ASPERGILLUS CONTAMINATION FOUND AT NECC — IS USP 797 “PHARMACEUTICAL COMPOUNDING — STERILE PREPARATIONS” WORKING?

 SHOULD THE FDA BE DOING MORE? 

Recently the New England Compounding Center (NECC) was found to have dispensed a number of syringes containing methylprednisolone acetate to treat pain control and inflammation.  Following a number of reports from various states, the FDA and CDC became involved in attempting to locate the source of the meningitis that began to occur one to four weeks following injection.  They ultimately traced the contamination to the NECC and a fungus, Aspergillus sp.  The facility has subsequently ceased production and is participating with the FDA and CDC in their investigation.

Unfortunately, this is not the first case in recent months of Pharmaceutical Compounding facilities producing contaminated parenteral product.  Franck’s Compounding Lab, Ocala, Florida recently was issued a Warning Letter (7/9/12) for Fusarium contaminated BBG as was InfuPharma, LLC, Hollywood, Florida (7/30/12) for Streptococcus.  Both of these companies were found by the FDA to have been repacking sterile injectable vials into sterile injectable syringes which were then being shipped to various end users.  The products were found to cause a variety of illnesses because of the contamination.  Please visit the Warning Letters for additional information.

Compounding Pharmacies are controlled by state health departments.  These health departments do not possess adequate manpower and equipment to assure that these pharmacies  are maintaining aseptic practices to dispense sterile preparations.  Unlike parenteral manufacturing facilities that the FDA audits approximately once every two years, they do not appear to typically audit these Compounding Pharmacies or become involved in these contaminations until they are advised of a problem.  With the recent number of deaths and serious injuries that have recently occurred, is this an area when the FDA now finds it needs to expend its resources?