FDA Sends Warning Letter to Compounding Firm

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.

"Please note that the violations cited in this letter are not intended to be an all-inclusive list of violations at your facility," the letter continues. "You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in legal action without further notice, including, without limitation, seizure and injunction."

Wickliffe was given 15 working days from receipt of the letter, dated Aug. 14, in which to notify the FDA office in writing of specific steps taken to correct violations or, if unable to complete corrective action within that time period, to state the reason for the delay and the time within which the correction will be completed.

The full letter can be viewed online.

Originally published on BloodHorse.com.

About the Author

Ron Mitchell/The Horse

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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