As 2017 heads toward the final quarter and the time intended for the Drug Supply Chain Security Act (DSCSA) to implement step 1, i.e., all pharma manufacturers distributing only serialized primary containers into the supply chain, we’ve learned a few things.
While there are certainly companies out there who dragged their feet, the majority of players I’ve encountered have been making a good faith effort to be ready for the deadline. There are several factors influencing whether they will be ready with the time to implement serialization solutions being the most critical. The industry learned (both manufacturers and suppliers) that serialization was quite time consuming to implement and validate. More than anticipated? I’d say not. The industry expressed their concerns about the complexity of serialized line of sight bar coding on a massive scale during the creation of the legislation in 2012 and 2013. After successfully turning back the efforts to have RFID as the carrier, the pharma industry counted on the complexity of bar coding and line of sight capture to delay or kill the legislation. They were wrong. So we are stuck with serialized bar coding for the foreseeable future and an agonizingly slow roll out of DSCSA until 2023, when pharmacies will finally acknowledge receipt of item level serialized product.