FDA: Additional Time to Refine Systems and Processes for Interoperable Electronic Tracing

Effective August 25, 2023: FDA issues new compliance policies to help supply chain stakeholders attain enhanced traceability under DSCSA.

FDA recognizes that additional time beyond November 27, 2023 is necessary to “stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

FDA is issuing this compliance policy to provide additional time, beyond November 27, 2023, to attain compliance without hindering access to prescription pharmaceuticals.

While FDA is strongly urging supply chain stakeholders to continue their efforts to deploy enhanced traceability solutions, FDA does not intend to take action to enforce enhance drug traceability until November 27, 2024.

Per FDA:

“This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”

> Read Updated FDA Guidelines

Gateway Checker Introduces Gateway CertifiedTM Program to Support DSCSA Interoperability Requirements

Lexington, MA, August 28, 2023 – Gateway Checker, the industry’s leading GS1-certified conformance testing service, today announced the introduction of the Gateway Certification program. A “Gateway CertifiedTM” drug transaction report enables organizations to be confident that they are compliant, interoperable, and fully conform to industry and regulatory requirements.

In November, all pharmaceutical trading partners will need to be compliant with DSCSA. Compliance requires electronic tracing of item-level product through interoperable systems. Although trading partners may be able to exchange records, there is no way to know if these transaction records are accurate, compliant, and interoperable, until problems emerge. Proactive identification of conformance issues minimizes surprises and time-consuming, costly exception handling, rework, and reverse logistics that can disrupt safe and secure access to essential medicines.

The Gateway Certification program leverages Gateway Checker’s TraceReady application for drug transaction quality assurance. Transaction records that pass TraceReady’s rigorous conformance testing requirements are eligible to be Gateway Certified.  The Gateway Certified seal of approval means all trading partners can be confident in the data’s quality, ensuring integrity across the entire supply chain.

“Today most trading partners are operating in the dark when it comes to DSCSA record conformance. Problems are discovered too late and can be very costly and time-consuming,” commented Gary Lerner, CEO of Gateway Checker. “The only way to know is to test. Gateway Checker’s fact-based approach to testing and certification allows users to quickly understand and address areas of non-conformance and dramatically improve supply chain efficiency.”

“As a distributor, we literally have to connect with 100,000 customers using varied DSCSA solutions.  It is not efficient or effective for us to negotiate the file transmission and completeness with every single one of those connections,” emphasized Scott Mooney, Vice President Distribution Operations at McKesson Corporation. “For that reason, we are firmly committed to following the GS1 DSCSA implementation guide and Gateway Checker is the best tool for us to be able to validate that our EPCIS files are conformant. Having our transactions Gateway Certified puts us in an affirmative position and significantly minimizes conflicts when we start sending data to our customers who may claim that our files are in error.”

Certification is available for manufacturers, distributors, wholesalers, and solution providers. Gateway Checker also offers Gateway Certification for validation of VRS product verification systems. To learn more about Gateway Checker and the Gateway Certified Program, please visit GatewayChecker.com.

Gateway Checker will be at the HDA 2023 Traceability Seminar, Washington DC, Aug 29-31, 2023.

Media Contact: Gary Lerner, glerner@nullgatewaychecker.com, 781-254-9987

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.

Antares Vision Group, through rfxcel, Joins the Gateway Certified™ Program to Lead VRS Standardized Testing Initiative

AV Group, which led an FDA-approved pilot to extend testing of the VRS, continues its DSCSA leadership by helping to test industry readiness.

Antares Vision Group, through rfxcel Technology, Joins the Gateway Certified™ Program to Lead VRS Standardized Testing Initiative

TRAVAGLIATO, BRESCIA, ITALY, August 22, 2023/EINPresswire.com/ — Antares Vision Group, an Italian multinational and a leading provider of track and trace and quality control systems, today announced that it has joined the Gateway Certified™ program for Verification Router Service (VRS) verification to help pharmaceutical stakeholders prepare for upcoming serialization and drug product verification requirements in the U.S. Drug Supply Chain Security Act (DSCSA).

The industry established the VRS specifications to help verify the authenticity of products for salable returns. Many providers have developed solutions based on the VRS specification and have voluntarily collaborated in testing to ensure compliance and interoperability.

The Gateway Certified™ program for VRS Verify was established in response to industry concerns that manual methods and self-testing among more than a dozen solution providers was time-consuming, was not scalable, and lacked independent oversight.

