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 13: Operation of Retail Drug Outlets
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13751
PURPOSE: This chapter sets forth operation requirements for retain drug outlets registered by the board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 14: Pharmacy Services at Rural Health Centers
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13762, 13763, 13764
PURPOSE: This chapter sets forth requirements for the pharmacy services provided by rural health centers licensed by the board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 15: Operation of Free Clinics
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723
PURPOSE: This chapter sets forth requirements for the operation of free clinics licensed by the board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 16: Operation of Wholesale Drug Outlets and Manufacturers
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13758
PURPOSE: This chapter sets forth operational requirements for wholesale drug distributors, including wholesale drug outlets and manufacturers.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 17: Operation of Nuclear Drug Outlets
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723
PURPOSE: This chapter incorporates by reference rules of the Maine Radiation Control Program applicable to nuclear drug outlets.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 18: Sterile Pharmaceuticals
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723
PURPOSE: This chapter sets forth rules governing 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 19: Receipt and Handling of Prescription Drug Orders
STATUTORY AUTHORITY: 22 MRSA §2681(6); 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13781, 13785, 13786-A, 13794, 13795
PURPOSE: This chapter sets forth requirements for creating, transmitting, filling and transferring prescription drug orders.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 20: Automated Pharmacy Systems
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722(1)(B-1), 13723
PURPOSE: This chapter sets forth requirements for automated pharmacy systems.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 21: Central Prescription Processing
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13784, 13785, 13794
PURPOSE: This chapter sets forth requirements for central prescription processing.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 22: Sale of Schedule V Controlled Substances
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722(1)(E), 13723
PURPOSE: This chapter sets forth requirements for the sale of Schedule V controlled substances.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 23: Accounting for Prescription Drugs
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723
PURPOSE: This chapter sets forth requirements relating to maintenance of a perpetual inventory, disposal of drugs, and reporting the loss of controlled substances.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 24: Retention of Records by Drug Outlets
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723(7), 13784
PURPOSE: This chapter sets forth record retention requirements for drug outlets.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 25: Patient Counseling
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13784
PURPOSE: This chapter sets forth the pharmacist’s obligation to counsel patients.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 26: Generic Substitutions
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13781
PURPOSE: This chapter defines and outlines the use of generic and therapeutically equivalent drugs by pharmacists.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 27: Possession and Administration of Noncontrolled Prescription Drugs by Nurses
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1), 13722, 13723, 13810
PURPOSE: This chapter defines the conditions under which nurses can possess and administer noncontrolled prescription drugs.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 28: Enforcement and Disciplinary Procedures
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(F), 13722, 13723, 13741
PURPOSE: This chapter sets forth a licensee’s right to appeal certain board actions and specifies the enforcement and disciplinary procedures used by the board.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 29: Violations of Federal Law or Rule
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(F), 13722, 13723, 13741, 13742(2)(F)
PURPOSE: This chapter recognizes certain federal statutes and rules as having established standards of professional behavior, the violation of which constitutes unprofessional conduct pursuant to 32 MRSA §13742(2)(F).
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 30: Unprofessional Conduct
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(F), 13722, 13723, 13741, 13742(2)(F)
PURPOSE: This chapter establishes standards of professional behavior, the violation of which constitutes unprofessional conduct pursuant to 32 MRSA §13742(2)(F)
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 31: Practice of Fraud or Deceit
STATUTORY AUTHORITY: 32 MRSA §§ 13720, 13721(1)(F), 13722, 13723, 13741, 13742(2)(A)
PURPOSE: For purposes of 32 MRSA §13742(2)(A), the practice of fraud or deceit includes, but is not limited to, the conduct described in this chapter.
ANTICIPATED SCHEDULE: Within one year, if necessary.
AFFECTED PARTIES: Licensees
CONSENSUS-BASED RULE DEVELOPMENT: Not Contemplated

CHAPTER 32: Issuance of Citations
STATUTORY AUTHORITY: 10 MRSA §8003-E; 32 MRSA §§ 13720, 13721(1)(F), 13722, 13723
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