Skip to main content

FutureLink Barcelona (6-8 October) is now open for registration. Sign up today!

Close

Amadeus

AI
Home
Clear Search
User Log In
  • Tracelink Classic
    TraceLink Classic app.tracelink.com
    Redirect
  • Opus Platform
    Opus Platform opus.tracelink.com
    Redirect
  • Supply Chain Orchestrations
    Left fast
    Supply Chain Orchestrations
    • Life Sciences Company

      Life Sciences Company

      Life sciences companies face distinct challenges in orchestrating supply chains with partners. TraceLink specializes in addressing and overcoming these challenges.
      Learn More
      Left fast
      Life Sciences Company
      • Orchestrating the supply chain
        • Life Sciences Company
        • Direct Material Supplier
        • Contract Manufacturer
        • Third Party Logistics
        • Wholesale Distributor
        • Healthcare Provider
        • Retail Pharmacy

      Related Content

      Learn More
      Life Sciences

      Products

      Explore products for life sciences companies.

      Learn More
      Life Sciences

      Resources

      Discover valuable insights and industry trends.

    • Direct Material Supplier

      Direct Material Supplier

      Direct material suppliers face unique challenges in supply chain coordination. TraceLink provides specialized solutions to address and overcome these issues.
      Learn More
      Left fast
      Direct Material Supplier
      • Orchestrating the supply chain
        • Direct Material Supplier
        • Life Sciences Company
        • Contract Manufacturer
        • Third Party Logistics
        • Wholesale Distributor

      Related Content

      Learn More
      Direct Material Supplier

      Products

      Explore products for direct material suppliers.

      Learn More
      Direct Material Supplier

      Resources

      Dive into a world of expert resources and cutting-edge industry knowledge.

    • Contract Manufacturer

      Contract Manufacturer

      Contract manufacturing organizations grapple with distinct supply chain complexities. TraceLink delivers innovative solutions to tackle and streamline these challenges.
      Learn More
      Left fast
      Contract Manufacturer
      • Orchestrating the supply chain
        • Contract Manufacturers
        • Life Sciences Company
        • Direct Material Supplier
        • Third Party Logistics

      Related Content

      Learn More
      Contract Manufacturer

      Products

      Explore products for contract manufacturers and contract packagers.

      Learn More
      Contract Manufacturer

      Resources

      Get insights and industry trends for contract manufacturers and packagers.

    • Third Party Logistics

      Third Party Logistics

      Third party logistics providers face unique challenges in managing intricate supply chains. TraceLink offers strategic solutions to effectively address these complexities.
      Learn More
      Left fast
      Third Party Logistics
      • Orchestrating the supply chain
        • Third Party Logistics
        • Life Sciences Company
        • Contract Manufacturer
        • Wholesale Distributor

      Related Content

      Learn More
      Third Party Logistics

      Products

      Browse our range of products for third party logistics providers.

      Learn More
      Third Party Logistics

      Resources

      Step into our resource hub for the latest in innovation and industry expertise.

    • Wholesale Distributor

      Wholesale Distributor

      Wholesale distributors navigate complex challenges in supply chain management. TraceLink provides advanced solutions to efficiently tackle these issues.
      Learn More
      Left fast
      Wholesale Distributor
      • Orchestrating the supply chain
        • Wholesale Distributor
        • Life Sciences Company
        • Healthcare Provider
        • Retail Pharmacy

      Related Content

      Learn More
      Wholesale Distributor

      Products

      Browse our range of products for wholesale distributors.

      Learn More
      Wholesale Distributor

      Resources

      Navigate the future of industry trends with our wholesale distributor resource center.

    • Healthcare Provider

      Healthcare Provider

      TraceLink provides specific solutions to help healthcare providers confront distinct challenges, including managing drug shortages and recalls in their supply chains.
      Learn More
      Left fast
      Healthcare Provider
      • Orchestrating the supply chain
        • Healthcare Provider
        • Life Sciences Company
        • Wholesale Distributor

      Related Content

      Learn More
      Healthcare Provider

      Products

      View our product portfolio for healthcare providers.

