Indiana Code 16-42-22-4. “Generically equivalent drug product”
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Sec. 4. (a) As used in this chapter, “generically equivalent drug product” means a multiple source drug product:
(2) if applicable, for which the manufacturer or distributor holds either an approved new drug application or an approved abbreviated new drug application unless other approval by law or of the federal Food and Drug Administration is required.
(1) that contains an identical quantity of identical active ingredients in the identical dosage forms (but not necessarily containing the same inactive ingredients) that meet the identical physical and chemical standards in The United States Pharmacopeia (USP) described in IC 16-42-19-2, or its supplements, as the prescribed brand name drug; and
Terms Used In Indiana Code 16-42-22-4
- brand name: means the proprietary or trade name selected by the drug manufacturer and placed upon a drug or the drug's container, label, or wrappings at the time of packaging. See Indiana Code 16-42-22-1
- generically equivalent drug product: means a multiple source drug product:
Indiana Code 16-42-22-4
- United States: includes the District of Columbia and the commonwealths, possessions, states in free association with the United States, and the territories. See Indiana Code 1-1-4-5
(b) A drug does not constitute a generically equivalent drug product if it is listed by the federal Food and Drug Administration on or after July 1, 1987, as having actual or potential bioequivalence problems.
[Pre-1993 Recodification Citation: 16-6-8.1-1 part.]
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.4.