The US Food and Drug Administration (FDA) plans to use a track-and-trace system to secure drug supplies. FDA made this announcement on 7 February 2019.
FDA is focused to ensure that drugs supplied to consumers are legit, safe and of high quality. In order to make that happen the FDA has launched a pilot project. This project will help the drug supply chain (manufacturers, stakeholders, repackagers, etc) to verify and trace prescription drugs.
The pilot project is in accordance with the Drug Supply Chain Security Act (DSCSA). The DSCSA Pilot Project Program will support the FDA and pharmaceutical distribution chain to help trace and track certain prescription drugs distributed around.
Participation in this project is voluntary and is open for pharmaceutical supply chain from 8 February to 11 March 2019. The track-and-trace system is set to take effect by 2023. This new system is aimed to reduce the diversion of drugs distributed and also stop fake drugs from entering into the supply chain.
FDA is exploring ways to improve traceability and using drug supply security like blockchains. Frank Yiannas has been recruited by the FDA to help use traceability technologies and to help strengthen the food supply chain in the US.
The idea is to secure electronic product tracing, which will provide information on where the drug has been located and who took care of it. This will help ensure that the drug is unaltered and safe for consumption.
Scott Gottlieb, M.D and FDA Commissioner said, “As part of our ongoing efforts to protect our nation’s drug supply, today, we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain.”
Gottlieb also said, “Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found.”
FDA has been working to improve the development and adoption of technologies that can help check and trace prescription drugs. Recently FDA issued a guidance draft on product identifiers with a unique serial number to improve verification of the drugs.
FDA invites pharmaceutical companies to participate and take advantage in learning ways to help identify and trace drugs for better and high quality.