"Bulk drug substance"
Ind. Code § 16-42-22.5-1
in effectSec. 1. (a) As used in this chapter, "bulk drug substance" means a substance that is intended:
(1) for incorporation into a finished drug product; and
(2) to furnish pharmacological activity or other direct effect;
in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
(b) The term does not include the following:
(1) A vitamin, mineral, herb, essential oil, extract, or other non-pharmaceutical ingredient not described in subsection (a).
(2) Intermediates used in the synthesis of a substance.
As added by P.L.136-2026, SEC.3. Amended by P.L.160-2026, SEC.15.
Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://iga.in.gov/laws/2026/ic/titles/16Fetched: 10/17/2026