The Legal Origins of the New England Compounding Center Crisis and the Future of Drug Compounding Regulation
57 Pages Posted: 8 Sep 2017 Last revised: 26 Feb 2018
Date Written: 2018
The outbreak of fungal meningitis in 2012 that injured more than 750 people involved more than misconduct by the New England Compounding Center. 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. This article explores the legal origins of the NECC crisis. It also examines how the state and federal government have responded and assesses the legislation enacted in 2013.
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