The pharmaceutical industry has entered a planning and preparation phase following the FDA’s publication of its final rule on 12-digit National Drug Codes.
Liberty Dewey, manager of DSCSA at Cardinal Health, describes the current period as one of assessment rather than full execution across the supply chain.
Dewey spoke ahead of her session at HDA’s 2026 Traceability Seminar, focused on how stakeholders will operationally manage the shift to the new format.
The session, titled “The Three-Year NDC-12 Transition Period,” examines the practical steps companies must take to align with the requirements set out in the final rule.
The rule was published on March 5, 2026, triggering a seven-year window for the industry to review and update its systems and internal processes accordingly.
The rule becomes officially effective on March 7, 2033, at which point existing 10-digit NDCs will automatically convert to the new 12-digit format.
That conversion opens a three-year labeling transition period running through March 7, 2036, after which the 12-digit format becomes the only one that can enter commerce without FDA regulatory action.
Independent and smaller pharmacies are expected to face particular challenges given that they often lack dedicated IT departments or the project budgets available to larger organisations.
Dewey says the transition for smaller operators will lean heavily on vendors, trade associations, and wholesalers rather than pharmacy-led initiatives driving compliance efforts internally.
She points to a range of support that should be available, including vendor readiness programs, association-provided toolkits, training materials, and standardised testing environments.
Those resources are intended to ensure systems covering inventory, ordering, reimbursement, and barcode scanning are all updated well ahead of the 2033 effective date.
The seven-year runway is designed to give the industry sufficient time to prepare, but Dewey’s framing of the current moment as a planning phase signals that early action will be critical.
With multiple stakeholder groups needing to coordinate across complex supply chains, the transition represents one of the more significant operational shifts the pharmaceutical sector has faced in recent years.