How Pharma Supply Chains Can Brace for FDA’s 12-Digit NDC Standard

The FDA is making a landmark change to how pharmaceutical products are tracked and identified. In a final rule published on March 5, 2026, the FDA established a standardized 12-digit National Drug Code (NDC), replacing the current variable 10-digit format.^1,2 The rule’s effective date is set for March 7, 2033, with a seven-year preparation window for the industry to update labeling, systems, and data infrastructure.^2,3 A subsequent three-year transition period will allow older 10-digit NDCs to remain in circulation while stakeholders complete the shift.³

While the change might sound like a simple labeling update, industry leaders warn it’s far more complex. The NDC isn’t just a number on a bottle—it underpins transactions across manufacturers, distributors, pharmacies, payers, and electronic health records. Coordinating this transformation across countless organizations has been likened to a “Y2K-style” event, requiring unprecedented alignment across the pharmaceutical supply chain. The stakes are high: errors could disrupt reimbursement, distribution, and even retail availability, particularly for over-the-counter products, in which barcode limitations complicate implementation.

To unpack what this transition means in practice, Pharmaceutical Commerce spoke with Matt Sample, SVP of Manufacturer, Quality, and Replenishment Operations at Cencora. In the interview, Sample offers a firsthand perspective on the operational challenges ahead, from managing prescription and OTC product streams to navigating complex label revisions. He explains why the transition goes far beyond a simple numerical update, comparing it to the coordination required during the Drug Supply Chain Security Act (DSCSA) rollout, and details how distributors are helping the industry prepare.

Sample also weighs in on the steps manufacturers, distributors, and pharmacies should take now, emphasizing the importance of impact assessments, system audits, and inventory planning. He shares why early action is critical, especially for companies managing thousands of SKUs, and offers a roadmap for ensuring a smooth coexistence of 10-, 11-, and 12-digit NDCs during the transition.

The full video interview dives deeper into these insights, offering practical guidance for supply chain stakeholders and a closer look at how the industry can navigate what Sample calls a once-in-a-generation regulatory shift.

A transcript of his conversation with PC can be found below.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

PC: You’ve called the FDA’s move to a 12-digit NDC a “Y2K-style” transition. From your perspective, why is this change so significant for the pharma supply chain?

Sample: So, the challenge when you read the ruling is it sounds like a labeling update, right? You're going to get new numbers. you know, you're going to phase them in. You get seven years to do all the labeling changes. The, the problem is the NDC code has morphed and taken different uses over the, whatever, however long they've been here. So, you know, while it's a labeling change, it also is the number that the entire industry uses to transact, and not just me, like reimbursements, PBMs, health, like everything. Think EMRs, right? So, that's why it's Y2K, because all these entities have to make the changes. What's different, Y2K, for the most part, you can make your changes in your own company, right? Make sure your vendors are doing blah, blah, blah, blah. Here, we have to figure out how do we coexist for that three-year period using ten, 11, or 12-digit NDC codes at the same time. Because if my downstream partner hasn't changed and I change, what's going to break? So that's why I call it Y2K, this level of coordination in the industry, we did it with DSCSA, and we were able to do it because it was the wholesalers led the charge and you had manufacturers and dispensers. That was easy. Now you got how many other entities that I can't even name?

How does the 12-digit NDC shift intersect with ongoing implementation of the Drug Supply Chain Security Act?

So, the good news is we know how to do this. and, and I actually, we were at a conference last week at HDA. I'm being very careful. This is not a DSCSA problem. The people that led DSCSA are over. We need to not over-index on the implication with DSCSA. There's a way. We've already did the 2D barcodes because the NDC 12 can't fit in your, your UP-this barcode. Your 12-digit code can't fit in there, right? We've already made the barcode changes in pharma. We're just going to put another index number and say, "Hey, this is your 12-digit NDC code." So we know how to do it. The biggest implication on DSCSA is more the labeling changes for the manufacturers. That's really the biggest hurdle. and I want to try to emphasize that 'cause at the conference last week, the people on the stage were the DSCSA people. And they kept saying, "You know, when you get to the end at the dispenser," and I said, "Wait, dispenser's in the middle. What about the reverse transaction chain so that they can get their money or the patient can get reimbursed," right? So we've got to, yes, there's DSCSA impacts. It's the easiest thing to do on the large scale of things.

