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.
21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.196 Distribution records
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 211.196
Form FDA 483 observations citing this section, fiscal years 2009–2025 (Drugs).
- Distribution Record Requirements 71
Warning letters citing § 211.196
1 FDA warning letters since 2017 cite this section :
- Genetech, Inc. 29 Nov 2018
FDA guidance that cites § 211.196
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff 4 Mar 2022
- Product Recalls, Including Removals and Corrections: Guidance for Industry 2 Mar 2020
Amendment history
Federal Register documents that created or amended this section.
- 49 FR 9865 16 Mar 1984
- 89 FR 51770 18 Jun 2024