Navigating DSCSA, Data Integrity, and Resilience in the Pharmaceutical Supply Chain with White Paper

***This content is based on insights from a white paper authored by Rose Campasano, Vice President of Industry Solutions at LSPedia, who continues to lead efforts in driving DSCSA readiness across the pharmaceutical supply chain.***

The U.S. pharmaceutical supply chain is undergoing a transformative shift. With the full implementation of the Drug Supply Chain Security Act (DSCSA) on the horizon and rising scrutiny on global manufacturing dependencies, stakeholders are navigating complex challenges—balanced by opportunities for improved efficiency, safety, and resilience.

At this critical juncture, supply chain leaders must do more than comply—they must adapt. From managing geopolitical risk and improving data quality to preparing for state-level enforcement and exception handling, the decisions made today will determine not just regulatory success, but operational excellence tomorrow.

A Shifting Manufacturing Landscape Demands Strategic Resilience

The pharmaceutical sector faces growing pressure to reduce reliance on foreign manufacturing due to geopolitical instability and the potential for tariffs on imported Active Pharmaceutical Ingredients (APIs). These changes bring the risks of price fluctuations, regulatory complexity, and supply disruptions.

To combat this, companies are turning to diversification strategies that include:

• Developing onshore and nearshore production capabilities

• Forming joint ventures or deeper partnerships with Contract Manufacturing Organizations (CMOs)

• Conducting thorough risk assessments of current manufacturing networks

By strategically expanding manufacturing footprints and fostering redundancy, companies can reduce the impact of disruptions and ensure a more secure, consistent supply of essential medications.

Technology and Transparency: Foundations for Resilience

Building supply chain resilience goes beyond facility location. It requires data-driven visibility across every node of the network.

Integrated technology platforms—like LSPedia’s OneScan—play a pivotal role in:

• Linking raw material and API data to finished product serialization

• Monitoring inventory and production trends to anticipate shortages

• Responding to disruptions in real time

This level of traceability not only improves agility but also protects revenue and patient safety.

DSCSA Compliance: Navigating a Complex and Evolving Landscape

The DSCSA's phased rollout has created a patchwork of requirements, with state boards of pharmacy interpreting and enforcing federal mandates differently. For companies operating across multiple states, staying compliant means staying informed.

This includes:

• Monitoring enforcement deadlines and exemption updates

• Participating in state-level forums and maintaining regulatory relationships

• Recognizing the growing role of Verification Router Service (VRS) networks in enabling rapid, interoperable product verification

Organizations that have embraced VRS integration report faster resolutions, reduced quarantine times, and increased trust in product authenticity—all critical to achieving full DSCSA compliance and protecting patients.

The 340B Challenge: Clarifying Compliance in a Complicated Program

The intersection of DSCSA requirements and the 340B Drug Pricing Program introduces another layer of complexity. Contract pharmacy arrangements and discounted pricing models complicate the ownership and exchange of EPCIS data, often blurring responsibility for traceability.

To address this, LSPedia actively participates in GS1-led working groups developing standardized approaches to 340B EPCIS identification. Continued engagement with HHS guidance and industry best practices is essential for stakeholders managing 340B-related shipments.

Data Integrity: The Cornerstone of Operational Excellence

At the heart of DSCSA success lies data quality. Poorly structured EPCIS messages, missing attributes, or inconsistent formatting can lead to exceptions, compliance gaps, and costly disruptions.

Best practices for safeguarding data integrity include:

• Defining and enforcing SOPs and Work Instructions that account for exception handling

• Requiring ongoing staff training across all trading partners

• Establishing performance metrics that evaluate EPCIS data for accuracy, completeness, and timeliness

Using platforms like LSPedia’s OneScan Investigator, companies can proactively detect and resolve exceptions before they cause downstream delays or audit issues.

Preparing for Saleable Returns Verification

One of the most significant DSCSA enforcement milestones is fast approaching: the August 27, 2025, deadline for saleable returns verification.

Given the high volume of returns, wholesalers must verify product identifiers before restocking. The Partnership for DSCSA Governance (PDG) Blueprint offers essential guidance on when and how to apply "direct-to-replicate" verification methods.

Pharmaceutical companies should:

• Familiarize themselves with PDG protocols

• Align internal SOPs with verification standards

• Update training documentation to reflect current guidance

These steps will help ensure compliance, reduce inventory errors, and protect both patient safety and product revenue.

Building a Compliant and Future-Ready Supply Chain

The path forward requires more than meeting mandates. It calls for collaboration, innovation, and a unified commitment to strengthening the supply chain.

At LSPedia, we believe that compliance is only the beginning. With tools like OneScan and Investigator, our mission is to help pharmaceutical companies build agile, data-driven operations that go beyond box-checking—supporting audit readiness, traceability, and long-term resilience.

As the industry adapts to regulatory and operational challenges, one thing is clear: success will belong to those who plan ahead, invest in transparency, and prioritize both security and efficiency across the entire supply chain.