Experts continue to sound the alarm on DSCSA compliance progress in the pharmaceutical manufacturing industry, withimplementing GS1 Electronic Product Code Information Services (EPCIS), as well as trading partner plans for exchanging data. The upcoming November 27, 2023 DSCSA compliance date requires transaction data with product identifiers to be provided with physical product.
作为杰夫•Falardeau经理,制药公司information technology atCardinal Health,said at the Healthcare Distribution Alliance (HDA) 2021 Traceability Webinar Series, “…we're just really concernedabout the runway left and the number of manufacturers that still need to jump in the pool here and start testing with us before 2023.”
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Watch this video onexchanging data EPCIS files. |
HDA’s Research Foundation released its inaugural report,EPCIS Implementation Benchmarking Survey,enlightening industry trading partners on the status of successful data connections, defined as “[connections that are] fully integrated and working in a production environment,” and perceived obstacles to implementation.
Available as a complimentary download, the 16-page report’s data reflects responses from 70 companies across the pharmaceutical supply chain, including manufacturers, distributors, and 3PLs.
The results offered some startling statistics, including the following:
- 59% of manufacturers report they are not currently sending data to distributors—HDA says manufacturers cite “delays due to either past or potential future enforcement discretion” as the top obstacle to implementing EPCIS at 43%.
- More than half (57%) of manufacturers have no successful connections in a production environment today.
- Most distributors are not connected to manufacturers in production today, and no connections in a production environment currently exist with distributors’ dispenser customers.
- A typical 3PL currently is working to connect an average of 67 manufacturer clients. Respondents cited “readiness of their clients” and “wholesale distributors … not articulating clear deadlines to trading partners for taking necessary steps” as barriers to implementation.
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Read this story onfour DSCSA guidances released this summer. |
Said Justine Freisleben, vice president, industry relations, HDA, “FDA’sexpectationsaround reaching the 2023 milestone on time are clear. Knowing this, HDAurgestrading 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.”
“虽然共享事务数据的最后期限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.”
Download the full complimentary report:EPCIS Implementation Benchmarking Survey
