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

Leo Takaoka

McCarter & English, LLP

David Pleynet

ImmunoGen, Inc

Marc A. Rodwin

Suffolk University Law School; Harvard University - Edmond J. Safra Center for Ethics

Date Written: 2018

Abstract

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.

Suggested Citation

Takaoka, Leo and Pleynet, David and Rodwin, Marc A., The Legal Origins of the New England Compounding Center Crisis and the Future of Drug Compounding Regulation (2018). Quinnipiac Health Law Journal, Vol. 21, p. 1, 2018, Forthcoming; Suffolk University Law School Research Paper No. 17-14. Available at SSRN: https://ssrn.com/abstract=3033304

Leo Takaoka

McCarter & English, LLP ( email )

United States

David Pleynet

ImmunoGen, Inc

Waltham, MA
United States

Marc A. Rodwin (Contact Author)

Suffolk University Law School ( email )

120 Tremont Street
Boston, MA 02108-4977
United States
617-573-8354 (Phone)
617-305-3087 (Fax)

HOME PAGE: http://www.law.suffolk.edu/faculty/directories/faculty.cfm?InstructorID=48

Harvard University - Edmond J. Safra Center for Ethics ( email )

124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

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