1. Regulations
  2. title 21
  3. chapter I-i3
  4. part 207
  5. subpart A
  6. § 207.3

View all text of Subpart A [§ 207.1 - § 207.13]

§ 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.

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

AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.

SOURCE: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.

CITE AS: 21 CFR 207.3