Blog Archives

Körber Supply Chain Achieves Gateway Certified® Accreditation

Posted by bryan hanley On March 23, 2026 at 10:48 pm | Comments Closed

Gateway Checker® is excited to announce Körber Consulting has successfully attained Gateway
Certified® EPCIS Verify™ accreditation. A leading global technology group, Körber has been
providing innovative supply chain solutions for decades. As the industry’s leading independent
GS1 Conformance Testing Service, Gateway Checker applauds Körber’s accomplishment, which
demonstrates their commitment to pharmaceutical supply chain integrity, data interoperability,
and overall patient safety.

Koerber and Gateway Checker at the 2026 DMC Conference

Körber Supply Chain Team (Matt Deep, left, and Steve Markham, right) with Gateway Checker
President, Gary Lerner, at the 2026 HDA Distribution Management Conference in Austin, Texas.


Leveraging its TraceReady™ application for drug quality assurance, Gateway Checker launched
the Gateway Certified conformance program after producing files pursuant to the strict GS1 US
Implementation Guideline. By earning the Gateway Certified seal of approval, supply chain
partners can be confident in data quality while providing their customers file integrity
confidence.

“The certification process helped us take a closer look at how our outbound files are structured,
validated, and delivered,” said Sherri Bauman, Quality and Testing Manager at Körber. “This
allows Körber to produce fully conformant files aligned with GS1 standards, highlighting
improvements that support greater consistency and accuracy.”

Bauman added, “This milestone better positions Körber to meet current requirements and adapt more easily to future compliance needs, while supporting smoother data exchange for our partners and customers. This is a foundational step that improves data quality, supports scalability, and reinforces our commitment to standards-based compliance now and in the future.”

“When EPCIS solution providers commit to testing and compliance to interoperability
application standards, like Körber, pharmaceutical supply trade partners benefit,” said Gary
Lerner, President of Gateway Checker Corporation. “As more suppliers follow Körber’s lead,
drug transaction records will flow faster with fewer inaccuracies, minimizing supplier
disruption.”

To learn more about the Gateway Certified program, reach out to our team or visit our
website.

Click here to read the Körber press release.

The Compounding Center Earns Gateway Certified® Accreditation for EPCIS

Posted by bryan hanley On March 20, 2026 at 2:06 pm | Comments Closed

Lexington, MA, March 19th, 2026 – Gateway Checker®, the industry’s leading GS1 Certified Conformance Testing Service, is proud to announce The Compounding Center has achieved Gateway Certified® EPCIS Verify™ accreditation, after creating files conforming to the specific demands of GS1 EPCIS 1.2 DSCSA requirements.  

“Gateway Checker’s GS1 certification and deep expertise haven’t just helped our team, they’ve elevated standards across the entire industry”, said Joel Gomez, President of The Compounding Center. “By leveraging the TraceReady™ platform and becoming Gateway Certified, we’ve not only maintained strict compliance but also reinforced our commitment to safe, reliable distribution for our customers.” 

The Compounding Center is a leading pharmaceutical and medical supply distributor serving more than 3,500 healthcare facilities across 45 different states nationwide; their accreditation demonstrates an outstanding commitment to DSCSA compliance, supply integrity, and patient safety, helping keep data and product moving efficiently to pharmacies and patients downstream. 

Gateway Checker EPCIS Verify is a cloud-based, EPCIS Conformance Testing Platform providing pharmaceutical manufacturers, repackagers, and wholesalers with a complete file assessment solution. As part of Gateway Checker’s Traceability Platform, EPCIS Verify comprehensively tests, evaluates, and validates file conformance to stringent GS1 EPCIS DSCSA requirements.  

With 16 different Pharmaceutical Traceability Scenarios (PTS) to verify against, EPCIS Verify provides users and their customers the confidence that their files are meeting advanced regulatory requirements. This process of continuous quality assurance helps prevent issues of noncompliance, costly rework, and product quarantines, while alleviating the threat of counterfeit product to patients. 

“We appreciate The Compounding Center’s commitment to patient safety, and we admire their sense of urgency to comply,” says Gateway Checker Founder and President, Gary Lerner. “As a team demonstrating consistent, clear communication with Gateway Checker and their supply chain partners, this accreditation illustrates their emphasis on minimizing file delivery complications and ensuring data is delivered safely and in a timely manner.” 

For more information about the Gateway Certified® Program for both EPCIS and VRS, or to discuss more about Gateway Checker’s comprehensive traceability platform, visit our website or contact our team here. Wherever you are in your compliance journey, Gateway Checker is here to help. 

Media Contact – marketing@nullgatewaychecker.com 

About Gateway Checker:  

Gateway Checker is a Software as a Service platform that facilitates product traceability, DSCSA compliance, and unambiguously verifies the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards. Gateway Checker is a GS1 Certified Conformance Testing Service and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC. 

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

NDC Distributors Earns Gateway Certified™ EPCIS Verify™ Accreditation 

Posted by bryan hanley On April 22, 2025 at 3:28 pm | Comments Closed

NDC Distributors Logo

Lexington, MA, April 22, 2025 – Gateway Checker, the industry’s leading independent GS1 Conformance Testing Service, is excited to announce NDC Distributors, an independently owned generic pharmaceutical wholesaler based out of Cranbury, New Jersey, has successfully attained Gateway Certified™ EPCIS Verify™ accreditation. 

EPCIS is a GS1 Standard that enables supply chain partners to capture event information about supply chain events (e.g., shipped, received, etc.), and to share that information with their trading partners securely and in near real-time. EPCIS is the only recognized standard by the pharmaceutical industry and recommended by the FDA to enable DSCSA enhanced traceability compliance. 

