FDA Sends Warning Letter to Compounding Firm

The FDA’s letter to Wickliffe Pharmaceutical indicates that tests show that some of the firm’s drug products are “adulterated and misbranded” under the federal Food, Drug, and Cosmetic Act.
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The U.S. Food and Drug Administration (FDA) has sent a letter to a Lexington, Kentucky, pharmacy that compounds drugs for horses notifying the firm that tests show that some of its drug products are "adulterated and misbranded" under the federal Food, Drug, and Cosmetic Act.

In a letter to Wickliffe Pharmaceutical Inc. and its president/owner Jacqueline S. Bernard, the FDA's district office in Cincinnati, Ohio, said an investigation of the pharmacy was initiated after two Kentucky horses died after receiving an oral paste containing toltrazuril and pyrimethamine compounded by the pharmacy. While the investigation was underway, the letter states, the agency received a report that eight horses in Florida had suffered adverse reactions after they were treated with a "suspension drug product compounded by your pharmacy that also contained toltrazuril and pyrimethamine."

Subsequent tests of two samples obtained from the pharmacy showed concentration levels between 81-83% of the declared concentration levels. In another test, the drugs contained 3.74% and 2,380% of the declared concentration levels.

Wickliffe has been sued by owners of at least three Thoroughbreds hospitalized after receiving a compounded drug from the company alleging their horses at an Ocala, Florida, training center were hospitalized after receiving a compounded drug to treat or prevent equine protozoal myeloencephalitis

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Written by:

Ron Mitchell is Online Managing Editor for The Blood-Horse magazine. A Lexington native, Mitchell joined The Blood-Horse after serving in editorial capacities with The Thoroughbred Record and Thoroughbred Times, specializing in business and auction aspects of the industry, and was editor-in-chief of the award-winning Horsemen’s Journal. As online managing editor, Mitchell works closely with The Blood-Horse news editor and other departments to make sure the website content is the most thorough and accurate source for all Thoroughbred news, results, videos, and data.

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