Judge Sets Trial Date for Pharmacy Suit Over FDA's Drug-Compounding Policy

The FDA's current policy on drug compounding will be tested in court later this year, as a federal judge has given the green light to a lawsuit filed against the agency by a coalition of 10 pharmacies.

The coalition, led by Medical Center Pharmacy of Texas, sued the FDA in September 2004, alleging that the agency has overstepped its authority by implementing an internal policy that prevents pharmacies from drug compounding. In addition to interfering with pharmacies' drug compounding activities, the agency is engaging in unauthorized inspections of pharmacies that have compounding operations, the plaintiffs contend.

The lawsuit will be heard later this year by federal Judge Robert Junell, of the U.S. District Court for the Western District of Texas, who recently issued a scheduling order calling for a trial to begin Dec. 5. The schedule calls for the parties to complete discovery of evidence by July 11.