FDA Regulations for export of Veterinary Products

Overview

The FDA verifies/ enforces certain requirements of animal and veterinary products at the time they are imported or offered for import into the United States. The products include animal food and feed, pet food, animal drugs, medicated feed, and veterinary devices.

The Center for Veterinary Medicine (CVM) is the FDA centre responsible for overseeing and regulating the animal and veterinary program.

Prior Notice requirements for importation

FDA’s laws and regulations require the submission of prior notification to FDA prior to the arrival in the United States of imported food and animal feed.

Requirements of animal feed and pet food verified at the time of importation

At the time of importation, FDA will verify compliance with the following requirements:

  • Food facility registration
  • Additionally, 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 Additive Status List, and animal and veterinary contaminants.

Requirements of veterinary drugs verified at the time of importation

At the time of importation, FDA will verify compliance with the following requirements:

  • 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 U.S.
  • FDA conducts field examinations and analyzes samples of veterinary drug products to ensure they comply with applicable standards and/or label requirements.
  • 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 importer alert.

Veterinary drug requirements compliance verification

FDA entry reviewers are trained to verify compliance with applicable product requirements. The FDA Entry Reviewers use the information provided to FDA in the importer’s entry transmission

  • 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, 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, 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. FDA’s screening tool, PREDICT, has the ability to verify the declared information against FDA internal data systems.

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.

Registration and listing verification

FDA will verify that the declared manufacturer, repacker or re-labeler is registered by comparing the submitted information to FDA’s internal data systems. Listing of the declared product is verified by comparing the declared product description to FDA’s internal data systems. If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.

Obtaining the manufacturer’s registration and listing information

The applicant may search the current drug establishment registration database for registration information for any drug firm that is registered with FDA. In order to obtain the listing number, the applicant will have to contact the firm that listed the drug product.

Legal Marketing Status for veterinary drugs

New animal drugs must be reviewed by 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 U.S. 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 U.S.

Verification of marketing status of veterinary drugs at the time of importation

If required, FDA will verify the declared NADA, conditional approval or index information by comparing the submitted information to 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, 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.

Obtaining information on veterinary drug approvals (NADA)

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. 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.”

Verification of medicated animal feed requirements at the time of importation

At the time of importation, 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.
  • Feed mill license. FDA requires certain medicated feed mills to be licensed with FDA.

Verification of the requirements for medicated feeds at the time of importation

FDA verifies the drug is approved for use in the animal feed by comparing the information submitted to FDA’s internal data systems. When required, FDA will verify the medicated feed mill license by comparing the information submitted to FDA’s internal data systems.

Veterinary device requirements verified at the time of importation

FDA conducts label examinations of veterinary devices to ensure the labelling states “For Veterinary Use Only.” For radiation-emitting veterinary devices, 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 labelled.

Labelling requirements for animal feed and pet food verified at the time of importation

Animal and pet food must be properly labelled for marketing in the United States. The federal regulations for animal food labelling can be found in Title 21 of the Code of Federal Regulations part 501 (21 CFR 501). FDA may conduct a label examination at the time of importation to verify animal feed and pet food labelling comply with FDA’s laws and regulations. FDA may examine the labelling 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, FDA examines product labelling to determine if the product contains a high risk bovine material.

USDA Permits and Certifications

Animal feeds that include plant and animal by-products 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.”

Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA) 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.

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. FDA was required to establish VQIP by the FDA Food Safety Modernization Act (FSMA).

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 FDA review. FDA uses A of C codes to assist in verifying that the product meets the appropriate requirements. Providing the correct A of C codes reduces the likelihood that any shipment will be held for further FDA entry review during 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 product entry.