Pharmacists Must Prepare for FDA’s 12-Digit NDC Update

The FDA is moving forward with a significant change to how drugs are identified and tracked across the supply chain, and pharmacists will need to prepare. The agency is transitioning from the current 10-digit national drug code (NDC) format to a standardized, 12-digit system, and the implications reach far beyond a simple label update.

“Today, we have, traditionally, a 10-digit NDC number that comes in a variety of formats, whether that's 4, 4, 2; 5, 3, 2; and other formats that come out there,” Neal Cooper, vice president of regulatory affairs and quality systems at American Health Packaging, told Drug Topics. “They're trying to transition this to the same system and [make it] uniform across all products.”

The new format follows a 6-4-2 structure: a 6-digit labeler code, a 4-digit product code, and a 2-digit packaging code. The change is driven by 2 key factors: the need for uniformity across all drug products and a practical capacity issue. With only 5 digits in the current labeler code, the industry is simply running out of available numbers.

For pharmacists, the impact extends well beyond what's printed on a bottle. The existing 11-digit NDC format—an industry-created standard used to power financial and administrative systems like insurance adjudication and reimbursement—will also be affected by the shift to 12 digits.

According to Cooper—as well as his colleague Matt Sample, senior vice president of manufacturer, quality, and replenishment operations at Cencora—this means that pharmacists should be asking the hard questions of every vendor and third party they work with. Dispensing software, wholesaler systems, and adjudication platforms will all need to be evaluated for readiness.

READ MORE: Dispensing Leadership: Shrinking the Gap

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