FDA locks up compounded drugs

LEXINGTON, KY.—The U.S. District Court for the Eastern District of Kentucky issued a seizure warrant Aug. 11 at the request of the Food and Drug Administration (FDA) for various compounded drug products at BET Pharm LLC, in Lexington, Ky.

FDA inspections revealed the firm is illegally manufacturing and distributing unapproved animal drugs, says Jon Scheid, Center for Veterinary Medicine (CVM), FDA.

The drugs and their components were subject to seizure because they have not been approved by the FDA as new animal drugs and are unadulterated under the Federal Food, Drug and Cosmetic Act, Scheid says.

These types of seizures do not occur often, says Gloria Dunnavan, director of CVM's Division of Compliance.

"Compounding of veterinary drugs has been on the increase in the last few years," Dunnavan says. "Compounding now includes copies of approved products, large-scale production, sale and distribution without the involvement of a veterinarian or based on a valid veterinarian/client/patient relationship.

"Compounding is legally permitted if the criteria established under the Animal Medicinal Drug Use Clarification Act is met, which includes starting with approved products to compound with," she adds.

Stephen Atwood, attorney for BET Pharm, says the drugs in question are still on the premises; they're just in locked boxes.

"BET is not manufacturing drugs, as the FDA phrases it; they are compounding them," Atwood says. "The drugs in question are not made by any other company, therefore there is no FDA-approved drug of its kind available on the market."

The compounding at BET is done under the instruction of veterinarians, Atwood adds.

"The FDA issued an 'ex parte' warrant; it's not even signed by a federal judge," Atwood says. "What the FDA did is not valid."

The drugs in question were predominately for the induction of ovulation in horses, pregnancy maintenance in horses and treatment of Cushing's disease in equines, Atwood says.

BET Pharm LLC previously was issued a warning letter outlining unacceptable practices, which is available on the FDA's Web site, Scheid counters.

The company was given an opportunity to correct the violations but failed to take appropriate actions, the press release states.

The violations could pose a health risk to horses because the safety and efficacy of the drugs are unknown, Scheid adds.

In the meantime, BET Pharm officials are assessing legal avenues. The company has not committed a crime, Atwood argues.

Settlement

It's possible the FDA and BET Pharm will reach an agreement, outlined in a court-ordered consent decree, which was signed by the government and the firm claiming the products, Scheid explains. The decree would describe the disposition of the products or how the products could be brought into compliance.

No court date was set at presstime.