FDA Launches New Track-and-Trace Pilot Program


The program aims to reduce the amount of illegal or suspect prescription drugs distributed throughout the United States.

The FDA has announced the launch of a new pilot project to inform the development of a new electronic, interoperable track-and-trace system, anticipated for 2023, as part of the Drug Supply Chain Security Act (DSCSA). The new system will be aimed at reducing incorrect domestic drug distribution and keeping counterfeit drugs from potentially entering the supply chain.

The DSCSA pilot program aims to help identity efficient processes for applying drug supply chain security requirements, and technology for disseminating information. Manufacturers, repackagers and other members of the supply chain can become some of the first to try the agency’s new approaches in tracing and verifying technology. The FDA is currently seeking applications for those qualified.

“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. ” said FDA Commissioner Scott Gottlieb, MD, in a prepared statement.

This is not the first instance that the FDA has taken steps to advance the adoption of track-and-trace technology for prescription drugs in the US supply chain. Officials with the agency recently issued draft guidance on both the use of product identifiers with a unique serial number, and the use of quarantine and investigation for suspect or illegitimate drugs.

“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,” Dr. Gottlieb said.

According to the press release, the DSCSA was enacted by Congress on Nov. 27, 2013, and outlines steps to build an electronic, interoperable system in order to identify and trace prescription drugs within the US supply chain.


FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines. FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630942.htm. Accessed January 8, 2019.

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