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GS1 US Introduces Best Practice Guidance for 340B Transactions and Drop Shipments

On November 12, 2025, GS1 US released a pivotal guideline titled "Best Practice Guidance for 340B Transactions and Drop Shipments." This initiative, developed in partnership with members of the GS1 Healthcare US team and the Rx Secure Supply Chain Workgroup, aims to bolster interoperability and facilitate efficient data exchange across the pharmaceutical supply chain.

The recently introduced guidelines focus on two prevalent transaction types: the replenishment of 340B drugs and drop shipments. They are crafted to assist trading partners in implementing GS1 Standards consistently, ensuring compliance with the U.S. Food and Drug Administration's Drug Supply Chain Security Act (DSCSA) as well as the federally mandated 340B Drug Pricing Program. This program is crucial for enabling eligible healthcare providers to procure outpatient drugs at reduced prices to enhance patient care.

Tracy Nasarenko, vice president of customer success in healthcare at GS1 US, emphasized the importance of consistent GS1 Standards usage in achieving accurate and interoperable data exchange. She stated, "By standardizing 340B replenishment and drop shipment transactions, pharmaceutical stakeholders can foster improved visibility and trust within the supply chain."

The guideline encompasses several best practices focused on reliable data exchange, detailing recommendations tailored for various stakeholders:

1. Reliable Transaction Information Exchange: The document outlines methods for the dependable exchange of transaction information among covered entities, contract pharmacies, and suppliers.
2. Drop Shipment Management: Best practices for managing drop shipment transactions are included, ensuring clarity and efficiency in the supply chain.
3. 340B Replenishment Transactions: The guidance provides actionable insights on managing 340B replenishment transactions where covered entities hold ownership of products sent through contract pharmacies.
4. Direct Shipments to Contract Pharmacies: It also highlights strategies for managing drop shipments directed to contract pharmacies.
5. Comingled Shipments: Guidance is given for handling shipments that include both 340B and non-340B products, addressing potential complexities in the supply chain.
6. Standardized Data Sharing: The guidelines advocate for the usage of standardized Electronic Product Code Information Services (EPCIS) data formats to support interoperable, event-based data sharing.

These best practice guidelines have been meticulously developed with inputs from healthcare industry stakeholders, including manufacturers, wholesale distributors, dispensers, and solution providers. The document serves as a comprehensive resource promoting a cohesive approach to data exchange that not only meets business and regulatory demands but also enhances collaboration within the supply chain.

For those interested in further exploring the details of this essential guidance, it can be downloaded from the GS1 US official site at www.supplychain.gs1us.org.

About GS1 US

GS1 US is a not-for-profit organization recognized for empowering companies to optimize their supply chains to deliver safe, consistent, and authentic experiences to consumers. Known primarily for its UPC barcode system, GS1 establishes a universal language for companies to monitor, capture, and exchange trusted data within their physical and digital supply chains. This initiative demonstrates the commitment of GS1 to supporting millions of businesses globally in driving commerce through effective standards. For more details, visit www.gs1us.org.