The sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated. The sponsor may authorize alternative disposition of unused supplies of the investigational drug provided this alternative disposition does not expose humans to risks from the drug. The sponsor shall maintain written records of any disposition of the drug in accordance with § 312.57 .
21 CFR Part 312 · Investigational New Drug Application
§ 312.59 Disposition of unused supply of investigational drug
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 312.59
Form FDA 483 observations citing this section, fiscal years 2009–2022 (Bioresearch Monitoring).
- Records of unused drug disposition 17
- Unused drug disposition (sponsor) 2
FDA guidance that cites § 312.59
- Conducting Clinical Trials With Decentralized Elements 18 Sept 2024
- Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies 21 Sept 2023
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 8831 19 Mar 1987
- 52 FR 23031 17 Jun 1987
- 67 FR 9586 4 Mar 2002