DSCSA: What You Need to Know
The Drug Supply Chain Security Act (DSCSA) is transforming how prescription drugs move through the U.S. supply chain. This page provides a clear summary of what’s required, what’s changing, and where to find trusted information.
Key Industry Changes
The stabilization period ended in late 2024.
The FDA gave trading partners until November 27, 2024 to implement electronic, interoperable systems without enforcement penalties.
Phased enforcement begins in 2025.
Full DSCSA requirements are being enforced in stages depending on your business type. Scroll down for a detailed timeline.
Serialized data exchange is mandatory.
All trading partners must transmit transaction data using EPCIS format to support product tracing and verification.
Your role determines your responsibilities.
Manufacturers, repackagers, wholesalers, and dispensers each have distinct obligations under the law.
Compliance requires operational readiness.
It's not just about software. It’s about people, SOPs, verification processes, and preparedness for product investigations.
Enforcement Timeline
Nov 27, 2024
Whom It Affects
All trading partners
Requirement
End of FDA stabilization period
May 27, 2025
Whom It Affects
Manufacturers & Repackagers
Requirement
Serialized data exchange (EPCIS), verification, traceability
Aug 27, 2025
Whom It Affects
Wholesale Distributors
Requirement
EPCIS exchange and traceability enforcement begins
Nov 27, 2025
Whom It Affects
Dispensers with 26+ pharmacists and/or technicians
Requirement
Must meet all DSCSA requirements
Nov 27, 2026
Whom It Affects
Dispensers with ≤25 pharmacists and/or technicians (small)
Requirement
Must meet all DSCSA requirements
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Not sure if DSCSA applies to you? We recommend checking with your legal or compliance team to confirm.