21 CFR 211.150: Distribution procedures
Requires drug manufacturers to follow written distribution procedures that ship the oldest approved stock first, allowing only temporary, appropriate deviations, and that track each lot's distribution so recalls can be done quickly.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart H, Holding and Distribution
How FDA words it
The opening lines investigators use most when they cite 211.150, from the 483s we hold.
A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.Most used
The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.211.150(b)
Written distribution procedures are not established.
Cited over time
483s citing 211.150, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.150
- Safrel Pharmaceuticals LLC · Dayton, New JerseyThe distribution system is deficient in that each lot of drug product cannot be… Jan 30, 2026
- SOFTAP INC · Livermore, CaliforniaWritten distribution procedures are not established and followed… Dec 11, 2023
- Boehringer Ingelheim RCV GmbH & Co KG · Vienna, AustriaSOP for critical steps in shipping is inadequate… Dec 5, 2023
- Delsam Pharma LLC · Bronx, New YorkA system by which the distribution of each lot of drug product can be readily… Mar 24, 2023
- Olein Recovery Corp · Yabucoa, Puerto RicoA system by which the distribution of each lot of drug product can be readily… Mar 18, 2021
The regulation text
§ 211.150 Distribution procedures.
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.
Questions
What does 21 CFR 211.150 require?
Requires drug manufacturers to follow written distribution procedures that ship the oldest approved stock first, allowing only temporary, appropriate deviations, and that track each lot's distribution so recalls can be done quickly.
How do FDA investigators word a 211.150 observation?
The most common opening is: “A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.”
Which sections are cited alongside 211.150?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.198 (Complaint files), 211.165 (Testing and release for distribution), 211.25 (Personnel qualifications).