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 Wednesday 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.

The agency is requesting that the companies either prove that
they are compounding medications for medical needs or stop
compounding.

“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.”