Montana Code Annotated 2023



Part 5. Drug Product Selection


37-7-502. Definitions. 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 administer and prescribe medicine and drugs.

(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.