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In new guidance from the U.S. Food and Drug Administration (FDA), the organization announced a 12-month stabilization period to give trading partners more time to finalize the implementation of DSCSA-compliant systems and processes.
The FDA states that companies should “use the additional time to implement, troubleshoot, and mature their systems and processes while supporting the continued availability of products to patients.” The FDA strongly reiterated that the law has not changed and this guidance “should not be viewed as providing a justification for delaying efforts… to implement EDDS requirements.”
So, what are the implications of the FDA’s guidance and what should pharmaceutical supply chain trading partners do next? Download our new strategy brief to find out. You’ll get actionable insight into the FDA’s latest guidance, covering topics like:
- What the FDA’s new guidance means for stakeholders across the drug supply chain.
- What actions trading partners need to take over the 12-month stabilization period.
- What the timeline for deploying and stabilizing DSCSA-compliant systems looks like.
- How TraceLink solutions offer the fastest and lowest-cost path to DSCSA compliance.
The clock is ticking and most pharmaceutical supply chain trading partners still have a lot of work to do. Download this strategy brief today to inform your next steps.
