NOTES AND COMMENTS


Update: Federal Legislative Response to the Controversy over Drug Compounding

Paul W. Shaw, Patrick C. McCooe, and Redi Kasollja

ABSTRACT: In the October 2012 issue of the Journal of Health & Life Sciences Law, a Comment entitled "The NECC Fungal Meningitis Outbreak Revives the Controversy over the Regulation of Drug Compounding" detailed the historical regulatory environment in which compounding pharmacists often exceeded the bounds of traditional pharmacy compounding, entering into the practice of pharmacy manufacturing. The Comment concluded with the authors’ prediction of possible regulatory responses to the New England Compounding Center (NECC) fungal meningitis outbreak. In this update, they examine the initial federal legislative response, the November 2013 Drug Quality and Security Act.

KEYWORDS: Pharmacy Compounding, Pharmacy Manufacturing, Food and Drug Administration, FDA, Drug Quality and Security Act

CITATION: Paul W. Shaw, Patrick McCooe, and Redi Kasollja, Update: Federal Legislative Response to the Controversy over Drug Compounding, J. Health & Life Sci. L., February 2014, at 84. © 2014 American Health Lawyers Association, www.healthlawyers.org/JHLSL. All rights reserved.

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