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How Much Legal Authority Does the FDA Have, and Use in Regulating Drug Compounding?

Posted on October 30th, 2012 by Oddo & Babat, P.C.

Legal experts are engaged in a new debate over the Food and Drug Administration’s authority of the drug compounding industry and perhaps their failure to use it. The recent outbreak of meningitis and the shutdown of Massachussets-based New England Compunding Center have again surfaced this issue with law makers and it is raising the question on the need for criminal investigation. Laws and regulations surrounding the compounding industry and the pharmaceutical industry and role that pharmacies play in mixing medicine for individual patients – which is related from state-to-state – are sketchy. It is unclear how many people may be at risk from the use of potentially contaminated drugs and could be at risk for severe infection and perhaps wrongful death. Several drugs produced by New England Compounding Center are used during surgical procedures. The October 15 New York Times article “F.D.A. Warns of Further Risk From Tainted Drugs” explains in more detail.

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