1. Regulations
  2. title 21
  3. chapter I-i4
  4. part 312
  5. subpart D
  6. § 312.61

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