Guidelines for Importation of Human Pharmaceuticals, Vaccines and Veterinary Pharmaceuticals

Guidelines for Importation of Human Pharmaceuticals, Vaccines and Veterinary Pharmaceuticals

GUIDELINES FOR IMPORTATION #1100  (Last Updated December 2016)

This Guideline applies to: 

Human pharmaceuticals, human vaccines, and veterinary pharmaceuticals approved by the Food and Drug Administration (FDA) and containing animal derived components.

This Guideline does not apply to: 

Antivenom, dietary supplements, nutraceuticals, and bulk pharmaceutical and vaccine ingredients.


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 and vaccines and veterinary pharmaceuticals in final dosage 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, human vaccines and veterinary pharmaceuticals. 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 http://www.fda.gov 

U.S. Public Health Service

Centers for Disease Control, Office of Biosafety

1600 Clifton Road Atlanta, GA 30329-4027 USA
800-CDC-INFO (800-232-4636), TTY: 888-232-6348

Website address http://www.cdc.gov/biosafety/ 

The USDA, VS, Center for Veterinary Biologics, Policy, Evaluation and Licensing (CVB, PEL), may have primary jurisdiction over veterinary biologics, including vaccines, imported for any purpose. For additional information, see the CVB web site https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/ct_vb_import_export_products , 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 and veterinary pharmaceuticals ready in final dosage ready for use (in bulk or packaged).

In order to facilitate correct identification of the shipment and to ensure tiemely 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 human and veterinary pharmaceuticals:

  1. A written statement supplied on foreign producer/shipper letterhead which
    1. Confirms that the product being imported is approved by the FDA; and

    2. Includes a copy of the FDA-approved commercial drug product label.

      OR

  1. 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.

    As a reminder, for vaccines for human use:

    A written statement supplied on foreign producer/shipper letterhead which

    1. Confirms that the product being imported is approved by the FDA;  and
       
    2. Confirms the human vaccine in final dosage form and packaging and intended for human use only.
       
    3. Confirms that the product does not contain live livestock and poultry viral agents; and

    4. 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.

If the pharmaceutical 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

The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at http://www.aphis.usda.gov/animal_health/permits/.

The current permit processing fee is $150 and permit duration is one year.

Applications can be submitted by any of the following ways:

USDA, APHIS, VS
National Import Export Services (NIES)
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300, Option 1

 

 

 

 

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