received from their local vendor to make sure they hadn't come from
the New England Compounding Center (NECC), the Massachusetts
pharmacy at the center of the 2012 deadly fungal meningitis outbreak,
the deadliest medication contamination case in U.S. history.
Fortunately for them and their patients, they hadn't.
State and federal regulators say NECC mixed and sold contaminat-
ed vials of steroids that sickened 778 unsuspecting patients, killing 76
of them. In the wake of the NECC tragedy, government oversight of
compounding facilities has increased, but you still have to do your
homework when choosing a compounder. How can you be sure your
lab takes medication safety as seriously as you do? You can start by
asking these 7 questions.
Is it licensed? Each state in the country is home to a state board of
pharmacy, an association of pharmacists who develop, implement and
enforce public safety standards for pharmacists. Every U.S. com-
pounding facility should be licensed by the relevant state board of
pharmacy. In some cases, when a lab ships compounded medication
over state lines, licensing is required by more than one board of phar-
macy. This information — who's current and who's not — is often
available on a State Board of Pharmacy website. Otherwise, you may
need to dig a little deeper; experts recommend calling a state board to
ask about any licensure revocations or suspensions.
503A or 503B? While the Food and Drug Administration's oversight of
compounders has historically been a murky area, regulation has
increased since the 2013 passage of the Drug Quality and Security Act
(DQSA), following the NECC scandal. Under this law, compounders are
classed according to 2 categories: traditional pharmacies that dispense
patient-specific compounds only with a prescription (503A); and bulk
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