GS1 US has published a new guideline titled “Best Practice Guidance for 340B Transactions and Drop Shipments,” developed in collaboration with GS1 Healthcare US industry initiative members in the Rx Secure Supply Chain Workgroup to promote interoperability and support more reliable data exchange across the pharmaceutical supply chain.
The new guidance provides best practices for two common transaction types: 340B replenishments and drop shipments. It is designed to help trading partners apply GS1 Standards consistently when exchanging ownership and shipment data under the U.S. Food and Drug Administration Drug Supply Chain Security Act (DSCSA) and the federally mandated 340B Drug Pricing Program, which enables eligible healthcare providers to purchase outpatient drugs at discounted prices to expand patient care.
“Consistent use of GS1 Standards supports more accurate, interoperable data exchange and helps trading partners work together with greater clarity,” says Tracy Nasarenko, vice president of customer success, healthcare, GS1 US. “By implementing standardized approaches to 340B replenishment and drop shipment transactions, pharmaceutical stakeholders strengthen visibility and trust throughout the supply chain.”
The “Best Practice Guidance for 340B Transactions and Drop Shipments” includes:
- Detailed recommendations for the reliable exchange of transaction information between covered entities, contract pharmacies, and suppliers
- Best practices for managing drop shipment transactions
- Best practices for managing 340B replenishment transactions, where covered entities maintain ownership of products dispensed through contract pharmacies
- Methods for handling drop shipment scenarios for shipments made directly to contract pharmacies
- Guidance for managing comingled shipments that include both 340B and non-340B products
- Use of standardized Electronic Product Code Information Services (EPCIS) data formats to support interoperable event-based data sharing
Developed by members of healthcare industry stakeholders, including manufacturers, wholesale distributors, dispensers and solution providers, the document serves as a resource to promote a consistent approach to data exchange that supports business and regulatory requirements and strengthens supply chain collaboration.
For more information or to download the “Best Practice Guidance for 340B Transactions and Drop Shipments,” visit www.supplychain.gs1us.org/standards-and-regulations/drug-supply-chain-security-act.
