Considerations for DSCSA Compliance Implementation

This document is a guide that outlines critical considerations for implementing the FDA’s Drug Supply Chain Security Act (DSCSA). The DSCSA mandates serialization and electronic track and trace for pharmaceutical products, with a deadline of November 27, 2023. The guide details the complexities involved in meeting these requirements, including the importance of accurate labeling and encoding in accordance with GS1 standards. It discusses child-to-parent aggregation, which, while not required, facilitates efficient scanning and tracking of products through the supply chain. Additionally, the document emphasizes the necessity of traceability documents and the use of Electronic Product Code Information Services (EPCIS) to maintain compliance. It highlights the verification process and the challenges companies face in ensuring proper licensing and robust procedures for suspect product investigations. The guide also addresses the handling of returned products and the need for thorough documentation of handling procedures to ensure compliance with DSCSA regulations. Lastly, it mentions exceptions to the DSCSA law and the importance of understanding these exceptions for consistent execution.