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.
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:
The DSCSA also requires implementation of an electronic, interoperable system to trace prescription drug products.
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:
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.
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).”
Learn all about DSCSA stabilization period and what it means for compliance. Get in touch with a compliance expert today!
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