Gateway Checker EPCIS Verify™ provides cloud-based, portal access to EPCIS Conformance Testing, where outbound EPCIS files are loaded, files evaluated, evaluation reports generated, and results retained. Gateway’s GS1 DSCSA EPCIS Conformance Testing Service comprehensively tests, evaluates, and validates conformance to standards. EPCIS file form, structure, content, and selected outbound GS1 Pharmaceutical Traceability Scenario (PTS) are unambiguously assessed. 

“Working with Gateway Checker has been a very seamless process,” says Mark Grant, Systems Analyst at NDC Distributors. “Gateway Checker’s internal verification process makes it easy to identify any files with EPCIS exceptions, and their team is always ready to step in and communicate issues with our vendors. We are truly very happy to have Gateway Checker as our EPCIS partner.” 

Transactions that successfully meet Gateway Checker EPCIS Verify™ testing requirements are eligible to become Gateway Certified™. When a transaction is Gateway Certified™, trade partners can be confident their data meets industry and regulatory (DSCSA) standards, helping ensure integrity across the entire supply chain.  

After successfully meeting strict conformance requirements, NDC Distributors achieved certification for a wholesaler to dispenser pharmaceutical traceability scenario, incorporating a single purchase order and aggregation. NDC Distributor’s Gateway Certification demonstrates their commitment to DSCSA conformance, supply chain integrity, and patient safety. 

“The Gateway Certified™ seal exemplifies a steadfast commitment to meeting full DSCSA requirements. In earning the seal, NDC Distributors’ trade partners can be confident the data they receive is both accurate, compliant with DSCSA regulations, and conforms to GS1 application standards,” says Gary Lerner, Founder and President of Gateway Checker. “ 

As the end of the stabilization period approaches quickly, we encourage manufacturers, distributors, and 3PLs to get certified by the only independent, GS1-certified conformance testing service available today.”

Next Steps 

About Gateway Checker:  

Gateway Checker™ is a Software as a Service platform that facilitates product traceability, DSCSA compliance, and unambiguously verifies the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards. Gateway Checker is certified by the GS1 US RX EPCIS Testing Service Certification Program and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC. 

Counterfeit Ozempic Once Again Found in the U.S. Supply Chain

Posted by bryan hanley On April 17, 2025 at 6:11 pm | Comments Closed

Counterfeit Ozempic Label

Ozempic: Back in the News

In what has become a sad yet true frequent occurrence, counterfeit Ozempic has once again been found in the U.S. supply chain.

On April 3rd, 2025 the FDA was notified by Novo Nordisk that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were distributed outside of their authorized supply chain. Nonetheless, these drugs have ended up in the hands of either patients, wholesalers, retail pharmacies, and/or healthcare professionals, with the FDA seizing a few identified counterfeit products on April 9th, 2025.

The FDA advises associated parties to check Ozempic products carefully, and to not use, distribute, or sell those with the lot number PAR0362 and serial numbers beginning with 51746517. Products within lot number PAR0362 that do not contain serial numbers beginning with 51746517 are still legitimate.

A Common Theme

Semaglutide and other Glucagon-like-Peptide-1 (GLP-1) medications have become popular for their treatment of type-2 diabetes, obesity, and cardiovascular complications. Their popularity has resulted in product shortages, further incentivizing counterfeiters and channel-diverters to manufacture counterfeit goods that put pharmaceutical vendors and their patients at risk.

When product is deemed potentially counterfeit, manufacturers launch investigations, impose quarantines, and destroy product to prevent these products from infiltrating the legitimate supply chain. The U.S. Code of Federal Regulations states that when a pharmaceutical manufacturer cannot differentiate between good and bad product, the entire returned shipment must be destroyed. However, quarantining and destroying highly-demanded products (like Ozempic) further contributes to the shortage issue if these products are legitimate.

The Importance of VRS Systems in Action

Product verification through Verification Router Service (VRS) systems alleviate this problem, helping pharmaceutical vendors quickly identify counterfeit goods. By facilitating the request for verification of the product identifier applied to a serialized product, VRS systems accurately pinpoint the source of product in seconds, confirming product came from a certified manufacturer and is suitable for subsequent commerce.

It’s hard to differentiate between a legitimate and counterfeit product without VRS systems. As a buyer of product, you can confirm the lot number, expiration date, and GTIN are all legitimate; however, it’s hard to tell if a serial number is legitimate without confirmation from the manufacturer. That’s where VRS systems come in.

VRS Systems are an efficient solution to preventing illegitimate product from entering the supply chain, while also preventing legitimate product from mistakenly being discarded or quarantined. Their continued implementation and widespread use will simplify product verification, prevent unnecessary shortages, and make our supply chains safer.

Unguessable Serialization

This instance of counterfeiting also demonstrates another major issue: consecutive serialization. As demonstrated by the above image, the FDA was able to conclude that potential counterfeits all begin with the same lot number, PAR0362, and contain serial numbers beginning with 51746517.

With consecutive serialization, counterfeiters are more easily able to guess which serial numbers occur next in the sequence. When serial numbers are randomized, non-sequential, they become unguessable and difficult to counterfeit.

Randomized serial numbers make it impossible for counterfeiters to identify a pattern when generating new, illegitimate serial numbers. Reverse-engineering from a genuine product becomes useless, as that single data point provides no reliable way to create other valid serial numbers.

Checking Serialized Product Identifiers

Lastly, continually checking the serialized product identifier as product travels throughout the supply chain ensures detection of counterfeit or diverted product before it reaches patients. In the absence of distributors scanning serialized product identifiers, counterfeit or diverted product can seep into the legitimate supply chain.

As identified in this instance, the importance of VRS Systems, unique serialization, and checking serialized product identifiers cannot be overlooked. Stop guessing and start checking.

Visit our website to learn more: https://gatewaychecker.com/