FDA Warns Three Firms to Stop Mass Producing Unapproved Inhalation Drugs
This press release from FDA cracking down on compounding practices got some broad coverage this past week. Compounding, the selective creation of new drugs using bulk drug substance or drug products by pharmacists, is a legal activity when done for an individual patient with special drug needs, in response to a valid prescription. FDA maintains a web site that describes what pharmacists may and may not do to be in compliance with compounding rules and regulations. FDA has long been wary of “compounding” activities that resemble large-scale manufacturing and distribution of drug products, as are alleged for the three pharmacies given warning letters. In response to the FDA warning, RoTech announced it would cease production of the compounded products and would switch 30,000 patients to brand-name drugs. Look for more FDA warnings in the weeks ahead, with “biodentical” hormone compounders probably the next to be targeted.
September 5th, 2006 at 2:53 pm
[...] FDA’s crack down on compounding has apparently been dealt a setback according to this FDA News Story describing a U.S. District Court opinion. I had previously discussed FDA’s recent crackdown on national compounders, which FDA claimed were behaving more like drug manufacturers than compounders, risking patient safety. Let’s have a brief look at the lawsuit and opinion itself (Decision). [...]