FDA appeals compounding ruling

Sunday, December 10, 2006

MIDLAND, Texas - The Food and Drug Administration is appealing a ruling that said compounded drugs are not new drugs and therefore outside the agency's jurisdiction.

The motion was filed Dec. 1 in the 5th Circuit Court of Appeals, and is the latest move pitting the agency against the practice of pharmacy compounding.

In September 2004, a group of 10 pharmacies known as the Midland Coalition filed suit against the FDA saying the agency had exceeded its jurisdiction. A federal court judge ruled in favor of the plaintiffs May 25, 2005, and issued a written opinion on the ruling Sept. 30.

Plaintiff's attorney Terry Scarborough, of Austin, Texas, said the appeal was widely expected.

"It really serves to underscore the importance of this case to the government, the compounding industry and the public-at-large," said Scarborough.

The FDA has long contended that compounded medications are new drugs subject to FDA approval and Scarborough expects that will be the basis of the agency's appeal.

The FDA had no comment.