Federal Raid on Kentucky Compounding Pharmacy
Updated: Friday, August 13, 2004 9:03 AM
Posted: Friday, August 13, 2004 9:03 AM
On Aug. 12, the United States Food and Drug Administration ordered federal marshals to raid BET Pharm, in Lexington, and seize illegally compounded drug products created for use in horses.
This followed a Nov. 17, 2003, warning letter from the FDA outlining practices the FDA considered illegal. Stephen Atwood, attorney for BET Pharm, said the FDA acted illegally in the raid and the company will formulate what legal action it feels should be taken on its behalf. Atwood said BET Pharm is operating legally under the regulations of the Kentucky Pharmacy Board.
Gloria Dunnavan, director of the Division of Compliance in the FDA's Center for Veterinary Medicine in Rockville, Md., said the FDA recommends horse owners and veterinarians not use any products from BET Pharm. She added that owners should discuss the BET Pharm products with their veterinarians before stopping usage in order to make sure there is an approved product available to use as a substitute.
Not all compounding is illegal, Dunnavan noted. "There are certainly options for the veterinarian to come up with a compounded product that is legal," she said.
Dunnavan said the FDA has investigations pending for about 20 firms in order to verify consumer/industry complaints. If the complaints prove valid, then appropriate enforcement action will take place. She could not disclose the names of the firms under investigation.
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