Committee advances legislation penned by co-chair Jeffrey Sánchez to improve licensing and oversight of compounding pharmacies, enforce strict quality standards for compounded drugs, and reform operations at State Board of Pharmacy
BOSTON—The Joint Committee on Public Health advanced a bill authored by House Chairman Jeffrey Sánchez (D-Jamaica Plain) that enhances transparency for both pharmacies and state bodies regulating them, increases pharmacy accountability for maintaining quality control while setting clearer standards for pharmacies to meet, and ensures patient safety through rigorous inspection of compounding pharmacies.
The Sánchez bill addresses failures in state oversight of compounding pharmacies and the lack of clear standards governing the operations of specialty pharmacies engaged in sterile compounding. The safety and quality problems in this field were highlighted by the meningitis outbreak linked to contaminated drugs compounded at the New England Compounding Center last fall. According to the latest figures from the CDC, the NECC outbreak has caused 6 1 deaths and sickened 749 individuals nationwide.
“This legislation will hold pharmacies to high standards in quality control and sterility. But these are achievable standards, and standards they must meet in order to prevent another tragedy like we witnessed with NECC and Ameridose,” Sánchez said. “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.”
Eric Kastango, a member of Governor Patrick’s Task Force on Compounding, said the Sanchez bill “shows commitment and serious leadership in elevating the practice and oversight of compounding practices in the Commonwealth.” Kastango, who is a nationally recognized expert in health care safety, added “This legislation will serve as a national model ensuring patient safety and of the robust oversight of the compounding practices.”
According to Boston University Health Law Professor Kevin Outterson, who served as an independent member of the Governor’s compounding task force, said “It is clear that the Commonwealth of Massachusetts cannot afford to wait on the US Congress. This Bill takes the necessary steps to improve oversight, increase transparency and give the resources necessary to do the job right."
Michael Cotugno, Director of Pharmacy Patient Care Services at Brigham and Women’s Hospital, said “This legislation shows serious leadership in elevating the practice and oversight of compounding in the Commonwealth. The legislative committee has taken the right steps towards improving the practice and oversight of compounding in the Commonwealth.” Cotugno, an independent expert on the Governor’s compounding task force, added that the bill “serves as a model for other states looking to improve the oversight of the pharmaceutical compounding industry.”
This compounding pharmacy bill modernizes pharmacy oversight in Massachusetts and maintains patient access to critical medications through provisions which include:
- Establishing a specialty license for all in-state and out-of-state sterile compounding pharmacies
- Enhancing patient safety through better communication between prescribers, pharmacies, government officials, and the public
- Mandating unannounced, detailed inspections of all sterile compounding pharmacies
- Requiring state pharmacy inspectors be trained in USP 797 industry standards for sterile compounding
- Requiring compounded medications be clearly labeled; mandating pharmacies to report compound drug production information by type and volume
- Requiring the state to collect and analyze data on adverse events tied to pharmaceuticals; and reforming operations at the board of pharmacy