GOVERNOR PATRICK SIGNS PHARMACY REFORMS INTO LAW TO ENHANCE INDUSTRY OVERSIGHT AND PROTECT PATIENTS
BOSTON – Thursday, July 10, 2014 – Governor Deval Patrick today signed into law comprehensive compounding pharmacy reform legislation, which allows Massachusetts to better protect patients inside and outside the Commonwealth’s borders. The Act includes new licensing, labeling, education and oversight requirements, in addition to new penalties and fines for pharmacies who do not comply with the law.
“Every patient deserves to know that the medication they are taking is safe,” said Governor Patrick. “This law gives Massachusetts the strength and flexibility to better oversee compounding pharmacy practice and protect patients.”
The Governor signed H. 4235, “An Act Relative to Pharmacy Practice in the Commonwealth,” at a ceremony at the State House following unanimous passage of the Act by both the Massachusetts Senate and House of Representatives.
“The tragic meningitis outbreak that was traced to a compounding pharmacy in Framingham seriously injured an alarming number of people all across the country, and it was imperative that we took action to prevent a similar situation from happening again in the future,” said Senate President Therese Murray. “This legislation strengthens our policies regarding the oversight, regulation and quality of our compounding pharmacies and these were necessary steps we needed to take to ensure the health of our residents.”
“This legislation ensures that we are doing all we can to guarantee the highest standards of safety, oversight and transparency for compounding pharmacies,” said House Speaker Robert A. DeLeo. “The distribution of contaminated drugs that occurred in 2012 was an egregious tragedy, but I’m proud of our strong and comprehensive response. Massachusetts prides itself on being a hub of health care and medical excellence. It is my hope that these reforms will set a national standard so that no individual is again affected by this kind of negligence.”
Today’s bill signing 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 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.
“We are committed to fully implementing these measures to ensure patients are receiving the highest-quality and safest products,” said Department of Public Health Commissioner Cheryl Bartlett, RN. “This law will also improve transparency in the industry, increase patient education and assure the public that their medications are safe.”
Governor Patrick filed comprehensive pharmacy reform legislation in January 2013, following the fungal meningitis outbreak linked to New England Compounding Center.
Thursday’s signing builds upon strong steps the Patrick 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. Additionally, Governor Patrick convened a Special Commission on the Oversight of Compounding Pharmacies to analyze needs and gaps in the industry and recommend changes. The signed Act advances many of these critical recommendations.
“This process has been long in the making,” said Senator John F. Keenan. “We wanted to ensure our consideration of this complex topic was thorough, and that our outcome would be a comprehensive policy that can be emulated across the country. With this legislation, we will go from the state where an unregulated pharmacy compounded a substance that killed dozens of people and caused more than 700 to deal with serious illness, to the state which provides patients with the best safety standards in the country.”
“I am pleased that this legislation incorporates a number of the changes to the industry my investigation as Chair of the Senate Post Audit and Oversight Committee recommended,” said Senator Mark Montigny. “Legislation can only go so far, we must continue to be vigilant in the monitoring of this industry and those special interests surrounding it if we are to be truly successful in protecting the public.”
“This legislation updates the state laws under which compounding pharmacies operate in a meaningful way to better prevent an event like the meningitis outbreak of 2012 from ever occurring in the future,” said Senator Richard T. Moore. “Where Massachusetts leads the nation in research, innovation and health care, it is essential that we also ensure patient safety for those who utilize compounded drugs that are manufactured within the Commonwealth.”
“This legislation clearly defines the boundaries of safe and appropriate compounding and applies strict standards to all pharmacies producing or shipping compounding drugs in Massachusetts,” said Representative Jeffrey Sánchez. “Massachusetts will now have among the most rigorous standards for compounding in the nation, but these are achievable standards that balance patient safety with patient access to medically necessary drugs.”
“Having begun work on this legislation as a member of the Governor’s Special Commission, I am pleased we were able to come to agreement on a piece of legislation which will clarify and strengthen the regulations around sterile and complex non-sterile compounding practices in the Commonwealth,” said Representative David T. Vieira. “This legislation will also broaden the representation on the Board of Pharmacy to make sure all stakeholders have a seat at the table.”