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  1. Drug Safety and Availability

Drug Supply Chain Integrity

The U.S. drug supply chain remains one of the safest in the world. However, the drug supply chain has become increasingly complex as it reaches beyond U.S. borders. Threats to the supply chain such as counterfeiting, diversion, cargo theft, and importation of unapproved or otherwise substandard drugs, could result in unsafe, ineffective drugs in U.S. distribution.

drug supply chain

FDA worked with the Asia Pacific Economic Cooperation (APEC) members to create a Supply Chain Security Toolkit for Medical Products to further protect consumers in the global marketplace. This toolkit covers the entire supply chain and lifecycle of medical products. The goal is to enhance global medical product quality and supply chain security.




FDA safeguards the integrity of the drug supply chain through initiatives that help protect consumers from exposure to substandard drugs and ensure that safe and effective drugs reach U.S. consumers. These initiatives include:

See Supply Chain Integrity News for information about recent supply chain issues.

Reporting Suspect Issues to FDA

Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any medication or device. See examples on how to identify these problems. The following links provide information on how to report these problems to FDA:

More Information on Drug Supply Chain Integrity

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