On May 19 and 20, 2026, I had the privilege of joining Leavitt Partners in Washington, D.C. for a two-day workshop focused exclusively on the implementation of the FDA's Final Rule revising the National Drug Code format. The session brought together more than sixty industry professionals from nearly every part of the healthcare ecosystem that touches the NDC. What I expected to be a focused regulatory discussion turned out to be one of the most substantive cross-sector conversations I have participated in this year, and the experience underscored just how much coordinated work lies ahead of the March 7, 2033 deadline.
Setting the Stage: A Brief Recap of the Final Rule
For readers who have not yet reviewed the rule in detail, RxLogic previously published a comprehensive overview titled FDA Finalizes the 12-Digit NDC: What the New National Drug Code Format and Barcode Requirements Mean for Healthcare. At a high level, the FDA's Final Rule, published in the Federal Register on March 5, 2026, establishes a uniform 12-digit NDC structured in a 6-4-2 segment format and modernizes the barcode regulations at 21 CFR 201.25 to permit two-dimensional data carriers alongside traditional linear barcodes. The rule converts every existing 10-digit NDC to its 12-digit equivalent through leading-zero padding rather than reassigning identifiers, takes effect on March 7, 2033, and provides a three-year labeling transition window through March 7, 2036. Critically, the FDA has been clear that this is an administrative change to the format of the NDC, not a reassignment or replacement of existing NDCs.
With that backdrop in mind, the Leavitt Partners workshop was designed to move the industry beyond reading the rule and into the practical, cross-sector work of planning for it.
About the Workshop
Leavitt Partners, an HMA Company, hosted the workshop at their Washington, D.C. offices. The session was deliberately structured to bring stakeholders from across the healthcare ecosystem into the same room to build a shared understanding of the rule, surface implementation challenges that cross sector boundaries, and begin shaping a coordinated view of the work ahead. Day 1 focused on understanding the rule and the landscape of risks and dependencies it creates. Day 2 shifted toward constructing a high-level, multi-year roadmap with critical milestones the industry can rally around.
The Stakeholders in the Room
One of the most impressive aspects of the workshop was the breadth of representation. Industry participants included:
In addition to private sector representatives, the workshop featured participation from several federal regulatory bodies, including the FDA, CDC, DEA, NABP, and others. I had the opportunity to sit at the table with one of the FDA representatives who was directly involved in drafting and advancing the Final Rule, which provided invaluable context throughout the two days.
CMS was not represented at the workshop. Given that the HIPAA Billing EDI Standards governing the 11-digit NDC format used across our segment of the industry fall under CMS authority, their perspective will be an important one in the broader implementation conversation, and I hope to see continued engagement with CMS as the work progresses. I will come back to the CMS dimension later in this article.
Day 1: Examining the Rule and Its Impact
The first day was devoted to working through the rule itself and developing a fuller picture of how it lands across different parts of the ecosystem. Having FDA representatives, including the individual who drafted the rule, physically present to answer questions in real time was extraordinarily valuable. A number of gray areas that participants had been wrestling with internally were clarified during the open discussion, and the candor of the regulatory voices in the room set the tone for the rest of the workshop.
A significant portion of the day was spent in cross-sector conversation about implementation impact. Each segment of the ecosystem brought a different perspective on the systems implicated, the milestones they see ahead, the strategies they are considering, and the risks and dependencies they anticipate. These conversations were grounded in pre-workshop input that the Leavitt Partners team had collected and synthesized, which gave the discussions a strong empirical foundation rather than starting from scratch.
From those sector-level conversations, the group worked to surface the cross-cutting challenges most likely to benefit from a coordinated approach. A representative example raised by participants was the practical question of how to determine whether a product labeled with a 10-digit NDC entered commerce before or after March 7, 2033. That kind of question can sound technical at first, but it has real downstream implications for inventory verification, claims processing, and supply chain accountability.
The conversation also touched meaningfully on the rule's barcode provisions and the implications of moving downstream scanning processes away from the linear barcode toward the 2D data matrix. Participants discussed scanning capabilities across pharmacies, hospitals, and other care settings, the readiness of existing infrastructure to handle the transition, and the broader opportunity to clean up other long-standing data quality and process challenges in parallel with the format change.
A final thread of the day produced a working map of the forums, standards bodies, trade associations, and industry work groups that are currently engaged in or expected to support the implementation effort. The exercise made clear where there is good coverage today, where there is likely overlap that will benefit from coordination, and where there are gaps that the industry will need to address as the work matures.
Day 2: Working Toward a Roadmap
The second day shifted from understanding the problem to constructing a high-level view of what a coordinated path forward could look like. Participants worked through a series of exercises designed to identify interdependencies among sectors and systems, develop a shared sense of the timelines associated with different implementation steps, and arrive at a consensus view of what a multi-year cross-sector roadmap should include. Even with the gaps in representation that the group openly acknowledged, the exercise made clear how quickly the March 7, 2033 date is approaching when the full scope of cross-sector coordination is considered, and how much of the truly difficult work sits at the boundaries between sectors rather than inside any one of them.
A meaningful portion of the day was dedicated to the complexities of the transition process itself. Participants worked through the questions associated with managing a period in which 10-digit and 12-digit products will coexist in the supply chain, including the practical realities of operating against both formats across interconnected systems, the role of crosswalks, and whether a uniform approach to the transition is necessary or whether different sectors can reasonably adopt different approaches. The conversation also grappled with the reality that some 10-digit products may remain in the supply chain well beyond 2036, and the importance of planning early for that long tail rather than treating 2036 as a clean cutover point.
