This page provides an overview of animal and veterinary products and the requirements that the FDA verifies and 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 regulating animal and veterinary products. These products include animal food and feed, pet food, animal drugs, medicated feed, and veterinary devices offered for import. Visit the Animal and Veterinary page for more information.
Visit the CVM Imports & Exports page for more information about importing animal and veterinary products.
- Animal Drugs
- What is an animal drug?
- What animal drug (including Type A Medicated articles) requirements are verified 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
- Types of Veterinary Drug Applications
- Animal Food and Feeds (which includes pet food)
- What is an animal food/feed?
- Prior Notice Requirements for Importation
- What animal food and feed (including pet food) requirements are verified at the time of importation?
- How does the FDA verify compliance with the animal food and feed requirements at the time of importation?
- USDA Permits and Certifications
- Food Safety Modernization Act (FSMA)
- Medicated Feed
- Animal Devices
- How can I determine if an Animal or Veterinary Product is subject to Import Alert?
- Affirmation of Compliance
The FDA defines the term drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and defines a new animal drug (in part) as “any drug intended for use for animals other than man, the composition of which is not generally recognized, among experts qualified by scientific training and experience, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.” Refer to section 201(g) of the Federal Food Drug and Cosmetic Act (FD&C Act Section 201(g)).
The term "new animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed.
For more information on animal drugs or for help determining if a product is an animal drug please Contact CVM | FDA
What animal drug (including Type A Medicated articles) requirements are verified at the time of importation?
Imported animal drugs, including Type A medicated articles, must meet FDA’s standards for quality, safety and effectiveness. FDA will verify compliance with the following requirements as applicable:
Visit the Importing Veterinary Drugs page for more information.
The FDA's entry reviewers are trained to verify compliance with applicable product requirements. The FDA's entry reviewers use 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)
- Intended Use Code
These entry declarations are compared to information in 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. The FDA also conducts field examination and analyzes samples of drug products to ensure they comply with applicable standards and/or label requirements.
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. The FDA’s screening tool, PREDICT, has the ability to verify the declared information against the FDA's internal data systems.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
Foreign drug establishments that manufacture, repack or relabel drug products and whose drugs are imported or offered for import into the United States are required to register with the FDA before offering a drug for import and renew annually.
Foreign animal drug manufacturers, repackers or relabelers are also required to list all of their commercially marketed drug products.
For more information visit the animal drug Registration and Listing page.
The FDA verifies that the declared manufacturer, repacker or relabeler is registered and the product is listed, by comparing the information submitted to the FDA against 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.
Search the drug establishments current registration page for registration information for any drug establishment that is registered with the FDA. To obtain the listing number, contact the firm that listed the drug product.
New Animal Drugs require an approved application to be legally market the product in the U.S. before being imported. Types of drug applications include approved new animal drug application (NADA), abbreviated NADA (ANADA), investigational new animal drug application (INAD), generic investigational new animal drug application (JINDA), conditional approval (CNADA) or index listing. Visit the Types of Applications page for additional information.
Visit the Unapproved Animal Drugs page for more information on approvals, conditional approvals and indexing.
When required, the FDA will verify the declared drug application information by comparing the information submitted to the FDA’s data systems. If the drug application information is not supplied or is incomplete or inaccurate, it may delay the review of your entry. If the information does not match, then the FDA may need to gather additional information or may detain the product.
If the product requires an NADA, ANADA, INAD, JINDA, CNADA or index listing and does not have one, it will be subject to refusal.
Most FDA-approved animal drugs are included in a publicly available list of approved animal drug products. This list is called the Green Book for short, and FDA updates it in its entirety every month. You can find these monthly updates on Animal Drugs @ FDA.
The FDA defines food as "articles used for food or drink for man or other animals...". Therefore, any article that is intended to be used as an animal food ingredient, to become part of an ingredient or food, or added to an animal's drinking water is considered a "food". Refer to section 201(f) of the Federal Food Drug and Cosmetic Act (FD&C Act).
