Overview

The U.S. life sciences market has specific regulatory challenges outlined by the FDA to protect public health. The U.S. Drug Supply Chain Security Act (DSCSA) defines a system with a timeline for reaching full item traceability by 2023. Each stage requires different levels of compliance by stakeholders.

The DSCSA Enhanced Drug Distribution Security compliance deadline (November 27, 2023) requires that transaction information must include the unique product identifier at the package level for all the packages included in the transaction. In addition, trading partners need to have systems and processes in place to promptly respond with the transaction information and transaction statement for a product, upon a request by an Authorized Trading Partner or the FDA. This request supports the verification or investigation of suspects or illegitimate products.