Steven Galson, director of the FDA's Center for Drug Evaluation and Research said, "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. To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible."
The FDA has said that it suspects that some of the compounders that make inhaled drug products may turn out millions of doses of the products per year which could "go well beyond traditional compounding."
The FDA said, "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 agency noted that many drugs can be legally compounded. These are often drugs that are typically prepared for patients with special needs like allergies to an ingredient in an FDA-approved drug.
