Blog Archives

US Pharmaceutical Product Verification and VRS – Ready for Prime Time?

Posted by bryan hanley On November 4, 2025 at 12:45 pm | Comments Closed

The Verification Router Service (VRS) can verify the printed product identifier barcode of U.S. prescription pharmaceuticals in about one second. As a result, Authorized Trading Partners (ATPs) can quickly determine whether a returned item is safe to resell or if commerce should be suspended due to recalls, expiration, or suspicion of illegitimacy.

This marks the realization of a 10-year effort. I remember participating in the 2015 HDA Traceability Work Group, wondering whether there was enough interest and esprit de corps to bring this vision to life.

Last Friday (October 24th), I presented on exception handling status codes and their implications alongside other industry leaders at the HDA VRS Quarterly Update. Based on a recent review of over 140,000 verification requests from September 2025, more than 80% of product verification requests are successfully processed, and 95% of those are verified as “True.”

Here’s what the analysis tells us:

  1. Requests are increasing, and there is a 75–80% probability that the product’s GTIN will be found in the VRS directory.
  2. About 5% of successful requests return “Verify = False,” with 75% of these due to a non-matching Product Identifier.
  3. Approximately 15% of GTINs requested are not found in the lookup directory.
  4. A variety of factors—such as unauthorized access, bad requests, and server errors—account for the remaining 5% of verification failures.
  5. Some responders are not faithfully following GS1 Application Standards, and a few solution providers have invented their own verification failure reason codes.

If you’re a pharmaceutical manufacturer or wholesaler, it’s time to fully embrace and adopt VRS. Here’s why:

  1. Under DSCSA, all trading partners must have “verification systems” for managing suspect and illegitimate products.
  2. Successful product verification using VRS is no longer a vision—it’s a reality.
  3. Manufacturers may face a competitive disadvantage if their competitors support VRS and they do not.
  4. ATPs achieve the fastest possible verification with VRS—especially when systems are maintained and manufacturing participation rates reach 95%.
  5. Wholesalers can easily facilitate saleable returns and avoid being caught off guard by recalled or suspect products.
  6. With regulators increasingly recognizing the value of product verification, the supply chain should expect more requests. Not being able to respond is a risk your business can easily avoid.
  7. If you’re struggling to reliably execute or respond to product verification requests, use the VRS test environment to troubleshoot your system.

Gateway VRS Verify can ensure your VRS system is functioning as designed, and help you become Gateway Certified, the industry seal-of-approval demonstrating commitment to DSCSA conformance. To learn more, contact the Gateway Checker team here.

Our recommendations for improving drug product verification:

  • Develop and Communicate Best Practices: Review GS1’s best practices for handling different HTTP status codes and share them with your trade partners to ensure timely and accurate responses. Analyze verification call patterns to identify common efficiency gaps.
  • Establish SOPs: Create step-by-step Standard Operating Procedures for various product verification scenarios. Ensure SOPs are well-documented and staff are properly trained.
  • Performance Monitoring: Continuously monitor your VRS system’s performance, including response times, the percentage of HTTP 200 responses, and the percentage of successful verifications (Verified = True).
  • Update Systems Frequently: Schedule regular updates to address deficiencies that impact output quality and user experience.
  • Test VRS Systems: Test your VRS system under various scenarios (expected vs. observed responses) using an independent, comprehensive testing application like Gateway Checker’s VRS Verify.

With so many solution providers offering different VRS systems, using an independent system provides impartial governance and auditable evidence of your VRS network’s readiness to support accurate product verification.

What are your experiences with VRS? Feel free to let us know by messaging our team: support@nullgatewaychecker.com

Why You Need VRS Validation

Posted by bryan hanley On March 13, 2025 at 1:45 pm | Comments Closed
female-pharmacist-with-table-checking-stock-pharmacy

Photo Credit: Freepik

The Importance of Validating Product-Verification Systems

As discussed recently, VRS Systems are the most effective way to verify product in accordance with DSCSA regulations. Additionally, the widespread use of VRS Systems provides invaluable information to trade partners, including product-specific information such as supply status by trade partner, volume of activity, and location.

Furthermore, immediate product verification provided by VRS systems proactively prevents non-suitable product from entering the supply chain, preventing timely and expensive recalls. The product-verification and commerce-related benefits of VRS Systems exemplify their value to any trade partner within the pharmaceutical supply chain.

The only way trading partners can benefit from VRS systems is if these systems function properly, and produce accurate and timely responses to verification requests. However, ensuring functionality is easier said than done.

