FDA Track and Trace requirements once slated to to into effect on November 1, 2015 now won’t go into effect until March 1, 2016. This is the second extension of the deadline, as the Drug Quality and Security Act (DQSA) Drug Supply Chain Act (DSCSA) was originally supposed to go into effect on July 1, 2015. The program was designed to reduce drug counterfeiting while also helping to improve the efficiency of drug recalls.
The second delay comes as a result of challenges in becoming compliant with the regulations. Pharmacies and pharmacists need time to implement systems, test the system, and create a workflow for the necessary data collection and storage.
Title II of DQSA requires prescription drug data be tracked through the supply chain, from the manufacturer through the dispenser. Hospitals and health systems are required to collect and store information manufacturers give them to identify drug products to the lot level. While the system will eventually create a safer environment for patients, it is a large undertaking for drug manufacturers and pharmacies requiring significant changes to workflow and system management.
According to the National Association of Chain Drug Stores (NACDS), members had made tremendous efforts to be able to comply with the original July 1 deadline, that the organization needed assistance with 340B drugs and drop shipment to ensure patients didn’t experience delay getting their medications.
Under the 340B program, wholesalers often send medications to a pharmacy and send the necessary tracing information to the health care entity. But under the DSCSA, tracing information must follow the product throughout the supply chain meeting drop shipped drugs pose a problem for pharmacies, as they are required to set up electronic systems to capture the necessary tracing data.
The extended deadline will hopefully provide pharmacies with the additional time they need to get everything in place to work out any kinks in the system before track and trace enforcement goes into full effect. By using the additional time to make sure systems are in order and fully compliant, this will hopefully minimize the impact on patients receiving medication from pharmacies nationwide. When implemented fully, the system should improve detection and removal of potentially dangerous drugs throughout the supply chain before they reach consumers.