21 CFR § 207.3 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code

§ 207.3 Bulk drug substance.

Current through Sep 8, 2026 · Read all of Part 207

⚠ 2 pending changes to Part 207

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]

← § 207.1 What definitions and interpretations of terms apply to this part?§ 207.5 What is the purpose of this part? →