Obviously there is a lot going
on in response to the 39 deaths and over 600 cases of meningitis and other
injuries caused by contaminated compounded drugs sold by a Massachusetts
pharmacy. The FDA has acknowledged its regulations
are inadequate and a recent
report issued by Massachusetts Congressman Ed Markey outlines initial
concerns with both state and federal oversight. The FDA recently held a daylong
meeting
with state regulators to discuss the role of states and the federal government going
forward.
At the state level, the Council
of State Governments (CSG) plans a webinar for this Thursday, January 3 titled "The
Meningitis Outbreak and the Regulation of Compounding Companies: Federal and
State Roles." The National Conference of State Legislators (NCSL) has compiled
a database of state laws and regulations, as well as an initial report on
actions under way in some states. The International Academy of Compounding Pharmacists
(IACP) has
its own recommendations for
state regulatory action.
There
is no question that state legislators, as well as pharmacy boards and public
health agencies will be looking hard at compounding pharmacy regulations and
the role of their states in assuring patient safety, and we will be reporting
on their actions in the weeks and months ahead.
