The Facts of the Franck's case

A veterinarian commissioned Franck's Compounding Lab, a Florida pharmacy, to compound an injectable solution of a prescription drug, Biodyl, which is not commericially available in the United States.  The Biodyl was injected into horses on the Venezuelan Polo Team in 2009.  After injected with the Biodyl, 21 horses died; five horses who did not receive the injection lived.  The Florida Board of Pharmacy investigated and determined that a mathematical error--the misplacement of a decimal point-had made the solution of Biodyl deadly.  The board believed that the mathematical error had nothing to do with preparing the compound from bulk materials. Although the Board fined and reprimanded Franck's, it allowed Franck's to continue its drug compounding business, which is approximately 40% of Franck's total business revenues.

After the Florida Board of Pharmacy closed its case, the Federal Drug Administration (FDA) began investigating Franck's.  The FDA sent Franck's a "Form 483" notice containing five alleged violations-none of these involved claims of bulk compounding of animal drugs. A Form 483 notification is used for "Factory Inspections" to communicate "inspectional observations."  The Form 483 notice requires a response.  Franck's responded, arguing it had not violated federal law and asserting that compounding is regulated by the states rather than by the FDA or federal government.  In April 2010, the FDA filed a civil complaint in federal district court and requested a permanent injunction prohibiting Franck's from compounding animal medications.  See Memorandum of Law in Support of Plaintiff's Preliminary Injunction  On September 12, 2011, United States District Court Judge Timothy J. Corrigan issued an 80-page opinion, deciding in favor of Franck's, granting its motion for summary judgment and denying the FDA's request for an injunction.

The FDA appealed the district court's decision to the Eleventh Circuit Court of Appeals.  The Department of Justice (DOJ), who represents the FDA, has filed its brief in case number 11-15350.  Franck's has filed its response brief.  DOJ's reply to Franck's brief is due now due on May 1, 2012, after they received an extension of time to file.