The next item that was hard to miss last year in the DSCSA 2024 Ten Count, list of top DSCSA moments and stories from 2025.

Number 7 is the apporaching NDC-12 rule finalization.

The FDA is Expected to Finalize the Proposed Rule to Require The Use of NDC-12 Soon!

Impact to the industry will be wider than DSCSA due to the upstream and downstream systems and processes.

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On July 22, 2022 the FDA released a proposed rule to adopt a 12-digit format for National Drug Codes. This proposal came after a series of public FDA and industry meetings prior as well as a previous drafted proposal. The primary challenge being addressed was the expected exhaustion of labeler codes which would prevent the FDA from issuing new codes for new manufacturers or repackagers. Various approaches were considered including moving to alpha numeric or free floating NDC numbers (without set positions) and others but ultimately the FDA decided that expanding the label code to 6 digits and the NDC to 12 was the chosen course expected. The proposed rule has some important considerations to keep in mind:

• Eliminate the linear UPC barcode requirement, to migrate the entire supply chain fully to the 2D GS1 DataMatrix barcode in place for DSCSA
• NDC codes (specifically, labeler codes) are expected to be exhausted between 2030 and 2035. Unlike DSCSA, the runway for NDC change has a fixed end (exhaustion of labeler codes).
• Expectations are for the rule to be finalized in 1^st half of 2026
• The impact for following GS1 standards is that the NDC will no longer be embedded within the GTIN, and a new Application Identifier (715) will be used for NDC
• A format is prescribed for existing NDC numbers to be padded with zeros to move from NDC 10 to NDC 12. The exact location of the zeros is dependant on the current NDC format leveraged.

Are there known challenges that are expected?

While many more discussions need to happen to explore, there are some significant impacts that are expected and will need to be managed. We share a list of ones we have captured from collaborating with trading partners.

1. Many systems utilize current NDC in 10 (or 11) digit formats and will need to be updated.
2. Impact goes from production planning all the way through dispensing and payments including multiple government groups beyond FDA.
3. Significant cost, time, resources likely needed due to the impact.
4. Integration impacts are within and outside of the organization.
5. Limited runway once rule is finalized (approx. 7 years).
6. The supply chain will be handling converted and not yet converted product at the same time
7. Implementation of this rule will require a level of collaboration the industry has never seen before.

What is happening in the industry?

Activities are picking up and expected to significantly increase once the FDA Law is finalized. We recommend checking with your trade organizations to determine if there are existing or plans for industry workgroups.

• GS1 US has identified over 100 systems used by trading partners, supporting organizations, and federal and state agencies that will be impacted by the change.
• GS1 US has formed a workgroup, a discussion group, and a Standards committee.
• HDA and other trade associations are expected to form work groups once the rule is finalized.
• The implementation timeline will be tight, and organizations need to hit the ground running as soon as the rule is finalized.
• Currently, organizations are focusing on strategic assessments to understand the full scope, impact, and needed budget to support implementations.
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How should your organization be preparing now?

Internal education to bring awareness of the upcoming changes

1. You should be conducting internal assessments and strategy work to understand the expected impact of this changes. Who are the stakeholders, what systems are involved, and what time/resources/budget needs to be ready?
   
2. Assign a business and IT champion to sheperd the effort into an eventual full program.
3. Seek expert advise in the early stages to ensure correctly planned
4. Join any industry group that make sense for your organization based on sector and impacts.

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We offer short engagement options to help your company analyze, strategize, and plan for the coming NDC-12.

👉 Ready to get your NDC-12 exploration stated? Contact Ten Count Consulting today to learn how we can help your team prepare with confidence.