US FDA Backs EPCIS, Refines Advice As November 2023 DSCSA Deadline Approaches
Executive Summary
Agency recommends the GS1 standard that stakeholders have been focusing on for working together to remove counterfeits from the US pharmaceutical distribution chain; adds its latest thinking on roles of additional types of trading partners.
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a global data sharing standard and updated its thinking about certain types of trading partners in revisions of two draft guidance documents on how to coordinate efforts to identify illegitimate drug products for removal from the legitimate US distribution chain by a 27 November 2023 Drug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 DSCSA pilot projects.
Stakeholders pilot tested the use of technologies like blockchain and radio frequency identification tags. (Also see "DSCSA Pilot Used Blockchain To Trace Drug Through 'Last Mile' of Supply Chain" - Pink Sheet, 28 Jul, 2020.) (Also see "RFID Tags Found To Improve Drug Supply Chain Tracking In Recent DSCSA Pilot" - Pink Sheet, 7 Aug, 2020.)
The Time For Paper Has Passed
The first draft covered initial stages of the 10-year, three-stage DSCSA implementation process, which it said could be paper-based. (Also see "US FDA tells industry how to exchange info to meet new drug tracing law " - Pink Sheet, 2 Dec, 2014.)
In comments on that draft, the Pharmaceutical Research and Manufacturers of America commended the agency for allowing paper-based approaches for initial 2015 DSCSA requirements.
However, the November 2013 DSCSA legislation will not allow the use of paper-based product tracing methods after the November 2023 deadline, and drug distribution chain participants will have to trace products down to the package level unless a waiver, exception or exemption applies, the FDA said in a Federal Register notice scheduled to be published on 6 July explaining the revision, which “is intended to facilitate the creation of a uniform methodology for product tracing while ensuring the protection of confidential commercial information and trade secrets.”
In the revised draft standards guidance, the FDA recommended a data sharing standard for trading partners to use – GS1’s global Electronic Product Code Information Services (EPCIS) standard – saying “FDA believes that EPCIS is an appropriate globally recognized standard, and FDA understands there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution requirements.”
The agency gave industry 60 days to comment on the revision at https://www.regulations.gov/docket/FDA-2014-D-1981/.
More Detail On Additional Participants
The FDA also 5 July proposed to revise its August 2017 draft guidance on identifying DSCSA trading partners with advice on additional roles in the pharmaceutical distribution chain as well as on additional situations. (Also see "FDA Drafts Guidance To Dispel Confusion About DSCSA Trading Partners" - Pink Sheet, 29 Aug, 2017.)
In response to comments and certain policy considerations, the agency said in another Federal Register notice scheduled to be published on 6 July that it has updated its thinking on the roles of private label distributors, salvagers, returns processors and reverse logistics providers.
The revised draft trading partners guidance also clarified certain drug distribution scenarios, including for emergency medical use, office use, and in research, as well as the licensure status of third-party logistics providers.
The 6 July notice gave stakeholders 60 days to comment on the revised draft at https://www.regulations.gov/docket/FDA-2017-D-1956/.