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Guidelines for Importation of Human Pharmaceuticals and Vaccines

GUIDELINES FOR IMPORTATION #1100  (Last Updated May 16, 2014)

This Guideline applies to: 

Human pharmaceuticals and human vaccines containing animal derived components that are in final dosage form and approved by the Food and Drug Administration (FDA).

This Guideline does not apply to: 

Antivenom, vaccines/pharmaceuticals for animal use, vaccines/pharmaceuticals containing live livestock or poultry viruses, dietary supplements and nutriceuticals.

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) Agricultural 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, pharmaceuticals and vaccines that are intended for use in HUMANS, packaged in their final dosage form and ready for resale to the consumer, 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.

However, due to the potential of diversion for animal use, bulk shipments of human vaccines, human vaccine ingredients, human pharmaceuticals, and human pharmaceutical ingredients containing animal components require a USDA, APHIS, VS import permit.

The U.S. Food and Drug Administration and U.S. Public Health Service, have primary jurisdiction over human drugs and human vaccines. They should be contacted for their importation requirements at the following locations:

U.S. Food and Drug Administration
Division of Import Operations and Policy, HFC-170
5600 Fishers Lane, Rockville, MD 20857
Tel. (301) 443-6553
Website address http://www.fda.gov/ora/import/

U.S. Public Health Service
Centers for Disease Control, Office of Biosafety
Atlanta, GA 30333
Tel. (404) 639-3534, (404) 639-3311 or (800) 311-3435
Website address http://www.cdc.gov/od/ohs/

PROCEDURES:

A USDA, APHIS, VS import permit will not be required for FDA approved human vaccines and human pharmaceuticals intended for use in humans, packaged in their final dosage form and ready for resale to the consumer. In order to facilitate correct identification of the shipment and to ensure timely delivery, USDA, APHIS, VS recommends that the following documentation accompany each shipment:

1. A written statement providing a detailed and accurate description of the material,
2. A written statement confirming that:                                                                                                                                                                                
     a) vaccine/pharmaceutical material is intended for human use only, and
     b) the material does not contain live livestock and poultry viral agents and
3.  The material is prepared, packaged, and physically labeled in the final dosage form ready for sale to the consumer.

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 Agricultural 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 for producer/shipper.

If the human vaccine or human pharmaceutical to be imported cannot meet these criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:

IMPORT PERMIT

Permit applications may be obtained several ways:

1. On-line at: http://www.aphis.usda.gov/animal_health/permits/
       a. submit the permit application on-line
       b. e-mail the completed application to: animalproducts.permitapplication@aphis.usda.gov
       c. fax the permit application

2. By writing to:
USDA, APHIS, VS
National Import Export Services (NIES)
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300 telephone, Option 1
(301) 734-8226 fax

 

 



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