The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013. Title 2 of the DQSA, the Drug Supply Chain Security Act (DSCSA) delineates steps to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.”
The DSCSA is a law that the Food and Drug Administration (FDA) enforces to improve the security of prescription drugs in safeguarding patients from exposure to counterfeit, stolen, contaminated or harmful drugs. Some DSCSA compliance requirements are already in play. The extended stabilization deadline is the second part of DSCSA, which addresses the Track and Trace serialization law, providing direction on how to track and trace transaction histories as prescription drugs move from pharmaceutical manufacturing sites to pharmacies. The deadline for manufacturers is May 27, 2025, and the deadline for wholesale distributors is August 27, 2025. Third-party logistics providers (3PLs) will align with the deadlines of their partner organizations.
DSCSA compliance applies to all entities in the pharmaceutical supply chain, including manufacturers, repackagers, wholesale distributors, dispensers (pharmacies), and third-party logistics providers (3PLs). Each entity has specific responsibilities for tracking and tracing prescription drugs as they move through the supply chain to ensure product authenticity and patient safety.
The enhanced Track and Trace requirements have staggered deadlines: manufacturers must comply by May 27, 2025, and wholesale distributors by August 27, 2025. Third-party logistics providers (3PLs) will follow the compliance timeline of their partner organizations. It’s critical to begin preparation well in advance to ensure your systems and processes are ready.
All prescription drug packages must have unique, human and machine-readable barcodes containing four essential data elements: the Global Trade Item Number (GTIN), a unique serial number (EPCIS serialization), the lot number, and the expiration date. This standardized information enables complete traceability throughout the supply chain.
If you identify a suspect product, you must immediately quarantine it and verify its authenticity with the manufacturer. You’re also required to notify your trading partners and report the incident to the FDA using Form 3911. Your organization should have documented Standard Operating Procedures (SOPs) in place that outline the specific steps for identifying and handling suspect drugs.
All electronic transaction data, including product tracing information and transaction histories, must be retained for a minimum of six years. This data must be complete, accurate, and readily retrievable for FDA inspection or in the event of product recalls or investigations. Implementing a robust electronic data management system is essential for maintaining compliance.
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