21 CFR 312.61 - Control of the investigational drug.

Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart D [§ 312.50 - § 312.70]

§ 312.61 - Control of the investigational drug.

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.

authority: 21 U.S.C. 321,331,351,352,353,355,360bbb,371; 42 U.S.C. 262.

source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

cite as: 21 CFR 312.61