A successful VRS network requires a common Product Identifier (PID) lookup directory, as well as a precise alignment of request/authentication/response functionality between multiple solution providers. Solution providers typically rely on self-testing to establish system readiness, and given the abundance of competing solution providers, VRS System validation is not straightfoward.

Additionally, since product verification requests originate external to a solution provider’s environment, pharmaceutical manufacturers can’t validate system readiness independently; manufacturers must rely on external testing to ensure their systems are working properly and are prepared to support specific use cases.

The Accreditation of VRS Systems with VRS Verify™

In recognizing the importance of properly functioning VRS Systems, particularly as more authorized trading partners and solution providers began adopting them, Gateway Checker developed the VRS Verify™ accreditation program.

The first of its kind, VRS Verify™ offers comprehensive, objective testing, documented evidence, and conformance certification for manufacturers and solution providers to ensure alignment with product verification application standards. These standards include the GS1 Lightweight Messaging Standard for DSCSA Verification of Product Identifiers, as well as the Healthcare Distribution Alliance (HDA) VRS Working Group Verification Router Service System Readiness Testing protocols.

VRS Systems who meet the protocols set forth by VRS Verify™ assure owners and operators of proper VRS functionality, providing both themselves and their trading partners the confidence that product verification needs will be met as necessary.

VRS Verify™:

  • Ensures the VRS system produces accurate and timely responses to verification requests.
  • Automatically generates and executes VRS validation test scripts.
  • Generates documentary evidence of tests executed and the results.
  • Assesses readiness of the VRS system to meet user and industry requirements.

To learn more about VRS Verify™, and for a complimentary product verification assessment, visit this link.

Who Needs Product Verification, and Why It’s Important for the DSCSA and Beyond

Posted by bryan hanley On March 12, 2025 at 2:45 pm | Comments Closed
pharmacist-white-uniform-walking-by-shelf-with-medicines-checking-inventory

Photo Credit: Freepik

How VRS Benefits the Entire Pharmaceutical Supply Chain

Last Friday, I described the importance of Verification Router Service (VRS) systems, introducing the benefits they provide within the pharmaceutical supply chain. As emphasized previously, the value of VRS systems extends beyond saleable returns, helping streamline product verification for trading partners and ensure product legitimacy. In this article, I dig deeper into the importance of product verification, and specifically, how VRS systems enhance supply integrity beyond saleable returns.

Manufacturers:

As the starting point of the supply chain, manufacturers are responsible for establishing accurate drug transaction records for each ownership change; they must inform trade partners when product is substandard, illegitimate, or for some reason is no longer fit for consumption. According to the DSCSA, manufacturers are required to respond to requests for product verification within 24 hours for any authorized trade partner, regardless of any direct relationship with that trade partner.

VRS systems allow manufacturers to confirm product identifier information (lot number, expiration date, trade identifier, and serial number) to other trade partners across the supply chain, within seconds. Absent a VRS, manufacturers must provide another method that executes the same product verification response (e.g. utilizing email or the telephone); alternatives are not only less effective, but also, more expensive.

Manufacturers who use VRS systems gain insight into all product verification requests, which include requester identification, email, phone number, and location. With widespread utilization of VRS for status checks, incoming inspection, and outbound checking, manufacturers gain additional product-specific supply status by trade partner, volume of activity, and location. VRS also enables early warning of nefarious activity, including product diversion and counterfeit activity.

Distributors:

Under the DSCSA, wholesale distributors are required to verify the authenticity of returned products before these goods re-enter the supply chain. If there is evidence that a returned product has been properly handled and is not expired or damaged, and its product identifier is verified, then that product can be resold. VRS systems provide immediate product verification, minimizing determination delays and helping prevent quarantines that may impede medication delivery.

Expanded use of VRS, beyond saleable returns, can facilitate confidence in authenticity and suitability for further distribution.  From inception, VRS is enabled to indicate if a specific product is suspect, illegitimate, or recalled. Integrating product verification requests into a distributor’s workflow can make the process more efficient and seamless, while yielding proactive awareness of pharmaceuticals not suitable for further distribution.

Widespread VRS use by distributors enhances the aforementioned benefits to manufacturers.  However, distributors are likely to consider expanding use of VRS only after increased participation by manufacturers.  So chickens and eggs need to worry less about which comes first, and commit to greater utilization for the benefit of the US pharmaceutical industry.

Dispensers:

For dispensers, product verification through VRS systems allows for authentication of products both received from distributors, and product brought to their attention by patients. In a recent investigation of suspect product, the Arkansas Board of Pharmacy demonstrated the value of VRS systems by successfully detecting counterfeit Ozempic.

