1. Responsibility. The board has the following responsibilities in regard to medications, drugs, devices and other materials used in this State in the diagnosis, mitigation and treatment or prevention of injury, illness and disease. The board shall:
A. Promulgate rules concerning the sale and dispensing of medications, drugs, devices and other materials, including the right to seize any such drugs, devices and other materials found to be detrimental to the public health and welfare by the board after appropriate hearing as required under the Maine Administrative Procedure Act, Title 5, chapter 375; [PL 1987, c. 710, §5 (NEW).]
B. Establish the specifications of minimum professional and technical equipment, environment, supplies and procedure for the compounding, dispensing or administering of medications, drugs, devices and other materials within the practice of pharmacy; [PL 2021, c. 146, §3 (AMD).]
B-1. Establish standards for the use, maintenance and supervision of automated pharmacy systems; [PL 2021, c. 289, §5 (AMD).]
B-2. Establish the terms and conditions for compounding drugs for veterinarian office use by rule, including, at a minimum:

(1) Requirements and specifications of minimum professional and technical equipment, environments, supplies and procedures and quality assurance requirements;
(2) Labeling requirements;
(3) Limits on the supply for administration to the veterinarian’s patient and the supply for dispensing to the veterinarian’s client;
(4) Record-keeping requirements; and
(5) Procedures for notifications regarding defective drug products and adverse events.
Compounding drugs for veterinarian office use is not permitted until rules are adopted by the board pursuant to this paragraph. Rules adopted pursuant to this paragraph are routine technical rules as defined in Title 5, chapter 375, subchapter 2?A; [PL 2021, c. 289, §6 (NEW).]
C. Assure that standards for purity and quality of medications, drugs, devices and other materials within the practice of pharmacy are met; [PL 1987, c. 710, §5 (NEW).]
D. Issue and renew licenses for purposes of ascertaining those persons engaged in the manufacture and distribution of drugs; [PL 2007, c. 402, Pt. DD, §9 (AMD).]
E. Promulgate rules concerning the sale and the dispensing of any exempt narcotic preparation. An “exempt narcotic preparation” means any medicinal preparation that contains in 30 milliliters or, if a solid or semisolid preparation, in 30 grams:

(1) Not more than 130 milligrams of opium;
(2) Not more than 15 milligrams of morphine or any of its salts;
(3) Not more than 65 milligrams of codeine or any of its salts;
(4) Not more than 30 milligrams of dihydrocodeine or any of its salts; or
(5) Not more than one of the drugs named in subparagraphs (1) to (4).
A record shall be kept of the sale of exempt narcotic preparations. The record must contain the date of sale, signature and address of the purchaser, name of the preparation, purpose for which purchased and signature of the person making the sale; and [PL 1987, c. 710, §5 (NEW).]
F. After notice and hearing, designate as potent medicinal substances any compounds of barbituric acid, amphetamines or any other central nervous system stimulants or depressants, psychic energizers or any other drugs having a tendency to depress or stimulate which are likely to be injurious to health if improperly used. [PL 1987, c. 710, §5 (NEW).]

[PL 2021, c. 146, §3 (AMD); PL 2021, c. 289, §§5, 6 (AMD).]

SECTION HISTORY

PL 1987, c. 710, §5 (NEW). PL 1999, c. 130, §6 (AMD). PL 2007, c. 402, Pt. DD, §9 (AMD). PL 2021, c. 146, §3 (AMD). PL 2021, c. 289, §§5, 6 (AMD).

Terms Used In Maine Revised Statutes Title 32 Sec. 13722

  • Automated pharmacy systems: means mechanical systems that perform operations or activities, other than compounding, relative to the storage, packaging, labeling, dispensing or distribution of medications, and systems that collect, control and maintain all transactional information. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Board: means the Maine Board of Pharmacy. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Compounding: means the preparation, mixing, assembling, packaging or labeling of a drug or device by a pharmacist:
A. See Maine Revised Statutes Title 32 Sec. 13702-A
  • dispensing: means the preparation and delivery of a prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug pursuant to a lawful order of a practitioner. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Drug: means :
    • A. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Manufacture: means the production, preparation, propagation, compounding, conversion or processing of a device or drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis and includes any packaging or repacking of the substances or labeling or relabeling of its container, except that manufacture does not include the preparation or compounding of a drug by an individual for personal use or the preparation, compounding, packaging or labeling of a drug:
    • A. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Person: means an individual, corporation, partnership, association or any other legal entity. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Pharmacy: means :
    • A. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Practice of pharmacy: means the provision of health care services that include the interpretation and evaluation of prescription drug orders; the compounding, dispensing and labeling of drugs and devices, except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices; the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records for these drugs and devices; the administration of vaccines licensed by the United States Food and Drug Administration that are recommended by the United States Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, or successor organization, for administration to adults; the administration to adults by intramuscular and subcutaneous injection of drugs approved by the United States Food and Drug Administration; the performance of collaborative drug therapy management; the responsibility for advising, when necessary or regulated, of therapeutic values, content, hazards and use of drugs and devices; the ordering and dispensing of over-the-counter nicotine replacement products approved by the United States Food and Drug Administration; the prescribing, dispensing and administering of an HIV prevention drug, as defined in section 13786?E, subsection 1, paragraph B, pursuant to a standing order or collaborative practice agreement or to protocols developed by the board; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy. See Maine Revised Statutes Title 32 Sec. 13702-A
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