GS1 Standards Resources for DSCSA Implementation Support

Resources to help you on your journey

GS1 US Implementation Guideline for Applying GS1 Standards for DSCSA and Traceability, Release 1.2.

Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA.

Guidance for Pharma Products with UPC-A and GS1 DataMatrix, R1.0.

GS1 DataMatrix Guideline - This Guideline provides detailed information on GS1 DataMatrix and its technical characteristics, including encoding, printing and reading.

Proof of Concept: Using GLNs to Reduce Rebate & Chargeback Claim Discrepancies.

Quick Start Guide – Implementing GS1 Global Location Numbers in Trace, Chargeback and Rebate Processes.GTIN Allocation Rules for Healthcare

GTIN Allocation Rules for Healthcare.

Pharmaceutical Supplier Global Location Number Quick Start Guide.

Pharmaceutical Dispenser Global Location Number Quick Start Guide.

Check Digit Calculator - The check digit is calculated from all the other numbers in the barcode and helps to confirm the integrity of your barcode number. The last digit of a barcode number is a calculated check digit. Use this Free GS1 US tool to calculate the last digit.

GS1 Company Database (GEPIR®) - Feel confident in your data — use this tool to verify U.P.C. barcodes, confirm company information, and more. The GS1 Company Database provides basic company information for more than one million GS1 member companies in more than 100 countries.

Assessing Current Implementation of DSCSA Serialization Requirements - To obtain a view of industry’s progress on meeting the November 2023 Drug Supply Chain Security Act (DSCSA) deadline, GS1 Healthcare US collaborated with AmerisourceBergen Corporation and McKesson Pharmaceutical to assess the barcodes on packages of “lowest saleable units” in their distribution facilities. Cardinal Health also conducted their own barcode assessment for homogeneous cases from pharmaceutical manufacturers. This report outlines the findings.

Infographic - Barcoding Recommendations from U.S. Pharmaceutical Wholesalers - Industry leaders AmerisourceBergen, Cardinal Health, and McKesson Pharmaceutical provide their Drug Supply Chain Security Act (DSCSA) barcoding recommendations for U.S. suppliers.

Infographic – GS1 Standards at a Glance in Healthcare – get a single view of the GS1 Identify, Capture, and Share Standards in Healthcare, including key terms and their definitions.

Infographic – Healthcare Industry – Know Your GS1 Barcodes and What Is In Them - This infographic outlines GS1 barcode tips for the Healthcare industry. The key to patient safety and supply chain efficiency.

GTIN Adoption and Usage Model - Implementation Roadmap for U.S. Healthcare Supply Chain – view this self-assessment tool to gauge your organization’s progress in adopting and using the Global Trade Item Number® (GTIN®). This document helps healthcare companies improve patient safety and supply chain efficiency by better leveraging unique product identification.

GS1 Standards in the Pharmaceutical Supply Chain – Overview of how the industry is preparing for product serialization, track-and-trace, and DSCSA using GS1 Standards.

White Paper - GS1 Standards Use in Clinical Research Supply Chain - Learn why pharmaceutical leaders, Dana-Farber Cancer Institute, Amgen, MSD, Eli Lilly and Company and Pfizer, are encouraging the adoption of GS1 Standards for the identification of investigational products and sharing information across the clinical research ecosystem.

GS1 US Rx EPCIS Conformance Testing Program - A voluntary program offered to support pharmaceutical industry members implementing EPCIS for DSCSA and traceability pursuant to the GS1 US Implementation Guideline.

Certificate and Customized Education

The DSCSA specifies that packages (“lowest saleable units”) must be marked with a two-dimensional (2D) barcode (e.g., GS1 DataMatrix barcode), and homogeneous cases with either a 2D barcode or linear barcode (e.g., GS1 DataMatrix barcode or GS1-128 barcode, respectively)—which will be accessed by healthcare providers for patient safety.

GS1 US® offers certificate education and implementation best practices to help you prepare for DSCSA by using GS1 Standards to track and trace products at the product and case level.

*For information about the act, see the 2013 Drug Supply Chain Security Act

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.