FDA Files Action Against Florida Drug Compounding Lab

The FDA filed a civil suit against a Florida pharmacy for producing a drug that the agency said killed 21 polo horses.
FDA Files Action Against Florida Drug Compounding Lab
Two teams play against each in the International Polo Club during the U.S. Open April 23, 2009 in Wellington, Florida. (Joe Raedle/Getty Images)
Conan Milner
4/20/2010
Updated:
10/1/2015
<a><img src="https://www.theepochtimes.com/assets/uploads/2015/09/86187774.jpg" alt="Two teams play against each in the International Polo Club during the U.S. Open April 23, 2009 in Wellington, Florida. (Joe Raedle/Getty Images)" title="Two teams play against each in the International Polo Club during the U.S. Open April 23, 2009 in Wellington, Florida. (Joe Raedle/Getty Images)" width="320" class="size-medium wp-image-1820849"/></a>
Two teams play against each in the International Polo Club during the U.S. Open April 23, 2009 in Wellington, Florida. (Joe Raedle/Getty Images)
The Food and Drug Administration (FDA) filed a civil suit against a Florida pharmacy for producing a drug mixture that the agency said killed 21 polo horses. The FDA alleged that Franck’s Compounding Pharmacy located in Ocala has been introducing adulterated, misbranded, and unsafe drugs into interstate commerce as part of the company’s veterinary pharmaceutical compounding business.

According to the FDA complaint, Franck’s compounded a drug mixture that last year killed 21 polo horses belonging to a Venezuelan team, in Florida to compete for the U.S. Polo Championships. The injunction, filed April 16 by the Department of Justice on behalf of FDA in the U.S. District Court for the Middle District of Florida, would permanently bar the company and its chief executive officer, Paul W. Franck, from compounding animal drugs from bulk ingredients without FDA approval.

For nearly three decades the privately owned and operated Franck’s has served patients in central Florida and throughout the country preparing drug mixtures for everything from pediatric cases to dental pain and bio-identical hormone replacement, as well as preparations for companion animals and horses. While Franck’s compounds drugs for both human and veterinary use, the suit for a permanent injunction only pertains to the company’s veterinary practices.

Drug compounding—the process of mixing, combining or altering drugs to accommodate the particular needs of specific patients—is common in both human and veterinary medical industries. However, the FDA is accusing Franck’s of using compounding as a way to avoid the regulatory requirements of the drug approval process. The agency said that practice could potentially put consumers and animals at risk.

“FDA recognizes the benefit of the traditional practice of pharmacy compounding providing a service in response to a valid prescription to accommodate the specialized needs of a particular patient,” said Bernadette Dunham, D.V.M., Ph.D., director of the agency’s Center for Veterinary Medicine in a press release. “But when compounders like Franck’s circumvent, and thus undermine, the statutory drug approval process by manufacturing drugs under the guise of pharmacy compounding, we are concerned that poorly compounded drugs can jeopardize the health of animals.”

In the past year, inspections at Franck’s found that the company compounded most of its veterinary drugs from active pharmaceutical ingredients called “bulk” ingredients. This practice is prohibited by the statutes and regulations that govern veterinary compounding. Animal drugs created from bulk ingredients do not undergo FDA approval, and no clinical testing or other controls are in place to ensure their safety. The government alleged that Franck’s use of a bad mixture of bulk drugs a year ago led to the deaths of the 21 horses.

In addition to using bulk drugs for compounding, Franck’s has been accused of trying to elude FDA regulation by creating and distributing drugs that are compounded copies or near-copies of approved pharmaceuticals that are already on the market. The company refused to stop these practices in spite of several FDA warnings that its activities were illegal. The most recent warning was in December 2009.

“We allege that the practices at issue in this case contributed to deadly results,” said Tony West, assistant attorney general for the Civil Division of the Department of Justice. “The Justice Department and our federal partners will work together to pursue pharmacies that put the health and safety of animals at risk.”
Conan Milner is a health reporter for the Epoch Times. He graduated from Wayne State University with a Bachelor of Fine Arts and is a member of the American Herbalist Guild.
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