The commissioner of the U.S. Food and Drug Administration has sent letters to state agencies and other stakeholders 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, dated Wednesday, reminds stakeholders of 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.
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.
"If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers that purchase compounded drugs necessary to meet the medical needs of their patients can provide their patients with drugs that were compounded in outsourcing facilities," which are subject to manufacturing standards and increased oversight, said the letter to governors, state boards of pharmacy and health departments.
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