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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

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.

Far From Compliant: Much Improvement Still Necessary for DSCSA Compliance

Posted by bryan hanley On September 26, 2024 at 11:31 am | Comments Closed

Many Manufacturers are Failing to Meet DSCSA Requirements

Published September 26th, 2024

The November 27th, 2024 deadline for DSCSA Compliance is just two months away. While many pharmaceutical partners have made tremendous efforts to adhere to updated guidelines, many remain far from compliant. DSCSA Compliance is a team effort; if certain trading partners fail to meet these new guidelines, the entire supply chain could be adversely impacted.

Pharmacies and the organizations that represent them, in particular, are discovering that manufacturers are behind when it comes to meeting updated traceability requirements. According to Jillanne Schulte Wall, Senior Director of Health & Regulatory Policy at the Alliance for Safe Online Pharmacies (ASOP), many manufacturers are only providing 20% to 30% of the data necessary for supply chain traceability. She believes this gap can be attributed not to purposeful noncompliance, but rather, to the various enforcement discretion periods and the complexities of the DSCSA itself.

Further Proof, and What it Could Mean for Consumers

These concerns align with the results of a recent survey conducted by the FDA and the Partnership for DSCSA Governance in June: close to one-third of pharmacies surveyed reported they are routinely receiving serialized data from 20% or less of their suppliers, and only 10% of them said they were receiving serialized data routinely from 95% to 100% of their suppliers.

The National Association of Chain Drug Stores (NACDS) gave their own input on DSCSA preparedness. The organization believes a phased, renewed approach to compliance is necessary, considering the number of manufacturer-level trading partners who are failing to provide complete and accurate EPCIS data consistently. Relying on the Waiver, Exception, and Exemption process alone could withhold negative implications for consumers, including higher prices and drug shortages.

The American Society of Health-System Pharmacists (ASHP) is communicating around the clock with the FDA as the end of the stabilization period approaches. “We are very concerned about the lack of preparedness we are seeing upstream, and whether or not there should be a continuation of the stabilization period,” Ms. Schulte Wall added. Nonetheless, the FDA hasn’t provided any reason for pharmaceutical partners to expect another stabilization period.

FDA: No More Stabilization

The FDA has made it clear they have no intention of continuing the stabilization period past November 27th. With this in mind, partners across the supply chain need to meet these updated requirements promptly. Though various organizations are pushing for modified compliance procedures or extensions to stabilization, the FDA has emphasized that this is not a likely scenario.

Pharmaceutical partners must focus on meeting updated compliance standards or risk consequences, including legal penalties, product seizures, downstream supply chain disruptions, and reputational damages.

How Gateway Checker Can Help

Gateway Checker has a variety of services intended to help pharmaceutical partners adhere to these updated DSCSA requirements. Our traceability platform, TraceReady™,  provides comprehensive drug transaction quality assurance, proactively identifying and remediating conformance and interoperability issues. Additionally, transaction records that pass TraceReady’s rigorous conformance testing requirements are eligible to be Gateway Certified™, our seal of approval verifying that your transactions are interoperable and meet updated DSCSA guidelines.

To learn more about our TraceReady™ Platform, and our Gateway Certified™ EPCIS and VRS conformance testing services, view our services or contact us.


The Importance of DSCSA Compliance

Posted by bryan hanley On September 4, 2024 at 12:30 pm | Comments Closed

Many Unprepared for New Guidelines

Published September 4th, 2024

With the November 27th, 2024 stabilization period deadline approaching quickly, pharmaceutical partners must be ready to adhere to new traceability and interoperability requirements. But a troubling number of partners haven’t made enough progress to reach these new standards, a statistic troubling to partners, the FDA, and one that should trouble consumers as well.

While Phase 2 of the Drug Supply Chain Security Act was supposed to come into effect last November, a stabilization period has granted pharmaceutical partners an extra year to adhere. However, the November 27th deadline is quickly approaching, and FDA officials announced that this deadline is firm. Manufacturers, distributors, and healthcare providers must be prepared to exchange EPCIS interoperable, product-level data across the supply chain… and the truth is, many aren’t ready.

In June, the Partnership for DSCSA Governance (PDG) hosted a joint public meeting discussing DSCSA implementation and stabilization efforts, allowing industry leaders to discuss progress made to adhere to these standards. While progress has certainly been made since June, many pharmaceutical players remain unprepared, including major wholesalers and manufacturers. However, making progress simply by adhering to requirements isn’t the only issue.

Why Updated Regulations Matter… and How to Be Prepared

Counterfeits remain a real threat throughout the United States. Recent reports found Ozempic counterfeits infiltrating the supply chain, with counterfeit boxes containing the same serial number on all packages. A third-party review of the product detected this complication, exhibiting the lack of quality systems and processes within that particular supply chain. Instances like this are far from uncommon, highlighting the importance of DSCSA Compliance and working with a trusted solution provider to help you comply.

As the leading GS1 Conformance Testing Platform, Gateway Checker has a suite of services designed to help you protect the integrity of your supply chain and conform to necessary DSCSA Standards.  

Keep your supply chain safe. Take a look at our traceability platform and conformance testing solutions, to see how we can help you prepare for the upcoming DSCSA regulations. 

Or, feel free to contact us to learn more.