FDA Urges Congress To Fix Compounding Oversight Issues

Law360, Washington (July 16, 2013, 7:17 PM EDT) -- The U.S. Food and Drug Administration on Tuesday urged a group of lawmakers to clarify and expand its existing authority over drug compounders, claiming the current reactive regulatory regime cannot curb the potential public health risks caused by negligent facilities. 

FDA's Center for Drug Evaluation and Research director Janet Woodcock told a House Energy and Commerce subcommittee that the drug compounding industry has mutated beyond the limits of the current federal and state regulatory patchwork, as large compounding practices have sparked national bacterial and fungal outbreaks...
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