      Learn More
      Healthcare Provider

      Resources

      Explore our comprehensive collection of resources for healthcare providers.

    • Retail Pharmacy

      Retail Pharmacy

      Retail pharmacies combat supply chain complexities, including regulatory compliance. TraceLink enhances efficiency and adherence.
      Learn More
      Left fast
      Retail Pharmacy
      • Orchestrating the supply chain
        • Retail Pharmacy
        • Life Sciences Company
        • Wholesale Distributor

      Related Content

      Learn More
      Retail Pharmacy

      Products

      Experience our advanced product lineup for retail pharmacies.

      Learn More
      Retail Pharmacy

      Resources

      Delve into our rich library of resources for retail pharmacies.

  • Network
    Left fast
    Network
    The Advantage of Integrate Once
    The TraceLink Network
    Network

    Explore how a single connection to the TraceLink network can transform your operations, streamline your supply chain processes, and bring unparalleled value to your organization.

    Learn More

    Menu Divider

    • Tracelink Icon The Power of the Platform
    • Tracelink Icon OPUS Solution Environment
    • Tracelink Icon Link Actions
    • Tracelink Icon Reports and Dashboards
    • Tracelink Icon Master Data Exchange
    • Tracelink Icon Message Center
  • Products
    Left fast
    Products
    • Partner Orchestration

      Partner Orchestration

      Transform partner collaboration and rapidly connect with all your partners for enhanced control while reducing risks and costs to improve supply chain visibility and customer delivery performance.
      View All Products
      Left fast
      Partner Orchestration
      • Multienterprise Information Network Tower
        • MINT for External Manufacturing
        • MINT for Serialized Shipments and Receipts
        • MINT for Direct Supply
        • MINT for Logistics
        • MINT for Commerce
        • MINT for Transportation

      Related Content

      Learn More
      Blog

      Accelerate Clinical-Phase Commercialization Through Supply Chain Digitalization

      Discover four essential steps to accelerate clinical-phase commercialization through end-to-end supply chain digitalization.

      Watch Now
      Video

      Cold Chain Excellence with AI and Digital Innovation

      Learn how to elevate your cold chain strategy through digitalization, patient-centric innovation, and AI-driven insights. Discover approaches to improve visibility and reduce risk.

    • Product Orchestration

      Product Orchestration Products

      Meet regulatory requirements around the globe and improve operational efficiency with our suite of Product Orchestration solutions, tailored for comprehensive compliance and streamlined supply chain management.
      View All Products
      Left fast
      Product Orchestration
      • Serialization
        • Serial Number Exchange
        • Serial Number Manager
        • Serialized Operations Manager
        • Smart Event Manager
      • Smart Inventory Tracker
      • Targeted Recalls
      • Product Information Manager
        • Targeted Recalls Notification
        • Product Verification
        • Master Data Sharing
      • Country Compliance
        • US Drug Supply Chain Security Act
        • European Union Falsified Medicines Directive
        • Kazakhstan Pharmaceuticals
        • Kyrgyzstan Pharmaceuticals
        • See All Countries
      • Crypto Code
        • Russia Crypto Code

      Related Content

      Learn More
      Deadline Approaching

      DSCSA

      Comply with U.S. DSCSA requirements.

      Watch Now
      Video

      Locate Recalled Product in Minutes

      See how TraceLink helps you pinpoint which locations received recalled product so you can retrieve it in minutes.

    • Process Orchestration

      Process Orchestration Products

      Streamline your supply chain with Process Orchestration, facilitating seamless collaboration on recalls, change requests, document reviews, compliance exception management, and more.
      View All Products
      Left fast
      Process Orchestration
      • Supply Chain Work Management
        • SCWM for Compliance Exceptions
        • SCWM for Incidents
        • SCWM for Change Requests
        • SCWM for Tasks
        • SCWM for Document Reviews

      Related Content

      Learn More
      Resources

      Supply Chain Collaboration

      Browse insights on how to improve end-to-end supply chain collaboration.

