1. (a) As used in this chapter, "bulk drug substance" means a substance that is intended:

   1. (1) for incorporation into a finished drug product; and

   2. (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.

2. (b) The term does not include the following:

   1. (1) A vitamin, mineral, herb, essential oil, extract, or other non-pharmaceutical ingredient not described in subsection (a).
   2. (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.