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United States |
Animal and |
Veterinary Services |
Guidelines for Importation of
Human Pharmaceuticals and Vaccines
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GUIDELINES FOR IMPORTATION #1100 (REVISED August 7, 2007) HUMAN PHARMACEUTICALS
AND HUMAN VACCINES CONTAINING ANIMAL COMPONENTS To Include: Human vaccines and human pharmaceuticals in final dosage form approved by the Food and Drug Administration (FDA). Not to Include: Antivenom, vaccines/pharmaceuticals for animal use, vaccines/pharmaceuticals containing live livestock or poultry viruses, dietary supplements and nutriceuticals, and insulin. 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 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 exotic animal 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 may enter the country 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 U.S. Public Health Service 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, USDA, APHIS, VS recommends that this document be supplied on foreign producer/shipper letterhead, with the letterhead containing the physical address of the foreign producer/shipper. USDA, APHIS, VS further recommends that the documentation, written in a clear and concise manner, accompany each shipment, and be presented as a separate document for review by the DHS, CBP Agricultural Specialists 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 foreign 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:
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VS - Safeguarding Animal
Health |
http://www.aphis.usda.gov |
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