GS1 US has published “Best Practice Guidance for the Handling of Saleable Return Transactions,” a new industry resource designed to help pharmaceutical trading partners consistently manage eligible prescription drug returns and the data needed to support Drug Supply Chain Security Act (DSCSA) requirements.
The guidance is intended for manufacturers, wholesale distributors, pharmacies, hospitals and other authorized trading partners that send, receive or process pharmaceutical returns for reintroduction into commercial distribution after product identifiers have been successfully verified and the products have been associated with the applicable transaction records. It provides recommended practices for return authorization, product verification, transaction record association, exception management, documentation and reconciliation, including considerations for more-complex return scenarios.
“Saleable returns can create operational and compliance challenges when product, serialized identifiers and transaction records do not align,” says Tracy Nasarenko, vice president of community engagement, GS1 US. “This guidance gives trading partners a common approach for verifying returned products, identifying and resolving exceptions and maintaining the records needed to support DSCSA requirements. Greater consistency across the industry can help trading partners make return decisions more efficiently and with greater confidence.”
Under DSCSA, a returned prescription drug product intended for resale must be associated with the applicable Transaction Information (TI) and Transaction Statement (TS), and its product identifier must be verified before the product is reintroduced into commercial distribution. The guidance outlines how trading partners can use transaction records and serialized product data to support that determination and address exceptions when the physical product and accompanying data do not match.
It also incorporates GS1 Standards used to identify products and locations and exchange supply chain data, including Global Trade Item Numbers (GTINs), Global Location Numbers (GLNs) and Electronic Product Code Information Services (EPCIS).
For more information about pharmaceutical supply chain visibility, visit the GS1 Standards and DSCSA resource page. To learn more about handling pharmaceutical saleable returns, download “Best Practice Guidance for the Handling of Saleable Return Transactions.”
