September 15, 2021
ARLINGTON, Va. — Results from a new HDA Research Foundation survey indicate that the pharmaceutical supply chain is entering a critical phase in achieving the transaction data connections required to comply with the Drug Supply Chain Security Act (DSCSA) in 2023.
The inaugural EPCIS Implementation Benchmarking Survey gauges the current state of industry adoption of GS1 Electronic Product Code Information Services (EPCIS) as well as trading partner plans for exchanging DSCSA-required data.
The DSCSA requires transaction data with product identifiers to be provided with physical product on November 27, 2023. Currently, EPCIS is the only widely recognized international standard that allows supply chain partners to share this data in a secure, electronic and interoperable manner, as noted in FDA guidance. The Foundation’s survey aims to inform industry trading partners on the status of successful data connections, defined as “[connections that are] fully integrated and working in a production environment,” and obstacles to implementation.
“Though the deadline for sharing transaction data is two years away, many healthcare supply chain trading partners are realizing there is work to be done to establish proper business-to-business connections; ensure data are formatted, transmitted and received successfully; that processes for troubleshooting are created; and that products in inventory have the right data attached to them for shipping after November 27,” said Perry Fri, Executive Vice President and COO of the HDA Research Foundation. “The Foundation’s survey shows where trading partners are in the process of adopting EPCIS — and digs into what might be leading to slow implementation rates across the supply chain.”
Data reflect responses from across the pharmaceutical supply chain, including 52 manufacturers, 21 distributors and five third-party logistics providers (3PLs); in some cases, certain companies fulfill several supply chain responsibilities. Among the key survey findings:
“As the Foundation’s data suggest, EPCIS implementation is clearly a huge undertaking for healthcare supply chain stakeholders; however, time is of the essence to comply with this critical DSCSA milestone,” said Justine Freisleben, Vice President, Industry Relations, Healthcare Distribution Alliance (HDA). “FDA’s expectations around reaching the 2023 milestone on time are clear. Knowing this, HDA urges trading partners to plan ahead, commit to implementing a solution as soon as possible, and work with their peers to achieve compliance — and for the continued safety and reliability of the U.S. healthcare supply chain.”
The HDA Research Foundation’s EPCIS Implementation Benchmarking Survey, sponsored by AmerisourceBergen, Antares Vision Group, LSPediA and Two Labs, is available as a complimentary download. The Foundation plans to conduct follow-up surveys biannually (subject to funding availability).
Implementation of EPCIS will be among the topics featured at HDA’s upcoming Traceability Seminar, to be held November 1–3. To learn more and register, visit www.HDA.org/Traceability.
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.