GS1 US Study Reveals Challenges with Barcodes Meeting DSCSA Compliance

    GS1 US Study Reveals Challenges with Barcodes Meeting DSCSA Compliance


    Get insight into the study and understand the issues to avoid. Learn about the nuances uncovered and how to solve them. Grasp the key requirements not to overlook. Ensure your Barcodes meet the regulation.
    Last year, GS1 US worked with two of the largest wholesale distributors in the United States to perform an exhaustive analysis of the barcodes received from drug manufacturers in their U.S. distribution centers. 
    In the study, GS1 scanned thousands of barcodes on products in their respective DC inventories and evaluated their conformance with GS1 US Drug Supply Chain Security Act (DSCSA) guidance. 
    Unfortunately, many problems were found.  The results of this important study raise concerns about industry readiness for the DSCSA November 2018 serialization deadline and beyond—not so much about the percentage of manufacturers or products that will be serialized, but about the quality and usability of the serial numbers that will be present on drug packages.
    • The study found that only 6.6% of the products inspected were in compliance. 
    • The rest of the products were either missing the 2D barcode entirely, or had one or more non-conformance issues that would either, 1) cause handling problems for the wholesale distributors, or, 2) in the worst cases, would not even conform to the DSCSA itself.  
    • If left unchecked, and if a barcode is unusable, this could cause serious disruptions to the supply chain as early as 2019 when the wholesale distributors must begin using these barcodes to verify saleable returns.
    The final report of this study was recently published by GS1 US. In this webinar, Peter Sturtevant, Sr. Director, Industry Engagement – Pharmaceuticals, at GS1 US, the key coordinator of the study, will explain the study and the issues it uncovered.  Joe Lipari, Director of Cloud Based Implementation Services, and Dirk Rodgers, Global Regulatory Strategist, both with Systech International, will join in the discussion of these issues and present the things companies can do to avoid them and ensure their products will meet the regulation, and be acceptable by the wholesale distributors in 2019 and in 2023.


    Peter Sturtevant

    Sr. Director, Industry Engagement – Pharmaceuticals - GS1 US

    Dirk Rodgers
    Global Regulatory Strategist - Systech International

    Joseph Lipari
    Director of Cloud Implementation Services - Systech International

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    Serialization Simplified: Demystifying the Complexities of Track and Trace Implementation

    Serialization Simplified: Demystifying the Complexities of Track and Trace Implementation


    Counterfeiting of medications is a major problem faced by the global pharmaceutical industry.  Owing to globalization, the supply chain for medicines has become lengthier with every step offering another opportunity for counterfeiters. Thus, global track and trace requirements have become stringent putting tremendous pressure on the supply chain’s transparency. Pharmaceutical companies do believe that counterfeiting can be reduced significantly by implementing product serialization. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Therefore, serialization is often looked upon as an effort- and cost-intensive process.

    ACG works closely with pharmaceutical companies across the globe as a track and trace implementation partner.  ACG’s webinar on “Serialization Simplified: Demystifying the complexities of track and trace implementation” aims at systematically decoding the Global Track and Trace requirements and preparing for the implementation.
    Brief Note:
    • Understanding Global Track and Trace regulations and Trends
    • EU Regulations and insights
    • Building the team for managing the Track and Trace project implementation
    • Understanding the implementation needs and selecting the right implementation partner
    • Key challenges and learnings from the worldwide implementation
    • Managing the serialization in actual production process


    Mr. Harpal Singh - Director , ACG Inspection Systems Pvt. Ltd
    Mr. Gaurav Mohite - Product Manager – Track & Trace , ACG Inspection Systems Pvt. Ltd
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