If 2023 was the year of implementing systems and processes for meeting the U.S. Drug Supply Chain Security Act (DSCSA) requirements, 2024 is the year of system and process maturation. The FDA’s “stabilization period” offers the industry time to refine their implementations, providing companies with 10 more months to further test and operationalize their DSCSA systems and processes to minimize disruption to the pharmaceutical supply chain.
A significant challenge that the industry will face as it takes a critical look at DSCSA processes is how to handle DSCSA-related compliance exceptions. This article looks at what the industry can do to improve exception management before the end of the stabilization period and how TraceLink can help automate and streamline this process.
New DSCSA requirements for product traceability result in new exceptions
In 2023, the final set of requirements for the U.S. DSCSA went into effect. Under this mandate, all entities in the pharmaceutical supply chain are now required to exchange serialized unit-level product data in a digital, interoperable, and secure manner to enhance drug traceability. While most trading partners are capable of sending and receiving lot-level transaction data with minimal problems, the shift to electronic exchange of serialized unit-level data adds another layer of complexity. Read more >
