Elizabeth A. Gallenagh

Traceability/Serialization
Op-ed: Collaboration Is Critical for DSCSA Stabilization
The FDA recently announced a DSCSA “stabilization policy,” but further clarity and education will be needed for all trading partners to ensure they reach compliance.
October 26, 2023
Getty Pharma Dscsa
Traceability/Serialization
Op-ed: Phased Approach to DSCSA an Alternative to Nov. 27 Disruptions
The pharmaceutical supply chain is not where it needs to be as the DSCSA deadline approaches. A new approach is necessary to ensure the safe and secure delivery of medicines come November.
July 6, 2023
HDA believes a phased approach is the best option to avoid drug shortages due to the interdependency of the data exchange under DSCSA (Image: Getty).
Traceability/Serialization
Op-ed: Data Issues Abound as DSCSA Deadline Nears
Trading partners are working diligently to connect data systems in compliance with the Drug Supply Chain Security Act (DSCSA). But significant challenges remain ahead of the November finish line.
February 22, 2023
Under the DSCSA, a distributor cannot accept or sell a product beginning on November 27, 2023, if that product does not have transaction information with the product identifier in an electronic file that meets DSCSA requirements.
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