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Animal Material __EXCLUSIVE__


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animal material


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Human pharmaceuticals, approved active pharmaceutical ingredients*, over- the-counter (OTC) drug monographs, human vaccines, human medical devices (including 510k and empty blood collecting tubes), veterinary pharmaceuticals, and veterinary medical devices (including 510k and empty blood collecting tubes) approved by the Food and Drug Administration (FDA) containing animal derived components.


FDA has regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated. It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled prior to importation to the United States. The labels of all veterinary devices should clearly indicate that they are for animal use only.


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.


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.


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 Protect (DHS, CBP) Agricultural Specialists at the port of arrival before entry into the United States is authorized. However, the USDA does not have regulatory authority over the importation of live laboratory animals or laboratory mammal material that have not been inoculated with or exposed to any livestock or poultry disease agents exotic to the United States.


The Centers for Disease Control and Prevention (CDC) has jurisdiction over live laboratory mammals and their material that may be infectious. Contact the Division of Select Agents and Toxins Importation Permit Program at 404-718-2077 or importpermit@cdc.gov regarding any documentation or other import requirements CDC may have.


A USDA permit will not be required for the importation of laboratory mammal material provided the material is obtained from laboratory mammals that have not been inoculated with, or exposed to any exotic livestock or poultry disease agents, and do not originate from facilities where work with exotic disease agents affecting livestock or avian species is conducted. 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:


Amphibians, fish, reptiles, shellfish, aquatic species and/or their materials such as: blood, chondroitin, collagen, emulsions, extracts, feces, fluids, gelatin, glucosamine, oils, tissues, serum, urine, and venom, from these species.


Materials derived from all animals are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security Customs and Border Protection (CBP) Agricultural Specialists/Inspectors at the port of arrival before entry into the United States is authorized. A USDA, APHIS, Veterinary Services (VS) Import Permit is required for animal material that may pose a risk of introducing foreign livestock and poultry diseases into the United States. However, material from the above listed animals that have not been inoculated with or exposed to any livestock or poultry disease agents or antigens may enter the United States without USDA restrictions.


NOTE: The U.S. Fish and Wildlife Service has jurisdiction over the importation of Convention on International Endangered Species of Wild Fauna and Flora (CITES) listed animals. Please contact their Office of Management Authority at 800-358-2104. The National Oceanic and Atmospheric Administration (NOAA) provides information regarding import of both marine mammals and seafood at -affairs.


A USDA VS Import Permit will not be required for these types of animal products if DHS, CBP Agricultural Specialists/Inspectors are provided documentation which may include: manifests, invoices, foreign producer/shipper statements on letterhead, or other shipping documents which provide the following information:


This Guideline does not apply to: Nucleic acids that contain sequences homologous to genes of livestock or poultry animals or organisms or vectors which are known to cause or transmit disease in livestock or poultry. This exclusion from the guideline applies to nucleic acids produced through polymerase chain reaction (PCR) or by another nucleic acid amplification method/protocol.


Materials derived from any animal, including those materials produced with animal products or extracts of microorganisms, are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security, Customs and Border Protection (DSH, 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, chemically synthesized biochemicals and chemically synthesized materials that do not contain and were not derived from animal products may enter the country without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.


A USDA import permit will not be required for chemically synthesized biochemicals, chemically synthesized materials that do not contain animal products, or chemically synthesized materials that were not derived from animal products. 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:


Products for human and animal consumption including but not limited to pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, medical devices, placebos, and investigational pharmaceuticals that contain lactose (milk sugar) and the following lactose derivatives, galactose and lactulose, as the ONLY animal origin ingredient. This would include bulk amounts of lactose or galactose or lactulose.


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/Officers 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, the USDA has assessed the risk of lactose (milk sugar) and the following lactose derivatives, galactose and lactulose, and determined that they are not a viable vectors for Foot and Mouth Disease (FMD), and the risk of entry of FMD via products containing lactose or galactose or lactulose is negligible. Therefore, products that contain lactose or galactose or lactulose as the ONLY animal origin ingredient may enter the United States without USDA, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) restrictions.


A USDA, APHIS, VS import permit will not be required for pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, and products for human and animal consumption that contain lactose or galactose or lactulose as the ONLY animal derived ingredient. 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 DHS, CBP Agricultural Specialists/Inspectors at the U.S. port of arrival.


If the pharmaceuticals, nutraceuticals, dietary/nutritional supplements, culture media, and products for human and animal consumption, etc. to be imported cannot meet the criteria, then a USDA import permit may be required. Permit applications may be obtained several ways:


Materials derived from any animal, or produced with animal products or extracts of microorganisms, are 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 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, microbes (usually E. coli or yeasts) that do not express material of a foreign livestock and/or poultry disease agent may enter the United States without USDA restrictions. 041b061a72


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