Inside the Three-Year Transition to NDC-12

With the FDA's final rule on 12-digit National Drug Codes now published, the industry has entered what Liberty Dewey, manager, DSCSA at Cardinal Health, calls a planning and preparation phase rather than a full execution phase. Pharmaceutical Commerce spoke with Dewey ahead of her session at HDA's 2026 Traceability Seminar, "The Three-Year NDC-12 Transition Period," which examines how stakeholders will operationally manage the shift to NDC-12 as laid out in the final rule. In this first installment of our conversation, Dewey lays out the timeline ahead and where smaller pharmacies can look for support along the way.

Dewey walks through the key dates: the rule's March 5, 2026 publication kicked off a seven-year window for the industry to assess systems and processes, with the rule becoming officially effective March 7, 2033. At that point, existing 10-digit NDCs convert to the 12-digit format, opening a three-year labeling transition that runs through March 7, 2036, after which the 12-digit format becomes the only one that can enter commerce without FDA regulatory action.

Turning to independent and smaller pharmacies, which often lack dedicated IT departments or large project budgets, Dewey says the transition will lean heavily on vendors, trade associations and wholesalers rather than pharmacy-led initiatives. She points to a range of support that should be available, including vendor readiness programs, association-provided toolkits, training materials and standardized testing environments to ensure systems across inventory, ordering, reimbursement and barcode scanning can communicate during the dual-format period. She also flags wholesaler-provided resources like NDC crosswalks and transition timelines, along with a need for regulatory and payer guidance, since the NDC-12 shift does not replace the separate HIPAA 11-digit reimbursement format pharmacies must continue using for claims.