Following Outbreak, Massachusetts Seeks Tougher Oversight of Compounding Pharmacies
By Jim Malewitz, Staff Writer
Massachusetts Governor Deval Patrick has unveiled legislation aiming to plug a regulatory gap that allows large compounding pharmacies to operate with little oversight.
The state’s effort to crackdown on compounders, which traditionally alter drugs to meet specific patients’ needs but have since expanded to produce medications in bulk, was sparked by a deadly outbreak of viral meningitis linked a now-shuttered pharmacy in Framingham, Massachusetts. The company distributed a tainted steroid suspected of sickening or killing as many as 620 people in 19 states.
The governor’s bill, announced Friday (January 4), would likely make Massachusetts the nation’s toughest regulator of compounders, requiring them to apply for special licenses, while authorizing the state Board of Pharmacy to levy fines against wayward companies and granting whistleblower protections to pharmacy workers who report violations. The legislation would also reorganize the board, adding experts from outside of the pharmacy industry, in an effort to reduce conflicts in interest.
“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. “Together these changes can ensure that the tragic events of last fall never happen again.”
The federal government regulates drug manufacturers, which make and sell drugs to wide markets. Oversight of compounders, meanwhile, has been left to states, which license pharmacists. But in the past decade, asStateline has reported, compounders have moved beyond their original one-patient, one-prescription standard and begun to develop and sell their products in bulk.
Critics say states are ill-equipped to oversee the large compounders, particularly because pharmacy boards typically lack enforcement capabilities, leaving the companies to operate largely unregulated.
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