Where do you expect the biggest operational challenges as companies move from the current 10-digit NDC format?

So there's two main streams. You've got your prescription drug stream. Those impacts are going to be how do we make sure, like we need a standard spec that everybody says, "These are how I'm going to change my systems." And I don't think it's hard, right? The requirement. Your systems need to be able to transact on a 10, 11, or 12 digit at the same time. That's it. But who, who creates that spec? Who gets it out there? Who gets it to the all the affected parties? How do we make sure that they do it in time? Does somebody try to project manage? I have no clue how that happens. The other track is over the counter, OTC. Because, like I said, the biggest, that linear barcode - you can't put an NDC code in there anymore. So who's going to guide the OTC manufacturers like we did with DSCSA to say, "Here's how to do your labeling. If you're going to move to a 2D, do it this way. If you're going to keep a 1D, you've got to go to a different one and do it this way." Because without that, you could end up with a labeling disaster, and then if you think about it, who sells OTC? Gas stations, kiosks, they now need to update their software. They need to know what barcodes to scan. You could create a massive retail disruption just on OTC. So there's almost two tracks, and that's going to be how it has to be tackled, too.

What role should major distributors like Cencora play in coordinating industry readiness for the transition?

I put my name next to the first pilot that was going to look at this. We partnered with NNIT, which is a consulting firm. I had no problem doing it. We did it with DSCSA, too. but I told them, I said, "I'm not driving this industry initiative. This is different than DSCSA." I, I think the wholesalers and I think especially HDA, where they have, you know, so I talked to Perry Fri, HDA, last week. I said, "Our role, I think, at least right now, is awareness." Like, Perry, call all your friends that are in pharma, AAM, NACDS, NCPDP. Insert your acronyms. Call them. We need to have a meeting so those trade associations are aware. I think that's what we can do. we can help educate our customers, but again, like the questions they're going to have are on adjudication, and then they're going to start talking J-codes, and I'm like, "I can't help you with that beyond education." So I, that's a big TBD. I know there's a desire. It's just different. The influence we had with DSCSA was different than here. We don't have that influence with the payers, providers, the PBM, blah, blah, blah, blah, blah.

With the 2033 deadline approaching, what should manufacturers, distributors, and pharmacies be doing now to prepare?

I think the biggest is an impact assessment. I mean, we know what's going to happen. if you're a manufacturer, understand all your labels, start planning for label revisions. some have said it's going to take them seven years if they have a portfolio of six hundred SKUs. Teva's got thousands. If you're a wholesale dispenser or if you're a wholesaler or dispenser, I mean, it's a question of -understand what systems and transaction feeds use NDC. Just do your assessment and your inventory. What are you going to have to change? That's easy. The action to do, it's going to be hard. But start doing that because when we get these specs and standards, hopefully from somebody, you need to have an inventory of what you got to go change and how you're going to change it and a lot of us have a lot of big initiatives going on. Everybody that's on SAP has to upgrade SAP, right? Now's the time to look at this.

References

1. U.S. Food and Drug Administration. Proposed rule: Revising the National Drug Code format and drug label barcode requirements. Published July 22, 2022. Accessed March 24, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format
2. U.S. Food and Drug Administration. Revising the National Drug Code format and drug label barcode requirements: Final rule. Federal Register. 2026;91(FR 10749). Accessed March 24, 2026. https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/revising-national-drug-code-format-and-drug-label-barcode-requirements-final-regulatory-impact
3. U.S. Food and Drug Administration. National Drug Code (NDC) format information. Updated 2026. Accessed March 24, 2026. https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/national-drug-code-format