FDA Tells Providers to Stop Compounding

Washington

The FDA has warned three companies to stop manufacturing and distributing unapproved compounded inhalation drugs.

Warnings were issued last month to Orlando, Fla.-based Rotech Healthcare; Clearwater, Fla.-based CCS Medical; and Reliant Pharmacy Services, which is owned by Clearwater, Fla.-based Lincare Holdings.

Traditional pharmacy compounding involves preparing drugs that are not commercially available. But according to the FDA, these pharmacies were mass-producing copies of brand-name drugs already out on the market.

“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 FDA’s Center for Drug Evaluation and Research. “To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible.”

In response, Rotech said it disagrees with the FDA’s assertion, but that it will begin switching 30,000 patients taking the compounded drugs to commercially available medications. The process will take several months to complete.