IC 16-42-22.5-1: "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.