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      DSCSA Compliance – What You Need to Know Today

       

      In 2013, the United States Congress enacted the Drug Supply Chain Security Act (DSCSA), putting in place requirements and a timeline to develop and enhance drug supply chain security by November 27, 2023. After this date, all stakeholders are subject to audits and potential penalties.

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      The DSCSA Compliance Timeline

      These DSCSA compliance requirements, which took full effect in November 2023, have significantly impacted all stakeholders, especially smaller players like distributors and pharmacies who may not have the essential technology infrastructure in place. As the stabilization period continues, partnering with the right DSCSA compliance solution vendor is crucial for avoiding costly penalties in the future.

      2013
      DSCSA Enacted

      Congress passes the Drug Supply Chain Security Act (DSCSA) to fortify the U.S. pharmaceutical supply chain. 
      2015-1
      Lot-Level Tracing Begins

      Manufacturers, re-packagers, wholesale distributors and pharmacies are required to trace products at the lot level. 
      2023
      Package-Level Compliance

      New set of requirements mandating all stakeholders to identify and track drugs down to the package level. 
      2024
      Stabilization Period Ends

      Ongoing period where full compliance and operational stabilization is expected. 

      DSCSA Compliance for Distributors:
      The New Landscape

      DSCSA Compliance


      Inventory Management Post-Compliance Deadline

      Distributors must now ensure their inventory meets the package-level serialization standards set by the DSCSA.
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      Mandatory Package-Level Serialization

      Without package-level serialization data, no inventory can be sold to anyone downstream (dispensers/pharmacies). This is a critical component of DSCSA compliance and is essential for legal distribution.
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      Technological Upgrades for Compliance

      Distributors in the pharmaceutical industry face the challenging task of managing compliance-related data and processes across a wide network. This complex onboarding process may require reaching out to more than 1,000 trading partners to handle data for existing inventory and to test processes for future orders.

      LEARN MORE ABOUT DSCSA COMPLIANCE CHALLENGES

      DSCSA Compliance : Top 3 Reasons for Distributor Preparedness

      The role of distributors is critical in the pharmaceutical supply chain. With the November 2023 DSCSA compliance deadline having passed, distributors are at the forefront of ensuring that the pharmaceutical supply chain remains secure and trustworthy.

      Ensuring Safe and Legitimate Products

      Health systems rely heavily on distributors, along with wholesalers and third-party vendors, to implement strong compliance plans. Distributors play a key role in guaranteeing that the products they handle meet all safety and legitimacy standards as per DSCSA requirements.
      Maintaining Customer Trust

      Building and maintaining trust with customers is paramount for distributors. Non-compliance or inadequate preparation for DSCSA regulations could significantly damage the trust that has been established or is growing with your clients. Demonstrating rigorous compliance efforts assures your customers of your commitment to safety and reliability.
      Regulatory Accountability

      Regulatory bodies are now heightening their oversight and auditing activities. Distributors could face inspections and will be held accountable for meeting all DSCSA compliance requirements. Ensuring your team and product lines are fully compliant is vital to avoid potential audits, penalties, or operational disruptions.

      READ MORE ABOUT DSCSA REQUIREMENTS

      The Distributor’s DSCSA
      Compliance Solution Checklist

      Distributors looking to overcome DSCSA compliance challenges will take more than a wait-and-see approach; finding a strategic partner and platform is crucial.
      Healthcare distributors should look for:

      DSCSA Expertise

      Partners play an important role in complying with DSCSA requirements. They are the keepers of the data repositories, which means they are the middleman in any transactions within the healthcare supply chain. Look for a strategic partner with proven DSCSA expertise.
      Integrated DSCSA Compliance

      The need for duplicate processes can be eliminated by using a warehouse management system (WMS) with a seamless DSCSA component rather than an add-on.
      Comprehensive System Features

      The WMS should be designed for DSCSA compliance, including agility, adaptability, scalability, efficiency, interoperability and personalization. It should also feature systematic multi-level serialization inference and systematic enforcement of all DSCSA rules and mandated, real-time event posting.

      Start Your Journey Toward True DSCSA Compliance

      POU03-Healthcare-Blue-Hue-725x391-1

      As the market leader in healthcare supply chain solutions, Tecsys Elite™ WMS for healthcare distribution is designed to address the needs of high-cost-of-failure supply chains, specifically in the pharmaceutical and healthcare setting.

      • Built-in DSCSA serialization compliance
      • No dual entry 
      • Out-of-the-box compliance
      • One single system vs multiple systems
      Brochure

      DSCSA Serialization: A Reality

      As the market leader in healthcare supply chain solutions, Tecsys Elite™ WMS for healthcare distribution is designed to address the needs of high-cost-of-failure supply chains, specifically in the pharmaceutical and healthcare setting.

      Get Expert Guidance

       

      Valerie Bandy PharmD MBA

      Tecsys is pleased to introduce Dr. Valerie Bandy, PharmD, MBA, an expert in DSCSA compliance with over 25 years in pharmacy operations, to guide you through its complexities.  

      Dr. Bandy's contributions to the Texas State Board of Pharmacy and her active roles in TSHP, ASHP and MSHP, underscore her influence and commitment to the field. Additionally, her involvement in ASHP’s Leadership Academy and her role as an ASHP Wellbeing and Resilience Ambassador highlight her dedication to fostering excellence and resilience in the pharmacy community. 

      Embark on your journey to DSCSA compliance with confidence. Dr. Bandy is ready to assist you with tailored advice and answers to your most pressing DSCSA questions. 

       

      Request a meeting with Dr. Bandy