Bill Improves Compounding Pharmacy Oversight, Quality

Sweeping reforms greatly enhance patient safety and increase transparency procedures 

(State House, Boston) - State Representative Garrett Bradley, D-Hingham, joined his colleagues in the House on October 2nd to pass legislation that will increase the oversight of compounding pharmacies, improve quality and safety standards in the Commonwealth, and establish rigorous transparency and accountability practices for compounding pharmacies across the state.

The unanimous vote distinguishes Massachusetts as the first state to pass comprehensive legislation relative to compounding pharmacies. The bill addresses a previous lack of consistent standards, at both a state and federal level, governing the operations of specialty pharmacies engaged in sterile compounding. This legislation was carefully crafted following the 2012 meningitis outbreak linked to contaminated drugs produced at the New England Compounding Center in Framingham, Massachusetts.

“The House has taken substantive action to help guarantee the highest standards of safety, oversight and transparency for compounding pharmacies,” said Rep. Bradley.  “In the wake of last year’s tragedy  in which dozens of people died or were seriously harmed, I am hopeful that these reforms will prevent this kind of negligence from occurring again in the future.”

This compounding pharmacy bill modernizes 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 national agencies communicate on oversight and potential problems.

The House voted 155-0 to pass the bill, which now moves to the Senate.