Mass. governor proposes new compounding pharmacy legislation

New legislation would strengthen state government's oversight over sterile compounding

BOSTON — Massachusetts Gov. Deval Patrick has introduced legislation that would give the state government broader power over compounding pharmacies, the governor's office announced.

Patrick's legislation would reform the board of pharmacy by requiring special licensing for sterile compounding; authorizing the pharmacy board to assess fines against pharmacies that violate policies while creating whistleblower protections for pharmacists and other staff; requiring licensing for pharmacies out of state that deliver and dispense medications within Massachusetts; and establishing a clear process to restructure and reorganize the board's membership to include four pharmacists, as well as several non-pharmacists, including one nurse, one physician, one pharmacy technician, one quality-improvement expert and three public members.

The legislation is based on recommendations from the state Commission on Pharmacy Compounding, which Patrick established in October 2012 amid a nationwide outbreak of fungal meningitis traced to contaminated injectable steroids prepared at the Framingham, Mass.-based New England Compounding Center. That epidemic has sickened 656 people and killed 39 in 19 states as of Monday, according to the Centers for Disease Control and Prevention.

"There is no action that we in government can take to prevent all abuses in all industries, but we must do what we can," Patrick said. "This legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows. Together, these changes can ensure that the tragic events of last fall never happen again."

In addition, Patrick will direct the Department of Public Health to increase inspection staff at the Board of Pharmacy and require that all inspectors be pharmacists with at least five years' clinical experience, as well as additional training for inspectors working in sterile compounding. Another rule will require sterile compounding pharmacies to report volume and distribution, alerting the Board of Pharmacy when a pharmacy is acting like a manufacturer, which requires a Food and Drug Administration license.

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