Massachusetts Gov. Deval Patrick is proposing the state exercise stricter control over compounding pharmacies by -- in part -- establishing new licensing requirements for the labs and letting the state assess fines against them if they break rules.
The New York Times: Massachusetts Plans Stricter Control of Compounding Pharmacies
New laws to strengthen state control of compounding pharmacies were proposed on Friday by Gov. Deval Patrick, in hopes of preventing another public health disaster like the current outbreak of meningitis caused by a contaminated drug made in Massachusetts. ... The legislation would establish strict licensing requirements for compounding sterile drugs; let the state assess fines against pharmacies that break its rules; protect whistle-blowers who work in compounding pharmacies; and reorganize the state pharmacy board to include more members who are independent of the industry and fewer who are part of it (Goodnough and Grady, 1/4).
Stateline: Following Outbreak, Massachusetts Seeks Tougher Oversight Of Compounding Pharmacies
Massachusetts Governor Deval Patrick has unveiled legislation aiming to plug a regulatory gap that allows 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 (Malewitz, 1/7).