State Rep. Tom Sannicandro, a Democrat who represents Framingham, 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.
“This comprehensive bill is a direct response to the tragic meningitis outbreak in 2012. Throughout the process our thoughts went out to the families affected by the outbreak.” said Sannicandro in a press release. “The strength of this bill sets a national example for regulating compounding pharmacies and keeping our communities and residents safe.”
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.
Governor Deval Patrick is scheduled to sign the bill into law at a public bill signing Thursday, July 10 at the Grand Staircase in State House at 11 a.m.