Drug Supply Chain Integrity
FDA works to protect consumers from unsafe drugs that can enter the U.S. drug supply chain
U.S Drug Supply Chain is Among the Safest in the World
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, theft and imports of falsified, unapproved or otherwise unsafe drugs, could result in unsafe, ineffective drugs in U.S. distribution.
FDA has safeguards in place to protect the integrity of the drug supply chain to help ensure safe, effective and high-quality drugs reach U.S. consumers. Federal and state laws create a closed drug distribution system to help ensure the U.S. drug supply remains secure. The agency remains vigilant in protecting the integrity of the U.S. drug supply chain.
Protecting consumers from unsafe drugs
Informing Consumers
FDA’s BeSafeRx campaign educates consumers about how to safely buy medicines online
Human Drug Imports
The agency ensures medicines imported into the U.S. comply with legal and regulatory requirements
Drug Recalls
FDA coordinates with manufacturers to recall drugs
Drug Supply Chain Security
FDA protects the U.S. drug supply from counterfeit medicine
Warning Letters
The agency issues warning letters to website operators illegally offering drugs for sale
Human Drug Exports
FDA helps ensure drugs exported from the U.S. meet quality, safety and effectiveness standards
Information for health care professionals and industry
Controlled Substance Summits
FDA hosts Online Controlled Substances Summits to reduce the illegal availability of controlled substances online
The Drug Supply Chain Security Act
The Drug Supply Chain Security Act (DSCSA) helps prevent harmful drugs from entering the U.S. supply chain, detect them if they do and remove them to protect patients
Notify FDA of Illegitimate Products
Notify FDA of illegitimate drugs in the supply chain
Safe Purchasing Practices
FDA's Know Your Source program educates health care professionals about safe purchasing practices
Supply Chain Security Toolkit
FDA collaborates with Asia Pacific Economic Cooperation to maintain the global supply chain security toolkit
Prescription Drug Marketing Act (PDMA)
Report significant losses, theft and falsified prescription drug samples to FDA
How to Report Issues to FDA
Use FDA’s MedWatch to Report Product Problems
Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA.
Report Potentially Unsafe Online Pharmacies to FDA
Report a website that you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics.
Report Suspected Criminal Activity
If you wish to report suspected criminal activity relating to FDA regulated products, describe the suspected criminal activity.
Notify FDA of Illegitimate Products
Companies must notify FDA within 24 hours of illegitimate products under the Drug Supply Chain Security Act (DSCSA)
Prescription Drug Marketing Act (PDMA) Reporting
Companies should report theft, significant losses and falsified prescription drug samples via email.
Report a Counterfeit Drug to FDA
Counterfeit medicine may be harmful. Report suspected unsafe products to FDA.