Rep. Lewis Supports Legislation to Improve Oversight and Quality Standards for Compounding Pharmacies

State Representative Jason Lewis joined his colleagues in the Massachusetts House of Representatives last week to pass legislation that will increase the oversight of compounding pharmacies, improve quality and safety standards for patients, and establish rigorous transparency and accountability practices for compounding pharmacies across the state. Rep. Lewis serves as the Vice Chair of the legislature’s Joint Committee on Public Health which crafted the legislation. The unanimous vote in the House distinguishes Massachusetts as the first state to pass comprehensive legislation relative to compounding pharmacies. The bill addresses a lack of consistent standards, at both a state and federal level, governing the operations of specialty pharmacies engaged in sterile compounding. In compounding, a licensed pharmacist alters ingredients in a prescription to create a drug that is tailored to a specific patient’s needs. This legislation was carefully crafted following the tragic 2012 meningitis outbreak linked to contaminated drugs produced at the New England Compounding Center in Framingham, Massachusetts. “This legislation will hold compounding pharmacies to high standards of quality control and drug safety,” said Rep. Lewis. “Sadly, we cannot reverse the tragedy that occurred last year from a preventable fungal meningitis outbreak, but we can take strong action to prevent such a tragedy from ever happening again.” The bill modernizes compounding pharmacy oversight while enhancing patient access to critical medications. The legislation addresses the unique needs of this industry through the following provisions: • Establishes a specialty license for all in-state and out-of-state sterile compounding pharmacies • Requires the Department of Public Health to track all sterilely compounded drugs made by state-licensed pharmacies • Requires the Department of Public Health to collect and analyze data on adverse events tied to pharmaceuticals • Creates an online database listing pharmacies that have prepared drugs resulting in adverse effects • Mandates unannounced, detailed inspections of all sterile compounding pharmacies • Requires state pharmacy inspectors to be specially trained and to take continuing education classes • Requires that compounded medications are clearly labeled • Mandates pharmacies to report the type and volume of compound drug production • Reforms the composition of the State Board of Pharmacy • Requires increased communications between prescribers, pharmacies, government officials and patients, including a support hotline for patients • Ensures that state and federal agencies communicate on oversight and potential problems The bill now moves to the state Senate for consideration where it is expected to be approved shortly. ###