FDA targets Lincare, Rotech and CCS Medical

Sunday, August 13, 2006

ROCKVILLE, Md. - The FDA last week warned Rotech, CCS Medical and Reliant Pharmacy--a Lincare subsidiary--to stop making their own versions of respiratory drugs.

The FDA said the companies were targeted because they made the inhalants without proving medical need. Steve Silverman, the FDA's acting assistant director of the office of compliance, said in USA Today that the agency expects the companies to either show they are filling legitimate medical needs or stop mass production.

According to the FDA, mass production of respiratory medications is a growing problem. Some pharmacies are producing unapproved copies of brand-name drugs under less stringent safety and sterility rules, said the agency.

"Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in a statement.

The companies had 15 working days to reply in writing what action they would take to correct any violations.