PHARMACY

FDA launches track-and-trace pilot

BY Sandra Levy

The Food and Drug Administration has unveiled a new pilot project in which manufacturers, repackagers and other stakeholders can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S.

Eligible entities may apply to participate in the program. The pilot will inform the 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.

The FDA said this new program will pilot technologies that may become part of its enhanced expectations for reliable track-and-trace systems. The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.

“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. 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 commissioner Scott Gottlieb said.

Gottlieb went on to say that the agency recognizes 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.”

The FDA is working with Frank Yiannas, an expert on the use of traceability technologies in global food supply chains, to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply.

“Under his leadership, we’ll continue to leverage all tools available to ensure greater accountability. 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,” Gottlieb said.

Finally, Gottlieb said, “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.”

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