The United States Food and Drug Administration (FDA) is set to launch a new pilot project for members of the pharmaceutical distribution supply chain for encouraging the use of innovative and emerging technologies for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain.
It is called the Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program), with the participants of the pilot representing the drug supply chain such as manufacturers, repackagers and other stakeholders.
The DSCSA Pilot Project Program began on February 8, 2019 and will continue through March 11, 2019. The duration of the DSCSA Pilot Project Program will depend on the pilot project(s) accepted into the program and when the projects are completed.
Though the participation in the DSCSA Pilot Project Program is voluntary, the FDA will ensure the participation reflects the diversity of the supply chain, including large and small entities from all industry sectors.
The open pilot will provide the pharmaceutical industry an opportunity to test new technologies to bring in greater accountability for participants in the supply chain and improve the FDA’s ability to trace prescription drugs at every point in the distribution chain.
The FDA Commissioner Scott Gottlieb has suggested the use of blockchain technology as part of the FDA’s plans to adopt modern technologies for improving the security of the drug supply chain to track and trace medicines.
Gottlieb noted that “We recognize that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain.”
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. It will also help identify and trace certain prescription drugs as they are distributed within the U.S.
Under this program, FDA will work with the stakeholders of the pharmaceutical industry to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.
The FDA said it is committed to sharing new approaches considered through this program with the broader drug supply chain community on the agency’s website. The new system is slated to go into effect in 2023 as part of the Drug Supply Chain Security Act.
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