FDA slaps Rotech, CCS, Reliant with warning

Thursday, August 31, 2006

ROCKVILLE, Md. - The Food and Drug Administration warned Rotech, CCS Medical and Reliant Pharmacy--a Lincare subsidiary--on Aug. 9 that they were in violation of federal law for making and distributing "thousands of doses" of nebulizer drugs.
The FDA said the companies were targeted because they made 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," said Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in a statement.
The companies had 15 days to reply in writing on what actions they would take to correct violations.