Compounding Pharmacy Reinforces Standards

A Lexington, Kentucky, pharmacy that makes compound products for horses said it has taken steps to reinforce its safety and quality standards and has cooperated with a federal agency's inquiry into "adverse events earlier this year."

The U.S. Food and Drug Administration (FDA) recently sent a letter to Wickliffe Pharmaceutical Inc., notifying the firm that tests show its drug products are "adulterated and misbranded" under the federal Food, Drug, and Cosmetic Act.

"Wickliffe Veterinary Pharmacy, a high-quality provider of customized medicinal solutions for veterinarians, cooperated fully with federal health officials' inquiry into the adverse events involving horses earlier this year," the company said in a statement in response to the FDA letter. "The recent compliance letter issued by the U.S. Food and Drug Administration is related solely to this previous incident. We took prompt action last spring in response to the incident to reinforce our high safety and quality standards for Wickliffe's compounded products. We are preparing a response to the FDA that outlines the steps that we have taken and the quality assurance program that we maintain."

In a letter to the firm and its president/owner Jacqueline S. Bernard, the FDA's district office in Cincinnati, Ohio, said an investigation of the pharmacy was initiated following the deaths of two horses in Kentucky after they were administered 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.

Earlier this year Wickliffe was sued by owners of at least three Thoroughbreds hospitalized after receiving a compounded drug from the company alleging their horses at an Ocala, Fla., training center were hospitalized after receiving a compounded drug to treat or prevent equine protozoal myeloencephalitis.

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