      Learn More
      Supply Chain Excellence Award

      2025 BSMA Supply Chain Management Innovation Award

      Gain insights into award-winning supply chain innovation—TraceLink wins the 2025 BSMA Supply Chain Management Innovation Award for its MINT solution.

    • Orchestration Intelligence

      Orchestration Intelligence Products

      Empower your supply chain decisions with Orchestration Intelligence, harnessing AI, machine learning, and the collective power of the TraceLink network for robust data-driven solutions.
      VIEW ALL PRODUCTS
      Left fast
      Orchestration Intelligence
      • Serialized Product Intelligence
      • Reports and Dashboards

      Related Content

      Learn More
      Reports and Dashboards

      Real-Time Insights with OPUS Reports & Dashboards

      TraceLink Releases OPUS Reports & Dashboards, the first end-user solution designed for real-time visibility into supply networks.

      Learn More
      Blog

      Explore the Top 10 Insights from LogiPharma 2025

      Discover how industry leaders at LogiPharma 2025 are transforming collaboration. Gain actionable strategies to drive business value across complex, global networks.

    • Network Platform-Enabling Products

      Network Platform-Enabling Products

      A comprehensive suite of solutions designed to empower users with advanced administration, communication, data management, and customization capabilities, coupled with services to extend the value of the platform.
      View All Products
      Left fast
      Network Platform-Enabling Products
      • OPUS Administer
      • OPUS Solution Environment
      • Link Actions
      • Master Data Exchange
      • Message Center
      • Automated Validation Manager
      • Healthcare Operational Services Team
      • Technical Account Management Services
  • Resources
    Left fast
    Resources
    • Resource Center

      Resource Center

      Explore our Resource Center for a wealth of knowledge, including videos, solution briefs, blogs, eBooks, and more, offering insights on TraceLink solutions, industry trends, and emerging topics.
      View All Resources
      Left fast
      Resource Center
      • By Segment
        • Life Sciences Company Life Sciences Company
        • Direct Material Supplier Direct Material Supplier
        • Contract Manufacturer Contract Manufacturer
        • Third Party Logistics Third Party Logistics
        • Wholesale Distributor Wholesale Distributor
        • Healthcare Provider Healthcare Provider
        • Retail Pharmacy Retail Pharmacy
      • By Type
        • Webinar Webinar
        • Blog Blog
        • Case Study Case Study
        • EBook EBook
        • Infographic Infographic
        • Podcast Podcast
        • Solution Brief Solution Brief
        • Video Video
        • Whitepaper Whitepaper
    • TraceLink University

      TraceLink University

      Enhance your expertise with TraceLink University: dive into a range of online and instructor-led courses, engaging tech talks, and certification programs designed to elevate your knowledge.
      Explore All
      Left fast
      TraceLink University
      • By Persona
        • Solution Designer Solution Designer
        • Tracelink Administrator Tracelink Administrator
        • User User
        • Orchestration Architect Orchestration Architect
        • Solution Partner Solution Partner
        • Technology Partner Technology Partner
      • By Orchestration
        • Manufacturing Manufacturing
        • Logistics Logistics
        • Commerce Commerce
        • Transportation Transportation
        • Clinical Supply Clinical Supply

      Related Content

      Learn More
      Subscriptions

      TraceLink University

      Ongoing education at your own pace.

      Watch Now
      FutureLink

      Experience FutureLink

      Watch FutureLink Barcelona sessions on demand.

