The Industry Is Ready. The NDC12 Map Isn’t.
The industry has known NDC12 was coming since 2018, yet the Final Rule remains trapped in a bureaucratic loop. Every month spent 'reviewing' is a month stolen from your implementation window. We need to stop 'waiting and seeing' and demand a date. Eric Marshall and the team at Leavitt Partners have initiated a push to expedite this; read more to see how you can join the effort.
October 2024, March 2025, and now January 2026.
What do these three dates have in common? They were all target dates for the NDC12 Final Rule. All three have slipped. Each slip shrinks the implementation window. Each month of delay pushes risk downstream to manufacturers, distributors, pharmacies, and health systems.
The industry is ready to move, but without the map, we cannot start.
The industry knows the 12-digit NDC (i.e., NDC12) is coming. A Public Hearing was initiated in 2018. A Proposed Rule and Impact Assessment was published in 2022. We’ve been planning for it, talking about it, and bracing for the IT overhaul. But we have still not received the final ruling.
Two target dates have already been missed. There is already industry consensus that the January target date will also slip. The Final Rule is currently stalled in the interagency review process between the FDA, HHS, and OMB.
The Shrinking Window Problem
Every month the government spends reviewing the rule is a month taken away from our implementation window.
We aren’t just swapping out a few labels. We’re re-tooling databases, pharmacy systems, and hospital workflows. If the FDA waits too long to finalize the rules, the transition period we’ve been anticipating is going to feel a lot more like a scramble. A scramble leads to mistakes, and in our industry, mistakes impact patients.
What’s Happening Now
Leavitt Partners is spearheading a sign-on letter to urge the FDA and the White House to stop the delay and finalize the rule.
The letter is a clear signal to the FDA that we need to move. It doesn’t argue about the how. It simply demands the when. We need a date so we can move forward with certainty.
Join the Push
I’m using this post and ndc12.com to help get the word out and rally support. If you’re in a position to sign on behalf of your organization, whether you’re a manufacturer, a distributor, or a health system, I’d urge you to do it.
Deadline for edits to the FDA Letter: Jan 20th.
Deadline to sign the FDA Letter: Feb 9th.
How: Email Eric Marshall (Eric.Marshall@leavittpartners.com) or Kim Boyd (Kim.Boyd@leavittpartners.com) at Leavitt.
We’re at a point where waiting and seeing is becoming a risk in itself. Let’s get this rule finalized so we can actually get to work.
P.S. Welcome to 2026… so much for relaxing after the DSCSA deadline.