21 CFR 312.69
Handling of controlled substances
21 CFR 312.69 is the regulation titled “Handling of controlled substances” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 312.60, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 312.69 most often, as written in the letters.
- 1 letterYou failed to take adequate precautions to prevent theft or diversion of an investigational drug that is subject to the Controlled Substances Act [21 CFR 312.69], and you failed to ensure that the investigation was…
The regulation
Read the text of 21 CFR 312.69 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.69.
Latest letters citing it
The letter citing 21 CFR 312.69 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.