21 C.F.R. § 207.3

Current through October 31, 2024

Section 207.3 - Bulk drug substance

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 .

21 C.F.R. §207.3

81 FR 60212 , Aug. 31, 2016, as amended at 86 FR 17061 , Apr. 1, 2021

81 FR 60212, 8/31/2016, as amended at 86 FR 17061, 4/1/2021