Join the Fight
Waiting on NDC12 is no longer neutral. The FDA failed to issue the final rule on NDC12. Some see this as a reason to wait. That is the wrong move.
Join the Fight
Waiting on NDC12 is no longer neutral
The FDA failed to issue the final rule on NDC12.
Some see this as a reason to wait.
That is the wrong move.
Waiting feels neutral. It feels safe.
This is the moment where waiting stops being passive and starts creating risk.
Fighting Words That Changed the Conversation
In the last article, I wrote about the FDA missing its expected deadline for the NDC12 final rule and why this isn’t just another policy slip. It’s a capacity problem.
The 10-digit NDC system will run out.
That part is not up for debate, even if the date is.
The article sparked comments from two trusted industry leaders:
Rose Campasano from Criterion Consulting
Michael Rowe from Two Labs
They shared perspectives that made the cost of waiting much harder to dismiss.
They were fighting words.
And they moved the conversation from abstract risk to real consequences.
The Cost of Waiting Is Not Abstract
This isn’t just a business planning problem.
It’s an operational and patient-care problem.
Rose said something that stuck with me:
What about the patient perspective? …I worry that the pace will ultimately hurt the patient interactions and what the nursing staff may face.
She’s right. That’s where this shows up.
Hospitals run on linear workflows.
Scan. Verify. Administer.
Those steps assume certainty.
They assume the identifier just works.
There’s no buffer for ambiguity.
No time to hesitate.
When identifiers change late, unevenly, or under pressure, the fallout doesn’t hit a steering committee.
It hits nurses and pharmacists making real-time decisions with real patients.
Waiting on NDC12 doesn’t pause risk.
It pushes it downstream.
Closer to the patient.
Every month we wait squeezes the change into a smaller window.
That’s how you end up with rushed updates, fragile workarounds, and higher odds of human error.
The FDA Can Delay. You Can’t.
Michael Rowe called out another assumption that keeps coming up. I hear it often, from leaders at both large and small organizations.
People assume this will be like DSCSA, where the agency kept kicking the can down the road… this is different.
Michael makes an important point.
DSCSA delays were policy enforcement decisions.
NDC12 is math.
Labeler codes are finite.
Once they’re gone, they’re gone.
No guidance.
No discretion.
No grace period changes that.
You can delay enforcement.
You cannot delay math.
This is the unavoidable reality:
NDC exhaustion will occur.
The numbers don’t care.
Comparing NDC12 to DSCSA may feel comforting, but it leads organizations to the wrong conclusion and, more importantly, the wrong behavior.
Industry Is Not Waiting Quietly
This isn’t just talk, and it’s not limited to one article or one comment thread.
Leavitt Partners drafted an industry letter to the FDA to raise the alarm on NDC12 and invite others to publicly align around the issue. The intent was simple: bring visibility to the risk of continued delay and create a clear signal that this isn’t a niche concern or a future problem.
The message of the letter was straightforward. Waiting increases risk, cost, and disruption across the healthcare system. The longer uncertainty persists, the harder the transition becomes for everyone downstream.
That letter matters because it comes from people who understand how policy decisions ripple into real operations and patient care. It wasn’t written to win a debate. It was written to get ahead of a problem.
What You Can Do Now
No uniform required.
No marching orders.
Just start.
You don’t need a mandate or a project charter to take meaningful action.
Small steps taken early create options later.
1. Raise Awareness of the Impact
Share this article with one internal team that supports clinical or operational systems.
IT.
Pharmacy Operations.
Supply Chain.
Quality.
Regulatory.
Add one simple sentence:
“This delay could harm patients if we wait too long.”
That’s enough to start the right conversation.
Awareness is the first step towards readiness.
2. Break the “They’ll Delay It Again” Assumption
Forward this article to one peer or leader and ask:
“Are we treating NDC12 like DSCSA, or are we planning for a fixed outcome?”
That question forces a mindset shift.
It separates hope from reality.
3. Ask One Question That Surfaces Reality
In your next meeting, ask:
“Do we know where NDC is hard-coded today across our systems?”
If no one can answer with confidence, the risk already exists.
It’s just hidden.
You don’t need all the answers right now.
You need visibility.
Join the Fight
This is where you decide whether to stand still.
Waiting makes the eventual transition harder, riskier, and closer to patients.
It also removes options that are still available today.
We don’t need to solve NDC12 today.
We just need to stop pretending time is on our side.
Because arithmetic doesn’t negotiate.