StacksVerified U.S. regulatory reference

21 CFR §207.3

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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.