§207.3. Bulk drug substance.
21 C.F.R. § 207.3
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.
Notes, amendments, and revision history
Amendments
[81 FR 60212, Aug. 31, 2016, as amended at 86 FR 17061, Apr. 1, 2021]
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source
Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.
Amendments
[81 FR 60212, Aug. 31, 2016, as amended at 86 FR 17061, Apr. 1, 2021]