Governor Patrick signs Sánchez-sponsored compounding pharmacy legislation, featuring sweeping reforms to greatly enhance patient safety and increase transparency.
BOSTON – Today, Governor Deval Patrick signed into law comprehensive compounding legislation filed by Representative Jeffrey Sánchez of the 15th Suffolk District. Prior to this law, pharmacy compounding was an industry that lacked consistent state and federal standards leading to the 2012 fungal meningitis outbreak linked to contaminated drugs produced at the New England Compounding Center in Framingham, Massachusetts. This law will improve quality and safety standards, increase oversight, and establish rigorous transparency and accountability practices for pharmacies engaged in compounding.
“This legislation clearly defines the practice of compounding and ensures that any pharmacy in the business of compounding will be held to the same standards, while focusing on accountability, transparency, and patient safety.” 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 and can serve as a model for what other states can do to modernize their own pharmacy regulations.”
The creation of this bill was a bi-partisan effort in the face of the tragic NECC incident, with unanimous passage in both the Massachusetts House and Senate. “This bill reacts to the situation in Framingham but it is also proactive,” according to Senator Keenan, Co-Chair of the Joint Committee on Public Health (D-Quincy). “This bill was a team effort…and proves when you work together you get great things done.”
At today’s bill signing, Massachusetts Department of Public Health Commissioner Cheryl Bartlett stated, “Today the residents of Massachusetts are better off.”
This law specifically guides the needs of a diverse 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, industry wide, all licensed compounding pharmacies will now be required to
adhere to strict, uniform quality control protocols, production standards and reporting
“This legislation addresses a grey area in policy that without clarity from state or federal level
led to bad behavior and hurtful behavior,” said Governor Deval Patrick, at the bill signing.
To ensure drug safety, this law mandates annual, unannounced, detailed inspections of all retail
sterile, retail complex non-sterile and institutional sterile compounding pharmacies. These state
inspectors are required to be trained in updated compounding standards. The law also looks to
inform the consumer by implementing public reporting and posting on the Department of Public
Health website, which will list the serious adverse drug events, board of pharmacy investigations
and enforcement actions. Pharmacies are also now required to clearly label sterile and non-sterile
The law mandates special training and continuing education for pharmacists engaged in
compounding. It requires retail compounding pharmacies and outpatient institutional
compounding pharmacies to operate a patient assistance hotline. This coupled with ensured
communication on oversight and potential problems between state and national agencies, this bill
will protect consumers in this growing industry.
This bill will also redefine the statutory definition of “serious adverse drug events” (SADE) to
meet current national standards to enhance mandatory reporting by health care facilities and
pharmacies to the appropriate state and federal agencies.