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Brings ongoing GS1 standards development into alignment with the DSCSA
The GS1 organization, and its GS1 Healthcare US unit, has been beetling away for years at standards for identifying and locating healthcare products in transit; when the Drug Supply Chain Security Act (DSCSA) was passed last year, that was merely a turn along the road GS1 has been on. For packaging and distribution managers, logistics providers and others in the US drug supply chain, however, DSCSA was a major milestone that set (among many other deadlines) a January 2015 date for having product identification and transaction data available to trading partners.
Now, GS1 Healthcare US has issued an update, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support the Drug Supply Chain Security Act. To the extent that trading partners in the pharma supply chain (from manufacturer to hospital or retail pharmacy) want to have interoperable data systems, alignment with the GS1 standards is all but mandatory (FDA has been careful not to specify GS1’s or anyone else’s specific standards, but most of the industry has already coalesced around the GS1 framework).
The new guideline provides additional information on how DSCSA’s mandated “transaction history” and related documents are to be formatted and transmitted between trading partners; it becomes a subset of the existing EPCIS guidelines that GS1 has already developed for pharma application. “The ability for stakeholders to share information at the lot-level, and to identify and trace prescription drugs at the item-level is essential for providing critical transparency and accountability in the pharmaceutical supply chain,” said Siobhan O’Bara, SVP of industry engagement, GS1 US, in a statement. “The new guideline shares the best thinking and practical applications for how to address requirements, while also establishing a solid business process for the pharmaceutical industry as we transition to a fully automated and serialized supply chain.”
The document is available for free download here. GS1 Healthcare is also setting up a solution providers page for directing industry managers concerned with DSCSA compliance to telephone contacts; more guidance is scheduled to be released in the near future.