Serialization Day in the US has come and gone. November 28th rolled around, and the system didn’t crash. A week later, we haven’t seen any real catastrophic failures. There aren’t any major reported supply chain issues. Systems didn’t crash, worlds didn’t collide, and we didn’t get what Pete Venkmann in Ghostbusters so eloquently predicted – “Dogs and cats – living together… MASS HYSTERIA!”
It’s still early (a week is by no means an enormous or even usable sample size), but thus far the date has passed with a whimper and not a bang. It’s almost like Y2K… I hope everyone backed their systems up and turned their computers off!
In speaking with some of the larger companies since 11/27/2018, they were already serializing well in advance. The day come and went for Pfizer, Merck, PCI, Amgen, and many others with nary a whimper because they were already compliant. That tracks fairly accurately with what we know about a lot of the larger and more prepared customers – that they weren’t going to get caught in a compromising position because they had the resources to be ready.
But what about the rest? If you believe AmerisourceBergen, Cardinal, and McKesson (and I do), then a large portion of the pharmaceutical world – nearly 80% - that should be experiencing challenges. Off hand, I can think of 2 people this past week who had a Come to Jesus moment when the date passed without a delay or extension. One of them at least is now scrambling to become compliant. Shouldn’t there be more than that, however? 80%. If that number is right, there should still be a lot of work to be done as we move on into the new normal, here in 11/2018 and beyond. If that number is right, then phones should be ringing, and quickly. Groups like Vantage should be busy optimizing lines. Optel should be jam packed with last minute orders. Domino’s service department should be littered with requests to solve unexpected solutions.
So what’s happening? Is this the calm before the storm? Is everyone about to get pounced on all at once? Is the FDA a toothless lion who can’t enforce the requirements for fear of a major HIV drug provider simply saying “no”? I don’t know. I don’t think that anyone knows. What I do know is that the DSCSA has at its core an altruistic goal – to secure the supply chain. To make things safer for consumers. To make sure counterfeit drugs don’t enter the stream, to provide consumers an increased amount of visibility, and to ultimately make the US a healthier and safer place. Regulation and punitive outcome aside, the goal is a good one, and one that deserves being implemented.
So if you’re ready for the DSCSA or if you’re still dragging your feet; if you’re a seasoned veteran at serialization, or if you’re a clinical product about to go commercial – take advantage of this quiet time. Look at your serialization checklist, evaluate your production line, and determine if you’re happy with the outcome. If you aren’t – give us a call. There’s still time. This quest doesn’t have an end date, and everything we’ve done up to 11/27 is set to prepare us for the journey. The prep is over, it’s time to begin the trek – and Domino is here to walk beside you every step of the way.