21 CFR § 312.69 Investigational New Drug Application

§ 312.69 Handling of controlled substances.

Current through Sep 8, 2026 · Read all of Part 312

⚠ 4 pending changes to Part 312

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.

← § 312.68 Inspection of investigator's records and reports.§ 312.70 Disqualification of a clinical investigator. →