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.
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:
- BeSafeRx: FDA’s BeSafeRx campaign is designed to educate consumers about the health risks of purchasing prescription medicine through rogue online pharmacies. FDA also issues warning letters to rogue Internet pharmacies and alerts consumers not to purchase medicines from these sites.
- Know Your Source: Protecting Patients from Unsafe Drugs: FDA’s Know Your Source program is designed to educate health care professionals so they can help prevent unsafe or ineffective drugs from reaching their patients by buying the medicines they administer from licensed sources.
- Letters to doctors who may have purchased counterfeit or unapproved prescription drugs: FDA issues letters to health care providers to inform them that they may have obtained counterfeit or unapproved drugs from a rogue distributor. The letters help reduce the public health threat posed by these potentially dangerous drugs and provide tips on safe purchasing practices.
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:
- The Prescription Drug Marketing Act of 1987 increases safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs. Under the law, significant losses, any theft, and falsification of prescription drug samples should be reported to FDA. FDA requests stakeholders submit these reports via email at PDMAreports@fda.hhs.gov.
- To report product problems, use FDA’s MedWatch Online Voluntary Reporting Forms.
- FDA requests stakeholders report suspected criminal activity.
More Information on Drug Supply Chain Integrity
- Drug Recalls
- Food and Drug Administration Safety and Innovation Act (FDASIA)
- Standards Development for Prescription Drug Supply Chain Security
- Supply chain issues related to drugs and components: DrugSupplyChainIntegrity@fda.hhs.gov
- Track and Trace: DrugTrackandTrace@fda.hhs.gov