The head of the nation’s largest trade group for the specialty pharmacies known as compounders said he will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug Administration and be subject to stricter standards enforced by the agency.
The new position by the International Academy of Compounding Pharmacists follows a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies, which make custom-ordered medications, operate like drug manufacturers but do not have to register with the federal government follow the same safety laws
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AN OUTBREAK of fungal meningitis from contaminated steroid injections shipped last May has claimed 45 lives and sickened 693 people. The New England Compounding Center in Framingham, Mass., which sent 17,676 of the adulterated injections to clinics in 23 states, has declared bankruptcy and shuttered its facility. But that is not the end of the story. As Kimberly Kindy, Lena H. Sun and Alice Crites reported in The Post on Feb. 8, troubles have run deep for years in the growth of lightly regulated firms that mix and ship medicines to hospitals and clinics known as compounding pharmacies. Some of the firms have expanded to manufacturing scale, yet without adequate protections and quality control.