States See Some U.S. Role Over Pharmacies After Outbreak
State regulators say U.S. health officials need a role in overseeing so-called compounding pharmacies following the meningitis outbreak that killed 39 people this year.
Health officials from the states and Food and Drug Administration met today to discuss whether the federal agency should take more responsibility when compounding pharmacies go beyond the traditional role of preparing personalized prescriptions. The states typically oversee these pharmacies while the FDA regulates drug manufacturing.
Contaminated steroid shots for back pain from New England Compounding Pharmacy Inc., known as NECC, led to 620 infections, including the deaths, according to the Centers for Disease Control and Prevention. Members of Congress argued the FDA should have treated the company like a drug manufacturer and shut it down while FDA Commissioner Margaret Hamburg said a patchwork of regulations restrained the agency from acting.
“I think most states feel that, with respect, that with the responsibilities within their own states they have the knowledge and the tools and the resources to address traditional compounding,” Hamburg said today in a briefing with reporters. “It gets more complicated when you get into the continuum of compounding.”
NECC suspended operations Oct. 3 and recalled 17,676 doses of the pain-killing steroid linked to the meningitis outbreak in 19 states.
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