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:

                Resources for You

Resources for You

                        For Industry
          For Veterinarians


                        CVM en español
          Animal Health Literacy Home
          Animal & Veterinary
          Resources for You
          FDA Regulation of Medicated FeedResources for You FDA Regulation of Medicated Feed
  
  	
    Share
    Post
    Linkedin

    Email
    PrintEspañol

Drugs in Animal Food (Medicated Feed)Veterinary Feed Directives

Drugs in Animal Food (Medicated Feeds)

Anyone who adds one or more drugs to animal food creates medicated animal food (medicated feed). Just as each label claim for a new animal drug must be approved, a drug must be specifically approved for use in or on animal food. When the new animal drug application for use of the drug in or on animal food is approved, a notice is published in the *Federal Register*. The medicated feed must be labeled in accordance with the approved representative labeling.

A drug may be mixed only into feed for uses and at drug levels specifically permitted by the approvals and listed in the regulations (21 CFR Part 558). The entity manufacturing medicated feeds using Category II, Type A medicated articles; or manufacturing liquid and free-choice medicated feed containing a Category II drug; or liquid and free-choice medicated feed containing a Category I drug that follow an approved proprietary formula and/or specifications, is required to be registered with the FDA as a drug manufacturer and must hold an approved medicated feed mill license.

It is a violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act) for drugs to be added to animal food for uses or at levels not specified in the approvals. Any individual authorizing the violation, as well as the individual illegally mixing the medicated feed, may be subject to regulatory action. Additionally, the feed itself may be subject to seizure. The agency is unlikely to consider taking a regulatory action when it encounters an extra-label use of medicated feed in minor species provided considerations listed in Compliance Policy Guide 615.115 are met, including the involvement of a licensed veterinarian.

Compliance Policy Guide 615.115.

Additional Information about Medicated Feeds

Back to the top

Veterinary Feed Directives

The Animal Drug Availability Act of 1996 (ADAA) amended the FD&C Act to establish a new class of drugs – veterinary feed directive (VFD) drugs. A feed containing a drug approved for use in or on animal food as a VFD drug can be fed to animals only under the professional supervision of a licensed veterinarian. The first rule covering the use and distribution of VFD feeds (medicated feeds containing VFD drugs) was published in the Federal Register on December 8, 2000. The second, and current, VFD rule was published on June 3, 2015.

The VFD process is straightforward in practice. A veterinarian, operating within the confines of a valid veterinarian-client-patient relationship, examines and diagnoses animal conditions and determines whether a condition warrants the use of a VFD drug. If it does, the veterinarian will issue a signed VFD order containing information specified by regulation. As with any other drugs used in or on animal feed, extra-label use of a VFD drug is not permitted. The statement specified by regulation calling for no extra-label use is required to appear on every VFD order. The veterinarian completes and signs the VFD order, keeps the original, and provides one copy to the client and another to the distributor. All three parties – the veterinarian, the client, and the distributor – are required to keep the VFD order in their files for 2 years from the date of issuance. The VFD order allows the VFD feed to be issued to the client for feeding to the animals specified on the VFD.

Anyone intending to distribute VFD feeds must notify CVM prior to beginning distribution. The definition of a distributor includes the VFD feed manufacturer or anyone in the distribution chain who supplies VFD feed to an animal producer upon receiving a valid VFD order. The veterinarian could be a distributor of VFD feed. A VFD feed may not be fed without a signed, valid VFD. VFD feed may be sent down the distribution chain without a VFD order if the consignee, i.e., another distributor, provides the distributor with a signed acknowledgment letter affirming that the consignee will only issue the VFD feed to a client upon receiving a valid VFD order or to another distributor upon receiving the acknowledgment letter.

Additional Information about Veterinary Feed Directives

Back to the top

                                                                                  Content current as of:
      07/19/2023Resources for You

          
                        For Industry
          For Veterinarians


                        CVM en español
          Animal Health Literacy
 
 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