The Mass. State Legislature has passed 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 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 the strong and comprehensive response by the Legislature. 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 am proud of the Legislature for taking the necessary steps to protect the health of our residents, especially after the devastating meningitis outbreak of 2012 that affected so many individuals across the Commonwealth and across the country as well,” Senate President Therese Murray (D-Plymouth) said. “This bill outlines reforms needed to increase the regulation, oversight and quality of our compounding pharmacies and these changes are important to help prevent a similar tragic accident from happening again in the future.”
“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 (D-Jamaica Plain), House Chair of the Joint Committee on Public Health. “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.”
“This process has been long in the making. 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,” said Senator John F. Keenan (D-Quincy), Senate Chair of the Joint Committee on Public Health. “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.”
“We’ve seen the tragic consequences that occur when a compounding pharmacy breaks the rules and the proper safeguards aren’t in place,” said Senate Minority Leader Bruce Tarr (R-Gloucester). “We have a moral obligation to ensure that compounders in our state have professional, comprehensive and responsible regulations and supervision, and this bill makes tremendous progress toward those goals.”
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, which include hospitals, and out-of-state businesses selling their products in Massachusetts. Additionally, all licensed compounding pharmacies will now be required to adhere to strict quality control protocols, production standards and reporting requirements.
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; and
Ensures that state and national agencies communicate on oversight and potential problems.
The bill also seeks to enhance patient access to information and improve the quality of compounded drug preparations 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 licensed compounding pharmacies to operate a patient assistance hotline, unless the pharmacy only provides drugs to patients that are admitted to the hospital; and
Redefining the statutory definition of “serious adverse drug events” (SADE) to meet current national standards and to enhance 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.