{"data":{"id":"us-in/ic-16-42-22.5-1","jurisdiction":"us-in","citation":"IC 16-42-22.5-1","heading":"\"Bulk drug substance\"","body":"Sec. 1. (a) As used in this chapter, \"bulk drug substance\" means a substance that is intended:\n(1) for incorporation into a finished drug product; and\n(2) to furnish pharmacological activity or other direct effect;\nin the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\n(b) The term does not include the following:\n(1) A vitamin, mineral, herb, essential oil, extract, or other non-pharmaceutical ingredient not described in subsection (a).\n(2) Intermediates used in the synthesis of a substance.","path":["TITLE 16. HEALTH","ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS","Chapter 22.5. Drugs: Restrictions on Bulk Drug Substances"],"source_url":"https://iga.in.gov/ic/2026/Title_16.html#16-42-22.5-1","current_through":"2026","vintage":"2026","retrieved_at":"2026-09-11T20:02:18Z","sha256":"780ed64229d464be94423e4b893aa4038d381788ec4860b95e2bbb6ec7537bdd","source_id":"us-in","stale":false,"prev":"us-in/ic-16-42-22.5-0.5","next":"us-in/ic-16-42-22.5-2"},"notice":"GroundRules: Original legal text. Not legal advice."}