The commissioner of the U.S. Food and Drug Administration has sent letters to state agencies and others across the country calling on them to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public.
The letter from Commissioner Dr. Margaret Hamburg is a reminder about a law passed last year in response to a meningitis outbreak from contaminated steroid pain injections that killed 64 people and sickened more than 750. The outbreak was traced to the now-closed New England Compounding Center pharmacy in Framingham.
At least five people in Illinois were tested because of the possibility they received the contaminated drugs.
Under the new law, large-volume compounding pharmacies that send medicine all over the country can voluntarily register with the FDA and submit to federal inspections and quality standards, much like drug manufacturers.
Jurisdiction over such large-volume compounding pharmacies has long been murky. Pharmacies are typically regulated through state boards, but the Food and Drug Administration regulates manufacturers of medicines.
The law attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar operations to skirt both state and federal regulations.
