Two years after a deadly nationwide meningitis outbreak linked to a compounding pharmacy in Massachusetts, Gov. Deval Patrick on Thursday signed a law he said would address a “gray area” between state and federal oversight of the pharmacies.
The measure includes new licensing and labeling requirements and steps up fines for violations of state rules.
It also reorganizes the board that oversees pharmacies and requires the board’s inspectors to be trained in sterile and non-sterile compounding practices.
A tainted steroid produced by the now-closed New England Compounding Center in Framingham was blamed for the fungal meningitis outbreak that caused 64 deaths and hundreds of illnesses in 20 states.
“I think this puts us ahead of other states,” Patrick said after a Statehouse bill-signing ceremony. “The gray area that I and so many other people talked about is an area of considerable ambiguity about where state authority leaves off and federal authority begins.”
While the U.S. Food and Drug Administration regulates large drug manufacturers, compounding pharmacies that mix and ship medications in bulk – like the one that operated in Framingham – often fell under less stringent state oversight.
The law would create four new categories of specialty licenses, including one for out-of-state pharmacies doing business in Massachusetts.
Pharmacies could be fined up to $25,000 per violation, with an additional $1,000 for each day a violation continues after it was supposed to be corrected.
While the state stepped up emergency inspections of compounding pharmacies after the 2012 outbreak, legislators said they worked at a more deliberate pace to craft a permanent law regulating the facilities.
Date: July 10, 2014
Source: Associated Press
Filed Under: Drug Discovery
