The Pending NDC and Barcode Rule: Healthcare IT Company Perspectives
Part one of HDA’s series on the Food and Drug Administration’s (FDA) pending NDC and barcode rule explored manufacturer perspectives. Part two explored distributor perspectives. Part three explored dispenser perspectives.
With the Food and Drug Administration’s (FDA) final rule covering amendments to its National Drug Code (NDC)1 and barcode rules anticipated in early 2024, it is essential for organizations throughout the supply chain to prepare for this regulation.
Should these rule changes go into effect as early as January 2024 with a delayed final milestone of five years (plus a three-year transitional period), companies will need to implement a new 12-digit NDC format system. That means all existing 10-digit NDCs assigned by FDA must be converted before the end of 2032. This work may begin in tandem with conversions to Drug Supply Chain Security Act (DSCSA)-compliant systems during the stabilization period, only underscoring the importance of thorough preparations as soon as possible.
We continue our review of comments to the FDA’s proposal by summarizing responses submitted by organizations within the healthcare IT industry.
Formatting Recommendations
Many organizations gave feedback about the proposed updated format for the NDC. Oracle, RedSail Technologies (RedSail), Elsevier and Synerio, among others, suggested that an alphanumeric format preserving the same length would be preferable to increasing the number of digits of the NDC. Oracle specifically mentioned that alpha characters could help mitigate medication errors, arguing those characters would not be easily confused with numbers of similar appearance. Given there are already multiple NDC formats in rotation, noted Elsevier, adding another format during the transition period would be even more challenging for supply chain entities to navigate.
HIMSS Electronic Health Record Association, while generally supportive of the FDA’s decision to migrate to a fixed format 12-digit NDC, also suggested the agency reconsider the idea of using a limited set of alpha characters.
Timeline and Level of Effort Concerns
As with other supply chain sectors, many companies shared worries about the proposed timeline. IBM asked the agency to consider a full 10-year implementation schedule like what was statutorily defined for the DSCSA. Altera Digital Health stated that the three-year transition proposed for NDC conversion would be too long and expose public health to more risks of medication errors.
Further, Synerio and RedSail remarked on the level of effort required for such a conversion, with Synerio stating that the FDA’s cost estimate is significantly underestimated with no predicted significant benefits.
A few companies, such as Synerio, cautioned FDA that confusion during the 12-digit format transition could lead to disruption. Altera Digital Health even warned this could risk a possible pathway for illegitimate products entering the supply chain.
Looking to 2024
It is evident from the feedback shared in all installments of this blog series that many healthcare supply chain stakeholders anticipate considerable challenges managing an NDC conversion to the proposed 6-4-2 format. HDA will continue to actively monitor developments related to the NDC transition and provide additional information based on an update from FDA at the beginning of next year.
Tim Stearns is HDA’s Senior Director, Industry Relations. He is focused on helping HDA members and industry stakeholders prepare for critical legislative mandates such as the NDC and DSCSA. For additional information or questions email tstearns@hda.org.
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1. For additional background, visit the FDA website.