The efficacy of these systems in preventing suspect and substandard product from reaching patients results in greater consumer trust in the supply integrity of pharmaceuticals, and possibly individual pharmacies as well.

Conclusion

VRS Systems are vendor-independent—regardless of a trade partner’s role in the pharmaceutical supply chain, there’s substantial benefits to implementing these systems. Instantaneous product verification minimizes supply chain disruptions and helps prevent substandard medicines from reaching (and potentially harming) patients.

With the DSCSA deadline approaching quickly, the importance of product verification has increased substantially. VRS Systems are the most effective way to verify pharmaceuticals in accordance with DSCSA regulations. Additionally, widespread use of VRS systems can provide reliable, actionable intelligence while improving drug supply security.

If interested in increasing the use of VRS, it is a challenge to test suitability and readiness to support specific use cases. Gateway Checker’s VRS Verify™ executes drug verification requests external to the product verification responders system, enabling the ability to emulate real-world conditions and validate the functionality of the response, including access to the lookup directory.

VRS Verify™:

  • Ensures the VRS system produces accurate and timely responses to verification requests.
  • Automatically generates and executes VRS validation test scripts.
  • Generates documentary evidence of tests executed and the results.
  • Assesses readiness of the VRS system to meet user and industry requirements.

Solution providers and manufacturers that successfully execute VRS Verify™ test scripts can become Gateway Certified, the industry’s seal-of-approval that a VRS system functions as necessary and adheres to strict industry requirements.

To learn more about VRS Verify™, and for a complimentary product verification assessment, visit this link.

Coming Up Next: “Ensuring VRS System Functionality: Why VRS Validation is Essential”

 

Conversation with GS1 to be Released January 22nd – Next Level Supply Chain Podcast

Posted by bryan hanley On January 17, 2025 at 5:37 pm | Comments Closed
 
 

GS1 Podcast, featuring Gary Lerner

Gateway Checker founder and president Gary Lerner recently had the opportunity to speak on the Next Level Supply Chain Podcast, hosted by GS1 US. His conversation focused on DSCSA guidelines and their benefits on the supply chain, best practices for conformance, and tons more. The episode will be released on January 22nd—to watch the full episode when it releases, visit this link.

What Isn’t Included in the Recent Exemption

Posted by bryan hanley On November 27, 2024 at 2:16 pm | Comments Closed

Who Does It Apply To?

Recently, I shared that eligible trading partners were temporarily exempted from specific components of the Drug Supply Chain Security Act, “Latest DSCSA Exemption”. However, considering the stabilization period ends tomorrow, I thought I’d share some further insights on what isn’t part of the recent exemption.

First, as noted in my previous posts, the recent exemption doesn’t apply to everyone. As the FDA emphasized in their release, trading partners who are eligible for the exemption include “those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners”, and “those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.” In other words, now is not time for trading partners to start initiating their systems and processes (that ship has sailed)—it’s time for trading partners to refine them.

Progress Necessary

The FDA wants to see progress made toward finalizing systems and processes capable of exchanging DSCSA transaction information and transaction statements with one another. Key enablers of this progress include:

  • Reconciling receipts of digital and physical representations of Serialized Information
  • Investigating suspect process
  • Verifying product for saleable returns
  • Responding to a trace request

In addition to documentation of progress, the FDA expects trading partners who plan to rely on the extension to communicate their intentions with immediate trading partners.

The FDA, similarly to when they announced their decision to implement the stabilization period, does not want trading partners to view this exemption as a “justification for delaying efforts to implement enhanced drug distribution security requirements.”

The deadline for compliance will come sooner than many expect, especially for manufacturers. In fact, there are only 129 working days until the May 27th, 2025 EDDS deadline.

Risks of Noncompliance

For those who haven’t initiated these systems and processes, punishments could be severe, and include:

  • Regulatory Risks: Potential for regulatory actions like warning letters, import alerts, or product seizures.
  • Operational Disruptions: Potential for supply chain disruptions and delays in product acceptance.
  • Market Exclusion: Risk of being completely excluded from the supply chain

Partners who do not meet the exemption criteria will need to submit a Waiver, Exception, or Exemption, or will more than likely face the consequences outlined above.

Stabilization Behind Us

Navigating DSCSA compliance amidst the constant changes to legislation can be tricky. However, one thing is for sure: if your business lacks systems and processes in place to implement EDDS requirements, the business is at risk.

With stabilization behind us, let Gateway Checker put you on the fast path towards supply integrity and regulatory compliance. Visit our website to view our services, or contact our team with any questions.