Veterinary Compounding Not under FDA

Court Rules Veterinary Compounding Not Under FDA Control

A Federal Judge ruled in favor of Franck’s Pharmacy when he denied the Food and Drug Administration’s petition for an injunction. The judge stated the FDA doesn’t have the authority to prevent Franck’s or any other animal compounding pharmacy from creating and distributing veterinary medicines compounded from bulk ingredients without the agency’s approval.

 

“The FDA has long been on notice that its statutory authority to regulate traditional, state-licensed veterinary pharmacy compounding was questionable. FDA to Revise Its Compliance Policy Guide on Veterinary Compounding, supra p. 32. Rather than follow through with this sensible approach, the FDA apparently abandoned it.96 Instead, it has decided to proceed with this enforcement action, asserting a “maximalist” interpretation of its authority. However, the FDCA does not support the FDA’s action. The Court holds that, in enacting the FDCA in 1938, Congress did not intend to give the FDA per se authority to enjoin the long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non food-producing animal by compounding from bulk substances.”

 

In 2009, 21 polo horses died from a compounded injectable solution of the prescription drug Biodyl; it was compounded at Franck’s Pharmacy. An investigation later revealed that the selenium levels were toxic due to a mathematical error in the conversion process as opposed to “faulty bulk drugs.” According to court documents, the incident was investigated by the Florida Board of Pharmacy, which fined Franck’s for the mis-filled prescription, however the pharmacy’s license remains in good standing in Florida.

 

The owners of the 21 horses that died and the horses’ insurer, Diamond State Insurance Company, filed suit against Franck’s Pharmacy in early 2010.