November 1, 2021
ARLINGTON, Va. — The pharmaceutical supply chain’s progress on implementing product serialization requirements to comply with the Drug Supply Chain Security Act (DSCSA) has slowed as the November 2023 deadline for compliance comes into view.
According to the HDA Research Foundation’s latest Serialization Readiness Survey, trading partners appear to be deferring their DSCSA-related investments into 2022 or 2023, which could hinder overall supply chain compliance with the federal traceability law.
Now in its sixth year, this survey, released today as part of HDA’s Traceability Online Seminar (November 1–3), assesses the current ability of manufacturers and distributors to meet the DSCSA product serialization requirements. Further, the survey probes into when distributors can expect to receive serialized product and perceptions of dispenser readiness. Data reflect survey responses from 40 manufacturers, including 13 of the 2019 top 20 pharmaceutical manufacturers by sales as listed by IQVIA, as well as 25 distributor companies.
The findings reveal:
HDA recently established an educational resource page in partnership with supply chain partners to help dispensers understand what is expected of them in 2023.
The results of the Serialization Readiness Survey track with the Foundation’s recent EPCIS Benchmarking Survey. The latter survey, released in September, found that few trading partners are prepared to share DSCSA-related data via GS1’s Electronic Product Code Information Services, a necessary requirement for 2023 implementation.
“As the Foundation’s data show, the healthcare supply chain is entering a critical work period over the next two years,” said Perry Fri, Executive Vice President, Industry Relations, Membership & Education, HDA; and COO, HDA Research Foundation. “The uneven state of readiness among supply chain partners has likely been exacerbated by operating under the pressures of the COVID-19 response; however, our findings also illustrate the range of interpretations and information gaps that must be overcome within the next two years. Educating trading partners, such as the dispenser community, and aligning on requirements will be crucial to getting implementation over the finish line.”The Serialization Readiness Survey, sponsored by LSPediA and Movilitas, is available as a complimentary download.
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 nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.