FDA letter moves compounding pharmacy law forward, passed after meningitis outbreak

BOSTON — 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 a producer of sterile drugs in an effort to protect the public.

The letter from Commissioner Dr. Margaret Hamburg dated Wednesday reminds stakeholders of last year's law passed 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.

Iowa U.S. Sen. Tom Harkin said Friday that the law and the FDA's letter help "ensure the safety of compounded drugs and is aimed at helping to prevent a future public health crisis."

Registering with the FDA under the law is voluntary.

http://www.therepublic.com/view/story/ff20e4667fe0495983fdd0328df20a92/MA--Compounding-Pharmacies