21 CFR Part 225 · Current Good Manufacturing Practice for Medicated Feeds

§ 225.110 Distribution records

Subpart E - Records and Reports Official text on eCFR Amendment history

(a) Distribution records permit the manufacturer to relate complaints to specific batches and/or production runs of medicated feed. This information may be helpful in instituting a recall.

(b) Distribution records for each shipment of a medicated feed shall comply with the following provisions:

(1) Each distribution record shall include the date of shipment, the name and address of purchaser, the quantity shipped, and the name of the medicated feed. A lot or control number, or date of manufacture or other suitable identification shall appear on the distribution record or the label issued with each shipment.

(2) The originals or copies of the distribution records shall be retained on the premises for not less than one year after the date of shipment of the medicated feed.

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 § 225.110

Form FDA 483 observations citing this section, fiscal years 2011–2016 (Veterinary Medicine).

  • Distribution record elements 3

Amendment history

Federal Register documents that created or amended this section.