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Importing Animal and Veterinary Products - FDA
Importing Animal and Veterinary Products - FDA
Importing Animal and Veterinary Products - FDA
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.
Animal Drugs
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?
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)
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?
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)
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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
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.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
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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 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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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:
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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.
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.
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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.
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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.
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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.
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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:
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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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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.
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
Contact FDA
(240) 402-7002
CVMImportRequests@fda.hhs.gov