Indiana § 16-18-2-249 - "New drug"

Full text of Indiana Indiana Code § 16-18-2-249 — "New drug", with citation guidance and answers to common questions.

§ 16-18-2-249. "New drug"

Sec. 249. "New drug", for purposes of IC 16-42-1 through IC 16-42-4, means:

(1) any drug whose composition is such that the drug is not generally recognized among experts, who are qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling of the drug; or

(2) any drug whose composition is such that the drug, as a result of investigations to determine the safety for use under such conditions, has become so recognized, but which has not, otherwise than in investigations, been used to a material extent or for a material time under such conditions.

[Pre-1993 Recodification Citation: 16-1-28-3(n).]

As added by P.L.2-1993, SEC.1.

Source: official Indiana text · Last verified 2026-08-27

Frequently Asked Questions About Indiana § 16-18-2-249

What does Indiana Code § 16-18-2-249 cover?

Section 16-18-2-249 (""New drug"") 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 § 16-18-2-249?

A common citation format is "Indiana Code § 16-18-2-249" (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 § 16-18-2-249 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.