FDA Reports Unsanitary Conditions at Compounding Facilities, Calls for More Regulatory Authority

FDA Commissioner Margaret A. Hamburg, MD, reported in a recent FDA blog article that agency inspectors encountered “objectionable conditions” at 30 of the 31 sterile compounding pharmacies they recently examined. Some of the conditions they witnessed included black particles floating in vials of supposedly sterile medicine, rust and mold in clean rooms, and technicians handling “sterile” products with bare hands. FDA conducted the inspections, most of which involved coordination with the relevant state board of pharmacy, in the wake of the fungal meningitis outbreak caused by contaminated injectable drugs compounded by NECC. In the blog article, Hamburg cited the resistance that FDA inspectors met – including some pharmacies blocking access to facility records – as grounds for granting the agency more authority to regulate sterile and nonsterile compounding firms. Additional information about the inspections is available on the FDA Web site.