DSCSA and Serialization: A Primer
In the United States, the pharmaceutical supply chain is undergoing a major transformation under the Drug Supply Chain Security Act (DSCSA).
Enacted in 2013, DSCSA aims to build an interoperable system to track and trace prescription drugs as they move through the supply chain. Its ultimate goal: protect consumers from counterfeit, stolen, contaminated, or otherwise harmful medications.
The final milestone of the law came into effect on 27 November 2024 and is now in full enforcement. All actors in the supply chain-from manufacturers and repackagers to distributors and dispensers-must exchange package-level events via EPCIS 1.3, with many early adopters already migrating to the newer EPCIS 2.0 JSON-LD format during 2025–26.
FDA has granted only limited “stabilization‐period” exceptions; otherwise, serialized data sharing is mandatory.
What Serialization Involves
Serialization means assigning each saleable unit of a drug product a unique identifier (often encoded in a 2D Data Matrix barcode) that links to batch, expiry, and manufacturer data. These identifiers are then tracked throughout distribution, aggregated into bundles or pallets, and reported through standardized interfaces. EPCIS 2.0 (ratified 2023) is increasingly preferred for its richer IoT metadata and compatibility with Digital Product Passport initiatives, but EPCIS 1.3 remains the regulatory baseline for DSCSA filings.
But serialization alone is not enough-it must be backed by data integrity and accessibility. That’s where track-and-trace platforms come in, enabling all authorized parties to verify the drug’s journey through the supply chain in real time.
DSCSA compliance has accelerated interest in advanced solutions such as blockchain, which promise tamper-proof, decentralized traceability. But is blockchain truly the future of supply chain visibility-or just a well-branded distraction?
How Blockchain-Based Track-and-Trace Works
At its core, blockchain is a decentralized digital ledger that records transactions in a tamper-evident and chronologically ordered structure. Unlike traditional databases controlled by a single entity, a blockchain network is distributed across multiple nodes-each maintaining its own synchronized copy of the ledger.
In the context of pharmaceutical supply chains, blockchain offers a way to log the movement of drug products-each transaction permanently recorded and cryptographically secured. This creates an immutable chain of custody from manufacturer to end-dispensing point.
How It Applies to Drug Traceability
In a blockchain pharma system, each step in the drug’s journey-from packaging and aggregation to shipping and delivery-is logged as a transaction:
- Manufacturer adds a serialized product to the blockchain.
- Wholesaler receives and verifies the product’s history.
- Distributor adds transfer confirmation and delivery metadata.
- Pharmacy or hospital verifies receipt and final dispensing.
- Regulators may be granted visibility or audit access.
This creates a transparent, shared source of truth accessible to all authorized participants. With proper integration, it can support DSCSA compliance by providing real-time visibility into product status, movement, and ownership.
Permissioned vs. Public Blockchains
In pharma, most proposed implementations rely on permissioned blockchains-networks where only verified participants (e.g., manufacturers, logistics providers, pharmacies) can write or read data. These are often built on platforms like Hyperledger Fabric or Quorum, which prioritize scalability, privacy, and governance.
Public or hybrid models, such as Ethereum-based pilots, are less common due to performance and privacy concerns, though they can offer benefits for certain use cases like patient-level transparency or international tracking.
Why Blockchain Over Traditional Databases?
Unlike centralized databases, blockchain enables independent verification without a single point of failure. Its key advantages include:
- Immutability: Data cannot be modified retroactively without consensus.
- Auditability: Full transaction history is transparently recorded.
- Trust minimization: Participants don’t need to fully trust each other—just the protocol.
- Resilience: No central authority means better fault tolerance.
These features make blockchain a strong candidate for scenarios involving multiple untrusted parties, regulatory oversight, or global supply chains-common challenges in the pharmaceutical ecosystem.
Real-World Pilots: MediLedger, IBM, and Beyond
While the potential of blockchain pharma solutions sounds promising in theory, it’s the real-world pilots that provide meaningful insights. Over the past few years, several major industry collaborations have tested blockchain-based systems for drug traceability and serialization, yielding valuable data on feasibility, adoption, and outcomes within the framework of DSCSA.
