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Pharmaceuticals Pilot #2: Traceability
Executive Summary
SagaPharma™ Pilot 2 DSCSA Supply Chain Traceability and Serialization
The Breakthrough
Pilot 2 delivers a breakthrough solution for one of the pharmaceutical industry’s most critical challenges: achieving full, real-time traceability of drug products from manufacturer to dispenser, preventing counterfeits, enabling instant recalls, and ensuring compliance with the U.S. Drug Supply Chain Security Act (DSCSA) using SagaChain™’s transparent, immutable ledger.
The Problem Today
Drug serialization and traceability systems are often fragmented, relying on centralized databases, manual verification, and delayed data sharing among trading partners.
Counterfeit and diverted products enter the supply chain, costing the industry billions annually and endangering patient safety.
Recalls are slow and incomplete due to incomplete transaction histories and inference challenges across aggregated packages (cases, pallets).
Aggregation and deaggregation events (packing, unpacking, partial dispensing) create reconciliation gaps, increasing administrative burden and compliance risk.
Manufacturers, wholesalers, dispensers, and regulators face high costs and limited visibility while patients bear the ultimate risk.
What Pilot 2 Achieves
Using SagaChain™’s persistent, programmable class tree, Pilot 2 introduces a unified traceability process that is:
Instant & Immutable – Serialized units (SGTIN) and containers (SSCC) are registered on-chain with permanent identifiers, lots, and expiration dates.
Fully Hierarchical – Supports real-time aggregation (units into cases/pallets) and deaggregation (partial unpacking or dispensing) with automatic parent-child linking and inference.
Event-Driven – Transaction events (commissioning, shipping, receiving, aggregation/deaggregation) are recorded immutably, creating a complete chain-of-custody visible to authorized partners.
Rapid Verification & Recall – Any trading partner or regulator can instantly verify authenticity and history; recall signals propagate immediately across the entire hierarchy.
Real-World Benefits
For Manufacturers & Repackagers
Eliminate reconciliation errors and costly chargebacks through shared, immutable records.
Reduce counterfeit exposure and strengthen brand protection with verifiable serialization at scale.
Seamlessly manage aggregation/deaggregation during production and repackaging.
For Wholesalers & Distributors
Instant verification of incoming/outgoing shipments without relying on third-party portals.
Faster, more accurate inventory management and returns processing.
Reduced risk of receiving suspect product and improved compliance audit readiness.
For Dispensers (Pharmacies & Hospitals)
Point-of-dispense verification ensures only legitimate products reach patients.
Support for partial deaggregation (e.g., breaking cases) while maintaining full traceability.
Immediate access to recall notifications tied directly to specific lots and units.
For Regulators & Patients
Regulators gain continuous, real-time visibility into the supply chain without burdensome reporting.
Patients benefit from dramatically reduced risk of counterfeit or recalled medicines.
Industry-wide savings from fewer recalls, disputes, and enforcement actions potentially billions annually.
For Platforms & Technology Partners
Lower integration costs through a single, open standard replacing fragmented verification routers.
New opportunities for value-added services built on transparent, shared data.
Projected total ecosystem value creation: $8–12 billion annually at full U.S. adoption through reduced counterfeits, faster recalls, and operational efficiencies.
Available now (on public development testnet) for review and testing
Pilots starts in ~90 days
Low-risk, high-impact, and ready for real serialized units, aggregation events, and multi-party workflows. We invite manufacturers, repackagers, wholesale distributors, dispensers, 3PL providers, solution providers (e.g., traceLink, rfxcel, LSPedia), standards organizations (GS1, HDA, PQG), and regulators (FDA, state boards) to:
- Test the pilot with your own serialization data and trading partner scenarios.
- Validate aggregation/deaggregation workflows and inference rules.
- Co-develop extensions for interoperability with existing systems (EPCIS, verification routers).
- Participate in governance to prepare for national production rollout.
More than a technical pilot…
The foundation for a safer, more efficient, and fully transparent U.S. pharmaceutical supply chain.
The pharmaceutical community has a unique opportunity to take custodianship of this transformative traceability framework.
By testing real-world scenarios, refining aggregation/deaggregation logic, and collaborating on standards alignment (DSCSA, GS1 EPCIS 2.0), you’ll accelerate a national rollout that delivers patient safety, operational savings in the billions, and regulatory confidence.
This open, shared infrastructure empowers every trading partner with instant visibility, eliminates counterfeit risks, and enables recalls in minutes rather than days.