Importing Animal and Veterinary Products

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
(/animal-veterinary) for more information.

Visit the CVM Imports & Exports page (https://www.fda.gov/animal-

veterinary/products/import-exports) 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 Compliance

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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 (/about-fda/center-veterinary-medicine/contact-cvm)
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 (/animal-veterinary/guidance-industry/labeling-guidances)
• Registration and Listing (/industry/fda-basics-industry/registration-and-listing)
• Marketing Applications (/animal-veterinary/development-approval-process) (as applicable)
• Medicated Feed Mill License (/animal-veterinary/animal-food-feeds/medicated-feeds) (as
applicable)
• Veterinary Feed Directives (https://www.fda.gov/media/70173/download) (as applicable)

Visit the Importing Veterinary Drugs (/animal-veterinary/import-exports/importing-

veterinary-drugs) page for more information.

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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) (/industry/entry-submission/affirmation-

compliance-codes)

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 (/industry/fda-import-process/examination-sample-
collection) of drug products to ensure they comply with applicable standards and/or label
requirements.

The submission of correct and accurate entry data (/industry/entry-submission/transmitting-

required-information) 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.

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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 (/industry/fda-basics-
industry/registration-and-listing) page.

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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.

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

Search the drug establishments current registration
(http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm) 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.

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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 (/drugs/how-drugs-are-developed-
and-approved/types-applications) page for additional information.

Visit the Unapproved Animal Drugs (/animal-veterinary/compliance-enforcement/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.

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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
(https://animaldrugsatfda.fda.gov/adafda/views/#/search).

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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 (/animal-veterinary/animal-health-literacy/animal-feed-regulations) 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).
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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 (/food/importing-food-products-
united-states/prior-notice-imported-foods) page.

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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 (/food/guidance-regulation-food-and-dietary-

supplements/registration-food-facilities-and-other-submissions)
• Foreign Supplier Verification Program (/food/food-safety-modernization-act-fsma/fsma-
final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals)
(FSVP) Importer DUNS number
• Labeling (/animal-veterinary/animal-food-feeds/product-regulation)
• Food Canning Establishment Registration (FCE) and Process Filing (SID)
(/food/registration-food-facilities-and-other-submissions/establishment-registration-process-
filing-acidified-and-low-acid-canned-foods-lacf) for LACF/AF products (as applicable)
• Medicated Feed Mill License (/animal-veterinary/animal-food-feeds/medicated-feeds) (as
applicable)
• Veterinary Feed Directives (https://www.fda.gov/media/70173/download) (as applicable)

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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) (/industry/entry-submission/affirmation-compliance-
codes)

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 (/industry/entry-submission/transmitting-

required-information) 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 (/industry/fda-import-process/entry-screening-systems-and-tools), 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 (/industry/fda-import-
process/examination-sample-collection) 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

(http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/importexport) can be found here.

Other USDA Links

USDA- APHIS Animal and Animal Product Import Information

(https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-
import-information/ct_animal_imports_home)

USDA-PPQ Plant Health Import Information

(https://www.aphis.usda.gov/aphis/ourfocus/planthealth/import-information)

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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.

Visit our FSMA (/food/guidance-regulation-food-and-dietary-supplements/food-safety-

modernization-act-fsma) page for more information.

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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 (/food/food-safety-
modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-
importers-food-humans-and-animals) page.

To determine if you are subject to FSVP review the Am I Subject to FSVP?

(https://www.fda.gov/media/94281/download) guide.

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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 (/food/importing-food-products-united-states/voluntary-

qualified-importer-program-vqip) page.

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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 (/animal-veterinary/resources-you/fda-regulation-

medicated-feed) page and the Medicated Feeds (/animal-veterinary/animal-food-
feeds/medicated-feeds) page for more information.

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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)).

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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 (/animal-veterinary/animal-health-literacy/how-

fda-regulates-animal-devices)
• Adequate Directions for Use (Species Designation) (https://www.fda.gov/inspections-
compliance-enforcement-and-criminal-investigations/compliance-policy-guides/cpg-sec-
607100-adequate-directions-use-species-designation-animal-drugs-and-veterinary-devices)
(/regulatory-information/search-fda-guidance-documents/cpg-sec-607100-adequate-
directions-use-species-designation-animal-drugs-and-veterinary-devices)
• Compliance Policy Guidance Manual, Sec. 607.100 for more information on veterinary device
labeling (/regulatory-information/search-fda-guidance-documents/cpg-sec-607100-adequate-
directions-use-species-designation-animal-drugs-and-veterinary-devices)

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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.

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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.

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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
(https://www.accessdata.fda.gov/cms_ia/industrygroup_8.html) page.

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Affirmation of Compliance
Affirmation of Compliance (A of C) (/industry/entry-submission-process/affirmation-
compliance-codes) 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 (https://www.fda.gov/media/96145/download) 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
(https://www.fda.gov/media/112800/download).

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Useful Links

FDA ACE External Outreach Presentation-Human & Animal Food

(/media/107149/download)
FDA ACE External Outreach Presentation-Animal Drugs & Devices
(/media/107170/download)
Automated Commercial Environment/International Trade Data System (ACE/ITDS)
(/industry/import-systems/automated-commercial-environmentinternational-trade-
data-system-aceitds)

Product Regulation (/animal-veterinary/animal-food-feeds/product-regulation)

Labeling Guidance (/animal-veterinary/guidance-industry/labeling-guidances)

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 (/about-fda/center-veterinary-medicine/contact-cvm)