The applicant of an abbreviated application or a supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioequivalence testing was performed under contract, the contract research organization shall retain reserve samples of any test article and reference standard used in conducting an in vivo or in vitro bioequivalence study required for approval of the abbreviated application or supplemental application. The applicant or contract research organization shall retain the reserve samples in accordance with, and for the period specified in, § 320.38 and shall release the reserve samples to FDA upon request in accordance with § 320.38 .
21 CFR Part 320 · Bioavailability and Bioequivalence Requirements
§ 320.63 Retention of bioequivalence samples
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FDA guidance that cites § 320.63
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application 29 May 2026
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies draft 3 Apr 2024
- Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for Industry draft 27 Mar 2024
- In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs draft 21 Oct 2022
- In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs draft 21 Oct 2022
- Bioavailability Studies Submitted in NDAs or INDs – General Considerations 15 Apr 2022
- ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers 15 May 2014
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations draft 18 Mar 2014
- Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action draft 3 Apr 2003
Amendment history
Federal Register documents that created or amended this section.
- 58 FR 25928 28 Apr 1993
- 60 FR 13595 13 Mar 1995
- 64 FR 402 5 Jan 1999
- 69 FR 13717 24 Mar 2004