An organization headed by biotech companies in Michigan is attempting to find a way to men a law that is pressurizing medical device companies to hire pharmacists. The law in question is the Pharmacy Control and Drug Practice law, Public Act 280 which came into effect on September 30, 2014.
The law came into effect to improve the safety standards of the drugs being sold by compounding pharmacies in Michigan. However, it was Department of Licensing and Regulatory Affairs (LARA) and the Attorney General's office in Michigan that made it a blanket law that brought all distributors, manufacturers, drug wholesalers, and durable medical equipment sellers under scrutiny.
The law requires the companies to recruit a trained pharmacist to supervise the safety standards as prescribed for the product supply chain. According to Stephen T. Rapundalo, President of MichBio, it was immediately after the law was passed that medical device companies started receiving notices for not complying with it.
Joe Hune, Michigan Senator included all under this law after an outbreak of meningitis that was traced back to tarnished steroids from New England Compounding Center, Massachusetts. This outbreak that spread over states lead to several infections and deaths, with Michigan being among the hardest hit state.
Medical devices companies argue that most medical devices establishments do not include pharmaceuticals. To add to their woes, most of the pharmacists do not have the adequate skill, experience, or expertise to oversee the supply chain operations. Rapundalo further added that in most of the cases medical devices units have nothing to do with pharmacies. The products they sell directly go to physicians or to other health systems.