As of May 27, 2025, the U.S. Food and Drug Administration (FDA) has officially begun enforcing the law’s final requirements. This is a pivotal moment for pharmaceutical manufacturers, wholesalers, 3PLs, repackagers, and dispensers. If you’re still relying on paper-based T3 documentation or haven’t validated your EPCIS data exchange, now is the time to act. Let’s walk through exactly what changed on May 27– and what it means for your operations going forward.
What Changed on May 27, 2025?
While the original DSCSA deadline was November 27, 2024, the FDA provided an informal stabilization period to give the industry time to finalize system testing and partner readiness. That stabilization period ended on May 27, 2025. The FDA is now enforcing the DSCSA as written in the law—meaning the expectations are clear, and the grace period is over.
Key requirements now being enforced
Serialized T3 Data Must Be Exchanged Electronically
All trading partners must now exchange T3 data (Transaction Information, History, and Statement) in a fully electronic and standardized format, typically EPCIS (Electronic Product Code Information Services). Paper, PDF, or manual spreadsheets are no longer acceptable. This applies to both shipping and receiving sides of the transaction.
Verification of Serialized Product Identifiers
You are required to verify that serialized product identifiers—specifically the 2D DataMatrix barcodes on packaging—match the corresponding electronic data.
Each barcode must include:
• GTIN (Global Trade Item Number)
• Serial Number
• Lot Number
• Expiration Date
Verification must happen in real time during transactions, returns, and any investigation of suspect product.
Authorized Trading Partner (ATP) Validation
You must confirm and document that your trading partners are Authorized Trading Partners (ATPs)—licensed and registered under state and federal law. This requirement applies to all entities in the supply chain, including manufacturers, wholesalers, dispensers, and 3PLs. Many organizations are implementing automated ATP lookup tools to streamline this step.
Electronic Recordkeeping & Retrieval
All serialized transaction records must be stored for six years and be retrievable within 48 hours in the event of:
- An FDA audit
- A product investigation
- A supply chain traceback
These systems must be tamper-proof and audit-ready, which is why EPCIS-compliant platforms like STEPLogic Trace are increasingly becoming the standard.
Exception Handling & FDA Notifications
The FDA now expects formal SOPs for handling serialization exceptions, such as:
- Missing or mismatched T3 data
- Failed Verification Router Service (VRS) responses
- Damaged or unreadable barcodes
- Illegitimate product investigations
If a product is deemed illegitimate, companies must notify the FDA within 24 hours using Form 3911, and inform all downstream recipients.
Why This Matters
Enforcement means your systems, processes, and partners are now under active regulatory scrutiny. The FDA has not indicated any further extensions. Companies who cannot demonstrate full compliance face the risk of:
• Product quarantines or holds
• Regulatory warning letters
• Business disruption during audits
• Reputational damage and downstream loss of trust
What Should You Do Next?
If you haven’t already:
- Audit your EPCIS implementation to ensure serialized data is flowing as expected.
- Test your ATP validation process and store evidence of current licenses.
- Review SOPs for exception handling and FDA response.
- Simulate a traceback or audit scenario to confirm your record retrieval system works.
Need Help? We created a free, practical guide that walks through:
- EPCIS and serialization requirements
- ATP lookup integrations
- Barcode verification and GS1 standards
- Exception management and decommissioning
- Real-world audit readiness tips
Download the guide now!
Final Thoughts
DSCSA compliance is no longer about preparing—it’s about proving. The May 27, 2025 enforcement milestone should be viewed not just as a regulatory obligation, but as a catalyst for building a more transparent, efficient, and resilient supply chain. Companies that embrace serialization and traceability as part of their daily operations will gain a competitive edge—not just in compliance, but in trust. If you’re attending the HDA Traceability Seminar, come find us—we’d love to talk about how you’re navigating this new phase.