MediLedger Project
Perhaps the most notable pilot in the U.S. pharmaceutical industry is the MediLedger Project, initiated by Chronicled and backed by a consortium including Pfizer, Gilead, Amgen, Genentech, and McKesson.
- Objective: Enable DSCSA-compliant verification of serialized prescription drugs and facilitate transaction histories using a permissioned blockchain.
- Technology: Built on a customized version of Quorum, an enterprise-grade Ethereum fork.
- Functionality: MediLedger’s system enables product verification, contract management, and dispute resolution across supply chain partners—without revealing sensitive business data.
- Result: The pilot successfully demonstrated end-to-end verification workflows, with positive feedback from both pharma and wholesale participants. However, full-scale production rollout remains gradual due to onboarding complexity and system integration.
IBM Food Trust and Pharma Extensions
While best known for food supply chain solutions, the IBM Food Trust platform has been extended to pharma applications. It provides:
- Blockchain-backed traceability using Hyperledger Fabric.
- Integration of serialization data, shipping status, and environmental metadata.
- Potential for combining with IoT cold-chain tracking (see more) for temperature-sensitive products.
Pilots have explored multi-tier transparency, where manufacturers, carriers, and retailers collaborate within a shared data environment. These efforts align with DSCSA and international compliance frameworks.
Key Takeaways from Pilots
- Feasibility is proven: Blockchain networks can support real-time traceability at scale.
- Data privacy is manageable: Permissioned models allow for selective data access.
- Onboarding remains a challenge: Aligning systems, standards, and workflows takes time.
- Blockchain is a layer, not a replacement: It complements-not replaces-existing DSCSA infrastructure.
These pilots show that blockchain can play a valuable supporting role in pharmaceutical serialization-but only when paired with thoughtful integration and cross-industry collaboration.
Limitations and Challenges
Despite the enthusiasm around blockchain pharma, the technology faces serious challenges-especially in highly regulated, globally distributed supply chains. The use of blockchain in drug traceability and serialization under DSCSA must be weighed against several limitations.
Cost and Complexity of Implementation
One of the biggest barriers is implementation cost. Blockchain networks require:
- Infrastructure setup and maintenance
- Integration with ERP, WMS, or DSCSA-compliant systems
- Staff training and technical support
- Ongoing governance and compliance validation
Smaller manufacturers or regional distributors may not see clear ROI-especially if current systems already handle EPCIS and serialization adequately.
Privacy and Data Governance
While transparency is a strength, not all data is meant to be shared. Commercially sensitive information-such as pricing and contract terms-must remain confidential. Even permissioned chains require complex access controls.
Furthermore, laws like GDPR mandate data deletion rights, which conflict with blockchain’s immutability by design.
Technical Limitations
Blockchain supply networks face scaling challenges. Large transaction volumes, especially across global pharma chains, can cause latency or throughput issues.
Another issue is vendor lock-in. Many platforms are proprietary, risking long-term interoperability and system flexibility.
Cross-Border Compliance Complexity
Pharmaceutical products often cross multiple jurisdictions. While DSCSA governs U.S. serialization, the EU now requires Digital Product Passports under Ecodesign rules (as of February 2025). Syncing these evolving standards across systems remains a challenge.
Conclusion and Recommendations
Blockchain won’t replace core DSCSA infrastructure. It functions best as a trust layer: improving auditability, decentralization, and cross-party coordination.
Recommendations:
- Deploy blockchain selectively where trust gaps exist and verification costs are high.
- Start small-pilot with DSCSA-compatible layers and minimal on-chain data.
- Use hybrid models where critical data is on-chain and sensitive data is stored off-chain.
- Collaborate with regulators early to ensure alignment.
- Track emerging standards such as EPCIS 2.0 and Digital Product Passport.
As the MediLedger FDA Pilot Project concluded:
“Through this project, we have shown that blockchain has the capability to be the technology underlying an interoperable system for the pharmaceutical supply chain, as mandated by DSCSA.”
For deeper analysis, see our related overview in How Technology Is Changing Pharma: A Complete Guide.
