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Monthly HealthRISC Overview | DSCSA Stabilization Period

The FDA recently announced a 1-year delay of the electronic prescription tracking system outlined under the Drug Supply Chain Security Act (DSCSA). The extension to November 27, 2024, provides a stabilization period, giving trading partners additional time to “implement, troubleshoot and mature their electronic interoperable systems” while avoiding supply chain disruption and ensuring patient access. Per the FDA, this period is not intended to provide justification for delaying efforts to comply with the DSCSA.

Two compliance policy guidance documents are available to support stakeholders with DSCSA implementation requirements. The FDA intends these compliance policies be read in conjunction with the final guidance document, Drug Supply Chain Security Act (DSCSA) Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs — Guidance for Industry, published on 9/6/23.

Stay in the know with all DSCSA related updates by subscribing to HealthRISC (Regulatory Intelligence and Simplified Compliance): Drug Supply Chain, a monthly reporting service curated to meet your regulatory and policy tracking needs.


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