FDA: New Steps to improve Supply Chain Security

Recommendation

14/15 December 2021

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The FDA supports the adoption of more modern technologies for improving the security of the drug supply chain. Innovations should improve tracking and tracing of medicines.

Now FDA 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. Currently the project is focusing on prescription drugs in the U.S., with the aim to prevent suspicious and illegitimate products from entering the supply chain.

The intention of the so-called "Pilot Project Program Under the Drug Supply Chain Security Act" (DSCSA Pilot Project Program) is to assist FDA and members of the pharmaceutical distribution supply chain in the development of an electronic, interoperable system.