    • Partners

      Partners

      We partner with leaders from across the globe, with an intense focus on partner companies that specialize in implementation, solution consulting, and application development.
      Partner Overview
      Left fast
      Partners
      • Tracelink Icon View Our Partners
      • Tracelink Icon Become a Partner
      • Tracelink Icon Access PartnerLink
    • Community

      Community

      Join our global community, uniting members across the supply chain to share insights and engage in discussions through virtual meetings and collaborative workshops.
      Learn More
      Left fast
      Community
      • Global Compliance Special Interest Group
      • Multienterprise Information Network Tower Innovation Forum
      • U.S. DSCSA Innovation Forum for Manufacturers and Distributors
      • U.S. DSCSA Dispenser Innovation Forum
    • Events

      Events

      Stay updated with our Events calendar: from industry conferences we attend to exclusive events we host and informative webinars, join us in shaping the future of supply chain management.
      View All Events
      Left fast
      Events
      • Tracelink Icon Industry Events
      • Tracelink Icon Webinars
      • Tracelink Icon TraceLink Events

      Related Content

      Register Now
      FutureLink

      FutureLink Barcelona 2025

      Join the movement shaping the future of supply chains. FutureLink is the must-attend event for Industry leaders.

      Register Now
      Paris Seminar

      Intelligent Orchestration of Your End-to-End Supply Chain

      Explore how intelligent orchestration enhances resilience, agility, and performance on June 11 in Paris.

    • Customers

      Customers

      Meet a selection of our valued customers: discover how diverse businesses are leveraging TraceLink's solutions to transform their supply chains.
      View Our Customers
      Left fast
      Customers
      • Success Stories
        • Santen Santen
        • Merck Merck
        • Patheon Patheon
        • Sentara Sentara
        • Merz Therapeutics Merz Therapeutics
  • About
    Left fast
    About
    • Tracelink Icon Our Story
    • Tracelink Icon Newsroom
    • Tracelink Icon Culture and Careers
    • Tracelink Icon Leadership
    • Tracelink Icon Our Values
    • Tracelink Icon Corporate Social Responsibility

    Menu Divider

    Related Content

    Awards and Recognitions

    Celebrating our impact

    We are honored and proud of the acknowledgment and industry recognition we have received.

    Innovation Award

    Supply Chain Orchestration Company of the Year 2025

    Discover how TraceLink is transforming supply chain orchestration—named Supply Chain Orchestration Company of the Year 2025 by Logistics Tech Outlook Magazine.

  • CONTACT US
  • User Log In
    • Tracelink Classic
      TraceLink Classic app.tracelink.com
      Redirect
    • Opus Platform
      Opus Platform opus.tracelink.com
      Redirect
Close
CONTACT US
Resources

Breadcrumb

  1. Home
  2. Resources
  3. Resource Center

PDG, HDA, and GS1 Hold Critical Workshop on DSCSA 2023 Compliance Exceptions Management

Feb 21, 2023
banner-image
  • Download PDF
  • Share
    • LinkedIn
    • Facebook
    • Mail
    • Twitter

Table of contents

TraceLink joined this past week with industry leaders from the Partnership for DSCSA Governance (PDG), the Healthcare Distribution Alliance (HDA), and GS1 at a key DSCSA 2023 exceptions workshop in Washington D.C. The DSCSA Exceptions Handling Workshop, held Feb. 6-7, was an interactive program where participants could analyze and propose operational processes and network data management approaches to resolve data exceptions related to the exchange and use of serialized DSCSA transaction information. This workshop comes on the heels of the recent TraceLink DSCSA webinar on Troubleshooting and Managing Exceptions Under DSCSA (watch on-demand).

As the end-to-end U.S. pharmaceutical supply chain quickly ramps up to meet the final November 27 deadlines of the Drug Supply Chain Security Act (DSCSA), new requirements for the exchange of serialized Transaction Information (unit-level serialized product identifiers and their B2B commercial transactional data) are mandated for pharmaceuticals sold between trading partners. Organizations such as HDA looked early at the potential for a significant increase in the risk of DSCSA compliance exceptions as serialized product and data flows across the supply chain (see HDA Exceptions Handling Guidelines).

