GroundRules
IC 16-42-22.5-4: Compliance with federal laws
Where this section sits in the code
- TITLE 16. HEALTH
- ARTICLE 42. REGULATION OF FOOD, DRUGS, AND COSMETICS
- Chapter 22.5. Drugs: Restrictions on Bulk Drug Substances
Sec. 4. (a) A pharmacy that is subject to Section 503A of the federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) shall comply with Section 503A of the federal Food, Drug, and Cosmetic Act, and any regulation promulgated under Section 503A of the federal Food, Drug, and Cosmetic Act.
(b) A facility that is subject to Section 503B of the federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) shall comply with Section 503B of the federal Food, Drug, and Cosmetic Act, and any regulation promulgated under Section 503B of the federal Food, Drug, and Cosmetic Act.
(c) A manufacturer required to obtain approval under 21 U.S.C. 355 shall comply with federal new drug approval and current good manufacturing practice requirements.
Collected 2026-09-11T20:02:18Z. Source file · JSON