The FDA basically stated that currently used methods of information exchange from paper to electronic were suitable “interoperable” exchange methods and that trading partners should continue to use available methods.

Many in the industry had expected FDA to begin establishing the blueprint for drug product tracing transaction exchange. Instead of recommending exchange standards that facilitate the accurate and efficient interchange of information among trading partners, FDA chose to list known information-exchange methods currently in widespread use and declare them acceptable.

EPCIS Implementation Guidelines are updated to support DSCSA compliance. Learn how GS1 Standards can best be applied to meet lot-level and item-level traceability requirements as stipulated in US FDA DSCSA regulation.