port of arrival before entry into the United States is authorized. 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. Material derived from any animal is potentially subject to U.S. Veterinary vaccines or veterinary diagnostic test kits, Anti-venom, dietary supplements, non-empty veterinary blood collecting tubes, nutraceuticals, FDA approved test kits, test kit reagents, test kit components, in vitro reagents including but not limited to bovine serum, monoclonal antibodies, cell lines, media, transport media, porcine blood, sodium heparin, heparin, ox bile, deoxycholic acid, deoxycholate and non-FDA approved bulk pharmaceutical and vaccine active ingredients. To learn more about the importation process, you may reference the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary Devices Information pertaining to veterinary devices may be accessed at the following FDA websites: The labels of all veterinary devices should clearly indicate that they are for animal use only. 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. *FDA approved active pharmaceutical ingredients (API) only derived from or containing gelatin and/or lactose.įOR VETERINARY MEDICAL DEVICES such as, but not limited to, empty blood collecting tubes and 510k medical devices:įDA has regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated.

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.

Exempted Category Cell