In an effort to prevent disease outbreaks similar to the cases of meningitis caused by the New England Compounding Center in October 2012, the Massachusetts House of Representatives unanimously voted in favor of stricter regulations for drug compounding pharmacies on Wednesday.
The bill would require compounding pharmacies to apply for special licenses and make them subject to random, unannounced inspections. The Senate must approve the bill before any further action can be taken.
“Drug compound centers were able to operate essentially out of sight of both the state and the Food and Drug Administration through a loophole that exists,” said Mass. Rep. Jeffrey Sanchez who co-chairs the Joint Committee on Public Health. “The legislation looks to establish a framework for oversight and enforcement to improve transparency for compounded drugs [that] will be made and increase safety.”
This legislation incorporates recommendations made by Mass. Gov. Deval Patrick in January after the NECC outbreak to reform the Massachusetts Board of Pharmacy and to strengthen oversight of compounding pharmacies in Massachusetts.
The bill contains provisions to create a stricter license renewal process for pharmacists in compounding centers and require the centers to report to the state government.
Sanchez, who represents the Boston area, said he hopes the legislation would set an example for policy changes across the country.
“The standards [on regulation] that we set here, we’ve set the bar so high that we hope that there are other states that are going to look to Massachusetts for services,” he said
Compounding centers, unlike traditional pharmaceutical facilities, mix and recombine ingredients to create medication tailored to patients’ specific needs. The FDA does not have the same control over compounders as it does with other pharmacy companies due to a law passed by U.S. President Bill Clinton in 1997.
64 people out of the 750 reported cases of fungal meningitis caused by the tainted NECC steroids died, according to data from the Centers for Disease Control. However, the CDC is uncertain how many people were affected from the outbreak in total.
NECC stopped manufacturing and shipping, recalled its products and voluntarily gave up its pharmacy license on Oct 3, 2012, the day after contaminated products were found at the Compounding Center. Since then, it has been processing returns as well as facing lawsuits from former customers.
The NECC did not return calls for comment on the legislation.
Several residents said they recognize the need to regulate compounding pharmacies to prevent any public health concerns in the future.
Meredith Kelley, 22, resident of Boston, said she finds regulations appropriate given the negative consequences that NECC faces.
“There’s no harm in regulation if [compounding centers] are going to be responsible for so many peoples’ health,” she said.
Diane Weld, 50, resident of Boston, said she thinks that the climate of the compounding pharmacy field has changed since the meningitis outbreak.
“There’s been so much media attention, so compounding centers should know that they’re under more scrutiny,” she said. “There has to be some professional standard.”
Paul Appollouis, 55, a resident of Boston, said the oversight was the only way safety could be guaranteed for the medical field.
“There needs to be somebody watching over the operation so that [compounders] are sensitive to the operation itself,” he said. “[Unless] there’s a boss or a teacher to watch over, nothing is going to get done.”