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MA Board of Pharmacy Approves Emergency Regulations for Compounding Pharmacies
The Massachusetts Board of Registration in Pharmacy has approved emergency regulations to enhance oversight of compounding pharmacies. The emergency regulations (PDF) will allow the state to track volume and distribution at compounding pharmacies in order to determine if a pharmacy is acting more like a manufacturing facility and is subject to FDA regulation. Also, pharmacies are required to report to the state when they are the subject of an investigation by another state or federal authority. Further, pharmacies that fail to comply with the regulations will face stiffer penalties. In addition, Massachusetts Governor Deval Patrick has established a Special Commission on compounding pharmacies to “explore potential changes to laws and regulations to fill the regulatory grey area between state and federal oversight,” as indicated in a press release. Christian A. Hartman, an expert in pharmacy practice and patient safety, will chair the Special Commission, which will be composed of representatives from the legislature, and experts in pharmacy practice, regulatory affairs, and patient safety. The Special Commission will report its recommendations by December 31, 2012.
