For Industry

Animal and Veterinary Products

Overview

This page provides an overview of animal and veterinary products and the requirements that FDA verifies/enforces at the time they are imported or offered for import into the United States.

The Center for Veterinary Medicine (CVM) is the FDA center responsible for overseeing the animal and veterinary program. CVM regulates animal and veterinary products offered for importation into the U.S. These products include animal food and feed, pet food, animal drugs, medicated feed, and veterinary devices. Visit the Animal and Veterinary page for more information.

Visit the CVM Imports & Exports page for more information about importing animal and veterinary products.

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Prior Notice requirements for importation:

  • FDA’s laws and regulations require the submission of prior notification to FDA prior to the arrival in the United States of imported food and animal feed. For more information visit the prior notice of imported foods page.

What animal feed and pet food requirements are verified at the time of importation?

At the time of importation, FDA will verify compliance with the following requirements:

Additionally,

What veterinary drug requirements are verified at the time of importation?

At the time of importation, FDA will verify compliance with the following requirements:

  • Registration
  • Listing
  • Approved new animal drug application (NADA), abbreviated new animal drug application (ANADA), investigational new animal drug (INAD), conditional approval, or index listing (applicable to minor species only). The only exceptions to these requirements are when there is a drug shortage or the drug is considered to be medically necessary and an approved version is not available in the U.S. Visit the Three Pathways to Legal Marketing Status page for more information on approvals, conditional approvals and indexing.
  • FDA conducts field examinations and analyzes samples of veterinary drug products to ensure they comply with applicable standards and/or label requirements.
  • FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an importer alert. For example, Import Alert 68-02 lists foreign manufacturers not in compliance with Veterinary Drug Good Manufacturing Processes.

Visit the Importing Veterinary Drugs page for more information.
 

How does FDA verify compliance with the veterinary drug requirements?
 

FDA entry reviewers are trained to verify compliance with applicable product requirements. The FDA Entry Reviewers use the information provided to FDA in the importer’s entry transmission

These entry declarations are compared to information in FDA’s internal data systems. FDA uses the internal data systems to verify registration, listing, drug approval (when required) or other product requirements and to determine if the firm is subject to DWPE. If the information submitted matches, then compliance is verified; if the information submitted does not match, FDA may need to gather additional information or may detain the product.
 

The submission of correct and accurate entry data and A of C codes will help expedite the entry review process. This increases the likelihood that your shipment may be processed electronically and not held for manual review. FDA’s screening tool, PREDICT, has the ability to verify the declared information against FDA internal data systems.
 

Note: Submitting inaccurate or incomplete information may delay the review of your entry.
 

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Registration and Listing
 

Establishments that manufacture, repack, or re-label animal drug products intended for distribution in the United States are required to register with the FDA. Animal drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process. For more information visit the registration and listing page.
 

How does FDA verify registration and listing?
 

FDA will verify that the declared manufacturer, repacker or re-labeler is registered by comparing the submitted information to FDA’s internal data systems. Listing of the declared product is verified by comparing the declared product description to FDA’s internal data systems. If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.
 

How do I obtain the manufacturer’s registration and listing information?
 

You may search the drug establishments current registration database for registration information for any drug firm that is registered with FDA. In order to obtain the listing number, you will have to contact the firm that listed the drug product.

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Legal Marketing Status for veterinary drugs
 

New animal drugs must be reviewed by FDA for safety and effectiveness and obtain legal marketing status before they can be marketed in the United States. All veterinary drug products offered for import into the U.S. must have an approved new animal drug application (NADA), conditional approval, or index listing (applicable to minor species only). The only exceptions to these requirements are when there is a drug shortage or the drug is considered to be medically necessary and an approved version is not available in the U.S. Visit the Three Pathways to Legal Marketing Status page for more information on approvals, conditional approvals and indexing

How does FDA verify marketing status of veterinary drugs at the time of importation?
 

If required, FDA will verify the declared NADA, conditional approval or index information by comparing the submitted information to FDA’s internal data systems. If the submitted information is not supplied, or is incomplete or inaccurate, it may delay the review of your entry. If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.
If the product requires an NADA, conditional approval or index listing and does not have one, it will be subject to refusal.
 

