§ 16-42-22-4 — "Generically equivalent drug product"

Indiana § 16-42-22-4

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 22: Drugs: Generic Drugs

Text

(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.]

Legislative History

As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.4.