Congress Must Clarify FDA Oversight On Compounding: GAO

Law360, New York (July 31, 2013, 4:01 PM EDT) -- Lawmakers must resolve the lingering uncertainty about what oversight authority the U.S. Food and Drug Administration has over the controversial drug compounding industry in the wake of a fatal meningitis outbreak in 2012 caused by contaminated compounded drugs, federal auditors said Wednesday.

After a series of vague appeals court rulings in the early aughts, confusion persists over whether compounding large quantities, in particular, qualifies as pharmacy — which states oversee — or as a form of drug manufacturing that would fall under the FDA’s purview, according...
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