FDA slaps Lincare site with warning

Monday, January 31, 2005

CLEARWATER, Fla. - The U.S. Food and Drug Administration in December sent a letter to Lincare President John Byrnes warning that the agency documented violations of the Federal Food, Drug and Cosmetic Act during an inspection of a Lincare facility in Southaven, Miss.

Based on a June 2004 inspection, the FDA ruled that the facility’s operations were “akin to that of a drug manufacturer” because it was producing sproducts that were similar to those available commercially.

“[These practices go] well beyond the scope of traditional pharmacy compounding and instead more closely resemble a drug manufacturing operation,” said H.Tyler Thornburg, director of the FDA’s New Orleans district, in the letter. Based on this decision, the FDA ruled that Lincare was also in violation of current Good Manufacturing Practice requirements.

“To the extent that the FDA takes the position that you are a manufacturer, well, no pharmacy is going to be in compliance with the good manufacturing practices that are imposed in drug manufacturers,” said Lisa Smith, an attorney with Brown and Fortunato.

Lincare’s situation illustrates a problem faced by many compounders since the FDA reasserted its jurisdiction over them. Compounding pharmacies had been exempt from FDA requirements under the FDA Modernization Act of 1997, which was struck down by the Supreme Court in 2002 because on unconstitutional restrictions on commercial speech.