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Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc. In its seventh year of implementation, trading partners involved in manufacturing, distributing, and dispensing prescription drugs in the U.S. (Industry) continue to grapple with requirements of the Drug Supply Chain Security Act (DSCSA), working to set up a fully interoperable electronic system for securing and tracing products across Industry sectors by November 2023. The goal of the DSCSA is to produce a system that enhances national pharmaceutical supply chain security; achieving this goal has required two phases of implementation. In the first phase, traceability requirements at the lot level were implemented beginning in 2015. In the second phase, interoperability requirements allowing for product tracing at the package level are scheduled to become effective in November 2023.

Madeleine giaquintoGreenleaf health incRegulatory affairsHealthcare distribution allianceNational drug codeDrug administrationGreenleaf healthDrug supply chain security actUnder sectionFederal foodCosmetic actDraft guidanceEnhanced drug distribution securityPackage level underDrug supply chain security act implementationSuspect product