§13722. Medications, drugs, devices and other materials
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).