Industry Readiness for DSCSA Compliance is “Progressing” but Far from Complete, says HDA

In a second annual survey tracking the evolution of US industry compliance with the Drug Supply Chain Security Act (DSCSA), the Healthcare Distribution Alliance Research Foundation (HDA) finds some progress from last year’s survey, but still a considerable distance to anything near full compliance by November 2023, the deadline date in the 2013 law. In particular, 87.5% of manufacturer respondents are using the EPCIS 1.2 standard to communicate necessary data, and about 95% of respondents have, or plan to have, EPCIS connections with distributors. However, only a small fraction of these connections are in a “production environment” (i.e., in working order) today; dozens will need to be in place for each manufacturer before the DSCSA system becomes a reality.

Some background: EPCIS is a standard developed by the GS1 organization expressly for transmitting the barcode identifiers of individual pharmaceutical packages to trading partners; HDA considers it the “minimum … required” capability. (Industry wags have noted that EPCIS standardization is not written into DSCSA; conceivably, a manufacturer could dump a ton of barcode data on distributors and tell them to deal with it; but distributors by and large have made electronic communication via an agreed-on technology their own business rule.) When fully functional, the DSCSA compliance system will enable the tracking of individual pharma packages from manufacturer to distributor to dispenser.

The HDA survey gives some shape to how DSCSA compliance will operate in the future: as of the survey period, 26% of manufacturers plan to connect to distributors directly, while 69% will use a third party—either a 3PL or a solution provider. Few manufacturer-to-dispenser connections are planned. “Respondents noted that many dispenser customers are planning to use a portal provided by the wholesale distributor, which explains the relatively low number of direct distributor-to-dispenser connections. Rather, distributors reported that transaction data will be exchanged interoperable with manufacturers and posted to a portal that the wholesale distributor maintains on behalf of the dispenser and accessed by the dispenser,” says the report.

“EPCIS Implementation Benchmarking Survey” was conducted in Q4 by the HDA Research Foundation, and is available for free download here. (https://hda.org/~/media/pdfs/center/epcis-implementation-benchmark-survey-q4-2021.ashx) It was sponsored by AmerisourceBergen, LSPedia, TwoLabs Pharma Services, and Antares Vision Group. The latter group, with its software subsidiary RfXcel, has set up an “EPCIS Center of Excellence” which will work with HDA in future surveys.