---
kind: "section"
citation: "21 C.F.R. § 207.3"
title: "21"
number: "207.3"
heading: "Bulk drug substance."
url: "https://uscodex.org/cfr/21/207.3"
---

# §207.3. Bulk drug substance.


Bulk drug substance, as referenced in sections [503A(b)(1)(A)](/cfr/21/503A.md?p=b-1-A) and [503B(a)(2)](/cfr/21/503B.md?p=a-2) of the Federal Food, Drug, and Cosmetic Act, previously defined in [§ 207.3(a)(4)](#a-4), means the same as “active pharmaceutical ingredient” as defined in [§ 207.1](/cfr/21/207.1.md).


## Notes

### 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]