How do I obtain information on veterinary drug approvals (NADA)?
 

FDA requires that each sponsor of an approved animal drug submit certain information regarding patents held for the animal drug or its method of use. FDA requires that this information, as well as a list of all animal drug products approved for safety and effectiveness, be made available to the public. This list is updated monthly and is known as the "Green Book." Access the Green Book here.
 

What medicated animal feed requirements does FDA verify at the time of importation?

At the time of importation, FDA will verify compliance with the following requirements:

  • Approval of drug use in animal feed. Any drug used in medicated animal feed must be approved for use in that specific medicated animal feed. For more information visit our Animal Feed page.
  • Feed mill license. FDA requires certain medicated feed mills to be licensed with FDA. For more information on Medicated Feeds and Medicated Feed Mill Licensing visit our Medicated Feeds page.

How does FDA verify the requirements for medicated feeds at the time of importation?
 

FDA verifies the drug is approved for use in the animal feed by comparing the information submitted to FDA’s internal data systems. When required, FDA will verify the medicated feed mill license by comparing the information submitted to FDA’s internal data systems.

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Veterinary device requirements verified at the time of importation.
 

FDA conducts label examinations of veterinary devices to ensure the labeling states "For Veterinary Use Only.” For radiation-emitting veterinary devices, FDA verifies the product is registered according to the radiological health regulations.
Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments and list veterinary devices. Unlike devices intended for use in humans, pre-market approval or notification (510(k)) are not required for devices used in veterinary medicine.
 

It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled. Visit the Compliance Policy Guidance Manual, Sec. 607.100 for more information on veterinary device labeling.
 

Guidance pertaining to veterinary devices may be accessed at the following FDA websites: 
 

How are labeling requirements for animal feed and pet food verified at the time of importation?

Animal and pet food must be properly labeled for marketing in the United States. The federal regulations for animal food labeling can be found in Title 21 of the Code of Federal Regulations part 501 (21 CFR 501). FDA may conduct a label examination at the time of importation to verify animal feed and pet food labeling comply with FDA’s laws and regulations. FDA may examine the labeling for the proper identification of the product, net quantity statement, name and place of business of the manufacturer or distributor, and proper listing of all the ingredients in the product in order from most to least, based on weight.

Additionally, FDA examines product labeling to determine if the product contains a high risk bovine material. Visit the All About BSE page for more information on BSE.
For more information visit the animal feed labeling page and the Guidance for Industry page for Animal & Veterinary labeling.
 

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USDA Permits and Certifications
 

Animal feeds that include plant and animal byproducts not suitable for human consumption may require a permit or certification through the U.S. Department of Agriculture (USDA). These include dairy products and meat products (like meat meal and bone meal) from countries with livestock diseases exotic to the United States, such as Bovine Spongiform Encephalopathy (BSE), commonly known as “Mad Cow Disease.”

Visit the All About BSE page for more information on BSE. More information on USDA import permits can be found here.

Other USDA Links

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Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, enables FDA to better protect public health by strengthening the food safety system. It gives FDA new tools and authorities to ensure imported foods (for humans and animals) meet the same safety standards as foods produced in the U.S.

The Voluntary Qualified Importer Program (VQIP) is a voluntary, fee-based program that allows importers to receive expedited review and importation of foods into the United States if they apply, and then achieve and maintain, a high level of control over the safety and security of their supply chains. FDA was required to establish VQIP by the FDA Food Safety Modernization Act (FSMA).  

Visit our VQIP page for more information.
 

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Affirmation of Compliance

Affirmation of Compliance codes (A of C) are three letter codes that can be provided at the time of import to facilitate FDA review. FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements. Providing the correct A of C codes reduces the likelihood that your shipment will be held for further FDA entry review during FDA’s import screening process. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.

For information on veterinary product affirmation of compliance codes as well as examples of the veterinary products affirmation of compliance codes, refer to the “Affirmation Of Compliance References” at the bottom of the affirmation of compliance codes page.
 

Contact FDA

240-402-7002
Center for Veterinary Medicine

Food and Drug Administration

7500 Standish Place, HFV-1

Rockville, MD 20855

Page Last Updated: 09/14/2018
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