"Bulk drug substance"

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.