“What Happens When We Run Out of NDC Numbers?” – FDA Announces Public Hearing

Just over a year ago, I wrote an article published in Computer Talk for the Pharmacist titled “What Happens When We Run Out of NDC Numbers?”  Many may have thought that there was still plenty of time to address the issue of running out of NDC labeler codes or that maybe this was not an immediate concern.

Now there is an indication that this issue is real.  The FDA announced a public hearing November 5, 2018 to consider the future format of the NDC.  A change will be necessary when the agency runs out of 5-digit labeler codes.  The FDA states it is aware that any modification to NDC format or length will impact all systems that use the NDC.

In my article last year, I posed several questions to start a discussion regarding this issue.  Length and utilization of alphabetical characters were two topics to consider.  The FDA is proposing four options regarding NDC length and some general questions to contemplate while studying the options.  PHSI encourages our readers to review the options and ask themselves the questions posed by the FDA.

FDA’s options A and B are the status quo, but at some point, the FDA will start assigning 6-digit labeler codes which will result in NDCs in five different configurations – the three currently used: 4-4-2, 5-3-2, and 5-4-1, plus two new configurations: 6-3-2 and 6-4-1.

FDA option C converts the current FDA 10-digit NDC to the 11-digit NDC format used by pharmacies and in claims processing systems.  When the FDA runs out of 5-digit labeler codes, it will begin assigning 6-digit labeler codes to be used in 6-3-2 and 6-4-1 formats.  A potential concern with this option exists because it could possibly lead to an identical 11-digit NDC for two different products, one with a 6-digit labeler code and the other with a 5-digit labeler code.

FDA option D has the FDA “harmonizing” NDC assignment by moving to a uniform NDC in a 6-4-2 format at a future date.  This results in every current 10-digit NDC being converted to a 12-digit NDC.  The FDA will give the industry time to prepare for this major change, but the industry MUST be ready when it is time for the FDA to assign the first 6-digit labeler code and requires NDCs to be presented in the 6-4-2 format.

I like Option D because it is the change that will take the industry well into the future without needing to resolve potential issues caused by Options A, B, and C.  However, I question if there is going to be expansion of the NDC and all the fields that accommodate the NDC, why not take it further, such as up to the 19 digits already allocated in the NCPDP standard?

For example, using the same format basis used now, create an 8-8-3 format.  Even though the addition of a digit to each section of the NDC exponentially increases the number of NDCs available, there may be a need to differentiate newer products (e.g., a radiologic, or a new dosage delivery system) at the product or package size level requiring an extra digit or two.  Sometime in the future there might be a move toward real harmonization of the various identifiers for health care products, such as the NDC and the UDI, which might require an extra digit or two to help with harmonization and differentiation.  It is also possible one or two digits would be needed to identify a product number as an NDC or UDI (like the UPC value used to do that), which might require the creation of a fourth partition.  These are ideas that stakeholders using NDC numbers need to consider when thinking about their response to the FDA options.

The industry needs to assess this situation, voice their position on each option, and consider the lead time required to implement any of the changes required by the final resolution.  I mentioned in my article last year that it would be better if the industry initiated the effort as opposed to the government.  Now the government is facilitating a discussion.  In one response, NCPDP’s Maintenance and Control Work Group has reactivated its NDC Scarcity Task Group to prepare comments on the proposed FDA options.  It is important the industry participates to prevent a government mandate with an aggressive timeline that does not meet industry needs.

By Dave Schuetz

 

Published September 2018

 

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