§ 16-18-2-249 — "New drug"

"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).]

Legislative History

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