A federal court judge sided with a Florida compounding laboratory when he ruled that the Food and Drug Administration (FDA) lacked the authority to prevent the laboratory from producing and distributing animal medications compounded from bulk ingredients without the agency’s approval.

The case stems from an April 2009 incident involving 21 polo horses that died after receiving a selenium, vitamin B, and potassium compound prepared by Franck’s Compounding Laboratory of Ocala, Fla. A subsequent investigation into the deaths revealed the compound contained levels of selenium toxic to horses. A mathematical conversion error was later blamed for the elevated selenium levels. According to court documents, the Florida Board of Pharmacy levied fines and reprimanded Franck’s for the misfiled prescription, but allowed the laboratory to continue its compounding practice without restriction.

In April 2010 the FDA filed a complaint in the U.S. District Court for the Middle District of Florida, asking the court to prevent the laboratory from producing the compounds without seeking an FDA new animal drug application on grounds that the compounded medications endangered animal health. The pharmacy voluntarily ceased compounding veterinary drugs in May 2010, while the temporary injunction order was pending. In August 2010 the pharmacy resumed compounding veterinary drugs after U.S. District Judge Timothy J. Corrigan denied the FDA’s petition for a temporary injunction while the case was under litigation.

Last Monday (Sept. 12), Corrigan denied the FDA petition for a permanent injunction against the laboratory on grounds that the agency does not have the authority to regulate state-licensed veterinary pharmacy compounding