Last week, Governor Patrick signed into law comprehensive compounding pharmacy reform legislation, House Bill 4235, An Act Relative to Pharmacy Practice in the Commonwealth. I am proud that with enactment of this legislation, Massachusetts will be better prepared and able to protect patients both inside and outside the Commonwealth’s borders.
House Bill 4235 directs the Board of Pharmacy to:
- Update its membership with enhanced expertise in critical areas of pharmacy practice;
- Create new state licensing for sterile, complex non-sterile, hospital, and out-of-state pharmacies;
- Authorize new penalties and fines for pharmacies who do not comply with the law;
- Require robust product labeling and reporting of serious adverse drug events;
- Set new continuing education rules;
- Eliminate the “gray area” between manufacturing and compounding;
- And, improve transparency in the industry as a whole, increasing patient education and confidence in received medications
As many of you may recall, following the 2012 national fungal meningitis outbreak, Governor Patrick directed DPH and the Board of Registration in Pharmacy to undertake a comprehensive approach to improving state oversight of the compounding pharmacy industry in Massachusetts. The Administration immediately implemented a series of aggressive actions – which in total – appropriately establish critical protections to ensure patient safety across the Commonwealth.
As part of this response, Governor Patrick convened a Special Commission on the Oversight of Compounding Pharmacies, charging them to analyze the needs and gaps of the industry in order to formulate recommendations on necessary policy, regulatory and legislative changes. The Commission relied on pharmacists, regulators, physicians, health law practitioners, legislators, namely, Senate President Pro Tempore Richard Moore, Senate Minority Leader Bruce Tarr, and State Representative David Vieira, as well as epidemiologists as part of its study of Massachusetts’ compounding practices. And in January 2013, formalizing many of the Commission’s recommendations, Governor Patrick filed comprehensive pharmacy reform legislation.
From new licensing, labeling, education and oversight requirements, in addition to new penalties and fines for pharmacies who do not comply with the law, today’s signing builds upon strong steps the Administration has already taken in partnership with the Legislature to increase oversight of the industry, including allocating additional resources to the Board of Pharmacy for additional inspectors and improved pharmacy oversight. This compounding reform Act truly advances many of the Special Commission’s critical recommendations and will ensure we have added protections, enforcement authorities, and the transparency necessary to better ensure what happened at NECC never happens again.
As a nurse and public health leader, I believe that what happened at NECC violated one of our most basic assumptions – the trust that a patient has that their medicine is safe and won’t make them sicker. NECC shook that principle to its core.
Here at DPH, I have taken reforming this agency and shedding light on what went wrong as my number one responsibility and measure of success. To that end, I am proud of the new investments we have made, the strengthened regulations we have ensured, and the new management and reporting structures I have put in place.
Today is a significant accomplishment that will better prepare Massachusetts’ public health infrastructure for a stronger tomorrow. Join me in congratulating Governor Patrick, Speaker DeLeo, Senate President Murray, as well as Chairman Jeffrey Sanchez, Chairman John F. Keenan, and all the staff of the Joint Committee on Public Health who made this critical reform a reality.
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