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A disclaim declaration is appropriate if APHIS Core does not regulate your product, if your product is regulated, but there are no data (i.e., LPCO) requirements, or if your product is flagged AQX and is not regulated by APHIS Core.
The Animal and Plant Health Inspection Service (APHIS) protects and promotes U.S. agricultural health, regulates genetically engineered organisms, administers the Animal Welfare Act, and manages wildlife damage.
APHIS regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective.
Veterinary biologics, including vaccines for animal diseases, are regulated by the U.S. Department of Agriculture. What FDA Does and Does Not Regulate Food and Drug Administration (.gov) animal-health-literacy what-fda- Food and Drug Administration (.gov) animal-health-literacy what-fda-
The U.S. Department of Agriculture regulates these vaccines. Center for Veterinary Medicine - FDA Food and Drug Administration (.gov) about-fda fda-organization ce Food and Drug Administration (.gov) about-fda fda-organization ce
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The Center for Veterinary Medicine (CVM) is the animal and veterinary arm of the FDA. In other words, the people working at the CVM are the ones actively regulating animal drugs, animal food, and animal medical devices at the FDA. Who Regulates Veterinary Drugs? - Anivive Lifesciences Anivive Lifesciences learn article who-regulate Anivive Lifesciences learn article who-regulate
States are responsible for determining their own vaccine prioritization. The Advisory Committee on Immunization Practices continues to provide recommendations to states. While USDA has thousands of employees in its workforce, states will make the final determination of how vaccine distribution is prioritized. Vaccines | USDA usda.gov coronavirus vaccines usda.gov coronavirus vaccines

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