Recognizing the importance of connectivity and interoperability, Antares Vision Group, through rfxcel technology, is committed to independent and objective VRS verification testing. “We recognize that solution providers need a more scalable, repeatable, and open testing approach,” said rfxcel CEO Glenn Abood. “We see the limitations of the current approach and see the potential impact on robust, reliable systems as well as adaptation to emerging requirements.”

“We appreciate Antares Vision Group’s leadership and ongoing commitment to facilitate information interoperability and product verification in the pharmaceutical supply chain,” said Gary Lerner, President of Gateway Checker Corporation. “We encourage all solution providers interested in establishing demonstrable VRS conformance to join the Gateway Certified™ program.”

The Gateway Certified™ program provides independent, objective, automated use-case testing to assure that pharmaceutical drug product verification requests and responses consistently meet industry and FDA regulatory requirements. It examines a system’s conformance to requirements and provides objective evidence that it consistently meets industry and regulatory needs.

Herb Wong, rfxcel senior vice president of product and strategy, will be facilitating a Roundtable Discussion about the VRS at the Healthcare Distribution Alliance (HDA) 2023 Traceability Seminar in Washington, D.C., on Wednesday, Aug. 30, from 1:30 to 3:00 p.m. To learn more, visit Antares Vision Group at Table-Top 21 at the seminar.

Herb Wong
rfxcel Corporation


Original article:



Blue Link Partners with Gateway Checker to Help Pharma Distributors Meet DSCSA Interoperability Deadline

Vaughan, Ontario, May 1, 2023. – Blue Link Associates and Gateway Checker are pleased to announce a new partnership that will help increase the security and stability of the pharmaceutical supply chain by providing robust software solutions to pharmaceutical wholesale and distribution customers.

Blue Link Associates, a leading provider of all-in-one pharmaceutical distribution inventory and accounting ERP software, has teamed up with Gateway Checker, a well-established provider of pharmaceutical traceability software that enables conformance to GS1 application standards and DSCSA compliance. The collaboration aims to offer integrated software solutions that will help pharmaceutical distributors streamline operations and comply with the DSCSA November 2023 deadline. By integrating the functionalities of the two software solutions, the partnership will enable pharmaceutical distributors to optimize their operations, enhance visibility, and improve regulatory compliance. With this partnership, both companies are committed to providing the pharmaceutical industry with innovative software solutions that will help them meet the evolving regulatory requirements and operational challenges.

The partnership is based on complete two-way integration between the two systems, Gateway Checker and Blue Link Associates, allowing customers to receive, translate, store and send EPCIS file information from suppliers and to customers in the pharmaceutical supply chain. The Gateway Checker integration is available to all Blue Link ERP customers in the pharmaceutical wholesale and distribution industry.

“With their next generation Pharmaceutical application, Blue Link ERP demonstrates DSCSA market leadership among ERP suppliers”, said Gary Lerner, President of Gateway Checker Corporation.  “By integrating Gateway Tracker™ into receiving, reconciliation, inventory management, and fulfilment, Blue Link ERP users gain seamless regulatory compliance without the need for separate, complex, and costly serialization systems.”

Blue Link has been a leader in the pharmaceutical software space for over 10 years and continues to build partnerships with great companies such as Gateway Checker to offer customers the latest and greatest technology. The two companies are committed to working together to provide their customers with the highest quality software solutions and support.

“Partnering with Gateway Checker allows Blue Link to offer our customers the functionality needed to meet the DSCSA requirements at an affordable cost. The Gateway Checker team and Gary Lerner have been a great company to work with and we look forward to the benefits this partnership provides our customers.” Mark Canes, President, Blue Link Associates.   

About Gateway Checker

Gateway Checker™ provides Software as a Service platforms to facilitate product traceability, DSCSA compliance, drug product verification, GS1 US Rx Certified Conformance Testing, and EPCIS interoperability. Gateway Checker Corporation was established in 2019 as a wholly owned subsidiary of BrandSure, LLC, based on 13 years’ experience establishing supply integrity and deploying serialization solutions to more than 50 companies.

Learn More About Gateway Checker

About Blue Link Associates

Headquartered in Vaughan, Ontario, Blue Link Associates provides all-in-one pharmaceutical inventory management and accounting ERP software to meet the needs of pharmaceutical wholesale and distribution businesses. Founded in 1992, Blue Link continues to be a leader in the pharmaceutical ERP space with innovative solutions and dedicated in-house experts to meet the changing needs of the industry.

Contact us for more information.