Margaret Hamburg in testimony before Congress tells them that there should be two classes of compounders. The first is traditional compounding for individual patients on an as needed basis. Non-traditional compounding, the kind practiced by NECC and others, poses a higher risk according to Hamburg and should require federal (i.e. FDA) oversight.
Hamburg suggests non-traditional compounders would be distinguished by characteristics or activities like -- sterile compounding, the amount of product made, production prior to prescriptions received for a patient, shipping drugs interstate, shipping drugs to sellers or distributors other than the patient (or their physician). etc.
Hamburg says these compounders should have to adhere to GMPs and be under more oversight. Addtionally, compounders should not make copies of drugs approved by FDA (i.e. Makena) except under extremem shortage situations, should not make complex dosage forms -- extended release, transdermal patches, liposomal products, etc -- or make biologics.
Why? I say if compounders want to act like small drug manufacturers they shouldn't be called compounders and should be required to adhere to the existing drug manufacturing regulations and be overseen as such. Then the FDA would have clear oversight without any more legislative needs for "clarity".
Why make it so complicated?
Posted by Bruce Lehr Nov 14th 2012.