FDA launches pilot technology programme to track and trace US drug supply chain

The Food and Drug Administration (FDA) has launched a new pilot project, designed to test innovative technologies in order streamline and optimise the tracing and verification process throughout the medicinal supply chain.

In a statement released this week, Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program) is designed to “assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States.”

The pilot programme will take place from February 8-March 11 2019 and will play a key role in development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act.

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Enacted by the US Congress in 2013, the DSCSA will enable the FDA to better protect customers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful while also working to detect and remove potentially dangerous drugs from the drug supply chain.

“We recognise that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply. We’re also focused on making improvements across the other products we regulate, especially related to food and our ability to address foodborne outbreaks. We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain,” said FDA Commissioner Scott Gottlieb, M.D.

“For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it; establish a more robust product verification to ensure that a drug product is legitimate and unaltered; and to make sure that any party involved in handling drugs in the supply chain must have the ability to spot and quarantine and investigate any suspect drug. We’re committed to staying at the forefront of new and emerging technologies and how they might be used to create safer, smarter and more trusted supply chains to better protect consumer safety and ensure the integrity of the high quality of products they deserve.”#