Tuesday, October 1, 2013

House to debate tougher rules for Mass. compounding pharmacies

The bill, released by the Ways and Means Committee, would also establish a reconfigured Board of Registration in Pharmacy and order up new regulations for the licensing of in-state and out-of-state pharmacies that distribute sterile compounded drugs in Massachusetts.

Almost a year ago, the New England Compounding Center, a Framingham drug manufacturer, found itself at the center of a national public health emergency as tainted steroids linked to the company were discovered to be the cause of an outbreak of fungal meningitis that killed 61 people around the country and infected hundreds more.

The reconfigured Board of Registration in Pharmacy would include six pharmacists with varying specialties, one pharmacy technician, one representative of the public with health care service delivery or advocacy experience, one physician and one expert in patient safety.

The board would be required to conduct inspections and random audits of compounding pharmacies in Massachusetts.

In addition to establishing a new category of licenses for pharmacies that engage in sterile drug compounding, the board would be required to establish a procedure to license out-of-state pharmacies that prescribe, ship, or dispense compounded medications in Massachusetts.

Violations of the new rules and terms of license could result in fines of up $25,000 against an offending pharmacy.

The commissioner of public health would also be required to maintain a free, publicly searchable website where people could look up enforcement actions against individual pharmacies or public health risks associated with certain drugs.


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