House, Senate Pass Comprehensive Legislation to Improve Oversight, Licensing and Quality Standards for Compounding Pharmacies
Sweeping reforms greatly enhance patient safety and increase transparency
BOSTON – Representative Sánchez joined his colleagues in the Legislature to pass final legislation that will increase oversight, improve quality and safety standards, and establish rigorous transparency and accountability practices for pharmacies engaged in the compounding of sterile and complex non-sterile drugs.
The bill creates comprehensive and uniform standards that will govern the operations of specialty pharmacies engaged in compounding, an industry that previously lacked consistent standards at both the state and federal level. This legislation was carefully crafted in response to the 2012 meningitis outbreak linked to contaminated drugs produced at the New England Compounding Center in Framingham, Massachusetts.
“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, Chairman of the Joint Committee on Public Health (D-Jamaica Plain). “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.”
The legislation addresses the unique needs of this industry by requiring the Board of Registration in Pharmacy to establish specialty licenses for retail sterile compounding pharmacies, retail complex non-sterile compounding pharmacies, institutional pharmacies including hospitals and out-of-state businesses selling their products in Massachusetts. Additionally, all licensed
compounding pharmacies will now be required to adhere to strict, uniform quality control protocols, production standards and reporting requirements.
“This closes a lot of the loopholes that currently exist,” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association. “This potentially can be a model for the rest of the country.”
"This legislation fills the gaps that previously allowed some compounding pharmacies to escape appropriate scrutiny, according to Boston University Health Law Professor Kevin Outterson, who served as an independent member of the Governor’s compounding task force. “Massachusetts has now set a clear standard that other states will do well to follow. This law also coordinates well with the new federal law, which left most of the heavy lifting to the states. I also applaud the transparency initiatives, which will allow everyone to be better informed about compounded products."
This compounding pharmacy bill modernizes pharmacy oversight through numerous provisions:
- Mandates both annual and unannounced, detailed inspections of all retail sterile, retail complex non-sterile and institutional sterile compounding pharmacies
- Reforms the composition of the State Board of Pharmacy
- Requires state inspectors to be trained in updated compounding standards
- Implements public reporting and posting on the Department of Public Health website of serious adverse drug events, board of pharmacy investigations and enforcement actions
- Ensures that state and national agencies communicate on oversight and potential problems
The bill also seeks to enhance patient access to critical medications and improve quality by:
- Mandating special training and continuing education for pharmacists engaged in compounding
- Requiring compounding pharmacies to clearly label sterile and non-sterile compounded drugs
- Requiring retail compounding pharmacies and outpatient institutional compounding pharmacies to operate a patient assistance hotline
- Redefining statutory definition of “serious adverse drug events” (SADE) to meet current national standard enhances mandatory reporting by health care facilities and pharmacies to the appropriate state and federal agencies
The bill now goes to the Governor for his final approval.