As the final implementation deadline for the Drug Supply Chain Security Act (DSCSA) approaches, the FDA has issued temporary exemptions to ease the path for pharmaceutical manufacturers, distributors, and dispensers. While these extensions offer some temporary relief, the goal of DSCSA remains crystal clear: to ensure that every step in the drug supply chain is secure, transparent, and traceable. In this post, we’ll unpack what DSCSA compliance even means and how SCLogic’s tracking solution can help companies not only achieve but also prove compliance.

What is DSCSA Compliance?

The DSCSA sets strict requirements for traceability in the pharmaceutical supply chain. It aims to protect patient safety by preventing counterfeit or unsafe drugs from reaching consumers, and it mandates that companies track every pharmaceutical product at the individual package level from production to the final point of dispensing.

To meet DSCSA standards, pharmaceutical supply chain partners must:

1. Enable Unit-Level Tracking: Each drug product must carry a unique ID to ensure it can be tracked throughout its lifecycle.
2. Maintain Full Chain of Custody: Each transfer of a product, from manufacturer to distributor to dispenser, must be documented to maintain a clear record of custody.
3. Establish Robust Data Exchange: Supply chain partners must share traceability data to create an unbroken chain of information, ensuring products are authentic and securely handled.

The FDA’s latest guidance grants temporary exemptions for partners working to achieve compliance but are facing technical or operational challenges with data exchange. These exemptions extend the timeline to allow companies to stabilize their operations.

How SCLogic’s Tracking Solution Helps Achieve and Prove DSCSA Compliance

SCLogic’s internal logistics tracking platform, Intra, provides the features and tools to streamline compliance efforts and easily demonstrate adherence to DSCSA regulations. Here’s how:

• Precise Unit-Level Tracking: SCLogic’s solution allows companies to track individual items with unique IDs (barcodes), ensuring visibility and traceability. By maintaining precise, real-time tracking, SCLogic helps companies fulfill the DSCSA’s unit-level tracking requirements. This is a critical foundation for proving compliance, as it establishes a clear record of each product’s journey through the supply chain.
• Comprehensive Chain-of-Custody Documentation: DSCSA compliance requires that every handoff in the supply chain is documented. SCLogic’s platform allows users to create an end-to-end chain-of-custody record, capturing every touch point and verifying custody to eliminate gaps in traceability. This digital record ensures that companies can present a complete audit trail upon request, proving that each product remained within the secure supply chain from start to finish.
• Facilitating Data Exchange for Complete Visibility: A significant DSCSA challenge is establishing seamless data exchange among all supply chain partners. SCLogic’s tracking solution supports real-time integration with other systems (like ERP and WMS) to enable data sharing across the supply chain. By creating a shared data environment, SCLogic helps companies prove they can meet the DSCSA’s data exchange requirements, which is essential for ensuring compliance.
• Scalable, Flexible Workflows for Phased Compliance: With the FDA’s phased compliance deadlines, companies may implement different levels of compliance readiness based on their operational capacities. SCLogic’s platform offers scalable workflows, allowing companies to adapt tracking and compliance protocols as needed to meet specific timelines. This flexibility not only aids in achieving compliance but also in demonstrating how and when compliance standards are met.
• Audit-Ready Reporting for Transparent Compliance Proof: Compliance is only as good as a company’s ability to prove it. SCLogic’s solution includes powerful reporting and documentation features that allow companies to generate audit-ready reports with a clear record of compliance activities. This ensures that companies can provide complete, accurate, and timely records that showcase compliance with DSCSA standards when the FDA or other regulatory bodies request proof.
• Enhanced Security for Data Integrity: Protecting the integrity of tracking data is essential to proving compliance. SCLogic’s logistics tracking solution incorporates encryption, access controls, and data integrity measures that safeguard against tampering or unauthorized access. By maintaining secure, accurate records, companies can confidently provide proof that their products and processes meet DSCSA standards.

Preparing for Future DSCSA Requirements with SCLogic

Although current exemptions provide temporary flexibility, DSCSA compliance will ultimately become mandatory for all pharmaceutical supply chain partners. SCLogic’s Intra platform is designed to support current DSCSA standards and adapt as regulations evolve. By implementing SCLogic’s tracking solution, companies can prepare for the future of traceability while confidently proving compliance today.

With SCLogic as a compliance partner, pharmaceutical companies gain the tools they need to meet DSCSA requirements, enhance supply chain transparency, and document their compliance in an audit-ready format. Are you ready to start your DSCSA compliance journey? Reach out to us at [email protected] and see how Intra can work for you.