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11th Jul

2013

Memorandum of Understanding (MOU) USDA and FDA

A Memorandum of Understanding (MOU) between the U. S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) and the Food and Drug Administration (FDA) has been recently added to the Center for Veterinary Biologics (CVB) Web site at :

http://www.aphis.usda.gov/animal_health/vet_biologics/publications/APHIS_FDA_biologics_MOU.pdf

This agreement reflects the understanding between the USDA APHIS and the FDA regarding procedures and responsibilities for resolving jurisdictional issues or questions about the regulation of certain animal products as biologicals under the Virus-Serum-Toxin Act (VSTA) 21 U.S.C. §§ 151 et seq., or as drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) § 201(g)(1), 21 U.S.C. § 321(g)(1)).

 

USDA APHIS and the FDA agreed on a process for exchanging information and for establishing a Standing Committee made up of members from the FDA Center for Veterinary Medicine and the APHIS Center for Veterinary Biologics. The MOU also provides an agreed-upon list of products that meet the definition of a drug under the FFDCA and those that meet the definition of a veterinary biological product under the VSTA.

 

 

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