Device manufacturers, wholesalers, and distributors who were ensnared unwittingly by a new Pharmacy Practice and Drug Control Law (i.e., “Drug Compounding Law”) passed last year in Michigan (P.A. 280), will get relief effective March 30, 2015, at least temporarily.
The less than one-year old law requires all such companies to employ a licensed “Pharmacist-in-Charge” (PIC) who would be criminally liable on behalf of the company for the integrity of products in their supply chains. Its passage was a response to the 2012 meningitis outbreak caused by compromised drugs, and the inability by the State to pursue the responsible pharmacy firms.
The policy predicament arose because the State of Michigan’s Licensing & Regulatory Agency (LARA) and Attorney General’s (AG) Office took a more expansive scope for enforcement. They wanted to pursue any company whose healthcare products are internalized by patients. The problem is that pharmacists have no expertise with non-pharmaceutical medical devices and do not handle them, whether issued by prescription or not. Indeed, the state’s health code includes no enabling authority for the Board of Pharmacy to grant licenses to companies selling/distributing device products. Moreover, the required licensure Compounding Law applications make no mention of device manufacturers/wholesales/distributors.
MichBio, alongside other medical device company stakeholders, secured an exemption for device manufacturers, wholesalers, and distributors from P.A. 280 and the PIC requirement, in legislation passed in late December 2014. That law, P.A. 413 (specifically Sec. 17748 (2) takes effect March 30, 2015, as a short-term fix while the entire Compounding Law is revisited to ensure a definitive and clear intent and scope, and then develop that as a longer-term legislative solution.
Device companies who have been denied licensure due to non-compliance with the PIC requirement should re-apply after March 1. Please inform MichBio at email@example.com if you to encounter any problems from LARA and AG after that date so that we can document them and follow up.