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Animal Health |
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Expand All Collapse All A: Veterinary biologics are vaccines, bacterins, diagnostics, etc, which are used to prevent, treat, or diagnose animal diseases. A: The U.S. Department of Agriculture (USDA) is authorized, under the 1913 Virus-Serum-Toxin Act as amended by the 1985 Food Security Act, to ensure that all veterinary biologics produced in, or imported into, the United States are not worthless, contaminated, dangerous, or harmful. Federal law prohibits the shipment of veterinary biologics unless these are manufactured in compliance with regulations contained in Title 9 of the Code of Federal Regulations, Parts 101 to 118. Veterinary biologics for commercial use must be produced at a USDA-approved establishment, and be demonstrated to be pure, safe, potent, and efficacious. A: The Veterinary Biologics Program of the USDA's Animal and Plant Health Inspection Service (APHIS) oversees the veterinary biologics industry in the United States. This Program consists of the Center for Veterinary Biologics and allied services:
A: Domestic manufacturers of veterinary biologics, for domestic use or for export, are required to possess a valid U.S. Veterinary Biologics Foreign manufacturers of veterinary biologics may export veterinary biologics to the United States, provided that the manufacturer's legal representative (permittee) residing in the United States possesses a valid U.S. Veterinary Biological Product Permit to import these products for general distribution and sale. The U.S. Department of Agriculture may also issue veterinary biologics permits for research and evaluation or for transit shipment. A: The Veterinary Biologics Pharmacovigilance Program is for the ongoing surveillance of adverse events associated with animal vaccines and other biologics, in cooperation with the veterinary profession and the veterinary biologics industry. An adverse event is any undesirable occurrence after the use of an biological product, including illness or reaction, whether or not the event was caused by the product. Reporting instructions are found on the Adverse Event web page. A: Establishment and product license requirements are discussed in Veterinary Services Memorandum 800.50 What documentation must a permittee submit to USDA in order to obtain a permit to distribute and sell in the United States a veterinary biologic manufactured abroad? The requirements for a permit to distribute and sell imported product are largely the same as those for domestically produced product (i.e., Veterinary Services Memorandum 800.50 ) . For additional details on permit requirements, see Veterinary Services Memorandum 800.101 A: A veterinary biologic may be exempt from Federal regulation in any of the following cases:
A: An individual or firm must receive USDA authorization prior to conducting research in animals with non-exempted experimental veterinary biologics. The items that must be submitted to the CVB to request such an authorization are discussed in Veterinary Services Memorandum 800.67.
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