21 CFR 211.150
Distribution procedures
21 CFR 211.150 is the regulation titled “Distribution procedures” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.137, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 211.150 (eCFR, as of Sep 1, 2026)
Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:
(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.150.
- 21 CFR 211.137Expiration dating2 letters cite both
- 21 CFR 211.165Testing and release for distribution2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance2 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2 letters cite both
- 21 CFR 201.100Prescription drugs for human use1 letter cites both
- 21 CFR 201.5Drugs; adequate directions for use1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 211.150 that FDA posted most recently.
- DrugsView Lexia LLCOTC drug products, including an OTC topical pain relief productIssuedApr 7, 2026PostedApr 28, 2026
- DrugsView Maison Terre, LLCGoldenseal Root Powder Organic, Orange (Sweet) Essential Oil 15 ml, Ylang Ylang 3 Essential Oil 15 mlIssuedApr 1, 2021PostedApr 13, 2021
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.