HDA Fosters DSCSA Learning and Collaboration Through Recent Traceability Seminar and New Survey Findings
Since helping secure passage of the Drug Supply Chain Security Act (DSCSA) in 2013, HDA has championed industry readiness, stakeholder collaboration and trading partner education around traceability implementation. With the compliance deadline now 13 months away, HDA and the HDA Foundation continued these efforts by hosting the annual Traceability Seminar and releasing the Serialization Readiness Survey and EPCIS Implementation Benchmarking Survey. These educational offerings gauge sector progress toward interoperability and help coalesce supply chain partners to align on critical next steps for compliance.
Encouraging Stakeholder Collaboration at the Traceability Seminar
HDA’s annual Traceability Seminar, held on October 12–14 covered key DSCSA topics through multiple sessions, roundtable discussions and expert panels. The seminar, which was held for the first time in person since 2019, brought together supply chain stakeholders to discuss FDA guidelines and expectations, state enforcement approaches, industry implementation processes, EPCIS onboarding and dispenser community concerns. Notably, Thursday morning’s schedule included an important update from FDA’s Connie Jung, RPh, Senior Advisor for Policy.
Jung opened the session discussing the history of the DSCSA, remarking, “We have been working for nine years, but even before then. It’s great to see we’re in year nine, and so much has been implemented — but there’s more to do.” She emphasized the importance of the critical remaining piece of the DSCSA compliance puzzle, which lies in “all electronic” tracing and verification at the package level and underscored “the requirements are here to stay.”
After reinforcing the eminent November 27, 2023, deadline, Jung told attendees to “look for an upcoming FDA meeting” about DSCSA, which is anticipated to be virtual. Toward the end of the session, Jung echoed messaging from HDA’s Perry Fri, EVP of Industry Relations, Membership & Education; and COO of the HDA Research Foundation, who talked about the importance of collaboration among trading partners and stakeholders, by saying, “collaboration among you all [industry trading partners], but also with us as well."
During the Q&A, attendees asked Jung about topics including the reconciliation portion of the Enhanced Drug Distribution Security (EDDS) Draft Guidance, decommissioning serial numbers and transition inventory guidance. Regarding the EDDS guidance, Jung shared the agency is planning “several revisions to that guidance in different parts, based on the comments we received.” Earlier this year, HDA and our members reiterated concerns with FDA’s initial proposal; the association called for the agency to withdraw it given the substantial compliance risks and barriers to implementation that would likely arise from the draft guidance as initially proposed.
Assessing DSCSA Readiness Through Benchmarking SurveysIn conjunction with the seminar, the HDA Research Foundation released the seventh edition of the Serialization Readiness Survey, which analyzes trading partners’ readiness to comply with DSCSA requirements. Of note, three-quarters of surveyed pharmaceutical manufacturers anticipate sending 100 percent of DSCSA-required serialized data with shipped products by November 27, 2023 — the deadline to comply with the law. While most manufacturers (84 percent) have no concerns with meeting the requirement to process serialized saleable returns, approximately 45 percent of distributors do have concerns with meeting the requirement, tied to continued lack of access to master data (though that access has improved since the 2021 survey).
This aligns with the reported data that though many distributors can receive serialized product today, they indicated that most manufacturer suppliers are not yet providing data for total product lines. Perry Fri commented that “The Foundation’s data show the industry is making progress, but also prompt us to ask what the operational impact to the supply chain will be come November 28, 2023, if manufacturers continue to defer their serialization investments well into the final year of DSCSA implementation.” Download the survey, sponsored this year by 3Keys GmbH, HealthFirst and LSPediA.
HDA also released updated data for the EPCIS Implementation Benchmarking Survey (now conducted quarterly in collaboration with Vantage Solutions). The survey assesses the status of successful trading partner connections using the FDA-recommended GS1 Electronic Product Code Information Services (EPCIS) standard. The latest data reflect responses from the first half of 2022 and show the industry still has significant work to do to address key obstacles including "lack of trading partner understanding/commitment" and "dedicated IT and employee resources." Download the survey.
As the November 2023 deadline nears, the sector appears to be making progress toward interoperability; however, the data and discussion from these recent events underscore the importance of sector-wide collaboration and continued education — and have also surfaced gaps in knowledge and readiness that must be overcome.