At DolphinDC, we know how critical compliance is in the pharmaceutical supply chain. The countdown is on for the full implementation of the Drug Supply Chain Security Act (DSCSA), designed to ensure that prescription drugs moving through the U.S. supply chain are verifiable at the package level — protecting patients, manufacturers, and distributors alike.

What the DSCSA Requires

Enacted in 2013 as Title II of the Drug Quality and Security Act (DQSA), the DSCSA applies to every link in the chain: manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (3PLs). 
Key obligations include:

• Product tracing: Trading partners must exchange Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) for each drug shipment. Since 2023 paper documentation has been phased out in favor of electronic traceability, and by 2025 serialized identifiers at package level are required.

• Verification systems: Entities must detect and investigate any suspect or illegitimate product — including checking identifiers and responding to requests from the Food & Drug Administration or partners.

• Licensing & reporting: Wholesale distributors and 3PLs must maintain national licensure, register with the FDA and update status annually.

• Interoperability: All electronic systems must be able to exchange data seamlessly — the FDA recommends using the EPCIS (Electronic Product Code Information Services) standard.

What Dispensers and Others Need to Know

If you’re a dispensing entity, your responsibilities include:

• Accepting only those products that come with complete TI, TH and TS records.

• Ensuring your trading partners are properly licensed and registered.

• Retaining records for at least six years.

• Quarantining and investigating any products suspected to be counterfeit, stolen or otherwise illegitimate.

Compliance Milestones You Shouldn’t Miss

The key timeline to mark:

• Manufacturers & Repackagers: May 27, 2025 for full compliance.

• Wholesale Distributors: August 27, 2025.

• Large Dispensers (26+ staff): November 27, 2025.

• Small Dispensers (25 or fewer staff): November 27, 2025.

Why It Matters to You — and How DolphinDC Can Help

For pharmaceutical manufacturers, logistic providers and dispensers, the DSCSA isn’t just another regulation — it’s a fundamental shift in accountability, traceability and data management. Failing to meet these requirements exposes your organization to risk: regulatory penalties, supply chain disruption, reputational damage and worse — potential threats to patient safety.

That’s where DolphinDC steps in. We provide tailored solutions that simplify your path to compliance: from verifying serialization and bar-code quality to integrating electronic traceability systems and ensuring all data exchanges meet DSCSA standards.

Key areas where we deliver value:

• Barcode verification to ensure your serialized identifiers are readable, properly formatted and compliant.

• Integration of interoperable electronic systems that align with EPCIS standards and enable seamless communication across trading partners.

• Auditing of your supply-chain workflows to ensure TI, TH and TS records are complete, retained and ready for inspection.

• Training and best-practice guidance, so your team understands what’s required, what to look for — and how to act when something goes wrong.

Time Is of the Essence

With the window closing on full DSCSA readiness, there’s no time to wait or assume “we’re already compliant.” The data exchanges, serialization systems and traceability workflows must be in place — and working flawlessly.

Let DolphinDC guide your organization through this transition. We’ll help you not just meet the deadline… but build a sustainable, resilient supply-chain infrastructure that sets you up for future regulatory success and operational excellence.

Reach out today at DolphinDC.com and ensure your supply chain is ready for the DSCSA deadline — because compliance isn’t optional, it’s foundational.