US FDA Backs EPCIS, Refines Advice As November 2023 DSCSA Deadline Approaches

The US FDA has recommended a global data sharing standard and updated its thinking about certain types of trading partners in revisions of two draft guidance documents on how to coordinate efforts to identify illegitimate drug products for removal from the legitimate US distribution chain by a 27 November 2023 Drug Supply Chain Security Act deadline.

One document initially drafted in November 2014 on interoperable exchange of information was revised 6 July to focus on the final stage of DSCSA implementation, and to reflect findings from...