The Drug Quality and Security Act (DQSA) created a national traceability framework that will continue to be implemented over the next eight years and will culminate in 2023 when fully serialized track and trace systems will be necessary to comply. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), outlines the steps necessary to build an electronic, interoperable system to identify and trace prescription drugs that are distributed in the US.
Requirements by Year
2015 – Pharmaceutical manufacturers are now required to provide lot level transaction information (TI), transaction history (TH), and a transaction statement (TS) of all shipments, and must be able to locate any batch or product that is suspect within 24 hours of notification. The deadline for pharmacies to comply with certain elements of the DSCSA has been moved from July 1 to November 1.
2017 – Full unit level serialization with electronic connectivity between trading partners will be enforced.
2023 – Fully serialized track and trace systems that enable product tracing at the package level will be enforced.
As you know, the DSCSA went into effect on January 1, 2015, for the pharmaceutical supply chain, and manufacturers, repackagers, wholesalers, and pharmacies/clinics now face tracing, verification, and serialization regulations. The DSCSA requires pharmaceutical manufacturers, distributors, and dispensers to pass lot level transaction reports to customers and provide a mechanism to verify products, handle suspect products, and respond to requests for information.
When approached correctly, complying with mandates such as the DSCSA and other international mandates provides a tremendous opportunity for ROI and increased operational efficiency. By generating and then leveraging serialization management data, pharmaceutical manufacturers have the ability to gain real-time, end-to-end visibility, traceability, and control over orders and shipments as they move through the supply chain.
Benefits of implementing a serialization solution:
- Achieve 100% compliance with domestic and international mandates, including the FDA DSCSA.
- The ability to capture, leverage, and track serialization data from the packaging line, through the distribution center and then out to the broader supply chain.
- Mitigate legal and business risk associated with counterfeiting and diversions.
- Improve the management and accuracy of chargeback and returns reconciliation.
- Get real-time exchange of information to track data on every unit.
- Aggregate and de-aggregate product across all packaging levels.
- Commission and decommission serialized data across all packaging levels as needed.
For more information on ACSIS’ comprehensive supply chain traceability solutions, please contact us at 856-673-3000.