Two Digits, Seven Years Out

At the HDA Traceability Seminar in Washington, D.C., much of the conversation centered on a change that does not take effect until 2033: FDA’s move to a uniform 12-digit National Drug Code.

NDC-12 is real work, but I came away thinking about the DSCSA programs already in place. Many are meeting the compliance requirement while pushing costs somewhere else in the business.

The compliance program is passing. The warehouse is paying for it.

That cost is easy to miss when DSCSA is measured mainly through EPCIS exchange and repository compliance. It shows up as held product, extra labor spent resolving exceptions, slower returns and working capital tied up while the physical product and electronic record are reconciled.

Three weeks before HDA, FDA extended certain DSCSA exemptions for small dispensers through November 27, 2027. The additional time allows FDA to complete its assessment of whether small dispensers can realistically access and use the technology required for interoperable, package-level tracing.

That extension is a useful reminder that DSCSA execution is still unfinished, even as manufacturers, repackagers, wholesale distributors and larger dispensers operate under the enhanced requirements today.

NDC-12 still deserves planning. FDA’s March 2026 final rule establishes a uniform 12-digit NDC beginning March 7, 2033, followed by a three-year labeling transition. The change will require updates to systems, processes, barcode structures and other infrastructure across the pharmaceutical supply chain.

For the person accountable for DSCSA, that planning is also a chance to ask a broader question: How much is the current compliance setup costing the operation?

The cost behind a compliant program

A 2025 survey of 100 pharmaceutical executives sponsored by Tecsys found that 55% receive data without corresponding product at least sometimes, while 49% have received product with incorrect data. When an exception occurs, 93% said their default response is to reject the product and send it back.

The cost shows up in held inventory, exception-handling labor and delays getting product back into normal flow. The accountability can extend beyond cost as well. Once a trading partner determines that a product is illegitimate, DSCSA requires notification to FDA and appropriate immediate trading partners within 24 hours.

Those costs can accumulate when DSCSA compliance and warehouse execution live in separate systems. The original buying decision often centered on getting connected, exchanging EPCIS data and meeting a regulatory deadline. Vendors were happy to sell DSCSA that way: as a data project separate from warehouse execution. Once DSCSA becomes everyday work, disconnected compliance and warehouse processes can create additional manual steps.

A repository can work exactly as designed while warehouse staff still re-enter information or reconcile exceptions manually. The compliance transaction succeeds, but the operating cost remains.

That gives DSCSA leaders a practical set of questions to take back to their vendors:

• What percentage of our inbound transactions generate exceptions?

• How much time does the operation spend resolving them?

• How many systems does someone need to use when the data and product do not match?

• Can our current setup support NDC-12 without adding another disconnected process?

A compliance checklist will not answer those questions, but they show how much work the program creates after implementation.

As teams prepare for NDC-12, they will already be updating master data, interfaces, scanners and barcode dependencies. That is a natural time to review whether compliance data is integrated into warehouse execution or moving alongside it in separate processes.

That is the approach we took with Tecsys WMS. DSCSA serialization workflows and EPCIS reconciliation are built into warehouse execution, keeping compliance data connected to the warehouse transactions it supports.

NDC-12 gives DSCSA leaders another major systems change to plan for. It also gives them a reason to look closely at the setup they already have and ask whether it is meeting the compliance requirement without creating unnecessary cost in the warehouse.