Are you DSCSA-compliant?

To protect consumers from prescription drugs that are counterfeit, contaminated, adulterated or otherwise unfit for U.S. distribution, the U.S. Congress enacted the Drug Supply Chain Security Act (DSCSA) in 2013. The DSCSA deadline to comply with interoperability requirements—November 27, 2023—has passed for drug manufacturers, repackagers, distributors and dispensers, but the FDA has mandated a one year stabilization period.

What constitutes compliance?

The DSCSA requires that every prescription drug package and homogeneous case have its own unique identifier in machine- and human-readable forms. The machine-readable form must be a 2D Datamatrix barcode that contains the following:

  • National Drug Code
  • Serial number
  • Batch number
  • Expiration date

The DSCSA also requires implementation of an electronic, interoperable system to trace prescription drug products.

Stabilization period checklist

There’s work to be done and time is short. We can help. As the global leader in serialization, Systech offers the speed, flexibility and proven expertise needed to get you to compliance. Together, we’ll implement solutions to:

  • Exchange EPCIS compliant data with authorized trading partners
  • Employ the Verification Router service to verify the legitimacy of saleable returns and suspect product
  • Exchange DSCSA enforced data with authorized trading partners through authorized trading partner (ATP) services
  • Store product tracing information for all relevant transactions to respond to tracing requests in less than 24 hours 
  • Implement exceptions management solution to ensure the physical matches the digital. 

Systech provides a complete traceability solution for everyone in the supply chain ecosystem—manufacturers, contract packagers, distributors, 3PLs, dispensaries and regulatory bodies. Our proven implementation process is configurable, scalable and built to meet the integration and compliance requirements of today and tomorrow.

Open Credentialing Initiative Member

Systech is proud to be recognized as a VRS provider committed to the Open Credentialing Initiative 

“OCI is an open initiative enabling trusted digital interactions between Authorized Trading Partners (ATPs) in the U.S. pharmaceutical supply chain to meet the requirements of the U.S. Drug Supply Chain Security Act (DSCSA).”

With the DSCSA enforcement deadline looming in Nov 2024, there's no room for delay!

Learn all about DSCSA stabilization period and what it means for compliance. Get in touch with a compliance expert today!

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