FDA may appeal compounding decision

Sunday, September 10, 2006

MIDLAND, Texas - A federal court judge issued a written opinion Aug. 30--expanding on his May 25 verbal ruling--that pharmacy compounding does not violate U.S. Food and Drug Administration regulations.

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. The ruling pertains to the FDA's belief that compounded drugs--including respiratory meds--are new drugs and require FDA approval. The pharmacies argued that as long at the drugs are compounded in accordance with state regulations, the FDA has no jurisdiction.

Plaintiff's attorney Terry Scarborough, of the Austin-based law firm of Hance, Scarborough, Wright, Woodward & Weisbart, said the ruling was a victory for American patients and their physicians.

The FDA is reviewing the opinion and may appeal, said an agency source.

"It continues to be the FDA's view that compounded drugs are new drugs, subject to various regulatory provisions," said the source.

The ruling, while binding in that geographic region, may not be followed elsewhere, said Jeff Baird, an attorney with Amarillo, Texas-based Brown & Fortunato.

"That's good law in that region," said Baird. "But while this might be good law in west Texas, is it going to flow in Pittsburgh?"

The FDA says not.

"We're going to abide by the decision in western Texas with respect to the plaintiffs covered by that decision," said the source. "Elsewhere, we're going to continue to follow the enforcement approach as reflected in our 2002 compliance guide."

The judge also ruled that FDA inspections should be limited in state compliant pharmacies.

"The case is very clear that the FDA is not entitled to get your books and records," said Scarborough. Without access to those records, the FDA cannot determine the volume of compounding a pharmacy does, said Scarborough.

In August, the FDA warned Rotech, CCS Medical and Lincare that their compounding operations were in violation of federal law.

"Our concern was there was a high volume of manufacturing of these products without demonstration of specific need," said the source. "We don't typically engage in close regulation of traditional compounding pharmacies."

The FDA has 60 days to file an appeal.