House Passes Comprehensive Legislation to Improve Oversight, Licensing and Quality Standards for Compounding Pharmacies

BOSTON—Chairman David P. Linsky of the House Committee on Post Audit and Oversight joined his colleagues in the House yesterday 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.

Chairman Linsky joined Chairman Sánchez, The House Chair of the Committee on Public Safety as well as Chairman Naughton, the House Chair for the Committee of Public Safety last November and December to hold a series of oversight hearings relative to the Department of Public Health. The first of the three hearings focused on the Massachusetts Pharmacy Oversight and Practice Environment, specifically relative to the New England Compounding Center which had been shut down earlier in the year due to contamination and its connection to the fungal meningitis outbreak.

“The federal government and the commonwealth of Massachusetts did not have sufficient regulations and sufficient oversight in place to be able to protect the lives and safety of the public. We need to take steps here. It is my hope other states will follow Massachusetts lead,” said Chairman Linsky. “It is an absolute tragedy that this happened on our watch, on Massachusetts’ watch.”

It was determined by these hearings that the current regulatory and oversight policies and procedures relative to pharmacies in the Commonwealth led to public health crisis of the meningitis outbreak from the NECC due to its sterility and licensing violations. Furthermore, an increase in oversight inspections that followed this discovery led to partial and in some cases full cease and desist orders both for pharmacies found in violation of compounding standards as well as the emergency regulations that were adopted at the beginning of the year. This compounding pharmacy bill modernizes pharmacy oversight while enhancing patient access to critical medications.

“This legislation ensures that we are doing all we can to guarantee the highest standards of safety, oversight and transparency for compounding pharmacies,” said Speaker DeLeo. “The distribution of contaminated drugs that occurred last year was a tragedy, but I’m proud of the comprehensive response by the House and Chairman Sánchez. 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.”

“This legislation will hold pharmacies to high standards in quality control and sterility,” said Representative Jeffrey Sánchez, Chairman of the Joint Committee on Public Health (D-Jamaica Plain). “These are achievable standards, and standards pharmacies must meet in order to prevent another tragedy like the one we witnessed with the New England Compounding Center and Ameridose. That being said, this bill recognizes the unique and necessary place specialty compounding holds in the delivery of modern health care as it strives to fill in the “grey area” surrounding current state and federal oversight of compounding pharmacies.”

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.

###

For More Information Please Contact:

Katelyn Kelly (617)-722-2575