Manufacturers, re-packagers and other stakeholders will inform the FDA of developments in electronic, interoperable track-and-trace systems as part of the Drug Supply Chain Security Act. The new program pilots technologies that may become standard for reliable tracing and verification protocols.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release.
Blockchain is among the technologies being recommended to reduce the division of drugs distributed domestically and keep counterfeit drugs from entering the supply chain. “We’ve 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.” Dr. Gottlieb said.
The DSCSA pilot program is intended to identify and evaluate whether blockchain or another technology is the most efficient process to comply with drug supply chain requirements.
“To advance these efforts, the FDA recently recruited Frank Yiannas, an expert on the use of traceability technologies in global food supply chains. He’ll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply,” said Dr. Gottlieb.
The FDA also plans to release the new approaches considered through the program with the drug supply chain industry through the agency’s website.
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