The outbreak of fungal meningitis in 2012 that injured more than 750 people involved more than misconduct by the New England Compounding Center (NECC). It was due to the unclear legal status of compounding pharmacies, problems with the legal oversight, limited FDA authority, and overlapping and unclear federal and state jurisdiction. These conditions became hazardous when compounding pharmacies assumed functions that went beyond traditional compounding. The presentation will discuss the legal origins of the NECC crisis and examine how the state and federal governments have responded.

Legal origins of the New England Compounding Center (NECC) crisis and the future of drug compounding regulation

256th National Meeting (2018)

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