DSCSA Can Trace a Package. It Cannot Tell Whether the Next One Will Arrive.

The US pharmaceutical supply chain has spent more than a decade building the digital ability to answer a vital question: Where did this package come from? As Drug Supply Chain Security Act (DSCSA) enforcement moves from implementation into daily operation, another question becomes equally important. Will the next package arrive?

DSCSA was designed to create an interoperable, electronic system for identifying and tracing certain prescription medicines at the package level. Its purpose is fundamental, helping prevent harmful products from entering the legitimate supply chain, detect them if they do, and support a rapid response when counterfeit, stolen, contaminated, or otherwise illegitimate medicines are identified.¹

That is a major public-health and operational achievement. It should not, however, be mistaken for complete supply-chain visibility. A serialized transaction record can show that a legitimate package moved from one authorized trading partner to another. It does not show whether the manufacturer has enough qualified capacity for the next month, whether an active pharmaceutical ingredient source is becoming constrained, whether batch-release timelines are deteriorating, whether a supplier can survive another price reduction, or whether a backup site could be activated before patients run out of medicine.

Traceability tells us what happened to a product. Resilience depends on understanding what may happen to supply.

A Security Milestone and A Management Misconception

The strongest case for DSCSA is also the simplest. The pharmaceutical supply chain should be able to verify the identity and movement of prescription medicines at package level. Electronic transaction information, product identifiers, verification processes, and authorized-trading-partner controls create a stronger defense against diversion and falsification than fragmented paper records.

The implementation journey has also forced manufacturers, repackagers, wholesale distributors and dispensers to improve master data, system connectivity and coordination across organizational boundaries. FDA's phased exemptions reflected the practical difficulty of stabilizing these connections without interrupting legitimate product flow. The general exemptions ended in stages for manufacturers and repackagers, wholesale distributors and larger dispensers, while qualifying small dispensers have until November 27, 2026, for certain enhanced requirements.² FDA has since extended that small-dispenser exemption further, to November 27, 2027, tied to completion of a small-dispensers assessment.

The risk now is conceptual rather than technical. Once executives can see serialized events on a dashboard, it is easy to conclude that the supply chain has become visible. But a chain of custody is not the same as a chain of dependency. The data required to authenticate movement is narrower than the data required to anticipate interruption. A package may be perfectly traceable while the product behind it remains commercially fragile.

What Serialized Traceability Does Not Reveal

Most shortages do not begin as traceability failures. FDA identifies manufacturing and quality problems, delays, and discontinuations among the reasons drug shortages occur.³ Other vulnerabilities can include unexpected demand, limited raw-material availability, long equipment lead times, constrained testing capacity, transport disruption, and the economics of maintaining technically demanding products.

These risks sit largely outside the transaction history of an individual package. A complete DSCSA record does not, by itself, answer whether:

• Two finished-dose suppliers depend on the same upstream API or key starting material.
• A manufacturing site is operating with meaningful reserve capacity or merely meeting current demand.
• Deviation rates, investigation age, or delayed batch disposition are beginning to erode dependable output.
• An alternative supplier is approved, technically transferable, and commercially willing to supply.
• Inventory is positioned where demand is emerging, rather than where it was expected.
• A trading partner's financial or operational weakness is increasing continuity risk.
• A cold-chain, transport, or systems interruption can be recovered within the product's clinically relevant window.

This does not represent a weakness in DSCSA. It reflects the law's defined purpose. The mistake would be asking a product-security architecture to perform the work of a full continuity-management system.

Why Exception Data Is More Than a Compliance Problem

The most valuable bridge between traceability and resilience may be the data generated when the digital and physical supply chains do not agree.

GS1 US implementation guidance groups serialized exceptions into two broad categories, product with no data and data with no product.⁴ Operational scenarios also include incorrect lot details, quantity mismatches, incorrect location information, transmission failures and incomplete master data.

These exceptions must first be resolved for compliance and product-flow reasons. Yet their pattern can also reveal something larger. A single missing file may be a clerical error. Repeated failures from the same connection may indicate weak master-data governance, unstable integration, poor partner readiness, or a process that depends on manual intervention. Long resolution times can translate into quarantine, delayed receiving, blocked inventory, working-capital pressure, and ultimately slower patient access.

Exception data should therefore be treated as an operational signal, not merely an IT service ticket. Commercial and supply-chain leaders should examine measures such as exception rate by product, partner, location, and transaction type; median and maximum time to resolution; hours of inventory held in quarantine because physical product and data did not match; repeat-exception frequency after a case is marked resolved; fill-rate, back-order, and customer-service impact linked to unresolved exceptions; and the percentage of critical products for which exception ownership and escalation routes are predefined.

