The pharmaceutical industry’s shift to 12-digit National Drug Codes carries its greatest risk not inside individual systems, but at the handoffs between organisations.
That is the central warning from Liberty Dewey, manager of DSCSA at Cardinal Health, who is speaking at HDA’s 2026 Traceability Seminar in a session titled “The Three-Year NDC-12 Transition Period.”
Dewey argues that no single organisation will steer the industry through the move to 12-digit National Drug Codes, with leadership expected to emerge across the supply chain.
Responsibility will be shared among the FDA, manufacturers, trade associations and industry standards bodies, all of which must coordinate closely to avoid disruption.
The transition is built around four distinct work streams, each carrying its own operational complexity and cross-industry dependencies that must be carefully managed.
The first work stream involves data and system remediation, requiring every organisation that stores, displays or processes the NDC in any format to audit its systems for embedded assumptions about format and length.
The second covers product labelling and barcode changes, with manufacturers responsible for updating packaging, artwork and barcode implementations while downstream partners prepare to receive those changes.
The third work stream is trading partner synchronisation, which Dewey says cannot be executed organisation by organisation, because a single break in the chain can disrupt the entire workflow across the supply network.
The fourth work stream calls for coordinated industry testing across ordering, inventory, dispensing, claims, reimbursement, returns and reporting platforms, all of which must be validated together rather than in isolation.
Each of these four work streams demands simultaneous progress across multiple organisations, meaning a delay in one can have cascading effects far down the supply chain.
Dewey has specifically highlighted the handoffs between organisations as the area she considers most vulnerable, pointing to the complexity of aligning partners with different timelines, systems and levels of readiness.
Her concern is whether the industry will construct a formal governance structure comparable to what was established during previous major regulatory transitions in pharmaceutical distribution.
Without that kind of shared governance, she warns, the risk of fragmented implementation increases significantly as the deadline approaches and operational pressure mounts.
Smaller pharmacies face particular challenges in navigating the transition, and Dewey has pointed to trade associations and standards bodies as key resources for those organisations seeking guidance.
The three-year transition window may appear generous, but the depth of system and labelling changes required means that organisations across the supply chain must begin preparatory work without delay.