Patrick-Murray Administration Appoints Chair of Special Commission on Compounding Pharmacies; Emergency Regulations Passed to Enhance Oversight of Industry
BOSTON — Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith today announced the Patrick-Murray Administration has named Christian A. Hartman, an expert in pharmacy practice and patient safety, to chair a Special Commission on compounding pharmacies. Earlier today, the Massachusetts Board of Pharmacy passed emergency regulations to enhance the state’s oversight of the compounding industry. These actions come at the direction of Governor Deval Patrick, and coincide with Congressman Ed Markey’s plans to unveil federal legislation today that will address the “regulatory black hole” currently governing these pharmacies.
“No one should live in fear that their medicine is unsafe, and these actions at the state and federal level will help ensure we’re at the forefront of efforts to protect public health,” said Interim Commissioner Smith. “Christian Hartman is an expert in this field and has worked for years on the cutting edge of patient safety and quality assurance. Today’s actions by the Board of Pharmacy move us closer to our goal of enhanced oversight of compounding pharmacies, and together with our federal partners, we will ensure that Massachusetts fulfills its responsibility in overseeing this transforming industry.”
Hartman will lead the Special Commission, comprised of representatives from the Legislature, along with experts in pharmacy practice, regulatory affairs, and patient safety, in its work to examine best practices in other states. The Commission will also explore potential changes to laws and regulations to fill the regulatory grey area between state and federal oversight. Hartman is founder and president of the American Society of Medication Safety Officers.
Emergency Regulations Approved
Earlier today the Massachusetts Board of Pharmacy approved emergency regulations to enhance oversight of compounding pharmacies. The Commonwealth’s rules overseeing compounding pharmacies are consistent, and in some cases more stringent, than those in place in other states. Today’s emergency regulations will for the first time allow the state to track volume and distribution at compounding pharmacies to determine if they are operating more like a manufacturing facility subject to FDA licensing. The regulations also require pharmacies to report to the state when they are the subject of an investigation by another state or federal authority, among other requirements. Finally, the regulations create stiffer penalties if pharmacies fail to comply with rules and regulations. Read the emergency regulations below:.
Special Commission Details Announced
Hartman will lead the Special Commission, comprised of representatives from the Legislature, along with experts in pharmacy practice, regulatory affairs, and patient safety, in its work to examine potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight. Hartman is founder and president of the American Society of Medication Safety Officers, director of clinical quality and patient safety at Wolters Kluwer Health, and a partner at Lucian Metrics in Oxford. Hartman previously served as medication safety officer at UMass Memorial Health System in Worcester and as a pharmacist at Brigham and Women’s Hospital. He is a former patient safety fellow at Virginia Commonwealth University and has taught at universities across New England. He holds a Doctorate in Pharmacy from the University of Kansas and an MBA from UMass Amherst. He completed his undergraduate studies at the Massachusetts College of Pharmacy and Health Sciences.
The Special Commission will consist of one member to be appointed by the Senate President, one member to be appointed by the Senate Minority Leader, one member to be appointed by the Speaker of the House, and one member to be appointed by the House Minority Leader; the commissioner of public health, or designee; and five members appointed by the Governor.
The Special Commission’s recommendations will be due by December 31, 2012. The Commission will draw from investigations by the Department of Public Health and the U.S. Food and Drug Administration, while examining the best policies in other states. The Commission is also directed to coordinate with any relevant action taken by the federal government.
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