The pharmaceutical industry needs an automated data exchange to achieve unit-level traceability as required by the Drug Supply Chain Security Act (DSCSA) by its 2023 deadline.

The DSCSA aims to enhance product legitimacy verification, improve recall efficiency, and detect illegitimate products in the supply chain. Serialization, which involves assigning a unique serial number to each saleable unit of prescription drugs, is a key component of the legislation.

Currently, the exchange of master data is predominantly done manually, with data being pulled from internal systems and shared through spreadsheets via email. The industry is facing challenges related to interoperability and data management among trading partners. The use of Electronic Product Code Information Services (EPCIS) files is proposed as a common framework for data exchange. However, the adoption of EPCIS has been slow, and manufacturers are encountering issues during the testing and production stages.

Challenges include errors in master data files, adherence to standards, and the need for communication and process improvements. It is essential for manufacturers and solution providers to upgrade to the latest version of EPCIS (1.2) and collaborate closely to ensure the quality and viability of data files. For low-volume manufacturers, there are options for generating EPCIS messages without requiring additional costly systems. Standard templates and forms are available for data exchange between manufacturers and wholesale distributors.

Regarding responsibilities, manufacturers are required to send transaction information to distributors, but some manufacturers may rely on third-party logistics providers (3PLs) for data transmission. However, manufacturers remain ultimately responsible for providing information to regulatory authorities.

The use of a Verification Router Service (VRS) is discussed in relation to saleable returns verification. While some manufacturers prefer using EPCIS files for verification, VRS may be necessary for cases where EPCIS events are not available.

Future considerations include data exchange with downstream trading partners and addressing data flow for drop shipments. Panelists emphasized the importance of establishing exception management processes and seeking assistance for data exchange. Timely adoption and collaboration between manufacturers and distributors are crucial, and proficiency levels in implementing the necessary changes vary across the industry. Automation, conformance testing, and seeking help from solution providers are recommended to meet the DSCSA requirements before the 2023 deadline.