Indiana § 16-42-22-4 - "Generically equivalent drug product"
Full text of Indiana Indiana Code § 16-42-22-4 — "Generically equivalent drug product", with citation guidance and answers to common questions.
§ 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.
Source: official Indiana text · Last verified 2026-08-27
Frequently Asked Questions About Indiana § 16-42-22-4
What does Indiana Code § 16-42-22-4 cover?
Section 16-42-22-4 (""Generically equivalent drug product"") is part of the Indiana Code, the codified statutory law of Indiana. It sets out the legal rule or procedure described in the text above. Statutes are amended regularly, so always verify against the official source.
How do I cite Indiana § 16-42-22-4?
A common citation format is "Indiana Code § 16-42-22-4" (Indiana). Legal writing may require the code abbreviation, section number, and year or edition. Match the style required by your court, professor, or publisher.
Is this the official text of Indiana law?
No. This page is for research and education and may not include the most recent amendments. For official current law, check the Indiana official source linked on this page or consult a licensed Indiana attorney.
How does Indiana § 16-42-22-4 apply to my situation?
Statutes are interpreted in context, and application depends on your specific facts. Only a licensed attorney in Indiana can advise on how this section applies to you. Contact your state or local bar association for a referral.
Sources & Verification
Not legal advice. Verify against the official source and consult a licensed attorney in Indiana.