Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 312 - Investigational New Drug Application |
Subpart D - Responsibilities of Sponsors and Investigators |
§ 312.61 - Control of the investigational drug.
Latest version.
-
§ 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.