Monday, January 7, 2013

Massachusetts Tries To Get Tough With Compounders--Ed Silverman's Blog

In the wake of the fungal meningitis scandal that regulators have traced to the New England Compounding Center, Massachusetts Governor Deval Patrick late last week proposed new laws in hopes of preventing another debacle. So far, the outrbreak has led to 656 cases and 39 deaths in 19 states (see this and this).
The move comes amid an embarrassing episode for both state health authotiries and the FDA, which have offered confusing explanations about their failure to follow up early indications that the compounder had committed various infractions. The ensuing ruckus has led to congressional probes in the proper role regulators are expected to play.
The new Massachusetts legislation would create strict licensing requirements for compounding sterile drugs; allow the state to assess fines against pharmacies; establish whistleblower protections for compounding pharmacy employees, and reorganize the state pharmacy board to include more members who are independent of compounders.
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