, 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 CFR Part 207 · 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
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FDA guidance that cites § 207.3
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act 6 Jan 2025
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act 6 Jan 2025
- Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry 29 Jul 2020
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry 28 Jan 2020
- Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act 13 Mar 2019
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry 19 Jan 2018
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance 2 Jul 2014
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing 1 Jun 2009
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP 11 Jan 2006
- Changes to an Approved NDA or ANDA: Guidance for Industry 8 Apr 2004
Amendment history
Federal Register documents that created or amended this section.
- 81 FR 60212 31 Aug 2016
- 86 FR 17061 1 Apr 2021