Code of Federal Regulations · Section
§ 207.3 — Bulk Drug Substance
21 C.F.R. § 207.3
View:
Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4), means the same as “active pharmaceutical ingredient” as defined in § 207.1.
Authorizing Statute
-
Definitions; generally21 U.S.C. § 321
-
Regulation of biological products42 U.S.C. § 262