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:

                Importing FDA Regulated Products

Importing FDA Regulated Products

                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
          Importing Human Foods
          Importing Medical Devices
          Importing Radiation-Emitting Electronic Products
          Importing Tobacco Products


                        Importing COVID-19 Supplies Home
          For Industry
          Import Program – Food and Drug Administration (FDA)
          Importing FDA Regulated Products
          Importing Animal and Veterinary ProductsImporting FDA Regulated Products Importing Animal and Veterinary Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Overview**

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
		How does the FDA verify animal drug registration and listing at the time of importation?
			How do I obtain the manufacturer's registration and listing information?
		Types of Veterinary Drug Applications
		How does the FDA verify animal drug application information at the time of importation?
			How do I obtain information on approved animal drug products?
	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)
		Foreign Supplier Verification Program (FSVP)
			Voluntary Qualified Importer Program (VQIP)
	Medicated Feed
	What is a medicated feed?
	Animal Devices
	What is an animal device?
		What animal device requirements does the FDA verify at the time of importation?
		How does the FDA verify the requirements for animal devices at the time of importation?
		Do devices intended for animal use require registration and listing?
	How can I determine if an Animal or Veterinary Product is subject to Import Alert?
	Affirmation of ComplianceBack to top

Animal Drugs

What is an animal drug?

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:

•    Labeling 
•    Registration and Listing
•    Marketing Applications (as applicable)
•    Medicated Feed Mill License (as applicable)
•    Veterinary Feed Directives (as applicable)

Visit the Importing Veterinary Drugs page for more information.

Back to top

**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. 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 CodeThese 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.

Back to top

**Registration and Listing**

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.

Back to top

**How does the FDA verify animal drug registration and listing at the time of importation?**

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.

Back to top

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

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.

Back to top

**Types of Veterinary Drug Applications**

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.

**How does the FDA verify animal drug application information at the time of importation?**

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.

Back to top

**How do I obtain information on approved animal drug products?**

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.

Back to top

Animal Food and Feeds (which includes pet food)

What is an animal food/feed?

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).

Back to top

**Prior Notice Requirements for Importation**

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.

Back to top

**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
•    Labeling
•    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)

Back to top

**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.

**USDA Permits and Certifications**

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

USDA- APHIS Animal and Animal Product Import InformationUSDA-PPQ Plant Health Import InformationBack to top

**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.

Visit our FSMA page for more information.

Back to top

Foreign Supplier Verification Program (FSVP)

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.

Back to top

Voluntary Qualified Importer Program (VQIP)

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.

Back to top

Medicated Feed

What is medicated feed?

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.

Visit the FDA Regulation of Medicated Feed page and the Medicated Feeds page for more information.

Back to top

Animal Devices

What is an animal device?

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)).

Back to top

**What animal device requirements does the FDA verify at the time of importation?**

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:

•    How FDA Regulates Veterinary Devices 
•    Adequate Directions for Use (Species Designation)
•    Compliance Policy Guidance Manual, Sec. 607.100 for more information on veterinary device labeling

Back to top

How does the FDA verify the requirements for animal devices at the time of importation?

The FDA conducts label examinations of veterinary devices to ensure the labeling states that the device is for veterinary use only.

Back to top

Do devices intended for animal use require registration and listing?

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.

Back to top

How can I determine if an animal or veterinary product is subject to an Import Alert?

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.

Back to top

**Affirmation of Compliance**

Affirmation of Compliance (A of C) codes are three letter codes that can be provided at the time of import to facilitate the FDA's review.

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.

Back to top

Useful Links
	Automated Commercial Environment/International Trade Data System (ACE/ITDS)
	Product Regulation
	Labeling Guidance



Contact FDA
	(240) 402-7002

CVMImportRequests@fda.hhs.gov



**Center for Veterinary Medicine**

Food and Drug Administration

7500 Standish Place, HFV-1

Rockville, MD  20855



Contact CVM

                                                                                  Content current as of:
      08/31/2021Importing FDA Regulated Products

          
                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
          Importing Human Foods
          Importing Medical Devices
          Importing Radiation-Emitting Electronic Products
          Importing Tobacco Products


                        Importing COVID-19 Supplies
 
 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