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

Trump’s Tariffs and the Price of Prescription Drugs

Posted by bryan hanley On May 13, 2025 at 7:58 pm | Comments Closed

Money and Pharmaceuticals on a table

Tariffs and the Pharma Supply Chain

The impact of the Trump Administration’s tariffs extends across numerous industries. While the reality of tariffs is yet to hit Finished Pharmaceutical Products (FPPs), the threat has become more and more real. Tariffs on FPPs have largely been avoided over the past decades as a result of the 1994 Pharmaceutical Agreement between the United States, the European Union, China, and a few other participants; the agreement was established to eliminate trade barriers on a large number of pharmaceutical substances.

A few weeks ago, however, the Trump administration proceeded with probes into pharmaceutical imports, setting the stage for potential tariff implementation. The administration has argued these tariffs will incentivize companies to bring production back into the U.S., helping make the supply chain more robust and decreasing the potential for disruptions. A few major pharmaceutical companies have already indicated plans to invest in the U.S. in response to this threat, including Roche, Novartis, AstraZeneca, and Eli Lilly.

Higher Costs, Higher Prices

However, many pharmaceutical leaders have spoken out against tariffs, arguing that tariffs could lead to supply chain disruptions and higher prices. According to Giovanni Barbella, the global head of strategy at Sandoz, because the margins of generic pharmaceuticals are so small, higher production costs stemming from these tariffs would directly increase the prices paid by consumers.

Barbella added that if tariffs further reduce these already tight margins, some players within the pharmaceutical supply chain may elect to leave the U.S. market altogether, instead focusing on more profitable markets. This will threaten the supply of U.S. pharmaceuticals, and in turn, lead to higher prices for drugs that remain in the U.S. as competition subsides.

Ernst & Young analyzed the potential increase in drug costs in the U.S. if tariffs are implemented, and the results are quite significant: a 25% tariff would increase drug costs by almost $51 billion annually. If companies choose to pass these tariffs onto consumers, Americans would be expected to pay 12.9% more (on average) for their prescription medications.

Remain Focused on Compliance

With the DSCSA Deadline just around the corner (May 27th, 2025, for manufacturers), the threat of tariffs and the additional costs associated with them are another added burden. Don’t let the threat of tariffs take away from compliance efforts – the penalties for noncompliance are substantial.

Gateway Checker’s suite of traceability and conformance testing services provides trading partners the confidence that their exchanges meet strict DSCSA requirements, all at a fraction of the cost. With the threat of tariffs and compliance demands on the rise, see how Gateway Checker makes compliance both simple and affordable.

To learn more, contact us or visit our website:

Coming Up Next

Trump’s recent executive order, which gave drugmakers a 30-day deadline for lowering the price of prescription drugs, will likely have a big impact on all stakeholders within the supply chain.

In the coming days, as the dust settles, I will provide some insights on how this legislation may play out alongside potential FPP tariffs.

With tariffs expected to raise prices, and the executive order seeking to lower them, what will the outcome be?

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.