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

§ 225.80 Labeling

Subpart D - Packaging and Labeling Official text on eCFR Amendment history

(a) Appropriate labeling identifies the medicated feed, and provides the user with directions for use which, if adhered to, will assure that the article is safe and effective for its intended purposes.

(b)

(1) Labels and labeling, including placards, shall be received, handled, and stored in a manner that prevents labeling mixups and assures that correct labeling is employed for the medicated feed.

(2) Labels and labeling, including placards, upon receipt from the printer shall be proofread against the Master Record File to verify their suitability and accuracy. The proofread label shall be dated, initialed by a responsible individual, and kept for 1 year after all the labels from that batch have been used.

(3) In those instances where medicated feeds are distributed in bulk, complete labeling shall accompany the shipment and be supplied to the consignee at the time of delivery. Such labeling may consist of a placard or other labels attached to the invoice or delivery ticket, or manufacturer's invoice that identifies the medicated feed and includes adequate information for the safe and effective use of the medicated feed.

(4) Label stock shall be reviewed periodically and discontinued labels shall be discarded.

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 § 225.80

Form FDA 483 observations citing this section, fiscal years 2009–2024 (Veterinary Medicine).

  • Maintaining proofread label 14
  • Appropriate labeling for medicated feed 7
  • Complete Bulk Labeling 5
  • Receipt, handling, and storage 3
  • Label stock review 3
  • Proofreading labels, labeling, placards 2

Warning letters citing § 225.80

2 FDA warning letters since 2017 cite this section :

Amendment history

Federal Register documents that created or amended this section.