Ten Count: GS1 Connect 25
Ten Count Consulting was pleased to attend GS1 Connect last week in Nashville, Tennessee!
Not familiar with GS1?
GS1 Global – "GS1 is a neutral, not-for-profit organization that develops and maintains the most widely used supply chain standards in the world."
Source: https://www.gs1.org/about
GS1 US – "GS1 US, a member of GS1®, develops and maintains supply chain standards for industries including retail, foodservice, healthcare, and apparel." GS1 US helps over 300,000 members in various industries improve visibility and efficiency. As a neutral organization, they work with businesses to address industry challenges and develop best practices using these standards.
Source: https://www.gs1us.org/about-gs1-us
GS1 US and DSCSA
GS1 US plays a critical role in enabling DSCSA compliance by providing the standards and guidance that allow all trading partners in the U.S. pharmaceutical supply chain to uniquely identify, label, and electronically trace prescription drugs at the package level. GS1 US standards form the technical foundation for product identifiers, barcode requirements, and interoperable data exchange, as required by DSCSA.
🔑 Importance of GS1 US in DSCSA:
· Defines the use of GTINs and GS1 barcodes to meet the FDA’s product identifier requirements.
· Develops and maintains the EPCIS standard, the FDA-recognized format for exchanging serialized data to achieve interoperable, electronic tracing.
· Supports the Verification Router Service(VRS) and lightweight messaging standards, enabling fast, scalable product verification in response to DSCSA saleable return and suspect product requirements.
· Provides implementation guidance, testing programs, and working groups to support industry-wide adoption and harmonization.
10 takeaways from GS1 Connect 25
Networking is always a wonderful experience, allowing us to reconnect with old friends while also meeting new people. We firmly believe that the Drug Supply Chain Security Act (DSCSA) has fostered an exceptionally collaborative spirit within the industry, with implications that will extend well beyond DSCSA itself. As we approach the final stretch, updates shared in public forums like this have evolved to focus more on operationally informed observations and potential applications for the tools brought about by DSCSA
1. DSCSA Data updates
The broad EDDS exemption for manufacturers ended May 27, 2025.
Volume:
Two large wholesale distributors reported fluctuations in receiving DSCSA data, but generally, 97+% of products are coming with data. A dispenser on the panel with 120 direct manufacturers reported receiving 80% from manufacturers and 90% from their wholesale distributor.
Quality:
One large wholesale distributor reported around a 5% error rate (~2% with data issues and ~1-2% with timing issues). Another large wholesale distributor reported they have started fully quarantining product on May 27th and reported they are working through 85-100 exceptions a day where the data does not accurately describe the product (not counting configuration/structural issues with the data). The dispenser on the panel reported 93% accuracy.
2. Exception handling-
Perfection should not be the expectation; however, minimizing occurrences and reducing the time needed to resolve issues will be essential to prevent products from being held up in quarantine. One of the large distributors noted that even if exceptions decreased to 1%, that still amounts to 11,000 exceptions to manage each month. Establishing clear lines of communication and ensuring adequate trained staffing are vital for initiating corrective actions. This will help reduce future exceptions and develop "muscle memory" efficiency for handling common exception types, ultimately keeping products moving smoothly through the supply chain.
3. Barcode quality-
Wholesale distributors have reported encountering increasing issues with barcode quality. Common problems include incorrect encoding, poor print quality, fading prints, and smudges. A question arose regarding whether the increase in scans at the unit level, which are used to build outbound shipments, is revealing issues that had previously been concealed. While there was no definitive answer to this question, it is reasonable to assume that this increase in scanning is a significant factor contributing to the increase in observed barcode quality issues. This is a significant concern as wholesale distributors expressed, they are not able to move product and do not have the ability to resolve this issue. Barcode readability issues will likely require more involved corrective action. These issues will be costly when they occur, as they could involve entire lots/runs of production, and it may be 90+ days after production before the issue is realized.
4. The “morgue”-
As a follow-up to #3, the term "morgue" is increasingly being used to describe products that will be destroyed as they won't make it out of quarantine. This happens when resolution is not possible or deemed unfeasible for moving the product. As the staggered exemptions expire, it will be essential to closely monitor and report on this to understand its impact on drug availability and organizational costs.
5. Audit Readiness-
Several organizations have indicated that preparing for State or FDA audits and inspections, and monitoring regulatory activity, such as FDA 483 observations for DSCSA, is a current key focus. Organizational DSCSA leads have shared that external support from industry DSCSA experts is valuable for conducting assessments or enhancing internal audits to achieve desirable outcomes. Learn more about Ten Count Consulting's DSCSA Audit Readiness Assessment here.
6. WEEs (Waivers, Exceptions, and Exemptions) -
Wholesalers have indicated that they currently know of two manufacturers with FDA-approved WEEs. They are requesting that the manufacturer share the approval letter from the FDA as official documentation and communicating with customers. The WEE states that ASNs (Advanced Shipping Notices) will be sent through 2026, but does not address T3. Wholesalers also mentioned that they can manage this product similarly to transitional inventory; however, they will not be able to handle lot-specific WEEs.
7. Recall-
Manual processes, snail mail, faxes, PDFs, multiple databases, multiple untargeted notifications, paper, paper, and more paper. Standards and methods for recall notification and handling have not kept up with tools now available (unit-level serialization, Unique Device Identifiers (medical devices), interoperable messaging, Verification Router Service, etc.). There is significant potential to greatly improve efficiency across the supply chain, resulting in major enhancements in patient safety.
8. NDC 12 Proposed rule-
- On 7/22/2022 FDA released a proposed rule to adopt a 12-digit format for National Drug Codes.
- Proposed rule would eliminate the linear UPC barcode requirement, permitting manufacturers to migrate to the 2D GS1 DataMatrix barcode in place for DSCSA
- NDC codes (specifically, labeler codes) are expected to be exhausted between 2030 and 2035. Unlike DSCSA, the runway for NDC change has a fixed end (exhaustion of labeler codes).
- Expectations are for the rule to be finalized in 1st half of 2026
- Barcode changes- With the increase in length of the Labeler Code, the NDC will no longer be embedded within the GTIN, and a new Application Identifier (715) will be used for NDC
9. Actions being taken now to prepare for NDC12-
- GS1 US has identified over 100 systems used by trading partners, supporting organizations, and federal and state agencies that will be impacted by the change.
- GS1 US has formed a workgroup, a discussion group, and a Standards committee.
- The implementation timeline will be tight, and organizations need to hit the ground running as soon as the rule is finalized.
- Currently, organizations are focusing on
- Internal education to bring awareness of the upcoming changes
- Conducting system assessments to identify where NDC data is stored
- Forming project teams and deciding who will initiate the project and provide funding for it within the organization
10. Other topics, RFID and AI-
There were informative panels and keynotes on RFID and AI that explored the potential of the technology (more valuable than what you see below), as well as considerations for its implementation.
Connect with us for a free consultation to discuss how your company is finishing DSCSA 2025 strong!
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