Pharma groups pressure FDA to finalize NDC rule
Pharmaceutical industry groups, drugmakers, and other industry stakeholders are pressuring the US Food and Drug Administration (FDA) to finalize its proposed rule to update the format of the National Drug Code (NDC) by the end of March 2026.The NDC consists of a labeler code, product code, and packaging code. Due to new labelers constantly coming online, FDA anticipates that it will run out of 5-digit labeler codes by 2032 at the earliest and new NDC formatting will need to be put in place to accommodate longer NDCs. If the new format and system updates necessary to support this new format are not developed and operational across all systems by that time, the delivery of medications to patients could face significant disruptions.
This information was conveyed in a letter dated 13 February 2026 and addressed to Russell Vought, director of the Office of Management and Budget (OMB); Robert Kennedy Jr., Secretary of the Department of Health and Human Services (HHS); Marty Makary, FDA Commissioner; and Vince Haley, director of the Domestic Policy Council.
This letter was signed by representatives of 39 pharmaceutical companies and trade groups, including AbbVie, the Association for Accessible Medicines (AAM), Apotex, GSK, Novartis, and the Pharmaceutical Research and Manufacturers of America (PhRMA). A serialization expert from Novartis also spoke to Focus about his concerns about the timing of the NDC final rule.
In July 2022, the FDA proposed an update to the NDC system. This update aims to replace the existing 10-digit format with a 12-digit format due to a projected exhaustion of available codes within the next ten to fifteen years. (RELATED: FDA announces plans to revamp national drug code, Regulatory Focus 26 July 2022)
The FDA noted in its spring 2025 regulatory agenda that it plans to issue a final rule on NDC codes in January 2026. (RELATED: FDA’s latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC, Regulatory Focus 5 September 2025)
The issuance of the rule has faced repeated delays. The FDA previously stated that the NDC rule would be finalized in 2024 or early 2025.
The letter said that “the NDC is utilized by virtually every system in health care, including manufacturing, customs, distribution, pharmacy operations, prescribing, care delivery, billing and reimbursement, safety monitoring and reporting, and more. In all, more than 100 different public and private systems across the health care ecosystem rely on the NDC. FDA expects to exhaust its current inventory of 10-digit NDCs as soon as 2032. If the new format, and system updates to handle that new format, are not in place and operational across all systems by that date, the delivery of drugs to patients will be severely disrupted.”
The letter indicates that implementation involves much more than just updating the NDC number on drug packaging. All downstream systems that support the distribution, prescribing, administration, and payment for these drugs must also be updated in a coordinated way.
“With each passing week, the implementation window gets shorter. The compressed implementation timeline will only make implementation more difficult and more expensive for the health care system and create greater risk to patient access,” said the letter.
Dave Mason, serialization lead for Novartis, told Focus that significant lead time is needed to prepare for and comply with the NDC rule. He noted that setting up the necessary systems for this change is a much larger undertaking compared to the labeling changes mandated by the Drug Supply Chain Security Act (DSCSA).
“The issue here is that there are only five years to implement this, with DSCSA we had ten years to implement. And a lot of companies did not even get it done in ten years.” He added that the scope of DSCSA is quite limited compared to getting systems ready for NDC labeling changes, which will impact enterprise systems, serialization systems, financial systems, and regulatory labeling systems.
He added that “I will tell you this, for Novartis it took 3 and a half years to change one piece of labeling for DSCSA. Most companies will need five full years to change the labeling on their NDCs and then you have the transition periods where you will use both NDCs.”
Mason added that “we are conducting an internal assessment, but we can’t really start anything until we have a final rule because things can change.” He added that the NDC rule was not like DSCSA, where collaboration with industry was built into the regulations. “This is like a box of tissues. When all the tissues are out, you’re done.”
Mason surmised that the delay in issuing a final rule may be due to the Trump Administration’s “10 to 1” rule, which requires federal agencies to identify and eliminate 10 existing regulations for every new regulation proposed.
An HHS spokesperson did not commit to a specific timeline for issuing a final rule. The spokesperson told Focus that “this rule remains a priority for the Agency. FDA may adjust the anticipated publication date of this and other proposed rules when appropriate. Several factors may impact FDA's ability to propose and finalize a rule, including, for example, Administration priorities, emerging public health issues, or other extenuating circumstances.”
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