Surprise Inspections in Massachusetts Result in Cease and Desist Orders to 11 Compounding Pharmacies

Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH), with another 21 pharmacies cited for minor deficiencies. The actions resulted from a round of surprise inspections of 40 Massachusetts pharmacies engaged in sterile compounding. DPH notes that the pharmacies that received notices of deficiency or cease and desist orders must submit a written plan of correction to the Massachusetts Board of Registration in Pharmacy, implement the corrective measures, and pass re-inspection. The inspections, initiated following the meningitis outbreak linked to drugs compounded by the New England Compounding Center located in Framingham, MA, were part of a series of initiatives implemented by Massachusetts Governor Deval Patrick. Governor Patrick’s 2014 budget includes funds for the hiring of additional Board inspectors. In addition, Governor Patrick filed legislation in January “that would require a special license for sterile compounding, create monetary fines for violations of law and regulations, institute whistleblower protections” and “require licensing of out-of-state pharmacies that do business in Massachusetts,” among other provisions, indicates a Massachusetts DPH news release.