The DSCSA Workshop focused on three specific areas of the exceptions handling challenge, that of the need to (1) identify, (2) understand, and (3) resolve compliance exceptions. Some key questions and takeaways from the discussions on these three topics included:

Identify
  • How can the FDA Enhanced Drug Distribution Security (EDDS) Guidance on reconciliation help inform identification of DSCSA exceptions?
  • What are the underlying business processes where identification of exceptions may occur? How would those business processes be impacted? What data do those processes have or need in this area?
  • How aware are pharmacy dispensers (healthcare providers, retail pharmacies, etc.) of the potential exceptions under DSCSA that may occur for products they receive and manage? How active will dispensers be in identification of potential exceptions given pharmacy receiving practices under DSCSA?
  • Should the holder (possessor of the product) perform a Product Identifier verification of a product (using the VRS network) when they identify an exception?
Understand
  • How will exception process analysis be related to, and distinctly separated from, related processes under suspect and illegitimate product processes identified under DSCSA?
  • What can supply chain members learn from current exception processes followed under controlled product receiving methods?
  • Why quantity receiving checking can play an important role in understanding a potential exception issue.
  • What are the expectations on overall volume, human resource needs, and time requirements of potential exceptions to be managed (based on previous DSCSA experience, learnings from the implementation of the EU Falsified Medicines Act, and other serialized product track and trace regulations)?
Resolve
  • What rules should be considered, and who makes the decision, on product disposition if there are discrepancies between the physical product received and the compliance data received?
  • What solutions, standards, and procedures are needed specifically to resolve “Product but No Data” and “Data but No Product” scenarios where there may be in existence today partial standards or process support?
  • What documentation, data archival needs, etc. are needed on how an issue was resolved given CFR Part 11 or other quality/audit requirements?
Why is the industry taking such a detailed look at DSCSA compliance exceptions? Because companies already face these issues. Specific examples of exceptions that occur include:
  • A shipment arrives at the dock of a distributor and the first pallet label on the truck is scanned. No EPCIS file has been sent for that shipment.
  • In addition to the 48 cases on a pallet, two additional cases of product have been shrink-wrapped on top of the pallet. The EPCIS file for that pallet only contains data for 48 cases and not 50.
  • The US DEA (Drug Enforcement Agency) was conducting an operation at a port.  They have opened a case of 48 bottles and removed two for sampling. The EPCIS file received contains data for 48 eaches.  Which two have been removed?
  • Due to low quality inkjet printers and ink used at a CMO, the 2D barcode  and the Human Readable Information (HRI) has faded/smudged and is not readable by scanners.

Without a network based solution to manage compliance exceptions, shipments and receipts may be delayed causing potential drug shortages, inventory awaiting investigation may pile up slowing distribution operations, and pressure to make decisions without proper data increases compliance risk.

With over a decade in supporting the serialization of product and the exchange of serialized product data between trading partners and with government agencies around the world to meet track and trace regulations, the challenge of compliance exception management is no surprise to TraceLink. TraceLink has processed almost 1 billion Transaction Histories between trading partners on our TraceLink Network since DSCSA went into effect in 2015, and today manages the commissioning of over 1 billion serialized product identifiers every month. Working with the over 290,000 entities on the TraceLink Network, this has given us both a deep understanding of the potential compliance exceptions faced by each segment of the supply chain, and broad insights as to the kinds of information needed by partners to identify, understand, and resolve issues before they impact product supply.

To help companies master DSCSA compliance exceptions, we augmented our core Compliance for DSCSA solutions with TraceLink Serialized Product Intelligence, and our new Supply Chain Work Management for Compliance Exceptions solution. SCWM for Compliance Exceptions enables pharmaceutical manufacturers, wholesale distributors, and other parties to rapidly identify, onboard, and engage supply chain partners in a multienterprise process to intake, triage, and resolve both internal and external issues associated with compliance exceptions. The solution provides a single, centralized location for cross-functional and cross-company users to collaboratively resolve compliance exceptions and capture insights into the current and historical status of exceptions, speeding resolution.

