Legislation calls for tighter oversight of Mass. compounding industry

January 7, 2013

Governor Deval Patrick of Massachusetts filed legislation on Jan. 4, to reform the state Board of Pharmacy and strengthen oversight of the compounding pharmacy industry in the state.

 

Governor Deval Patrick of Massachusetts filed legislation on Jan. 4, to reform the state Board of Pharmacy and strengthen oversight of the compounding pharmacy industry in the state.

The legislation was introduced following recommendations from the Special Commission on the Oversight of Compounding Pharmacy that were published in December 2012. Gov. Patrick established the commission in October 2012 as part of its response to the national fungal meningitis outbreak that was linked to the New England Compounding Center in Framingham, Mass. Christian A. Hartman, PharmD, MBA, FSMSO, an expert in pharmacy practice and patient safety, served as chairman of the commission.

To date, 39 individuals have died and more than 600 have been injured from contaminated steroids that were compounded and distributed by NECC.

The legislation would change the governing statutes by reforming the Board of Pharmacy and its functions, according to Gov. Patrick, who announced the provisions at the State House.

"The Board will include more members not practicing in the industry they are responsible for regulating," explained Gov. Patrick. His bill proposes an 11-member board consisting of four pharmacists, one nurse, one physician, one pharmacy technician, one quality improvement expert, and three public members.

In addition, pharmacies will be required to obtain a special license for sterile compounding to help regulators hold compounders responsible for their practices, Gov. Patrick said.

Also, for the first time, the Board of Pharmacy will be authorized to fine Massachusetts licensed pharmacies that violate Board policies, regulations, or statute. And whistleblower protections will be put into place to protect pharmacists, pharmacy technicians, pharmacy interns, and other pharmacy staff.

All out-of-state pharmacies will be required to be licensed if they deliver and dispense medications in Massachusetts.

"The new regulations also require all licensed pharmacies and pharmacists to report to the Board when they are subject of any disciplinary action by any state or federal agency," said Gov. Patrick. "This enables the Board to know when issues arise with Massachusetts pharmacies doing business in other states."

Massachusetts is continuing random, unannounced inspections of compounding facilities, he noted. The governor also has directed the Department of Public Health to hire more inspection staff and raise the bar on training requirements.

All inspectors must be pharmacists with 5 or more years of clinical experience and specific knowledge in sterile compounding. The Department of Public Health continues to communicate with FDA surrounding any investigations of its licensed pharmacies in Massachusetts.