October 30, 2013
Boston – Senator Richard J. Ross (R-Wrentham) voted today to pass legislation to strengthen regulatory management of Massachusetts compounding pharmacies. The bill was filed in the aftermath of an outbreak of fungal meningitis that was linked to a compounding pharmacy in Framingham. It alters the composition of the Board of Registration in Pharmacy and establishes several licensing requirements. The bill was passed unanimously by the Senate.
“This is an important step in ensuring the safety of patients across the Commonwealth and the United States,” said Senator Ross. “We have experienced the terrible consequences resulting from insufficient oversight and management of compounding pharmacies in Massachusetts. By enhancing the regulations governing this industry, we hope to implement high standards of care and to prevent this tragedy from occurring again.”
The bill alters the composition of the Board of Registration in Pharmacy to include 6 pharmacists, as well as a pharmacy technician, nurse, physician, expert in patient safety and public member to provide an outside perspective to the board. It also removes the current limit on the number of agents that the board may use to conduct inspections, and mandates that all inspecting agents be trained according to federal standards.
All pharmacists will be required to complete twenty hours of continuing education annually. Random audits of licensure applicants will be conducted by the board to confirm that these orders are being complied with.
Pursuant to the bill, the board will create a sterile compounding license, which will be granted in addition to the other required licenses. Those licensed as sterile compounders must abide by federal and state standards.
The board will be responsible for licensing out-of-state pharmacies that ship prescriptions into Massachusetts, requiring those pharmacies to comply with all state licensing regulations. Furthermore, those non-resident pharmacies must designate as a liaison a Massachusetts licensed pharmacist to guarantee the pharmacy’s compliance with state regulations.
A public website will be maintained by the Commissioner of Public Health to provide information on adverse drug events, as well as enforcement actions against any pharmacies or pharmacists. Pharmacies may be fined up to $25,000 per violation and an additional $1,000 per day for each day that the pharmacy is not in compliance with the corrective plan.
The House of Representatives passed a similar version of this bill earlier this legislative session. A conference committee will now be appointed to resolve the differences between the two bills.
Please contact the office of Senator Ross with any questions or concerns at (617) 722-1555 or Richard.Ross@masenate.gov.