GS1, the global supply chain standards organization, has launched a new messaging standard in collaboration with GS1 US to help meet the requirements of the US Drug Supply Chain Security Act (DSCSA) for salable returns of serialized prescription drugs. Developed and vetted by a global GS1 workgroup comprised of manufacturers, distributors and solution providers, this new standard specifies a lightweight messaging framework for product verification request and response. With this development, supply chain partners will be able to verify that a product in their possession is suitable for forward distribution. Manufacturer verification of the product identifier and associated data will give supply chain stakeholders actionable information helping them to determine whether to accept, reject or quarantine a product.
“In record time, GS1 has delivered a standard that fully meets our needs. It will facilitate our ability to manage interoperability between trading partners within US regulations surrounding salable returns, while incorporating the use of Global Trade Item Numbers (GTINs) and Global Location Numbers (GLNs) for identification of products and parties. Moreover, it is a standard extensible for use in other sectors or additional use cases,” said Jeff Denton, senior director, IT Global Secure Supply Chain at AmerisourceBergen.
Beginning November 27, 2019, the DSCSA will require wholesalers and distributors to verify the unique identifier of returned products before these can be placed into inventory for resale. A manufacturer that receives a verification request from a repackager, wholesale distributor or dispenser will be obliged to respond to that request within 24 hours. Against this backdrop, pharmaceutical supply chain trading partners asked GS1 to develop a verification messaging standard.
“Workgroup members and industry stakeholders should be commended for coming together so quickly to develop and agree upon a standard that aids pharmaceutical, and potentially all industries, create a safer supply chain,” said Siobhan O’Bara, senior vice president, Community Engagement, GS1 US. “The new messaging standard is a significant advancement in driving visibility and helping trading partners authenticate unique product identifiers and data elements to assess product viability.”
Potential Use in Different Sectors Worldwide
Although this standard was driven by pharmaceutical regulatory requirements in the US, it has been developed as a generic lightweight framework that will support re-use and extension for other product sectors (e.g., food, components in technical industries), in all geographic regions.
This standard is a new addition to the “Share” layer of GS1 Standards. The request/response is a form of transactional messaging, albeit without a direct link to existing GS1 Electronic Data Interchange (EDI) standards. This is the first GS1 Standard to include JSON as a message response syntax; it is also the first GS1 Standard to leverage the new GS1 Digital Link (Web URI) standard for the request syntax.