21 CFR 312.61
§ 312.61 Control of the investigational drug.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 312.61, § 312.61 Control of the investigational drug, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86294
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.