The session closed with an open conversation between Leavitt Partners facilitators and the FDA representative who wrote and championed the Final Rule. The exchange covered key takeaways from the two days, reactions to the workshop conversations, and action items going forward. It was a fitting close to the session and a reminder of the openness the FDA has demonstrated in engaging the industry on implementation questions.
Implications for the Pharmacy, PBM, and Health Plan Industry
For our corner of the industry, the NDC format change carries implications that have yet to be fully resolved at the regulatory level. The Final Rule was very clear that it is not a cross-functional rule change. The CMS HIPAA Billing EDI Standards, which require an 11-digit NDC for all pharmacy claims and related transactions, fall under a separate regulatory authority and are not modified by the FDA's Final Rule. CMS will need to issue its own rulemaking to align the HIPAA standard with the new 12-digit format.
Continued coordination with CMS will be important as the industry moves forward. Assuming that CMS pursues a corresponding update to the HIPAA standard ahead of March 7, 2033, every pharmacy claims processing system, PBM platform, health plan adjudication engine, and downstream financial system that consumes NDCs will need to be ready to accept the new 12-digit format. The timing of CMS rulemaking, its alignment with the FDA effective date, and the implementation window granted to industry participants are all open questions that the industry will be eager to engage on collaboratively with CMS as planning matures.
A second important nuance for our industry is that the FDA's Rule Change is explicitly an administrative change to the NDC format, not a reassignment or replacement of existing NDCs. On March 7, 2033, the FDA will execute a system-wide update across its data and systems to convert every existing NDC to its 12-digit equivalent. From the FDA's data perspective, 10-digit NDCs will effectively no longer exist as of that date. Downstream consumers of FDA data, including our platforms and those of our partners, will need to be ready to receive 12-digit NDCs from that point forward.
By the Numbers: A Useful Bit of Context on NDC Volume
One data point shared during the workshop helped reinforce why the move to a larger labeler code space is not merely a forward-looking convenience. On average, the FDA assigns approximately 1,000 Labeler Package Codes each year. In 2020 alone, driven by the COVID-19 pandemic, the FDA assigned approximately 7,000 Labeler Package Codes, which represented roughly seven years of typical issuance compressed into a single year. The 6-digit labeler segment within the new 12-digit format substantially expands the available code space and addresses the very real risk of exhaustion that has been quietly building under the legacy structure.
A Note of Thanks to the Leavitt Partners Team
I want to extend my sincere appreciation to the entire Leavitt Partners team for the invitation to participate, for the warm hospitality they extended throughout the two days, and for the thoughtful organization and skilled facilitation of the workshop itself. Convening more than sixty stakeholders from across the healthcare ecosystem and guiding the group through two days of structured discussion is no small undertaking, and the Leavitt team executed it exceptionally well. The depth of preparation, the quality of the pre-workshop participant survey, the structure of the sector-based discussions, and the deliberate inclusion of regulatory partners all reflected a level of care that meaningfully elevated the conversation. It was an honor to be part of the session, and RxLogic is grateful for the opportunity to contribute.
RxLogic's Position on Readiness and Participation
RxLogic is fully committed to being ready for the March 7, 2033 effective date and to supporting the broader industry effort to achieve a coordinated transition. The NDC is a foundational data element across every product in our platform, including CoreRx claims adjudication, PayRec payables and receivables, our Rebate Administration Services, and the RTPB Responder for real-time prescription benefit transactions. We are actively assessing the implications of the format change across each of these platforms and are building the readiness work into our roadmap.
In addition to internal preparation, RxLogic intends to participate in any pilot or testing programs that emerge across the ecosystem. We are committed to working alongside vendors, trading partners, standards organizations, and our clients to validate the transition, surface integration issues early, and support the kind of cross-sector coordination that this rule will require. If your organization is planning pilot or testing activities and would like to coordinate with us, we would welcome the conversation.
Looking Ahead: The June 17 Webinar
For those who were unable to attend the workshop in person, Leavitt Partners will be hosting a webinar to review the outputs and summarized takeaways from the two-day session. The webinar is scheduled for Wednesday, June 17, 2026, at 1:00 PM ET. Registration is available through the following link:
I encourage anyone whose organization will be affected by the NDC format change to attend. The conversation has only just begun, and the more voices that are at the table over the next seven years, the better positioned the industry will be to execute a clean and coordinated transition.
About the Author
Billy Buckles is a founding member of RxLogic and brings nearly two decades of experience working at the intersection of pharmacy benefit management, healthcare technology, and product strategy. His career spans roles in product management, PBM and network services, project leadership, and healthcare IT, with deep exposure to pharmacy claims processing, real-time prescription benefit transactions, ePrescribing, revenue cycle management, claims clearinghouses, and HL7-based integrations across the healthcare ecosystem. Prior to RxLogic, Billy held leadership roles at Scriptcycle, Care Services LLC, and WellCare Health Plans, contributing to platform modernization and operational delivery for pharmacy benefit managers, retail pharmacy chains, health plans, and self-insured employers. He has worked extensively with industry standards including NCPDP and HIPAA EDI, and his current focus areas include business development, growing the RxLogic business, and leading client implementations across the PBM technology landscape.
This article reflects the author's personal observations and takeaways from the Leavitt Partners NDC Workshop held May 19 and 20, 2026. It is provided for informational purposes only and does not constitute legal or regulatory advice. Organizations should consult with qualified regulatory counsel regarding specific compliance obligations related to the FDA Final Rule.