Part 216 — Human Drug Compounding

Current through Sep 8, 2026

Authority: 21 U.S.C. 351, 352, 353a, 353b, 355, and 371.

Source: 64 FR 10944, Mar. 8, 1999, unless otherwise noted.

Sections

§ 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.
§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.