U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover May 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0173

Docket Number:
FDA-2022-D-0173
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Drug carryover generally occurs when a drug used in the manufacture of a batch of medicated feed, for which the drug is approved, gets inadvertently included in a subsequent batch of: (1) a non-medicated feed, (2) a different medicated feed for which the drug is not approved (e.g., medicated feed for another species), or (3) a medicated feed that contains the same drug that can result in a higher drug level than is stated on the labeling.  Drug carryover can occur for various reasons, including, for example, the use of the same equipment to manufacture both medicated and non-medicated feed; the design, construction, or inadequate maintenance of feed manufacturing equipment; poor dust control in a feed mill; inadequate cleanout practices for manufacturing and distribution equipment between sequential batches of animal feed; or human error.

Our regulation “Current Good Manufacturing Practice for Medicated Feeds,” 21 CFR part 225, contains requirements for equipment cleanout procedures to avoid unsafe contamination of feeds with drugs (see 21 CFR 225.65 and 225.165).  In this guidance, we provide information on some ways to comply with these requirements to help prevent unsafe contamination of animal feed from drug carryover.  
 

Questions?

Contact Point
Kevin Klommhaus
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place, HFV-236
Rockville, MD 20855
[email protected]
240-402-7001
Back to Top