September 12, 2024
FDA: No More Delay for Updated DSCSA Guidelines
The FDA has reaffirmed its commitment to the November 27, 2024, deadline for pharmaceutical partners to adhere to upcoming DSCSA regulations. With time running out, pharmaceutical stakeholders must assess their readiness and address any outstanding challenges. Ensuring accurate and complete data exchange between trading partners is critical for DSCSA compliance. Yet many partners remain unprepared […]
September 4, 2024
The Importance of DSCSA Compliance
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 […]
August 28, 2024
HDA Traceability Seminar Insights
Published August 28th, 2024 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 […]
August 27, 2024
TraceLink Attains Gateway Certified for GS1 US Pharmaceutical Traceability Scenarios
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 […]
July 12, 2024
FDA Announces Small Dispenser Exemption
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 […]
