The FDA will begin enforcing the Drug Supply Chain Security Act (DSCSA) of 2013 in a little more than 11 months, further securing the U.S. pharmaceutical supply chain against the threat of illegitimate product movement. Over the past 10 years, pharmaceutical supply chain stakeholders have been preparing for this complete overhaul of systems and processes for shipping and verification of medicines and drug products. After November 27, 2023, pharmaceuticals will travel through a multi-layered chain of custody — from manufacturers to dispensing pharmacies — with transaction data with product identifiers required to be provided with physical product.
Stakeholders have identified the standards for exchanging transaction data, which include product identifiers for the package(s) transacted in a secure, electronic, interoperable manner complying with all elements of the published FDA guidance. FDA has named GS1’s Electronic Product Code Information Services (EPCIS) as the recognized standard that will allow trading partners to exchange transaction data.
The following key elements continue to be prioritized by trading partners:
HDA continues to benchmark progress of EPCIS adoption and trading partner plans for sending datathrough quarterly surveys. As the DSCSA deadline approaches, HDA seeks to inform industry trading partners on the status of successful connections — defined as a connection that is fully integrated and working in a production environment — and the key obstacles that manufacturers, distributors, repackagers and third-party logistics providers (3PLs) face in establishing those connections. This edition of HDA’s EPCIS Implementation Benchmarking Survey is a follow-up to survey conducted in June 2022.
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