House OKs Bill To Regulate Compounding Pharmacies
Nearly a year after a deadly national meningitis outbreak that originated at a Framingham pharmacy, the House on Wednesday unanimously approved legislation subjecting the industry to stricter oversight regulations and new licensing requirements.
The bill also institutes inspection procedures on compounding pharmacies that operate in Massachusetts, reconfigures the Board of Registration in Pharmacy, and requires new regulations for the licensing of in-state and out-of-state pharmacies that distribute sterile compounded drugs in Massachusetts.
In compounding, a licensed pharmacist mixes or alters ingredients in a prescription to create a medication tailored to an individual patient's medical needs, according to the U.S. Food and Drug Administration.
"We are here to make sure we don't let compounding pharmacies operate without strict oversight any longer," said the bill’s sponsor, Rep. Jeffrey Sanchez, before it was approved.
Sanchez said that as the industry has grown, some compounders have been acting like manufacturers.
The bill puts protections in place that will ensure compounded drugs are as safe as any other drug, Sanchez said, describing it as a national model.
"Transparency is key to encouraging accountability so that compounding pharmacies will be held to the highest standards, their products will be just as safe as any others on the market," Sanchez said.
The legislation heads to the Senate, where Senate President Therese Murray expects it to surface quickly.
"As soon as we get it, we'll look at it and most likely take it up right away," Murray said Wednesday.
Tainted steroids originating from the New England Compounding Center in Framingham caused a national outbreak of fungal meningitis that killed 61 people and infected hundreds of others last year.
Lawmakers have said that while NECC was to blame, they could have done a better job preventing the national outbreak through oversight and regulation.
Rep. David Linsky, D-Natick, said NECC, "motivated by nothing more and nothing less than pure greed," was able to manufacture drugs and ship them across state lines because of oversight failures by the federal and state governments.
'Absolute Tragedy'
"It is an absolute tragedy that this happened. It is an absolute tragedy that this happened on our watch, on Massachusetts' watch, and that it was an absolute failure of government at all levels," Linsky said.
Last week, a Congressional committee agreed to legislation that would give the FDA greater authority to regulate companies that compound sterile drugs and ship them across state lines. The bill, the Drug Quality and Security Act, is in response to the deadly outbreak that originated at the Massachusetts compounding pharmacy.
Rep. James Lyons, R-Andover, said it became apparent during hearings on the compounding bill the state Department of Public Health lacked a system to inspect compounding facilities.
"I think it is also important for us to recognize the Department of Public Health has to be held accountable," Lyons said.
Sanchez said lawmakers realized there was a lack of conversation between government, health agencies and patients on compounded drugs. To address it, the bill requires the Department of Public Health to maintain a website listing of all compounded pharmacies and violations or adverse events tied to the pharmacy, he said.
After very little discussion, the House adopted only one amendment, filed by Sanchez. Under the legislation, the Board of Registration in Pharmacy will be reconfigured to include six pharmacists with varying specialties, one pharmacy technician and one representative of the public with health care service delivery or advocacy experience, one physician and one expert in patient safety.
The board will be required to conduct inspections and random audits of compounding pharmacies in Massachusetts, and compounding pharmacies would be required to comply with new drug labeling mandates, inventory reporting, and mandated disclosure of "adverse drug events" to the FDA, which would include deaths, hospitalizations, birth defects or other negative impacts from the use of a drug.
WBJ Web Partners
Most Recent
Most Recent
0 Comments