US FDA Backs EPCIS, Refines Advice As November 2023 DSCSA Deadline Approaches
Agency recommends the GS1 standard that stakeholders have been focusing on for working together to remove counterfeits from the US pharmaceutical distribution chain; adds its latest thinking on roles of additional types of trading partners.
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Despite a raft of measures to prevent substandard or falsified (SF) medicines from reaching individuals, these medicines proliferated with the growth of e-commerce during the COVID-19 pandemic. The problem requires multistakeholder counter efforts, and for providers and patients to change their behaviors.
A pilot that used RFID tags with 2D barcodes was touted as more effective than using 2D barcodes alone in tracking drugs through the supply chain.
A blockchain application for mobile devices was successfully piloted to conduct real-time tracking of a high-cost drug through the “last mile” of the supply chain to the point of dispensing. Such a tool can be useful for manufacturers in tracing their products through the supply chain and complying with a forthcoming mandate of the US FDA Drug Supply Chain Security Act (DSCSA).