HDA Survey Results Indicate More Preparation Necessary for Connecting EPCIS-Enabled Systems Before DSCSA Deadline

May 22, 2023

Data released by the Healthcare Distribution Alliance (HDA) indicate more preparation is needed to ensure all healthcare supply chain partners are ready to meet the requirements of the Drug Supply Chain Security Act (DSCSA). HDA’s latest EPCIS Implementation Benchmarking Survey provides a final report on supply chain partners’ progress toward the November 27, 2023, deadline to connect data systems to exchange serialized transaction data for all pharmaceuticals.

DSCSA aims to deter the presence of illegitimate products across the U.S. pharmaceutical supply chain. By the November 27 implementation deadline, all trading partners must exchange unit-level data for products in a secure, electronic, interoperable manner in compliance with Food and Drug Administration (FDA) guidance. FDA has recognized GS1’s Electronic Product Code Information Services (EPCIS) as the standard that will enable trading partners to exchange serialized transaction data.

Since HDA began collecting data in 2021, there have been significant strides regarding EPCIS implementation, onboarding and connecting to partners as transaction data move downstream. This final edition of the survey was conducted in the fourth quarter of 2022, and participants included manufacturers, distributors, repackagers and 3PLs. The topline findings from this latest survey include:

  • From 51 percent in the third quarter, there was a slight increase in planned connections between manufacturers to distributors deemed “in-process/complete.” The number rose to 56 percent by the end of the fourth quarter.
  • Manufacturer participants report they face crucial obstacles in establishing connections through EPCIS. The top three challenges associated with implementation include onboarding length of time, employee knowledge and information technology-related issues.
  • The industry reports EPCIS adoption is beneficial for “meeting GS1/DSCSA compliance,” “standardization” and “efficient data capture/transfer.”

“It is critical for the FDA to communicate how they plan to address the very real potential for product shortages and supply chain disruptions if trading partners are not ready by November 27. To that end, HDA also reiterates its request for the agency not to exercise blanket enforcement discretion for DSCSA implementation,” said Perry Fri, Executive Vice President, Industry Relations, Membership & Education and COO, HDA Research Foundation. “The hard work of implementation must continue across the supply chain and HDA will remain a resource to stakeholders and the FDA by providing relevant education as well as timely information sharing and communication.”

To read the full report, click here. Additional DSCSA-related resources are available through the HDA website.

About HDA

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.