FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain - Drug Information Update

A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in our nation’s drug supply chain. As part of these efforts the agency is launching a new pilot project in which participants representing the drug supply chain (e.g., 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. to ensure suspect and illegitimate products do not enter the supply chain. 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. This new program will pilot technologies that may become part of our 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. The DSCSA pilot project program is intended to help identify and evaluate the most efficient processes to comply with and apply drug supply chain security requirements. The program will aid in identifying attributes the system will need for enhanced product tracing and verification, as well as electronic means to share the information. The FDA is committed to sharing new approaches considered through this program with the broader drug supply chain community on the agency’s website. Our goal is to ensure that all parties can be apprised of its progress and take advantage of any shared learning. The FDA has previously taken steps to advance the development and adoption of technologies that can help identify and properly trace prescription drugs as they move through the supply chain. For example, the FDA recently issued draft guidance on the use of product identifiers with a unique serial number to improve verification down to the package level. Additionally, the FDA has provided draft guidance for verification systems to quarantine and investigate suspect and illegitimate drugs. Enhanced verification and tracing in the supply chain can translate to a more rapid response by industry and the FDA when an illegitimate product is found. DSCSA was enacted by Congress on Nov. 27, 2013. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. For more information, please visit: DSCSA.