None of these indicators proves that a shortage is coming. Together, however, they can expose friction before it becomes normalized and invisible.

Build Continuity Intelligence in Four Layers

The industry does not need to replace DSCSA infrastructure. It needs to build outward from it. A useful continuity-intelligence model has four connected layers:

1. Product authenticity and transaction integrity. This is the DSCSA foundation, package-level identification, electronic transaction information, authorized trading partners, verification, investigation, and response.
2. Product flow. This layer connects serialized events with orders, receipts, inventory, back orders, in-transit status, returns, exception queues, and customer demand. It answers whether legitimate product is moving as expected.
3. Supply capability. This includes site and line capacity, batch-release performance, quality trends, API and intermediate concentration, approved sources, lead times, supplier sustainability, and the regulatory status of alternatives. It answers whether supply can continue.
4. Decision readiness. Data only creates resilience when somebody has authority to act. Thresholds, escalation rules, cross-functional ownership, bridging-inventory assumptions, and pre-agreed contingency pathways determine whether an organization can convert a signal into an intervention.

These layers should not be collapsed into one oversized dashboard. They should be connected through common product and partner identifiers, clear data ownership, and a small number of decision-focused metrics. The objective is not to collect every available data point. It is to know earlier when patient supply is moving from normal variation toward a continuity event.

Do Not Let Compliance Create a New Access Barrier

The transition to interoperable package-level data also creates a practical risk. Legitimate medicine can be delayed when the product arrives but the accompanying data are missing, incorrect, or unreadable. That is why exception management is not a secondary technical function. It is part of patient access.

The industry needs disciplined quarantine and verification controls, but it also needs rapid, evidence-based routes for resolving ordinary data mismatches. A compliance program that blocks product without creating fast ownership, communication, and correction processes may protect the system from one type of risk while introducing another.

This is particularly important during the remaining transition for small dispensers. Interoperability is only as strong as the connection between immediate trading partners. Manufacturers and wholesalers should therefore treat onboarding, testing, master-data support, and clear contact channels as part of service continuity, not simply as a requirement imposed downstream. The measure of maturity is not the absence of exceptions. Complex networks will always generate them. The measure is whether exceptions are detected quickly, classified correctly, resolved consistently, and used to prevent recurrence.

The Executive Questions Have Changed

For years, the central DSCSA question was: Are we ready? The better questions now are:

• Can we trace the package without manual reconstruction?
• Can we distinguish a data error from a genuine product-security concern quickly enough to protect both safety and availability?
• Can we see which partners, products, and processes generate recurring friction?
• Can we connect downstream movement with upstream capacity, quality, and sourcing risk?
• Can the organization act before a disruption reaches the customer?

Boards should also be cautious about accepting a high electronic-data-exchange success rate as proof of resilience. A network may exchange files successfully while depending on one fragile plant. It may have clean serialization data while carrying insufficient inventory. It may identify every package in circulation while lacking an approved second source. A perfect digital history of an unavailable medicine is not supply continuity.

DSCSA gives the United States pharmaceutical market a stronger digital foundation for product security. The next opportunity is to use that foundation without overstating what it provides. Package-level traceability can help establish whether a medicine is legitimate, where it moved, and which trading partners handled it. Resilience requires additional visibility into whether the network can keep manufacturing, releasing, transporting, and supplying that medicine under stress.

The difference is crucial. Product security asks whether the package in front of us should be in the supply chain. Continuity intelligence asks whether the patient will receive the next one. The industry should not choose between these objectives. It should connect them.

The organizations that gain the most from DSCSA will not be those that treat implementation as a completed compliance project. They will be those that convert serialized movement, exception patterns, operational performance, and upstream risk into earlier decisions. The goal is not simply a supply chain that can reconstruct the past. It is one that can protect the future.

Vishal Chakravarty is founder and chief executive officer of NovaPharm Healthcare Ltd.

References

1. U.S. Food and Drug Administration. Drug Supply Chain Security Act (DSCSA). Accessed August 3, 2026. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
2. U.S. Food and Drug Administration. Waivers and Exemptions Beyond the Stabilization Period. Accessed August 3, 2026. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period
3. U.S. Food and Drug Administration. Drug Shortages. Updated July 15, 2026. Accessed August 3, 2026. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
4. GS1 US. Applying GS1 Standards for DSCSA and Traceability: Diagrams and XML Examples for Serialized Item-Level Exception Handling, Release 1.3. February 28, 2025. Accessed August 3, 2026. https://documents.gs1us.org/adobe/assets/deliver/urn:aaid:aem:2789c06a-cb56-4642-8daf-a63e790306e4/Addendum-Diagrams-and-XML-Examples-for-Serialized-Item-Level-Exception-Handling-R1-3.pdf