The FDA is coming down on drug compounder Wickliffe Pharmaceuticals for poor compliance to manufacturing practices after receiving a report that two horses died following adverse reactions to drugs produced by the Lexington, KY-based operation.
In a warning letter dated Aug. 14 and posted last week, the FDA cited Wickliffe for both adulteration and misbranding. The letter followed an inspection at the compounder's facility in late April and May. In the letter, the FDA said it started its investigation after the death of two horses in Kentucky following the application of an oral paste containing toltrazuril and pyrimethamine that was compounded by the pharmacy. While that investigation was going on, the FDA received a report that 8 horses in Florida had adverse reactions after they were treated with a suspension drug from Wickliffe that also contained toltrazuril and pyrimethamine. Two of those horses died.
The FDA said it collected samples of both products. Tests, the letter said, showed concentration levels that were both subpotent and superpotent. One sample contained pyrimethamine at 2,380% of the declared concentration. The FDA said the fact that the drugs did not meet the labeled specifications meant they were both adulterated and misbranded. The drug compounder was given the standard 15 working days to respond to the FDA on how it intends to correct violations.
The American Veterinary Medical Association (AVMA) is looking into how to regulate animal drug compounding and also last month formed its Task Force on Veterinary Compounding Legislation to combat illegal compounding. The team is comprised of 8 vets aiming to update the compliance policy guide "Compounding of Drugs for Use in Animals" by the end of the year, as well as push legislators for new policies on veterinary compounding.
The FDA is also coming down on medicated feed manufacturers. In a warning letter dated July 15, the agency cited Syfrett Feed--based in Okeechobee, FL--with "significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for unlicensed medicated feed manufacturers." It also cited Syfrett with using new animal drugs contrary to NADA approval and further cited the company for failing to label an active drug ingredient.
In a warning letter to Riverside, CA-based Brookhurst Mill, the FDA found the medicated feed manufacturer in violation of both misbranding and adulterating its Gamebird Grow product. The regulator also cited Brookhurst for marketing the product for game birds that the concentration of its active ingredient is not approved for.