Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 312 - Investigational New Drug Application |
Subpart D - Responsibilities of Sponsors and Investigators |
§ 312.69 - Handling of controlled substances.
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§ 312.69 Handling of controlled substances.
If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.