US: The Pending NDC and Barcode Rule: Dispenser Perspectives

Part one of HDA’s series on the Food and Drug Administration’s (FDA) pending NDC and barcode rule explored manufacturers’ perspectives (Read more). Part two explored wholesale distributors’ perspectives (Read more).

With less than six months before the Food and Drug Administration (FDA) anticipates posting an amendment to its National Drug Code (NDC),¹ supply chain partners are preparing for this immense change. HDA is continuing dialogue around this impactful regulation — that could cost wholesale distributors hundreds of millions of dollars to implement and maintain.

In this next installment of our series assessing supply chain sector comments, we will review feedback from dispenser trade groups and other community members.

Cost and Timeline Concerns

Many of the dispenser respondents — including the National Council for Prescription Drug Programs (NCPDP), American Society of Health-System Pharmacists (ASHP), National Association of Chain Drug Stores (NACDS), National Community Pharmacists Association (NCPA) and CVS Health — and individuals within the dispenser community expressed concerns about the costs required for the proposed NDC and barcode rule format.

• NACDS noted that FDA appeared to have overlooked changes needed to order management systems, how transaction interaction with wholesale distributors and transaction interactions between businesses would need to evolve and the unique challenges of managing prescription drug monitoring and controlled substance reporting.
• NCPDP asserted that FDA’s cost estimations based on the International Classification of Diseases (ICD) system conversion are inaccurate, since the ICD codes are not used as extensively throughout the healthcare system and supply chain as the NDC.
• CVS Health further contended that FDA did not take into account key stakeholders in their cost estimations and encouraged the agency to account for pharmacy, government and commercial payers and any others that may have been excluded.

Additionally, the proposed effective date and transition period timelines were raised as cause for concern by trade groups, including the American Pharmacists Association (APhA) and National Alliance of State Pharmacy Associations (NASPA), as well as CVS Health. As a solution, CVS Health asked for two additional years, making the total implementation timeline 10 years.

Code Format Perspectives

Many comment letters questioned the proposed code format as well as the anticipated simultaneous use of the new and existing code structures.

ASHP, APhA and NASPA were among the groups that advised against having the three 10-digit NDC formats (4-4-2, 5-3-2 and 5-4-1) operating alongside the 5-4-2 and 6-4-2 syntax during the three-year transition.

One solution presented by several organizations — including NACDS, NCPDP and NCPA — as less costly and disruptive than a six-digit labeler code was the incorporation of letters into the code structure. Alphanumeric codes were also perceived as providing the benefit of minimizing errors and confusion, though most proposed excluding certain letters that can be confused with numbers, such as O, I and B.

An additional perspective raised by individual pharmacists was that expanding the labeler code by only one digit would be insufficient and require the industry to repeat this process soon, citing the recent transition to the five-digit code. Some suggested a 7-4-2 or even 8-4-2 format while others agreed with certain pharmacy trade groups (noted earlier) in introducing a limited set of letters to expand labeler code capacity much further.

Industry Engagement Support and DSCSA Impact Mitigation

Some individual pharmacists and organizations urged FDA to ensure effective industry outreach, collaboration and education for the proposed NDC and barcode change, both leading up to and during the transition. Specifically, ASHP urged FDA to keep in regular communication as the number of five-digit labeler codes are depleted and presented the industry engagement for the Drug Supply Chain Security Act (DSCSA) as a positive example to replicate.

DSCSA was also raised in organizational feedback from APhA, NASPA and NCPA, which cited concern over how the NDC change could impact ongoing compliance efforts for the law.

The next post in this series will look at the comments from healthcare IT systems vendors impacted by the proposed NDC change.

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.

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