State inspectors who monitor compounding pharmacies that custom mix drugs will be required to have special training, under compromise legislation unveiled Sunday by Massachusetts lawmakers. Adding one pharmacist with expertise in the most risky type of compounding to the board that regulates the industry, would also be mandated under the legislation.
In addition, the bill would require hospital pharmacies, which currently are not subject to routine monitoring by the state’s pharmacy board, to be inspected by state regulators and follow Massachusetts rules by June 2015.
The legislation comes after tainted drugs produced in 2012 at a Massachusetts commercial compounding pharmacy, New England Compounding Center, sickened 751 people, killing 64.
The Massachusetts House and Senate last fall each issued different proposals aimed at closing loopholes that investigators said led to the deadly fungal meningitis outbreak from the tainted drugs, and the compromise package issued Sunday includes many key proposals from both.
“With this legislation, we’ll go from a state with essentially unregulated pharmacy compounding substances to a state which will provide patients with some of the best patient care in the country,” said state Senator John F. Keenan.
“It’s a very good bill . . . that broadens scope and really serves to protect the patients in the commonwealth of Massachusetts,” Keenan said.
“This closes a lot of the loopholes that currently exist,” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, a group that represents most compounders. “This potentially can be a model for the rest of the country.”
After the meningitis outbreak, some state inspectors testified at a public hearing that they didn’t have the expertise they needed to effectively monitor pharmacies, such as New England Compounding, that do the most risky type of compounding — mixing drugs that are injected into the body.
The fungal meningitis outbreak was traced to an injectable steroid manufactured at New England Compounding.
“If they are not trained properly, they don’t know what they are looking at,” Brown said.
The compromise legislation also expands the pharmacy board from 11 to 13 members, and would require that eight of its members be pharmacists, including one with expertise in so-called sterile compounding, which is the type of drug mixing done at the now-defunct New England Compounding.
The company closed following the meningitis outbreak.
Governor Deval Patrick last year proposed legislation to decrease the number of pharmacists on the board to four members, saying he believed that fewer pharmacists on the board would mean stronger oversight. He said he believed it would bring a greater range of professional perspective to the board.
The pharmacists association fought that move, saying the field had become so complex, the board needed pharmacists who understood the issues.
The compromise legislation also will require out-of-state pharmacies that ship products to Massachusetts to be licensed by the state and subject to its rules.
Other portions of the package would require inspectors to conduct both planned and unplanned inspections of all licensed compounding pharmacies, and to assess penalties up to $25,000 for each violation by a pharmacy, and up to $1,000 a day for each violation that continues beyond the date prescribed for correction.
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