We recently notified our clients and partners of several regulatory changes that will affect manufacturers and wholesalers doing business in Minnesota. In May 2019, Minnesota Governor Tim Walz signed House Bill 400, which created an Opioid Stewardship Advisory Council to confront the opioid addiction crisis and overdose epidemic. Parts of the law are already in effect as of July 1, 2019, and more pieces of the bill will [...]
In the pharmaceutical industry, state licensing requirements can change at a moment’s notice. Though no central “hub” exists listing all licensing updates for each state, our team of experts works with state boards on a routine basis to track all license requirement updates. Recently, we’ve notified our clients and partners of changes that affect virtual manufacturers specifically in Arizona, Vermont, and New Hampshire. Government agencies in these states [...]
Licensing is a required step in the pharma industry, and unfortunately, it can be incredibly complicated. The consequences for not carrying the correct license can range from fines to an immediate stop in sales to felony charges – and that’s just the beginning. We covered the basics in an earlier post, but while a general knowledge of the ins and outs is helpful, you’ll need more than an overview [...]
The Drug Supply Chain Security Act (DSCSA), passed in November 2013, has become a buzzword in the pharma industry in the past few years, and will continue to be until the completion of the implementation in 2023. DSCSA describes creating an electronic, inter operable system that stores transaction information and history of a drug from the time of manufacture to when it is dispensed to a patient. The big license earthquake [...]
With the rising cost of health care, many US citizens are crossing into Canada to buy less expensive prescription drugs. In fact, a group from Maine, consisting of state employees, Portland employees, and one large company, claims to have saved approximately $10 million over several years by purchasing their drugs through a Canadian mail-order pharmacy. However, the legality of importing drugs into the US continues to be a gray area. Illegal [...]