Montana Code Annotated 1995

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     50-31-301. Definitions. As used in this part, the following definitions apply:
     (1) "Antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of any such substance).
     (2) "Code imprint" means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, marks or monograms unique to the manufacturer or distributor of the drug, or both.
     (3) "Distributor" means a person who distributes for resale a drug in solid dosage form under his own label whether or not he is the manufacturer of the drug.
     (4) "Established name", with respect to a drug or ingredient thereof, means:
     (a) the applicable official name designated pursuant to section 508 of the federal act;
     (b) if there is no such name and such drug or such ingredient is an article recognized in an official compendium, then the official title thereof in such compendium; or provided that where this subsection (b) applies to an article recognized in the United States Pharmacopoeia, the official title used in the United States Pharmacopoeia shall apply;
     (c) if neither subsection (4)(a) nor (4)(b) applies, then the common or usual name, if any, of such drug or of such ingredient.
     (5) "Legend drug" means any drug defined by section 503(b) of the federal Food, Drug and Cosmetic Act, as amended on January 15, 1980, under which its label is required to bear the statement: "Caution: Federal law prohibits dispensing without prescription."
     (6) "Manufacturer" means a person who mixed the final ingredients and prepared the final drug product.
     (7) "Solid dosage form" means capsules or tablets intended for oral use.

     History: En. Sec. 15, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-715(part); amd. Sec. 1, Ch. 403, L. 1979; amd. Sec. 1, Ch. 95, L. 1981; amd. Sec. 1, Ch. 239, L. 1983.

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