Multitude of Issues Said to Have Derailed Past Compounder Regulation

Posted on December 28, 2012

A fungal meningitis outbreak that caused numerous illnesses and fatalities across the country in the past few months has led lawmakers to reconsider the way that compounding pharmacies are regulated.  In particular, the Commissioner of the Food and Drug Administration has asked Congress to more clearly delineate who has authority over compounders.  She said that all efforts to establish clearer boundaries went nowhere prior to this most recent incident.  Officials say that a combination of quarreling among FDA members and lobbying by compounder groups previously led to a lack of action on a law establishing regulatory guidelines.  In addition, various court case results are contradictory, further clouding the regulatory issue.

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