Monday, February 11, 2013

Questionable Expansion of State Pharmacy Board Regulatory

In an excellent piece published in the BNA Pharmaceutical Law and Industry Report, “Confounded in Compounding Apothecaries: The Critical Need for Confining State Pharmacy Boards to Self-Regulation,” William G. Schiffbauer takes a close look at state pharmacy boards and the conflicts of interest and other problems that have arisen in connection with recent expansions of their activities.
He finds that pharmacy boards, mostly made up of pharmacists, have strayed from their core mission of “self-regulating” pharmacists – that is maintaining the competence of professional pharmacists and identifying and disciplining problem pharmacists. An example of inappropriate pharmacy board regulatory activity is the regulation of compounding pharmacies such as the New England Compounding Center whose negligence is reported to have caused 44 deaths and sickened 678 people in 19 states. Schiffbauer notes that it took 25 deaths and 344 injuries to “move” the Massachusetts Board of Pharmacy to adopt emergency regulations – long after the facts were known and after similar tragedies had already occurred. According to Schiffbauer, compounding pharmacies act more as pharmaceutical manufacturers than as local pharmacists, and pharmacy boards have neither the resources nor the competence to regulate pharmaceutical manufacturing processes.
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