Saturday, March 23, 2013

Confounded in Compounding Apothecaries: The Critical Need for Confining State Pharmacy Boards to Self-Regulation by WILLIAM G. SCHIFFBAUER

Policy makers are all calling for greater federal
regulation of the ‘‘compounding’’ activities of
pharmacies after the New England Compounding
Center’s laboratory let loose contaminated injectable
steroids. The most recent report notes that this pharmacy
negligence has to date killed 44 people and sickened
678 people in 19 states. See, Centers for Disease
Control, Multistate Fungal Meningitis Outbreak Current
Case Count (January 14, 2013). This is the result of
one small pharmacy among thousands of such pharmacies
across the nation in all 50 states that engages in
combining, mixing, or altering prescription drugs.
Greater federal regulation of the ‘‘compounding’’ activities
of pharmacies does not address the fundamental
flaw that has laid this danger on the nation’s doorstep
once again. The real question is just ‘‘who’’ is setting
and enforcing the standards for these pharmacies? In
nearly all cases it is state pharmacy boards consisting of
the very same professionals who have committed compounding
negligence. It took 25 deaths and 344 injuries
at the hands of the New England Compounding Center
to actually ‘‘move’’ the Massachusetts Board of Pharmacy,
months after the fact and years after similar tragedies,
to adopt ‘‘emergency regulations’’ for compounding
pharmacies (10 PLIR 1438, 11/9/12).
This article reviews the make-up of these state
boards, provides a very brief review of history of the

‘‘compounding’’ controversy, and offers some possible
reforms for states to consider if they want to retain the
state primacy of regulating the ‘‘practice of pharmacy.’’
Pharmacists Are a Self-Regulated
Pharmacies and pharmacists are ‘‘self-regulated’’ at
the state level by legislatively created state boards of
pharmacy. These state boards are comprised largely of
pharmacists empowered to regulate the practice of
pharmacy, admission to practice pharmacy, standards
of pharmacy practice and licensure, and the discipline
of pharmacists. The core premise of ‘‘self-regulation’’ is
that the knowledge base, training and skills required to
be a professional pharmacist would make regulation by
non-professionals who are incapable of assessing quality
difficult, and that the profession should be able to be
trusted to carry out this necessary standard-setting and
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