Indiana § 16-18-2-249 "New drug"

Indiana Statutes

§ 16-18-2-249 — "New drug"

Indiana § 16-18-2-249

Title 16HEALTH

Art. 18GENERAL PROVISIONS AND DEFINITIONS

Ch. 2Definitions

This text of Indiana § 16-18-2-249 ("New drug") is published on Counsel Stack Legal Research, covering Indiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Ind. Code § 16-18-2-249 (2026).

Text

"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).]

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"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).]