Boston (WWLP) - The Massachusetts House voted unanimously 155-0 in favor of tougher state regulations on drug compounding pharmacies following last year’s deadly meningitis outbreak linked to tainted medications manufactured at the New England Compounding Center.
64 people died and 750 others were sickened nationwide.
“One of the most important things, I think, for the first time, you know this gives us some oversight in terms of …what’s going on at these compounding facilities,” said House Speaker Robert DeLeo (D-Winthrop).
The new bill requires compounding pharmacies to apply for special licenses, makes them subject to unannounced inspections, and holds them to higher manufacturing standards. At the same time, Congress has proposed a bill that allows the FDA to oversee compounding pharmacies.
“If after passing this and after enactment, Congress, you know, they decide to come back from wherever they’re coming from because while they’re shutdown, we’re open and we’re working,” said Rep. Jeffrey Sanchez (D-Jamaica Plain). “We are going to be able to work with them and put together something that [reconciles] with them.”
The state legislation requires compounding pharmacies to report the volume and type of drugs they produce, creates whistleblower protections for pharmacy workers and requires them to report illnesses or other “adverse” events. The bill now heads to the state Senate.
“We worked with the House and with the Senate on this, this is a really good bill so I look forward to it getting through the Senate and signing it,” said Governor Deval Patrick.
The bill increases fees for pharmacies that want to be licensed and penalizes them for up to $25,000 dollars for regulation violations.