IC 16-42-22.5-1 — "Bulk drug substance"
Chapter 22.5. Drugs: Restrictions on Bulk Drug Substances
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Section text
Sec. 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: official publisher (2026 edition)