Animal and Veterinary Products
Overview
This page provides an overview of animal and veterinary products and the requirements that the 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 United States. 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.
- Prior Notice Requirements for Importation
- What animal feed and pet food requirements are verified at the time of importation?
- How does the FDA verify labeling requirements for animal feed and pet food at the time of importation?
- What veterinary drug requirements are verified at the time of importation?
- How does the FDA verify compliance with the veterinary drug requirements?
- Registration and Listing
- Legal Marketing Status for Veterinary Drugs
- What medicated animal feed requirements does the FDA verify at the time of importation?
- How does the FDA verify the requirements for medical feeds at the time of importation?
- What veterinary device requirements does the FDA verify at the time of importation?
- USDA Permits and Certifications
- Food Safety Modernization Act (FSMA)
- Affirmation of Compliance
Prior Notice Requirements for Importation
- The FDA’s laws and regulations require the submission of prior notification to the 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, the FDA will verify compliance with the following requirements:
- Food facility registration. For more information visit the Registration of Food Facilities page.
Additionally,
- The FDA conducts field examinations and analyzes samples of animal feed and pet food to ensure they comply with applicable standards and/or label requirements such as ingredients and additives, generally recognized as safe (GRAS), food additives, and animal and veterinary contaminants.
How does the FDA verify labeling requirements for animal feed and pet food 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). The FDA may conduct a label examination at the time of importation to verify animal feed and pet food labeling comply with the FDA’s laws and regulations. The 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, the 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 Product Regulation and Labeling Guidances pages.
What veterinary drug requirements are verified at the time of importation?
- 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 United States. Visit the Unapproved Animal Drugs page for more information on approvals, conditional approvals and indexing.
- The FDA conducts field examinations and analyzes samples of veterinary drug products to ensure they comply with applicable standards and/or label requirements.
- The 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 import alert. For example, Import Alert 68-02 lists foreign manufacturers not in compliance with the current good manufacturing practices for drugs.
Visit the Importing Veterinary Drugs page for more information.
How does the FDA verify compliance with the veterinary drug requirements?
The FDA's entry reviewers are trained to verify compliance with applicable product requirements using the information provided to the FDA in the importer’s entry transmission such as:
- Declared manufacturer
- Declared importer/consignee
- Product description
- Affirmations of Compliance (A of C)
These entry declarations are compared to information in the FDA’s internal data systems. The 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, the 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 because the FDA’s screening tool, PREDICT, can verify the declared information against the FDA's internal data systems.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
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 the FDA verify registration and listing?
The FDA will verify that the declared manufacturer, repacker or re-labeler is registered by comparing the submitted information to the FDA’s internal data systems. Listing of the declared product is verified by comparing the declared product description to the FDA’s internal data systems. If the information matches, then compliance is verified; if the information does not match, the 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 the FDA. In order to obtain the listing number, you will have to contact the firm that listed the drug product.
Legal Marketing Status for Veterinary Drugs
New animal drugs must be reviewed by the 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 United States 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 United States. Visit the Unapproved Animal Drugs page for more information on approvals, conditional approvals and indexing.
How does the FDA verify marketing status of veterinary drugs at the time of importation?
If required, the FDA will verify the declared NADA, conditional approval or index information by comparing the submitted information to the 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, the 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)?
The 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. The 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 the FDA verify at the time of importation?
At the time of importation, the 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 FDA Regulation of Medicated Feed page.
- Feed mill license. The FDA requires certain medicated feed mills to be licensed with the FDA. For more information on Medicated Feeds and Medicated Feed Mill Licensing visit our Medicated Feeds page.
How does the FDA verify the requirements for medicated feeds at the time of importation?
The FDA verifies the drug is approved for use in the animal feed by comparing the information submitted to the FDA’s internal data systems. When required, the FDA will verify the medicated feed mill license by comparing the information submitted to the FDA’s internal data systems.
What veterinary device requirements does the FDA verify at the time of importation?
The FDA conducts label examinations of veterinary devices to ensure the labeling states "For Veterinary Use Only.” For radiation-emitting veterinary devices, the 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:
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
Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, enables the FDA to better protect public health by strengthening the food safety system. It gives the FDA new tools and authorities to ensure imported foods (for humans and animals) meet the same safety standards as foods produced in the United States.
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. The FDA was required to establish VQIP by the FDA Food Safety Modernization Act (FSMA).
Visit our VQIP page for more information.
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 the FDA's review. The 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 the 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.
(240) 402-7002
AskCVM@fda.hhs.gov
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-1
Rockville, MD 20855