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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.

 

TraceLink Attains Gateway Certified for GS1 US Pharmaceutical Traceability Scenarios

Posted by bryan hanley On August 27, 2024 at 12:47 pm | Comments Closed

Published August 27th, 2024

got tested?

Gateway Checker™, the leading provider of GS1 Certified Conformance Testing Services, applauds TraceLink’s recent attainment of GS1 US Conformance Trustmarks and Gateway Certified™ accreditation.

The Gateway Certified™ accreditation program provides independent, objective testing and conformance certification for entities seeking to comply with enhanced drug distribution security requirements. Such requirements are mandated under the FDA Drug Supply Chain Security Act (DSCSA).

Users of Gateway EPCIS Verify can automatically apply for a GS1 US Trustmark after fulfilling Pharmaceutical Traceability Scenario (PTS) requirements and earning a Gateway Certificate.

TraceLink, as the first solution provider to attain Gateway Certified for all 16 PTS use cases, demonstrates a commitment to GS1 Application Standards and DSCSA interoperability that is currently unmatched by its peers.

“Despite the necessity for alignment on information content and adherence to EPCIS application standards, it is our understanding that few other solution providers have demonstrated the confidence or commitment to subject their solutions to independent and impartial testing”, said Gary Lerner, President of Gateway Checker Corporation. “We encourage all solution providers, pharmaceutical manufacturers, and wholesalers interested in attaining DSCSA compliance and information interoperability to join the Gateway Certified™ program.”

Learn About the Gateway Certified Program

The GS1 US Rx EPCIS Conformance Testing Program ensures pharmaceutical supply chain integrity and facilitates information interoperability and compliance of data exchanges as mandated by DSCSA.

For a complimentary EPCIS and VRS conformance evaluation, get tested by an independent, certified testing service.

Be Confident, Get Certified.

 

Gateway Certified Seal, signaling accreditation attainment for GS1 US Pharmaceutical Traceability Scenarios

FDA Announces Small Dispenser Exemption

Posted by bryan hanley On July 12, 2024 at 5:38 pm | Comments Closed

On July 12th, 2024, the FDA announced an exemption for small dispensers from the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026.

However, the FDA will not extend further enforcement discretion for other parts of the supply chain.

Trading partners who are not prepared to meet the DSCSA’s enhanced traceability requirements by Nov. 27, 2024, are urged to seek individual waivers, exceptions, and exemptions (WEEs). However, the FDA has emphasized there’s no guarantee they will grant or deny these requests by the deadline, and the recommended deadline to submit these requests has already passed.

Furthermore, broad-scale WEEs could complicate DSCSA implementation and stabilization, particularly impacting those diligently preparing for interoperable traceability.

Gateway Checker is here to help you navigate these quickly approaching requirements. 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.

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