State Representative Paul J. Donato (D-Medford, Malden) joined his colleagues in the House today to pass legislation that will increase the oversight of compounding pharmacies, improve quality and safety standards in the Commonwealth, and establish rigorous transparency and accountability practices for compounding pharmacies across the state.
The unanimous vote distinguishes Massachusetts as the first state to pass comprehensive legislation relative to compounding pharmacies. The bill addresses a previous lack of consistent standards, at both a state and federal level, governing the operations of specialty pharmacies engaged in sterile compounding. This legislation was carefully crafted following the 2012 meningitis outbreak linked to contaminated drugs produced at the New England Compounding Center in Framingham, Massachusetts.
“This legislation ensures that we are doing all we can to guarantee the highest standards of safety, oversight and transparency for compounding pharmacies,” said Speaker DeLeo. “The distribution of contaminated drugs that occurred last year was a tragedy, but I’m proud of the comprehensive response by the House and Chairman Sánchez. 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.”
“I was proud to join with my House colleagues in passing this historic legislation which will ensure high standards and thus protect Massachusetts residents,” said Representative Paul J. Donato.
“This legislation will hold pharmacies to high standards in quality control and sterility,” said Representative Jeffrey Sánchez, Chairman of the Joint Committee on Public Health (D-Jamaica Plain).
“These are achievable standards, and standards pharmacies must meet in order to prevent another tragedy like the one we witnessed with the New England Compounding Center and Ameridose. That being said, this bill recognizes the unique and necessary place specialty compounding holds in the delivery of modern health care as it strives to fill in the “grey area” surrounding current state and federal oversight of compounding pharmacies.”
This compounding pharmacy bill modernizes pharmacy oversight while enhancing patient access to critical medications. The legislation addresses the unique needs of this industry through the following provisions:
- Establishes a specialty license for all in-state and out-of-state sterile compounding pharmacies;
- Requires the Department of Public Health to track all sterilely compounded drugs made by state-licensed pharmacies;
- Requires the Department of Public Health to collect and analyze data on adverse events tied to pharmaceuticals;
- Creates an online database listing pharmacies that have prepared drugs resulting in adverse effects;
- Mandates unannounced, detailed inspections of all sterile compounding pharmacies;
- Requires state pharmacy inspectors to be specially trained and to take continuing education classes;
- Requires that compounded medications are clearly labeled;
- Mandates pharmacies to report the type and volume of compound drug production;
- Reforms the composition of the State Board of Pharmacy;
- Requires increased communications between prescribers, pharmacies, government officials and patients, including a support hotline for patients;
- Ensures that state and national agencies communicate on oversight and potential problems.
The House voted 155-0 to pass the bill, which now moves to the Senate.
- Submitted by State Representative Paul Donato