Compounding pharmacies hit FDA with lawsuit

Monday, January 31, 2005

MIDLAND, Texas - A coalition of 10 pharmacies this fall filed a lawsuit against The U.S. Food and Drug Administration claiming the FDA is engaging in “unauthorized” inspections of compounding pharmacies.

The pharmacies petitioned the U.S. District Court in Midland, Texas, hoping that the judge will rule that the FDA has no jurisdiction over compounding pharmacies, which they consider to be under the control of state boards of pharmacy. The pharmacies want to be able to continue filling prescriptions using compounding techniques without the FDA considering them a manufacturer and forcing them to meet manufacturing levels of standard, according to Lisa Smith, an attorney at Amarillo, Texas-based Brown and Fortunato.

“The bottom line is right now the FDA has tremendous enforcement discretion and some of the guidelines are a little nebulous,” said Smith. “It’s not crystal clear where the line is, so a pharmacy that is compounding a significant volume can’t feel comfortable that the FDA is not going to take the position that they are a manufacturer instead of a pharmacy.”

The FDA Modernization Act of 1997 exempted compounding pharmacies from certain FDA requirements. That law was overturned in 2002 when the Supreme Court ruled that a section of it was unconstitutional. The FDA has since resumed exercising its enforcement over compounding pharmacies, said Smith. The plaintiffs contend, however, that since they are filing prescriptions that they can only be considered pharmacies.

The lawsuit is in its beginning stages, with the government in the process of filing an initial response. When the suit is finally settled, the ruling will only have bearing in the western district of Texas until it is ruled on in an appellate court.