21 CFR 211.196: Distribution records
Requires drug manufacturers to keep distribution records showing product name, strength, and dosage form, the consignee's name and address, the date and quantity shipped, and the lot or control number.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart J, Records and Reports
How FDA words it
The opening lines investigators use most when they cite 211.196, from the 483s we hold.
Distribution records do not contain the lot or control number of drug product.Most used
Distribution records do not contain the name and strength of the drug product, description of dosage form, name and address of consignee, date and quantity shipped and lot or control number of drug product.
Recent 483s citing 211.196
- GenoGeni x · Boca Raton, FloridaBatch production and control records are not prepared for each batch of drug… Jul 18, 2025
- Cosco International, Inc. · Marietta, GeorgiaDistribution records do not contain the name and strength of the drug product, name… Oct 25, 2024
- Zhejiang Meimi Technology Co., Ltd · Yiwu, Zhejiang, ChinaDistribution records do not contain the lot or control number of drug product… May 17, 2024
- Family Dollar Distribution Inc. · West Memphis, ArkansasDistribution records do not contain the lot or control number of drug product… Feb 11, 2022
- Nature's Innovation, Inc. · Buford, GeorgiaDistribution records do not contain the lot or control number of drug product… May 14, 2019
The regulation text
§ 211.196 Distribution records.
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product.
[89 FR 51770, June 18, 2024]
Questions
What does 21 CFR 211.196 require?
Requires drug manufacturers to keep distribution records showing product name, strength, and dosage form, the consignee's name and address, the date and quantity shipped, and the lot or control number.
How do FDA investigators word a 211.196 observation?
The most common opening is: “Distribution records do not contain the lot or control number of drug product.”
Which sections are cited alongside 211.196?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.188 (Batch production and control records), 211.198 (Complaint files), 211.192 (Production record review).