DSCSA Requirements And Responsibilities For Drug Manufacturers (Sponsor Vs CMO)

With the FDA's final compliance deadline for the Drug Supply Chain Security Act (DSCSA) nearing, it's crucial for organizations to assess their readiness. While the FDA has extended the deadline to November 27, 2024, to allow additional time for implementing and stabilizing electronic, interoperable systems, the emphasis remains on timely action. The FDA has urged continued efforts to meet the enhanced drug distribution security requirements without delay.

At ProPharma, we understand the significant responsibilities that pharmaceutical sponsors and contract manufacturers bear in ensuring the integrity of the drug supply chain. From product serialization to comprehensive tracing and verification systems, it's essential to meet all DSCSA mandates effectively. Our services include support in validation programs, quality systems development, and supplier management to help organizations ensure compliance before inspections.

As the DSCSA deadline approaches, taking proactive steps to secure your processes and maintain a secure supply chain is vital. If your organization seeks guidance on meeting these regulatory requirements, we are here to assist in navigating these complexities and ensuring readiness.