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With new mandates right around the corner, there is an unwavering demand for pharma operations to perform at peak efficiency.
In the ever-evolving landscape of healthcare supply chain management, the Drug Supply Chain Security Act (DSCSA) looms large. With the November 2023 DSCSA compliance requirements officially taking effect the 27th of this month and a one-year stabilization period following that, there is an added urgency to ensure traceability and transparency in the pharmaceutical supply chain. The need for efficient and streamlined pharmacy operations has never been more critical given shifting regulations and compliance requirements.
While traditional pharmacy logistics have been effective, they now face new challenges in the modern pharmaceutical landscape. The DSCSA mandates fully interoperable, enhanced electronic unit-level drug traceability requiring a serialized identifier, as well as verification of saleable returns for manufacturers and trading partners. With the complexities of medication management, drug shortages and global supply chain disruptions, there is a pressing need to adapt and innovate in pharmacy logistics.
Against the backdrop of these DSCSA compliance requirements, the future of pharmacy logistics lies in centralization, modernization, and strategic use of technology. By adopting a patient-first approach that harnesses supply chain innovation, healthcare systems can ensure timely, affordable, and efficient access to essential medications while ensuring full compliance with regulatory standards. As the healthcare landscape continues to evolve, centralized pharmacy distribution, combined with modern systems and automation, will play an essential role in shaping the future of medication management and patient care.
After becoming authorized and licensed, all trading partners have an obligation to familiarize themselves with the law and communicate their plan for compliance to their customers. They must provide, capture, and maintain information about transactions involving products distributed within the United States and the trading partners who engaged in such transactions of products. Manufacturers and repackagers are required to include a product identifier with standardized graphics, an encompassing NDC (national drug code), a serial and lot number, and an expiration date. These details must be available in both human and machine-readable formats using 2D data matrix barcodes for packages, and either linear or 2D data matrix barcodes for homogenous cases.
They are also required to establish systems and processes to:
Much of this is achieved via modern software applications that offer more than just operational efficiency. These applications are pivotal in ensuring compliance with regulatory frameworks like the DSCSA. They enable real-time tracking to ensure traceability, a core requirement of the Act. With predictive analytics to anticipate medication needs, they ensure that patient care is not compromised even with the added layers of regulatory compliance. And with the potential integration of automation in centralized pharmacy operations, they can significantly reduce human errors, ensuring more accurate and efficient drug distribution, which is paramount in the face of strict regulatory requirements.
Compliance from a health system’s perspective
Pharmacy supply chain management at the health system level is going through a period of innovation and maturation. As healthcare providers adopt emerging best practices like consolidated pharmacy service centers (CPSC), they are paying greater attention to logistics optimization, traceability, system modernization, and regulatory compliance. As this awareness grows, they are increasingly expecting the same level of sophistication from their pharmacy distribution counterparts.
With DSCSA requirements in full effect, health systems must now ensure they become familiar with the law and ensure their trading partners do the same. Their teams must be trained on handling suspect or illegitimate products, on verifying that trading partners are authorized, and on the timely reporting concerning licensing or quarantined product. If they are delivering to non-owned facilities or customers, they must also provide product tracing information.
While the specific impacts and compliance requirements may vary between the pharma industry and the health systems that rely on those pharmaceuticals, one undeniable truth remains: the importance of accurate DSCSA compliance is a shared imperative. Central to this is harnessing the transformative potential of centralized pharmacy distribution, the role of modern systems, automation integration, and the importance of all partners adhering to the stringent regulatory frameworks.
As we enter an era where DSCSA compliance is non-negotiable, there are many reasons why health systems care that pharma companies and their distributors are DSCSA ready now, including:
The interconnected roles of pharmacy-related trading partners highlight the critical need for alignment in the supply chain. As we move forward, it is imperative that all stakeholders recognize that DSCSA readiness is not just a regulatory necessity, but a fundamental commitment to patient safety, supply chain integrity, and the future of healthcare. By forging strong partnerships, staying proactive in compliance efforts, and embracing innovation, we can ensure a safer, more efficient and resilient supply chain.
About the Author
Valerie Bandy, PharmD, is Senior Director of Pharmacy Solutions at Tecsys.