Blog Archives

HDA Traceability Seminar Insights

Posted by bryan hanley On August 28, 2024 at 11:41 am | Comments Closed

The 2024 HDA – Healthcare Distribution Alliance Traceability Seminar was an amazing opportunity for pharmaceutical industry leaders to discuss DSCSA compliance challenges, and present innovative solutions to help partners remediate these challenges. Below, we discuss some important HDA Traceability Seminar Insights. One of the major takeaways from the conference was the role of Waivers, Exceptions, and Exemptions (WEEs) on DSCSA deployments.

DSCSA Compliance Clock is Ticking

With the deadline for compliance less than 3 months away, the compliance clock is ticking, and ticking fast; however, many appear unprepared. Despite reasonable efforts, many pharmaceutical supply chain partners are far from fully compliant, and likely won’t be by the time the stabilization period ends this November 27th.

The FDA has exempted small dispensers (25 or fewer full-time employees for the corporate entity owning the dispenser) from upcoming DSCSA electronic and data-driven requirements; these small dispensers account for about 1/3rd of total dispensers. What remains unclear is whether distributors who ship to these dispensers will also be exempt for those specific transactions.

Furthermore, the FDA cannot guarantee all of those who apply for WEEs will be answered by the end of the stabilization period, and the recommended deadline to submit these requests ended nearly a month ago.

The ambiguity over who is and who isn’t exempt and the indefiniteness of WEE approval could have detrimental implications on pharmaceutical supply chain integrity. Furthermore, handling common exceptions has proven difficult for big wholesalers and other partners, likely to further inhibit pharmaceutical supply chain security.

How Gateway Checker Can Help

The good news? Gateway Checker’s services provide wholesales, distributors, dispensers, and logistics providers the capabilities necessary to handle a variety of common exceptions, including:

  • Resending of a file with corrections (even after acceptance)
  • Reconciliation of partial shipments/short shipments
  • Digital instantiation of products with no corresponding EPCIS data (only to be used in accordance with SOPs)
  • Visibility into EPCIS errors

See for yourself how Gateway Checker simplifies DSCSA Compliance. Explore our features for yourself, or contact us to discuss your specific needs.

Gayr Lerner representing Gateway Checker at the 2024 HDA Traceability Seminar in Washington, DC.

TraceLink Attains Gateway Certified for GS1 US Pharmaceutical Traceability Scenarios

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

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

The Importance of Anti-Counterfeiting Solutions

Posted by bryan hanley On January 11, 2024 at 11:00 am | Comments Closed

The global pharmaceutical industry faces a significant challenge with counterfeit medicines, estimated to be one in 10 medical products in low- and middle-income countries, leading to a $30.5 billion spending on substandard drugs.

Counterfeit medicines, often indistinguishable from genuine ones, pose severe risks, including toxic ingredients that can be life-threatening.

The US pharmaceutical supply chain is among the safest and most secure especially when medicines are exclusively supplied through authorized trading partners. Nonetheless, recent counterfeit Ozempic and Muro 128 products remind us that risks from fake medicines remain.

To combat this, healthcare and pharmaceutical organizations must embrace innovative anti-counterfeit technology solutions, prioritizing simplicity, ease of deployment across the supply chain, and adherence to standards.

Mapping the supply chain, leveraging digital tracking, financial transaction analysis, and evaluating delivery infrastructure can identify vulnerabilities, while trusted champions in the supply chain can be crucial in verifying authenticity.

While you can’t prevent counterfeiting, you can make it harder to do, and criminals easier to catch. And this all starts with implementing a traceability solution that protects the integrity of your supply chain.

See how Gateway Checker makes this possible.