From DSCSA to NDC-12: You’ve Been Here Before…
By Paul Hammond | Sector Manager – Life Sciences, ProMach Labeling & Coding
I remember the conversations surrounding pharmaceutical serialization back in 2013 and 2014. Depending on who you spoke with, the Drug Supply Chain Security Act (DSCSA) was either going to revolutionize pharmaceutical traceability or become an outright catastrophe.
Think Peter Venkman: “Dogs and cats, living together! MASS HYSTERIA!”
And you know what? There were legitimate reasons for concern.
Remember what you were being asked to do back then. Manufacturers faced substantial investments in printing, inspection, software, aggregation, and data management. Packaging lines needed modifications, equipment required validation, and everyone was trying to figure out how to implement these changes without disrupting the supply chain.
It was a fundamental transformation of pharmaceutical packaging in an industry where change doesn’t exactly happen overnight.
But here’s the part I think deserves more recognition: You did it.
DSCSA-era pharmaceutical serialization line · Image 03, approved Optel Group image
You adapted your operations, qualified new technologies, worked through the inevitable headaches, and made serialization part of everyday pharmaceutical manufacturing.
Now, with the FDA’s transition to the 12-digit National Drug Code (NDC-12), another significant change is approaching.
And I’ve heard some familiar concerns.
A New Challenge, Not a New Beginning
During a recent industry discussion, Scott Mooney at McKesson made a point that stuck with me. In essence, the industry has already navigated a far more substantial transformation through DSCSA implementation without the widespread supply-chain disruption so many feared. NDC-12 is an addition to that success, not an invitation to start over.
In other words, you’ve already done the heavy lifting. Now we build on it.
I think he’s exactly right.
Does that mean NDC-12 will be painless? Of course not. If you’ve spent any time around pharmaceutical packaging equipment, you know that adding a few characters to a code isn’t necessarily as simple as it sounds.
DataMatrix sizes, human-readable information, available print space, inspection capabilities, and aging equipment all deserve a closer look.
But here’s where I’d challenge both manufacturers and equipment suppliers: Let’s not turn every new regulatory requirement into an automatic equipment replacement project, as much as my wallet and I might appreciate it.
Reviewing printed code samples before making equipment decisions · Image 15
Some existing systems will accommodate the changes. Others will need modifications, and yes, some will need to be replaced.
Our responsibility as technology suppliers is to help you understand the difference, even when the answer doesn’t involve selling you something new.
Why the Serialization Playbook Matters
That’s the thinking behind our Pharmaceutical Serialization Playbook.
We’ve brought together practical information and industry perspectives to help manufacturers navigate evolving requirements, evaluate their existing infrastructure, and make informed decisions about what comes next.
I’ve had the opportunity to work through the original DSCSA implementation with many of you, and I’m now honored to participate in the GS1 NDC-12 working group, including helping lead the effort around printing requirements.
If those experiences have taught me anything, it’s that the best solutions come from understanding the application, asking the right questions, and occasionally being willing to challenge the assumptions we started with.
That’s the approach we’re taking at ProMach Labeling & Coding, and it’s the perspective we hope this playbook helps reinforce.
You’ve already accomplished something remarkable. The next challenge is making sure the systems that got you here are ready to take you further.
