Complete records shall be maintained for each shipment of Type A medicated article(s) in a manner that will facilitate the recall, diversion, or destruction of the Type A medicated article(s), if necessary. Such records shall be retained for at least 2 years after the date of the shipment by the manufacturer and shall include the name and address of the consignee, the date and quantity shipped, and the manufacturing dates, control numbers, or marks identifying the Type A medicated article(s) shipped.
21 CFR Part 226 · Current Good Manufacturing Practice for Type a Medicated Articles
§ 226.110 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 § 226.110
Form FDA 483 observations citing this section, fiscal years 2014–2014 (Veterinary Medicine).
- Records maintenance 1
FDA guidance that cites § 226.110
- CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers 29 Apr 2024
- Product Recalls, Including Removals and Corrections: Guidance for Industry 2 Mar 2020
Amendment history
Federal Register documents that created or amended this section.
- 40 FR 14031 27 Mar 1975