January 01, 2012

 

 Ruling favoring compounder will be appealed

Posted on December 15, 2011
 

Federal authorities will appeal a court ruling that indicated a Florida pharmacy can compound veterinary drugs from bulk pharmaceutical ingredients.

On Sept. 12, U.S. District Judge Timothy J. Corrigan had ruled in favor of Franck's Compounding Lab, which the Food and Drug Administration had accused of illegally manufacturing unapproved animal-use drugs rather than compounding (see JAVMA, Nov. 15, 2011, page 1266). The agency had sought an injunction to prohibit the company from using bulk ingredients, rather than approved whole drugs, when compounding.

On Nov. 10, officials with the FDA and U.S. Attorney's Office filed notice that the government intends to appeal the ruling.

Corrigan wrote in his ruling that the FDA can distinguish drug manufacturing from compounding, but the agency misinterpreted its authority over traditional compounding of animal medications "in the context of a pharmacist-veterinarian-patient relationship."