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FDA Gives Stabilization Period for DSCSA

FDA Delays Full Enforcement of EDDS Requirements: What You Need to Know

The FDA announced on Friday, August 25, 2023, that it will be delaying full enforcement of the Enhanced Drug Distribution Security (EDDS) requirements of the Drug Supply Chain Security Act (DSCSA) until November 27, 2024. 

“Don’t Call It A Delay”

First and foremost, it's important to note that the DSCSA itself has not been delayed. Instead, the FDA is granting suppliers additional time to transition from the current state transmission of Advanced Shipping Notices (ASN) via Electronic Data Interchange (EDI) 856 to Electronic Product Code Identification System (EPCIS) file formats. This transition period is being referred to as a "Stabilization Period." 

FDA's Perspective

The FDA acknowledges that while they generally expect trading partners to have systems and processes in place to meet EDDS requirements by November 27, 2023, technical and operational issues may not be fully resolved by that time. They strongly urge trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements. Check the FDA Guidance document for specifics. 

The Impact on Your Store

The Core DSCSA Requirements Remain In Place: The first five requirements of the DSCSA are still in place and are being actively enforced. These requirements are subject to inspection and audit by various regulatory bodies, including State Boards, FDA, DEA, OIG, and PBMs

To comply with the core DSCSA Requirements, Pharmacy Marketplace members are invited to get the traceability tool they need through our partner Capital Drugs 360, powered by Advasur. Get our best deal for DSCSA traceability, two months FREE and no sign up fees when you join. 

Read More and get started here: Capital Drug 360, powered by Advasur Brochure