Gov announces reforms to compounding pharmacies

BOSTON, Mass. (WWLP) - Governor Deval Patrick announced new legislation Friday to strengthen oversight over the compounding pharmacy industry.  39 people are dead and more than 600 people sickened nationwide because of a meningitis outbreak linked to the New England Compounding Center in central Massachusetts.

“Together these changes can ensure the significant harms that we have seen from sub-standard compounding never happen again,” said Patrick.

The reforms include creating special licenses for sterile compounding pharmacies, fines against pharmacies that violate state regulations, and whistleblower protections for pharmacy staff.  It requires compounding pharmacies to report how much and where they send medications so the state can determine whether they are operating as a local pharmacy or mass manufacturer. Manufacturers are subject to regulation by the U.S. Food and Drug Administration.

“What we saw happen with NECC is it was a manufacturer in pharmacy clothing and so several of the regulations that have been put in place are there precisely to be able to identify that,” said Department of Public Health Interim Commissioner Dr. Lauren Smith.

Governor Patrick will also direct the Department of Public Health to increase inspection staff at the state Board of Pharmacy – And also make sure that members of the Board include people from outside the pharmacy industry.

State officials say these reforms will make Massachusetts a leader in overseeing the compounding pharmacy industry.