50-31-301 Definitions

50-31-301 . Definitions. As used in this part, the following definitions apply:

(1) "Antibiotic drug" means any drug intended for use by humans containing any quantity of any chemical substance that is produced by a microorganism and that has the capacity to inhibit or destroy microorganisms in dilute solution (including the chemically synthesized equivalent of such a 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 the person's own label whether or not the person is the manufacturer of the drug.

(4) "Established name", with respect to a drug or ingredient of the drug, means:

(a) the applicable official name designated pursuant to section 508 of the federal act (21 U.S.C. 358);

(b) if there is no official name and the drug or the ingredient is an article recognized in an official compendium, then the official title of the drug or ingredient in the compendium. If this subsection (4)(b) applies to an article recognized in the United States Pharmacopoeia, the official title used in the United States Pharmacopoeia applies.

(c) if neither subsection (4)(a) nor (4)(b) applies, then the common or usual name, if any, of the drug or of the ingredient.

(5) "Legend drug" means any drug defined by section 503(b) of the federal act (21 U.S.C. 353(b)), 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.