21 CFR 312.59
§ 312.59 Disposition of unused supply of investigational drug.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 312.59, § 312.59 Disposition of unused supply of investigational drug, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86292
- Permanent ID
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Full text
The sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated. The sponsor may authorize alternative disposition of unused supplies of the investigational drug provided this alternative disposition does not expose humans to risks from the drug. The sponsor shall maintain written records of any disposition of the drug in accordance with § 312.57.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.