21 CFR 211.150
Distribution procedures. This section left the CFR when the QMSR took effect on Feb 2, 2026; the text below is as of Feb 1, 2026.
- Inspections citing it: 268
- Of those classified, ended OAI: 26%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Paragraphs Cited
As FDA posts them, all years.
- 211.150(b)
- 145 · Recall facilitation
- 211.150
- 112 · Written distribution procedure
- 211.150(a)
- 11 · Distribution of oldest approved drugs
Regulation Text
eCFR, as of Feb 1, 2026Written 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.
Recently Cited Sites
Newest inspections citing this section; each opens the site- Global Packaging Systems, IncUnited States · Apr 9, 2026
- NexCell Scientific IncUnited States · Feb 5, 2026
- Safrel Pharmaceuticals LLCUnited States · Jan 30, 2026
- Regen Suppliers LLCUnited States · Dec 16, 2025
- Ferring Microbiome Inc.United States · Jun 26, 2025
- SOFTAP INCUnited States · Dec 11, 2023
- CellSure, L3CUnited States · Dec 8, 2023
- DSP Skin Care LLCUnited States · Oct 12, 2023
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR