Navigating DSCSA Compliance for Dispensers

This guide outlines the Drug Supply Chain Security Act (DSCSA) compliance requirements for dispensers, effective March 1, as enforced by the FDA. It details the phased approach to compliance, beginning with initial requirements established in 2015, which mandate that dispensers receive lot-level documentation known as Transaction History, Transaction Information, Transaction Statement, or T3 for every product purchased. The guide explains the operational impacts of these requirements on pharmacies and hospitals, emphasizing the need for proper documentation management and compliance processes. Future serialization requirements set for 2020 and 2023 are also discussed, highlighting the necessity for dispensers to adapt their operations to meet evolving compliance standards. Additionally, the guide presents various approaches to achieving compliance, including reliance on paper documentation, supplier portals, and third-party compliance solutions, each with its advantages and drawbacks. The document emphasizes the importance of timely and accurate compliance to mitigate risks associated with regulatory enforcement.