---
kind: "section"
citation: "21 C.F.R. § 312.61"
title: "21"
number: "312.61"
heading: "Control of the investigational drug."
url: "https://uscodex.org/cfr/21/312.61"
---

# §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.


## Notes

### Authority

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

### Source

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