To learn more about TraceLink’s comprehensive approach to DSCSA compliance exception management, we would love to talk about your unique supply network. 
 

BlogUS Drug Supply Chain Security ActDSCSA for Dispensers, DSCSA for ManufacturersUnited States

Table of contents

Subscribe to Agile Supply Chain Insights
Subscribe to stay informed with the latest patient-centric agile supply chain thought leadership content.
Related Content
Manufacturer
DSCSA 2023 Requirements and the Capabilities You Need to Keep Up
The final phase of DSCSA traceability requirements go into effect on November 27, 2023.
View More
For Internal 70
DSCSA 2023 for Manufacturers: Critical 2022 Partner Requirements
Henry Schein and TraceLink on DSCSA 2023 Compliance.
View More
network
DSCSA 2023 Compliance for Drug Manufacturers Solution Brief
DSCSA 2023 introduces significant regulatory compliance challenges and new operational complexities for drug manufacturers.
View More

Cookie Settings

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies or similar tracking technologies. Please see below for an overview of the categories of cookies and similar technologies used on this site. You can allow or deny some of all of them, except Strictly Necessary Cookies which are required to provide the site to you. However, blocking some types of cookies may impact your experience of the site and services we are able to offer.

Please see our Cookie Policy for more details, including a list of the cookies we use. You can change your consent options at any time by following the “Cookie Settings” link in the Cookie Policy.
'Strictly Necessary' cookies let you move around the Site and use essential features like secure areas, shopping baskets and online billing. Without these cookies you would not be able to navigate between pages or use certain vital features of our Site, so we do not require your consent for their use. These cookies don't gather any information about you that could be used for marketing or remembering where you've been on the internet. For example, we use these Strictly Necessary cookies to identify you as being logged in to the Site. You can set your browser to block or alert you about these cookies, but if you do so, some parts of the Site will not work.
'Performance' cookies collect information about how you use the Site, such as which pages you visit, the time spent on the Site and if you experience any errors. We use performance cookies to provide aggregated statistics on how the Site is used and help us improve the Site including by measuring any errors that occur.
'Functional' cookies are used to provide services or to remember settings to improve your visit. We use 'Functionality' cookies to remember your settings and choices and show you when you're logged in to the Site.
‘Targeting' cookies are linked to services provided by third parties, such as 'Like' buttons and 'Share' buttons. The third party provides these services in return for recognizing that you have visited the Site. We also use 'Targeting' cookies to gather information that could be used to display content that we think may interest you.
Home

Footer

  • Quick Links
    Get a Demo
    Fast Facts
    The Network
    OPUS Platform
    Technical Support
    Open Jobs
    API: Terms of Use
  • Products
    Multienterprise Information Network Tower
    U.S. DSCSA Compliance
    Targeted Recalls
    Supply Chain Work Management
    Serialization
    Global Compliance
  • Resources
    Resource Center
    Events
    TraceLink University
    Partners
    Customers
    Community
  • About TraceLink
    Our Story
    Newsroom
    Culture & Careers
    Leadership
    Our Values
    Corporate Social Responsibility
  • Hot Topics
    Supply Chain Visibility
    DSCSA Compliance
    Supply Chain Collaboration
    Kazakhstan Compliance for Pharmaceuticals
    Kyrgyzstan Compliance for Pharmaceuticals
Follow Us on Social
Facebook
Linkedin
X
Legal & Trust.
© TraceLink Inc. 2009-2025 All Rights Reserved
Contact Us Today
Contact us today to digitalize your end-to-end supply chain for streamlined orchestration.
Contact Us
Stay Up-to-Date
Subscribe to receive industry insights and stay at the forefront of evolving trends.
Subscribe