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/

Movilitas.Cloud Earns Gateway Certified™ Accreditation for VRS Solution

Posted by bryan hanley On March 14, 2025 at 2:43 pm | Comments Closed

Movilitas.Cloud Logo

Movilitas.Cloud: VRS Verify™ Accreditation

Lexington, MA, March 14, 2025 – Gateway Checker, the industry’s leading independent GS1 Conformance Testing Service, today announced Movilitas.Cloud, as part of Engineering Industries eXcellence, has become the first product verification solution provider to successfully attain both Level 1 and Level 2 Gateway Certified™ VRS Verify™ accreditation.

The FDA Drug Supply Chain Security Act (DSCSA) requires Pharmaceutical trade partners to have systems to facilitate saleable returns verification. In response to regulation, the Verification Router Service (VRS) was developed by the Healthcare Distribution Alliance (HDA), aiming to automate verification requests and achieve near real-time responses.

With VRS systems, authorized pharmaceutical trading partners can confirm that the unique set of product information (lot number, expiration date, trade identifier, and serial number) assigned to a drug matches the information recorded by the manufacturer.

Successful system-to-system interoperability requires extensive testing and validation, and the cooperation and resource commitment of competitive systems. Up until now, VRS testing results are typically self-executed and reported by the solution provider, a tedious and often inaccurate approach to testing and validation. Gateway Checker developed an independent, unbiased VRS conformance testing platform, VRS Verify™, that quickly, robustly and reliably executes VRS test scenarios.

Demonstrating a commitment to supply chain integrity and DSCSA compliance, Movilitas.Cloud has become the first DSCSA solution provider to be awarded Gateway Certified VRS Verify™ accreditation.

“Gateway Checker has always been heavily involved in the development of the VRS standards and builds tools to measure the health of this multivendor platform,” said Marc Blekkink, Founder and Managing Director of Movilitas.Cloud. “We are very pleased that an independent organization has begun certifying these solutions, allowing the market to select a trusted partner for DSCSA verification requirements.”

Next Steps

  • For more information on VRS Verify™ and to receive a free product verification assessment, please complete the form at this link.
  • To check out Gateway Checker’s other suite of services designed for DSCSA Compliance, click this link.
  • To read the full press release from Movilitas.Cloud, click this link.
  • Media Contact: Gary Lerner – glerner@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 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.

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”