On November 21, 2012, the Massachusetts Public Health Council approved final amendments to 105 Mass. Code Regs. 970.000, the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law ("Massachusetts Marketing Code of Conduct"). These final amendments will implement changes to the Massachusetts Marketing Code of Conduct, Mass. Gen. Law ch. 111N, which were included in the fiscal year ("FY") 2013 Commonwealth budget, effective July 8, 2012. The Massachusetts Department of Public Health ("DPH") will file the amendments with the Secretary of the Commonwealth for final promulgation, which is scheduled to occur on December 7, 2012, at which time they will take effect. The final regulations can be found at http://www.mass.gov/dph/pharmamed.
Significantly, the final regulations adopt most of the September 19, 2012, emergency amendments, but with some substantive changes. Specifically, the key areas that have changed from the emergency regulations include federal preemption for annual reporting and the content of quarterly reports. Those areas that generally have remained the same from the emergency rules include modest meals, expenses related to training, and the requirement for annual fees. This Client Alert provides an overview of the final regulations. It also briefly discusses some key considerations for pharmaceutical and medical device manufacturers as they seek to implement the final regulations.
Please see full alert below for more information.
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