21 C.F.R. § 312.61 Control of the investigational drug.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
Subpart D—Responsibilities of Sponsors and Investigators
§ 312.61 Control of the investigational drug.

