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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 312 - Investigational New Drug Application |
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Subpart D - Responsibilities of Sponsors and Investigators |
§ 312.61 - Control of the investigational drug.
Latest version.
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§ 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.