Animal feed is food made for animals. Animal feed includes pet food and pet treats for dogs and cats as well as food for farm animals. Refer to section 201(w) of the Federal Food Drug and Cosmetic Act (FD&C Act).
Additionally, animal food/feed to which an animal drug has been added is further categorized as a Type A Medicated Article (animal drugs) or a Medicated feed (food).
The FDA must receive notification before food (including animal food, feed, and pet food) is offered for import into the United States. The purpose of prior notice is to enable the FDA to target inspections or examinations of the imported food at U.S. ports of entry more effectively, and to determine whether there is any credible information that the imported food shipment presents a threat or serious risk to public health.
For more information visit the Prior Notice of Imported Foods page.
What animal food and feed (including 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
• Foreign Supplier Verification Program (FSVP) Importer DUNS number
• Food Canning Establishment Registration (FCE) and Process Filing (SID) for LACF/AF products (as applicable)
• Medicated Feed Mill License (as applicable)
• Veterinary Feed Directives (as applicable)
How does the FDA verify compliance with animal food and feed (including pet food) requirements at the time of importation?
FDA entry reviewers are trained to verify compliance with applicable product requirements using the information provided to 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 FDA’s internal data systems. FDA uses the internal data systems to verify registration, LACF/AF process filing, when required, or other product requirements and to determine if the firm/product is subject to DWPE. If the information submitted matches, then compliance is verified; if the information submitted does not match, FDA may gather additional information or may detain the product.
The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that your shipment will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDA's data systems.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
The FDA also conducts field examinations and analyzes samples of animal feed and pet food to ensure they comply with applicable standards and/or label requirements.
Animal feeds and feed ingredients that contain plant and animal byproducts not suitable for human consumption may require a permit or certification through the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). The purpose of these requirements is to prevent foreign animal diseases and plant pests from entering the U.S.
More information on USDA import permits can be found here.
Other USDA Links
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.
Visit our FSMA page for more information.
One of the new key import authorities for foods under FSMA is importer accountability. For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. The FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final.
For more information on FSVP and the key requirements visit our FSVP page.
To determine if you are subject to FSVP review the Am I Subject to FSVP? guide.
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, achieve, and maintain, a high level of control over the safety and security of their supply chains. Participating importers can import their products to the United States with greater speed and predictability, avoiding unexpected delays at the point of entry.
For more information visit the VQIP page.
Medicated feed is animal feed that contains an FDA-approved animal drug. Medicated feed is fed to animals to treat, control, or prevent a disease, or to improve the animals' growth and productivity.
The Food, Drug, and Cosmetic Act defines medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or [which is] intended to affect the structure or any function of the body of man or other animals ... ." Further, a device "does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and ... is not dependent upon being metabolized for the achievement of its primary intended purposes." (FFDCA Section 201(h)).
The FDA will verify animal devices are safe, effective, and properly labeled.
Guidance pertaining to animal devices may be accessed at the following FDA websites:
The FDA conducts label examinations of veterinary devices to ensure the labeling states that the device is for veterinary use only.
Device manufacturers who exclusively manufacture or distribute devices for animal use are not required to register their establishments and list veterinary devices. Unlike devices intended for human use, pre-market approval (PMA) or notification [510(k)] are not required for devices intended for animal use.
The FDA provides a list of import alerts by industry. To view the list of import alerts related to animal or veterinary products visit the import alerts for animal drug and feeds page.
The Automated Commercial Environment (ACE) requires the electronic transmission of an intended use code for each animal and veterinary product offered for import. The intended use code determines the A of C code that may be required. 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. Some of the A of C codes for animal products include:
• REG (Animal Drug Establishment Registration Number)
• VIN (Investigational New Animal Drug Number (INAD) or JINDA)
• VNA (New Animal Drug Application)
• VFL (Medicated Feed License)
For information including a full list of animal product affirmation of compliance codes refer to the ACE affirmations of compliance document. To determine the mandatory and optional A of C’s for your product, refer to the Industry Quick Reference Guide to the FDA ACE Supplemental Guide.