PC: Could you provide a brief overview of the Drug Supply Chain Security Act (DSCSA)?
Rowe: The DSCSA, which stands for the Drug Supply Chain Security Act, is a federal law that was passed by Congress in November of 2013 and within the law, there were a series of milestones that established a federal universal standard around track and trace of prescription pharmaceuticals in the United States. The reason the law partly came to be was prior to the law being in place, there were a series of patchwork of states that were passing different laws around the regulation of pharmaceuticals, and how they’re being distributed and tracked and traced.
Mainly, in 2008, you had the California track-and-trace regulations and Florida pedigree requirements. The industry came together to say a patchwork of 50 different laws to try to comply with different packaging requirements would really not be feasible. Thus, the DSCSA was born. Within that law, there were a series of milestones around developing and getting to what’s called unit level traceability through serialization. Some people call this the serialization law, as a result of it changing how manufacturers needed to package the product, but more importantly, it came with a lot of other provisions around data exchange, around the ability for the industry to quickly verify the serialization data, and around requirements for licensing for 3PLs [third-party logistics providers] and wholesalers in the United States. While many people call it the serialization law and think it’s just about putting a serial number on a package, it’s really much more complex than that, where it has a lot of different requirements on all different trading partners within the industry.
One thing the DSCSA also did is identify and define different types of trading partners, such as the difference between a pharmacy called a dispenser, a manufacturer, etc. It really did, in some cases, revolutionize but also standardize how the industry should be approaching security of pharmaceuticals, and the intent of the law at the end of the day is to curb counterfeit products from entering the legitimate supply chain. That’s really the ultimate goal and what the DSCSA is all about.