Indiana Code
Chapter 22. Drugs: Generic Drugs
16-42-22-4. "Generically Equivalent Drug Product"

Sec. 4. (a) As used in this chapter, "generically equivalent drug product" means a multiple source drug product:
(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
(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.
(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.

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