What does the FDA’s delay of enforcement of the DSCSA EDDs requirements mean to pharmacies?
The DSCSA act in and of itself has not been delayed; the FDA is allowing suppliers additional time to complete the conversion from current state transmission of ASN via EDI 856 to EPCIS file formats in what they term a “Stabilization Period.”
FDA generally expects trading partners to have the systems and processes in place to meet
the EDDS requirements as of November 27, 2023. Reference the FDA Guidance document.
What is DSCSA?
The Drug Supply Chain Security Act (DSCSA) is a critical piece of legislation enacted to enhance the security and traceability of pharmaceutical products as they move through the supply chain. It aims to safeguard the public health by identifying and eliminating counterfeit, adulterated, or stolen drugs from entering the market.
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