FDA Warns 3 Compounders on Inhaled Drugs

The U.S. Food and Drug Administration said Thursday it warned three pharmacy compounders to stop selling unapproved inhaled drugs.

The FDA said it sent warning letters to RoTech Healthcare, CCS Medical and Reliant Pharmacy Services telling the companies to halt their manufacture and distribution of thousands of doses of compounded inhalation drugs that treat conditions like asthma and emphysema.

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 Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible.

The agency said it believes that some of the compounders that make inhaled drug products turn out millions of doses of the products per year and may go well beyond traditional compounding.

These compounded drugs often simply copy FDA-approved, commercially available drugs, and any differences from FDA-approved drugs do not appear to be related to patients’ medical needs, the FDA said.

Many drugs can be legally compounded and are typically prepared for patients with special needs, such as those who are allergic to an ingredient in an FDA-approved drug, the agency noted.