FDA's Push For Compounding Oversight Meets Skepticism

Law360, New York (November 21, 2012, 5:51 PM EST) -- Legal and public health experts are skeptical of the U.S. Food and Drug Administration's push for new authority over compounding pharmacies, arguing the FDA could have used its existing power to shut down illegal manufacturers to stop the compounder responsible for a deadly meningitis outbreak.

FDA Commissioner Margaret Hamburg recently appeared before Congress to ask for more legal authority over compounders, which are largely regulated by the states. She proposed creating a category of “nontraditional compounders,” such as those that transport drugs across state lines or engage in sterile compounding, that would be under the agency's direct authority. Such pharmacies would...

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