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T04-30 |
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At the request of the Food and Drug Administration (FDA), the U.S. District Court for the Eastern District of Kentucky issued a seizure warrant on August 11, 2004, for various illegally compounded drug products for use in horses found at BET Pharm, LLC, Lexington, KY. The U.S. Marshals Service executed the seizure warrant on August 12, 2004.
FDA inspections of BET Pharm, LLC, revealed the firm is illegally manufacturing and distributing unapproved animal drugs intended for various uses in horses. These drug products and their components were subject to seizure by the federal government because the drug products were not approved by FDA as new animal drugs and thus are adulterated under the Federal Food, Drug, and Cosmetic Act.
BET Pharm, LLC, was previously issued a Warning Letter outlining unacceptable practices. The Warning Letter cited violations including manufacturing drug products from bulk drugs without approval from FDA; compounding of drug products that are copies of approved drugs, and selling compounded drugs in the absence of a valid relationship between a veterinarian and horse owner. The company was given an opportunity to correct the violations, but failed to take appropriate actions.
These violations could pose a health risk to horses because the safety and efficacy of these drugs are not known. The FDA advises horse owners not to purchase or use these products. Horse owners may wish to consult their veterinarians for advice on which products are appropriate to treat their animals.
The FDA has initiated this action as part of its responsibility to promote and protect the health of animals by enforcing the animal drug, device, and feed provisions of the Federal Food, Drug, and Cosmetic Act. FDA's mission includes ensuring the safety or safety and effectiveness of a broad spectrum of regulated animal products, including feed, drugs, and veterinary devices.
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