Sunday, July 27, 2014

Masschusetts Enacts Strict Compounding Pharmacy Oversight

Gov. Patrick recently signed Ch. 159 of the Acts of 2014, "An Act Relevant to Pharmacy Practice in the Commonwealth".  It was passed unanimously by both Houses to regulate compounding pharmacies in Massachusetts, after a 2012 meningitis outbreak that killed 64 and sickened hundreds across the U.S., was traced to a compounding pharmacy in Massachusetts.  The now closed Framingham pharmacy was found to be actually operating as a drug manufacturer, rather than a pharmacy filling individual prescriptions.   These large scale operations will now have to register with the federal Food and Drug Administration and follow regulations for drug manufacturers.

The legislation is extensive and charges the Board of Registration in Pharmacy with creating new regulations to implement changes regarding licenses, education, labeling and inspections.  It requires these pharmacies to have staffed consumer hotlines during working hours.  Compounding pharmacies must also eventually report certain information on the Department of Public Health website for viewing by consumers.  The law also cites mandatory compliance with  U.S. Pharmacopeia and National Formulary standards.