An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it.
21 CFR Part 312 · Investigational New Drug Application
§ 312.61 Control of the 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 § 312.61
Form FDA 483 observations citing this section, fiscal years 2009–2019 (Bioresearch Monitoring).
- Unauthorized recipients (investigator) 17
FDA guidance that cites § 312.61
- Conducting Clinical Trials With Decentralized Elements 18 Sept 2024
- Identifying Trading Partners Under the Drug Supply Chain Security Act draft 5 Jul 2022
- The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators 2 Sept 2004
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 8831 19 Mar 1987