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Pink Sheet Roundtable: Experts Advise On How To Prepare For DSCSA In 2020

Executive Summary

2020 is when supply chain partners must agree on a vision for the track-and-trace anticounterfeiting system due in November 2023, experts tell the Pink Sheet.

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Lack Of Readiness In Responding To DSCSA Verification Requests Major Concern

Roughly half of all pharmaceutical manufacturers have misgivings they will have the necessary systems to electronically verify saleable returns under DSCSA, even though they must respond to these requests within 24 hours.

New DSCSA Track And Trace Governing Body Up And Running

Despite some previous uncertainty about sufficient funding commitments from members, the coalition of manufacturers, wholesalers and distributors is operational, with a meeting planned for early next year. It will oversee data governance systems for implementing the US supply chain safety law, a key element of the law's third phase set to go into effect November 2023.

FDA Gives Wholesalers One-Year Breather From Saleable Returns Verification

As expected, the FDA will not take enforcement action against wholesalers that are unable to comply with DSCSA’s saleable return verification requirements by the 27 November deadline.

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