GS1 Standards in Use in Healthcare

Increasing visibility of pharmaceuticals through the healthcare supply chain ensures timely delivery and authenticity. The U.S. Food and Drug Administration (U.S. FDA) Drug Supply Chain Security Act, or DSCSA, regulates the supply chain to address dangers in counterfeiting, contamination, and stolen drugs. By using a 2D barcode, like a GS1 DataMatrix, encoded with a Global Trade Item Number® (GTIN®), manufacturers can provide required data including the National Drug Code (NDC), serial number, lot number, and expiration date. Assigning locations, like a pharmacy dispenser or distribution center, with a Global Location Number (GLN) can help identify the “Who” and “Where” of the product movement. Utilizing Electronic Product Code Information Services (EPCIS), a GS1 Standard, will help trading partners share data across different systems and speak the same language. Monitoring movement through the supply chain ensures authenticity and protects patients with unique barcodes and data that’s automatically shared from end to end along the supply chain.

The U.S. FDA requires a unique identifier that appears on the package and label of medical devices. The Unique Device Identification (UDI) Rule mandates that the code be printed in both a human-readable format and a machine-readable format, like a barcode. Using 2D barcodes, like a GS1 DataMatrix, encoded with a GTIN can help ensure accuracy and streamlined recalls. Also, leveraging the Global Data Synchronization Network^TM (GDSN®) allows companies to electronically share standardized, up-to-date product data to the U.S. FDA Global Unique Device Identification Database (GUDID). For instance, if a product is recalled, trading partners can leverage the unique identifier, in this case a GTIN, to help identify where the product is or has been used and remove it from the shelf or alert patients.