Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CVM Updates

CVM Updates Home
          Animal & Veterinary
          News & Events
          CVM Updates
          FDA Issues Draft Guidance that Consolidates and Updates Policies on Practices to Prevent Contamination of Animal Food from Unsafe Drug CarryoverCVM Updates FDA Issues Draft Guidance that Consolidates and Updates Policies on Practices to Prevent Contamination of Animal Food from Unsafe Drug Carryover
  
  	
    Share
    Post
    Linkedin

    Email
    PrintEspañol

Updated on January 27, 2023: The FDA has issued a final Guidance for Industry (GFI) 272: Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover. The FDA received comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were also made to the final version to improve clarity.

This final GFI #272 is replacing the now withdrawn CPG Sec. 680.500, Unsafe Contamination Compliance Policy Guides of Animal Feed from Drug Carryover and CPG Sec. 680.600, Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds.


May 9, 2022

Today the U.S. Food and Drug Administration issued a draft guidance for industry (GFI) that compiles and describes established practices that medicated feed manufacturers can use to prevent contamination of animal food from unsafe drug carryover into other batches of medicated feed or non-medicated animal food. Drug carryover usually happens when an approved drug used in a batch of medicated feed is inadvertently included in a subsequent manufactured batch of animal food.

Drug carryover can occur for various reasons, including: the use of the same equipment to manufacture both medicated feed and non-medicated animal food; the design, construction, or inadequate maintenance of manufacturing equipment; poor dust control in a feed mill; inadequate cleanout practices for manufacturing and distribution equipment between sequential manufactured batches of animal food; or human error.

It is important to avoid carryover of a drug from one batch of animal food to another to protect animals from unintended exposure to animal drugs. However, factors like the ones described above could make it difficult for manufacturers to completely avoid drug carryover. This is why manufacturers need to establish and follow Current Good Manufacturing Practice requirements (CGMPs), including proper cleanout procedures. The draft GFI issued today covers several commonly used practices to help medicated feed manufacturers minimize the risk of drug carryover.

The FDA has advised animal food manufacturers and the public about the unfortunate and sometimes fatal consequences of unsafe drug carryover. For example, monensin, an ionophore animal drug approved for use in cattle and poultry feed, is highly toxic and potentially lethal to horses, even at relatively low levels. The FDA issued two warning letters (letter 1, letter 2) to animal food manufacturers for, among other issues, mixing cattle food containing monensin and then mixing horse food using the same equipment in a manner that failed to prevent carryover of the monensin. In one case, multiple horses died and in another, multiple cows died.

When finalized, draft GFI #272 will not change the substance of existing policies or introduce new policies. Rather, it will consolidate much of the information found in two outdated Compliance Policy Guides (CPGs) and include current animal food regulatory information and updated examples of factors to consider when designing sequencing practices. The FDA plans to withdraw CPG Sec. 680.500, Unsafe Contamination Compliance Policy Guides of Animal Feed from Drug Carryover and CPG Sec. 680.600, Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds after this new guidance has been finalized.

Beginning on May 10, 2022, the FDA will accept public comments on Draft GFI #272, “Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover.” Submit comments by August 8, 2022, to ensure that the FDA considers them before it begins work on the final version of the guidance.

To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2022-D-0173 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2022-D-0173 on each page of your written comments.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Additional Information

Draft Guidance for Industry #272: Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover
	Federal Register Notice
	CVM GFI #235: Current Good Manufacturing Practice Requirements for Food for Animals
	Part 225 – Current Good Manufacturing Practice For Medicated Feeds
	Medicated Feeds**Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.**

                                                                                  Content current as of:
      01/27/2023CVM Updates
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop