(Last updated January 2023)
Introduction
Material derived from any animal is potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DHS, CBP) Agriculture Specialists/Inspectors at the U.S. port of arrival before entry into the United States is authorized. A USDA import permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, human pharmaceuticals, human medical devices, approved active pharmaceutical ingredients (usually shipped in bulk), human vaccines, veterinary pharmaceuticals and veterinary regulated medical devices, containing animal derived ingredients and approved by the Food and Drug Administration (FDA) may enter the United States without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.
The U.S. Food and Drug Administration and U.S. Public Health Service both may have primary jurisdiction over human pharmaceuticals, approved active pharmaceutical ingredient (usually shipped in bulk), human vaccines, veterinary pharmaceuticals and medical devices. They should be contacted for their importation requirements at the following locations:
U.S. Food and Drug Administration
Division of Import Operations and Policy
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Website address https://www.fda.gov
U.S. Public Health Service
Centers for Disease Control and Prevention, Office of Biosafety
1600 Clifton Road Atlanta, GA 30329-4027 USA
800-CDC-INFO (800-232-4636), TTY: 888-232-6348
CDC Biosafety Resources and Tools
FDA has authority over “devices,” as defined in the Federal Drug & Cosmetic Act, for animal use.
The USDA, Center for Veterinary Biologics, Policy, Evaluation & Licensing (CVB, PEL), may have primary jurisdiction over veterinary biologics, including vaccines, and veterinary medical devices imported for any purpose. For additional information, see the CVB web site, email cvb@aphis.usda.gov and/or call (515) 337-6100.
Procedures
A USDA APHIS VS import permit (VS Form 16-6), will not be required for FDA approved human pharmaceuticals, approved active pharmaceutical ingredients (usually shipped in bulk), over- the-counter (OTC) drug monographs, human vaccines, human medical devices, veterinary pharmaceuticals, and veterinary medical devices shipped in bulk (fully manufactured to be packaged) and/or in final-use packaging.
In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation or information accompanies each shipment and be presented for review by the Department of Homeland Security, Customs and Border Protection (CBP) Agriculture Specialist/Officers at the U.S. port of arrival. For FDA approved human and/or veterinary pharmaceuticals, human vaccines and human and/or veterinary medical devices: or
- A written statement supplied on foreign producer/shipper letterhead which:
- Confirms that the product being imported is approved by the FDA; and/or
- Includes a copy of the FDA-approved commercial drug product label.
OR
- Based on information contained in shipping documents including, invoices, manifests or products labels, CBP will use information provided in the Orange Book to verify FDA approved pharmaceuticals for human use or the Green Book to verify FDA approved pharmaceuticals for veterinary (animal) use or refer to the FDA website to verify FDA approved human medical devices that contain animal origin ingredients.
As a reminder, for FDA approved human vaccines:
A written statement supplied on foreign producer/shipper letterhead which:- Confirms that the product being imported is approved by the FDA; and
- Confirms the human vaccine in bulk (fully manufactured in final dosage to be packaged)and intended for human use only.
- Confirms that the product does not contain live livestock and poultry viral agents; and
- Includes a copy of the FDA-approved commercial vaccine label.
USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead. USDA, APHIS, VS further recommends that the documentation accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agriculture Specialists/Inspectors at the U.S. port of arrival. We do not recommend that the foreign producer/shipper place this document inside the shipping containers. We further recommend that you provide a copy of this guideline to your producer/shipper.
For FDA regulated Veterinary Medical Devices
FDA has regulatory oversight over veterinary devices such as 510k medical devices and/or empty blood collecting tubes. The FDA can take appropriate regulatory action if a veterinary medical device is misbranded or adulterated. Imported FDA regulated products are expected to comply with all applicable regulations at the time of entry.
The labels of all veterinary devices should clearly indicate that they are for animal use only.
Guidance pertaining to veterinary devices may be accessed at the following FDA websites:
- How FDA Regulates Animal Devices
- CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary Devices
- CPG Sec. 655.100 - Devices for Use in Animals
If the pharmaceutical, medical device or vaccine to be imported cannot meet these criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:
Import Permit
USDA APHIS VS Permit applications can be submitted by any of the following ways:
- Online via eFile: https://efile.aphis.usda.gov/s/
- By e-mail: Submit a completed VS 16-3 (found on Animal Health Permits) to apie@usda.gov
- Contact us at apie@usda.gov or 301-851-3300 with questions/concerns.
