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.
21 CFR Part 312 · Investigational New Drug Application
§ 312.69 Handling of controlled substances
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 312.69
Form FDA 483 observations citing this section, fiscal years 2009–2023 (Bioresearch Monitoring).
- Controlled substances (investigator) 3
Warning letters citing § 312.69
1 FDA warning letters since 2017 cite this section :
FDA guidance that cites § 312.69
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 8831 19 Mar 1987