On August 25 and before policymakers could bring their concerns up to the United States Congress in September, the Food and Drug Administration (FDA) announced it was granting pharmaceutical manufacturers and their trading partners, including distributors and dispensers, a temporary reprieve from the regulatory requirements under the Drug Supply Chain Security Act (DSCSA) for implementing digital and interoperable traceability systems in their supply chains to track products.
Initially set for November 27, 2023, as the compliance deadline, the FDA has now shifted it to the same date in 2024. Highlighting the rationale behind this move, the FDA expressed that more time seemed to be necessary for supply chain stakeholders to achieve seamless and secure interoperability to exchange unit-level serialization data.
The reprieve was largely influenced by concerns the pharma industry and government officials voiced about varying degrees of readiness among businesses and their trading partners. During a virtual assembly in December 2022, it was pointed out that organizations differed significantly in their preparedness levels. Some lacked an understanding of their responsibilities concerning the DSCSA and underestimated the time and resources needed to fulfill them.
It’s crucial to embrace a cohesive, standardized traceability ecosystem. A siloed approach to compliance simply won’t work. The ecosystem should integrate cobots especially designed for the pharma industry’s unique needs and labor challenges, a comprehensive L1-L5 serialization system, and a robust traceability platform. This would facilitate data sharing with partners’ third-party systems, becoming the springboard to true interoperability as required by the DSCSA.
All players in a pharmaceutical supply chain, spanning manufacturers, distributors, logistics experts, and dispensaries, stand to benefit from a singular traceability system. Such a platform streamlines data sharing and instantly generates DSCSA-compliant documentation to satisfy FDA audits. In addition, advanced data assessment and visualization capabilities can help companies refine inventory strategies, fine-tune distribution plans, and pave the way for both operational cost-savings and efficiency.
Just because the pharmaceutical industry has gained more time does not mean organizations shouldn’t keep up the pace as they prepare for compliance. Here are some tips to ready your business for the looming regulation.
Familiarize yourself with DSCSA’s interoperability requirements. Dedicate a team to learn more about the requirements and work with compliance experts like OPTEL to guide you.
Review your existing traceability reporting systems to identify areas that need updating or changes to meet DSCSA standards.
Implement serialization and traceability solutions that comply with DSCSA’s digital interoperable requirements. Ensure they can integrate with existing systems and accommodate future regulatory changes.
Engage with trading partners to align your traceability initiatives and test interoperability months in advance of the 2024 deadline.
Regularly test your systems and processes for DSCSA compliance. Mock audits can help identify gaps and areas for improvement when you report to the FDA.
Ensure that product identifiers, including serial numbers, lot numbers, and expiration dates, are consistently and accurately captured and stored. Many of OPTEL’s clients notice discrepancies in their data integrity.
Establish comprehensive methods for verification requests, particularly in scenarios involving suspect or counterfeit products.
Regular training ensures that staff understand the importance of DSCSA compliance and are equipped to handle related tasks effectively. Regulations and industry standards evolve at a rapid-fire pace. Join industry groups, attend relevant webinars, and subscribe to updates from the FDA and other regulatory bodies to stay informed.
The DSCSA deadline might have changed, but it’s not too late for pharmaceutical companies to address the legislation’s complexities and ensure they are on the right track. By identifying the challenges, focusing on core problem areas, and securing the services of a trustworthy traceability vendor, businesses in the pharmaceutical industry can meet their compliance goals head-on.
Your Go-to Technology Partner to Meet the DSCSA Deadline and Transform the Pharmaceutical Industry for Future Generations
Your Go-to Technology Partner to Meet the DSCSA Deadline and Transform the Pharmaceutical Industry for Future Generations
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