The NDC12 Final Rule Is Here

After years of discussion and delays, the FDA has officially issued the final rule revising the National Drug Code (NDC) format.

Read the rule here: https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/national-drug-code-format?utm_medium=email&utm_source=govdelivery

This rule does two big things:

• First, it confirms the move to a standardized 12-digit NDC format (6-4-2).
• Second, and more importantly, it puts a real date on the transition.

For years, the industry knew NDC10 would eventually run out of capacity. But without a firm deadline, it was hard to mobilize budgets and programs.

Here are the key takeaways:

1️⃣ A standardized 12-digit NDC

The FDA will move from the current 10-digit system (with multiple formats) to a single standardized 12-digit format: 6-4-2

• 6 digits — Labeler
• 4 digits — Product
• 2 digits — Package

2️⃣ Timeline

The rule provides a window so the industry can update systems and packaging before the new format becomes mandatory. Here are the key dates:

• 7-Year Systems transition closes: March 7, 2033.
• 3-Year Labeling transition closes: ~March 2036.

This will become a major topic of discussion at the HDA - Healthcare Distribution Alliance Distribution Management Conference (DMC) on March 8-11 in Austin. An NDC12 panel discussion will be hosted by industry leaders who excel at getting things done.

• Ameer Ali – Cencora
  Cencora recently published “The End Is Near… At Least for the 10-Digit NDC.” Strong distributor perspective. I’m looking forward to hearing that live.

• Michael Berman – Hikma Pharmaceuticals
  Commercial Operations. Pricing. GTN. Contracts. That’s where NDC format changes hit the P&L.

• Michael Mazur – Pfizer
  Mike and I spoke at GS1 Connect on NDC12. He understands trade complexity at scale and is one of the most knowledgeable people I know.

• Tim Stearns – HDA - Healthcare Distribution Alliance
  Tim hosted the NDC12 workshop at the last HDA Traceability Seminar. He has a clear pulse on industry alignment.
  

I will be at the conference and will recap all important points raised by the panelists.