Outsourced Pharma’s Post

We had a very successful meeting in DC with the Partnership for DSCSA Governance (PDG) and FDA . Thank you for hosting and putting all of this together. The FDA previously provided a one-year stabilization period, for enhanced drug distribution security requirements of section 582 of the FD&C Act for all trading partners which ends on November 27, 2024. The agency is not extending the stabilization period beyond November 27, 2024. We sat down with as many of the manufactures, distributors, and dispensers as we could. Many won’t be ready by the end of this year. LumiRx has a solution that will allow many to become compliant by the end of this year. We also can help the companies that won’t make it file for the. WEE extension. Trading partners that do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements of section 582 of the FD&C Act by November 27, 2024, may request a waiver or exemption from those requirements. This does make it hard on the different companies across-the-board, especially those that have thousands of different locations. And also for small shops that only have a few locations. We are able to help provide a solution that can only bring you up to compliance, but save the medicines that will expire after November 27, 2024. There were a few hurdles to get over, but we can help with the issues such as data exchange, TI epcis reporting. There is an issue sending this information downstream. Let’s us send the information with the products itself and we can make sure the data properly gets there. Let’s work together in bringing the industry up to standard. #dscsa #epcis #pharma #medicine #dscsa2024 #pharmacies #medicinedistributers

The #DSCSA exemption: who’s in/who’s out, what’s in/what’s out #pharmacy #independentpharmacy Learn more https://lnkd.in/esy669-X

The #DSCSA exemption: who’s in/who’s out, what’s in/what’s out #pharmacy #independentpharmacy Learn more https://lnkd.in/esy669-X

On July 12, 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. Visit our Website at www.gatewaychecker.com to learn more. #PharmaSupplyChain #DSCSACompliance #Traceability #HealthcareInnovation

🚨 ‼️ Dear Valued Partners, ‼️ 🚨 As we approach the firm deadline for the Drug Supply Chain Security Act (DSCSA) in November 2024, it is imperative to highlight that there will be no further extensions. Adherence to these regulations is critical for continuing our operations and ensuring the integrity of the drug supply chain. At Landstar Drugs, we are fully compliant with all federal regulations and are prepared for the DSCSA requirements. Our commitment to compliance ensures that we maintain the highest standards of safety and efficacy in our distribution processes. For our partners in animal and human health sectors, it is crucial to ensure readiness for these changes. Please confirm that your systems are equipped with a GS1 Global Location Number (GLN) to meet the traceability requirements stipulated by the DSCSA. We appreciate your immediate attention to this matter and your continued cooperation in meeting these regulatory standards. #DSCSA #FDA #Pharmaceuticals #Farmacias

🚨 Important DSCSA comments from the #FDA at 2024 FDLI Annual Conference! 🚨 Dr. Patrizia Cavazzoni, Director of CDER at the FDA, made it clear: the deadline for November 2024 is set in stone. 📅 There will be no further extensions. "... come this November, there will be no more reprieves. “I really want to emphasize that this is not really a matter of kicking the can down the road.” Industry should use the one-year stabilization period to “troubleshoot and get assistance and secure their processes” so that all systems are ready by November 2024." Don’t wait until it’s too late! Contact LSPedia today to ensure you're #DSCSA compliant and fully operational by November 2024. 🔗 https://lnkd.in/g_D_H3rh #FDA #compliance #pharmaceuticals #regulation #LSPedia #pharmacy #DrugSupplyChainSecurityAct #healthcare #pharma

The phased approach is key to stabilizing #dscsa throughout the supply chain

November 27, 2023, was a significant milestone for the pharmaceutical industry. The Drug Supply Chain Security Act (#DSCSA) officially went into effect. The law is a game-changer for the safety and security of the U.S. pharma supply chain. It mandates full interoperable electronic unit-level traceability for all stakeholders. But remember, this is not the finish line — it’s a starting point. The FDA announced an “extended stabilization period” until Nov. 27, 2024, delaying by one year enforcement of key requirements. The industry shouldn’t view this as a time to pause; instead, it’s an opportunity to actively enhance and implement robust drug distribution security systems. If you don’t feel prepared or are uncertain about DSCSA compliance, don't panic. We are committed to supporting our customers and their trading partners in this journey. We offer industry-leading solutions and expertise to guide you through this transformative process. Don't slow down now. The future of the pharmaceutical supply chain depends on our collective efforts today. Get in touch to learn more about how we can navigate this new era together. Remember, in a world where transparency is key, supply chain optimization isn't an option — it's a necessity. Click here to learn more about our DSCSA compliance solutions: https://hubs.la/Q02brgZf0 #FDAUpdate #Compliance #PharmaIndustry #DSCSA

We attended "FDA’s Fifth Online Controlled Substances Virtual Summit," hosted by the U.S. Food and Drug Administration (FDA), in partnership with the Reagan-Udall Foundation for the FDA. We learned there is a significant increase in illegal internet sites selling non-approved dangerous and counterfeit medications. This summit aimed to identify innovative solutions to eliminate the unlawful availability of controlled substances online. Patient safety is our #1 priority. Rx Outreach is a licensed and accredited pharmacy. You can trust us to provide only FDA-approved medications. For your safety, check to ensure your pharmacy is licensed and accredited. #LicensedPharmacy #FDAApprovedDrugs #RxOutreach #Trust #Affordable #Convenient Sergio Barranco Ph.D. / RPh Julie Erickson Dr. Jordyn Nordé, PharmD, MBA

Next week, DDI expert Dr. Brian Ogilvie will be discussing the impacts of the newly finalized ICH M12 on #invitro #druginteractions study design and interpretation. The Guideline replaces corresponding guidance documents from the US FDA, EMA, and PMDA, among others. Make sure your studies meet these new regulatory expectations – learn more and register now: https://hubs.ly/Q02GxZFD0 #ADME #DMPK #DrugMetabolism #Enzymes #DrugTransporters