* Proposal aims to keep up with changes in industry-Gov.
* Would require special licenses for sterile compounding
By Scott Malone
BOSTON, Jan 4 Massachusetts Governor Deval
Patrick on Friday proposed new state rules to more closely
regulate the type of pharmacy at the heart of a U.S. meningitis
outbreak that has killed 39 people.
The proposed legislation would require special licenses for
compounding pharmacies, allow the state Board of Pharmacy to
fine companies that violate its rules and require out-of-state
pharmacies that ship drugs to Massachusetts to be licensed by
The aim is to more closely monitor companies that cross the
line from mixing the raw materials of drugs for individual
prescriptions and those that begin to operate more like
An injectible steroid produced by the Framingham,
Massachusetts-based New England Compounding Center (NECC) was
linked to an outbreak of bacterial meningitis that has sickened
656 people in 19 states, according to the Centers for Disease
Control and Prevention.
"The regulations that we have in place and governing
authority hasn't kept up with an industry that's changed,"
Patrick told reporters on Friday. "It's really built around the
corner drug store, but we've seen and experienced with NECC that
businesses that call themselves pharmacies are actually doing a
form of manufacturing."
Federal investigators have found multiple violations of
standard sterility practices at NECC, which has closed and, on
Dec. 21, filed for bankruptcy protection.
Companies registered as pharmacies are regulated by the
individual states, while drug manufacturers face the tighter
oversight of the U.S. Food and Drug Administration. Patrick's
legislation calls on Massachusetts to more closely work with the
FDA to ensure that larger pharmacies do not escape oversight.
The state has since ordered the temporary shutdown of four
other compounding pharmacies where investigators found problems.
The FDA last month urged states to crack down on loopholes
that allowed compounding pharmacies to produce drugs on an
industrial scale without drawing FDA scrutiny.