The pharmaceutical industry is undergoing a significant regulatory shift with the implementation of the Drug Supply Chain Security Act (DSCSA), signed into law in 2013. This act aims to enhance supply chain transparency and security, with phased implementation deadlines that manufacturers need to be aware of. This article summarizes some the key insights from a recent LinkedIn live session focusing on DSCSA compliance, serialization and best practices for pharmaceutical companies with me Sanjay Padaki (Principal at Spark Consulting) and Joe Lipari (Director of Product at Systech).

Understanding DSCSA compliance and deadlines

The DSCSA was enacted to create a more secure and transparent pharmaceutical supply chain. Prior to its enactment, various state-level initiatives aimed to achieve similar goals. The FDA has established a phased implementation plan for DSCSA, with specific deadlines for different stakeholders:

• Manufacturers and Repackagers: May 27, 2025
• Wholesale Distributors: August 27, 2025
• Large Dispensers (26 or more FTEs): November 27, 2025
• Small Dispensers (25 or fewer FTEs): November 27, 2026

To avoid regulatory issues and ensure compliance with serialization and traceability requirements, pharmaceutical companies must prepare well in advance of these deadlines.

Serialization and traceability across drug development

Serialization and traceability are critical for ensuring product authenticity and patient safety throughout the supply chain. Requirements vary across drug development phases:

• Clinical Trial stage: Manual tracking methods, such as spreadsheets and barcodes, are typically used, and DSCSA compliance is not mandatory at this stage.
• Commercial stage: Full serialization (L1–L5) is required to track and trace drugs from manufacturing to the patient.

While this approach applies to small molecules and biologics, Cell and Gene therapies require more rigorous processes to maintain chain of identity and custody. Thus, companies often invest in more robust solutions earlier in the development phase.

L1–L5 serialization explained

Serialization is structured into five levels to ensure seamless tracking at every stage:

• L1–L3 (Manufacturing & Packaging): These levels ensure that products are labeled and tracked at both the line and site levels, enabling real-time data collection on production and packaging.
• L4–L5 (Enterprise & Network-Level data exchange): This level facilitates regulatory reporting, return management and global traceability, ensuring compliance with DSCSA requirements.

Best practices for manufacturers

To meet DSCSA-Konformität while improving operational efficiency, manufacturers should adopt proactive strategies:

• Start early: Compliance implementation is a time-consuming process. Companies developing small molecules and biologics should begin serialization planning and implementation during Phase 3 clinical trials.
• Collaboration is key: Serialization requires cross-functional teamwork. Departments such as manufacturing, packaging, IT, regulatory affairs, quality, marketing and finance must collaborate to ensure a robust and compliant solution.
• Choose the right partners: Working with trusted CMOs, packaging vendors and serialization providers can streamline implementation and prevent delays. These partnerships should be long-term, as changing suppliers can be expensive and time-consuming.
• Prioritize scalability: A short-term solution may not be sufficient. Serialization should support the transition from clinical trials to full commercialization, ensuring systems can handle increased production volumes as the product goes through its lifecycle.

Technology and automation trends

Since DSCSA implementation has a long timeline, manufacturers must stay updated on technological advancements that can streamline compliance, such as:

• Verification Router Service (VRS): This technology automates product verification requests, enabling real-time request-response performance and minimizing errors.
• Data integration (APIs, Cloud Systems): This improves data exchange between trading partners, lowers compliance costs and enhances regulatory reporting accuracy.

Future DSCSA considerations

Companies must go beyond the minimum compliance requirements and consider serialization as a strategic advantage as DSCSA regulations continue to evolve.

• Compliance extends beyond serialization: It also includes data storage, seamless partner integration, and real-time traceability across the supply chain.
• Leverage serialization for competitive advantage: Companies that invest in advanced serialization and aggregation will see benefits such as stronger supply chain security and enhanced transparency.

Final thoughts

The DSCSA compliance deadlines are approaching quickly, and pharmaceutical manufacturers must act now to ensure readiness. By implementing L1–L5 serialization, automating processes, and leveraging technology, companies can achieve compliance while enhancing operational efficiency.

For deeper insights into cell and gene therapy compliance, stay tuned for the next live session on Thursday, February 20th.