Mont. Code Ann. § 37-7-502
Definitions
En. 66-1529 by Sec. 2, Ch. 403, L. 1977; R.C.M. 1947, 66-1529; amd. Sec. 11, Ch. 379, L. 1981; amd. Sec. 12, Ch. 388, L. 2001; amd. Sec. 1, Ch. 42, L. 2017; amd. Sec. 7, Ch. 726, L. 2025.
As used in this part, the following definitions apply:
- (1) "Bioavailability" means the extent and rate of absorption from a dosage form as reflected by the time-concentration curve of the administered drug in the systemic circulation.
- (2) "Bioequivalent" means a chemical equivalent that, when administered to the same individual in the same dosage regimen, will result in comparable bioavailability.
- (3) "Biological product" has the meaning provided in 42 U.S.C. 262.
- (4) "Brand name" means the proprietary or the registered trademark name given to a drug product by its manufacturer, labeler, or distributor and placed upon the drug, its container, label, or wrapping at the time of packaging.
- (5) "Chemical equivalent" means drug products that contain the same amounts of the same therapeutically active ingredients in the same dosage forms and that meet present compendium standards.
- (6) "Drug product" means a dosage form containing one or more active therapeutic ingredients along with other substances included during the manufacturing process.
- (7) "Generic name" means the chemical or established name of a drug product or drug ingredient published in the latest edition of an official compendium recognized by the board.
(8) "Interchangeable biological product" means a biological product that the federal food and drug administration has:
- (a) licensed; and
(b)
- (i) determined meets the standards for interchangeability pursuant to 42 U.S.C. 262(k)(4); or
- (ii) determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal food and drug administration's approved drug products with therapeutic equivalence evaluations.
- (9) "Person" has the meaning provided in 37-7-101.
- (10) "Prescriber" means a medical practitioner, as defined in 37-2-101, licensed under the professional laws of the state to purchase, administer, and prescribe medicine and drugs. For the purposes of this chapter, the term includes a naturopathic physician and a physician assistant.
- (11) "Present compendium standard" means the official standard for drug excipients and drug products listed in the latest revision of an official compendium recognized by the board.
- (12) "Product selection" means to dispense without the prescriber's express authorization a different drug product in place of the drug product prescribed.
- (13) "Therapeutically equivalent" means those chemical equivalents that, when administered in the same dosage regimen, will provide essentially the same therapeutic effect as measured by the control of a symptom or a disease and/or toxicity.
History: En. 66-1529 by Sec. 2, Ch. 403, L. 1977; R.C.M. 1947, 66-1529; amd. Sec. 11, Ch. 379, L. 1981; amd. Sec. 12, Ch. 388, L. 2001; amd. Sec. 1, Ch. 42, L. 2017; amd. Sec. 7, Ch. 726, L. 2025.