21 C.F.R. § 312.61

Control of the investigational drug.

Last amended: 2016Year: 2026Length: 44 wordsOfficial source

Cite as 21 C.F.R. § 312.61 (2026)

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 C.F.R. § 312.61: Control of the investigational drug. | Justis AI