State officials weigh changes in drug compounding laws
BOSTON – State health officials and legislators are taking steps and considering other changes to prevent a repeat of a national meningitis outbreak linked to a Framingham-based compounding pharmacy.
A first step came Wednesday when state health officials announced all compounding pharmacy companies will be required to file an affidavit swearing compliance with state laws and regulations.
“Today the board of pharmacy issued an alert to all compounding pharmacies in the commonwealth to reinforce for them the rules they must abide by in Massachusetts,” said Madeline Biondolillo, an official with the Department of Public Health at a news conference.
New England Compounding Company (NECC), the firm at the center of the meningitis outbreak is one of 26 compounding pharmacies in Massachusetts. NECC had about 21 employees and $8 million in annual revenue in 2009, according to the latest federal records available.
According to the Department of Public Health, most of those firms are small neighborhood pharmacies that are only inspected upon initial licensure, if they move location, or if they are the subject of a complaint.
“We do not have any reason to believe at this time that other compounding pharmacies are operating outside the rules. This alert and order was issued purely out of an abundance of caution consistent with our commitment in the public safe,” Biondolillo said.
Both state Sens. Susan Fargo and Richard Moore suggested decreased funding for the Department of Public Health over the past four years could have been a factor in the crisis.
“I’ve warned my colleagues and said you can’t keep cutting and cutting because we’re starting to chip away at the many mandates that they’re supposed to carry out,” said Fargo, D-Lincoln, chairman of the Legislature’s Committee on Public Health. “Obviously something wasn’t in place that needed to be, or else this wouldn’t have happened.”
Under state licensing regulations, compound pharmacies are required to have an individual doctor’s prescription for every dose that’s produced. That’s raised questions over how NECC was able to ship its tainted steroids to 23 states and reach as many as 13,000 people.
While U.S. Rep. Ed Markey, D-7th, and Gov. Deval Patrick are pressing for federal legislation to better regulate the industry, state legislators are beginning to mull over next steps for the commonwealth.
Moore, D-Uxbridge, chairman of the Committee on Health Care Financing, said legislators have asked to meet with health department officials to see what kind of action is necessary.
“We need to determine whether it’s a matter of better enforcement, or whether they need any greater regulatory authority,” Moore said. “We’ll continue to monitor the situation and meet with folks at the DHP and pharmacy board to see what they need, whether its legislation or resources.”
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