Drug Supply Chain Integrity
FDA works to protect consumers from unsafe drugs that can enter the U.S. drug supply chain
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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. Our system of 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
FDA works to prevent unsafe drugs from reaching and harming U.S. consumers, including:
- informing consumers about the risks of purchasing prescription medicine from unsafe online pharmacies through FDA’s BeSafeRx campaign. BeSafeRx helps educate consumers about how to safely buy medicines online.
- ensuring medicines imported into the U.S. comply with all legal and regulatory requirements. All imported drugs must meet FDA’s standards for quality, safety and effectiveness.
- protecting the U.S. drug supply from counterfeit medicine, which may be passed off as authentic but may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients.
- issuing warning letters to inform website operators they are engaged in illegal activity in violation of the Federal Food, Drug and Cosmetic Act. Additionally, FDA, in partnership with international regulatory and law enforcement agencies, protects American consumers from harm by taking action against websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids.
- coordinating with drug manufacturers to recall drugs that may be unsafe, ineffective or poor-quality.
- helping to ensure drugs exported from the U.S. meet quality, safety and effectiveness standards.
Information for Health Care Professionals
FDA’s Know Your Source program educates health care professionals about buying the medicines from licensed sources, including safe purchasing practices, to help prevent unsafe or ineffective drugs from harming patients.
Information for Industry
- The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic product tracing at the package level to identify and trace certain prescription drugs as they are distributed in the U.S. This will enhance FDA’s ability to help protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs.
- FDA issued a guidance for industry on anti-counterfeiting for drug manufacturers who want to use physical-chemical identifiers in solid oral dosage forms. A physical-chemical identifier is a substance or combination of substances that possesses a unique physical or chemical property that unequivocally identifies and authenticates a drug or dosage form.
- Prescription Drug Marketing Act of 1987: Report significant losses, theft and falsified prescription drug samples to FDA.
Domestic and International Engagement
Securing the U.S. drug supply chain reaches beyond the U.S. border. FDA works with domestic and international stakeholders to help ensure the integrity of the supply chain.
- FDA collaborates with Asia Pacific Economic Cooperation to maintain the Supply Chain Security Toolkit for Medical Products. The toolkit is a resource for member and non-member economies to further protect consumers in the global marketplace by covering supply chain and lifecycle and medical products.
- Visit FDA’s role in the WHO’s Member State Mechanism on Substandard and Falsified Medical Products for more information on our international partnership with the World Health Organization.
- FDA hosts Online Controlled Substances Summits to collaborate with stakeholders in the internet ecosystem, government, academia and other important partners to reduce the illegal availability of opioids and other controlled substances online.
Report Issues by Email
Notify FDA about specific issues through the following contacts:
- Supply chain issues related to drugs and components: DrugSupplyChainIntegrity@fda.hhs.gov
- Wholesale distributor or third-party logistics provider requirements: WDD3PLRequirements@fda.hhs.gov
- Drug imports: CDERImports@fda.hhs.gov
- Drug recalls: Recall coordinator contact information
- Drug exports: CDERexports@fda.hhs.gov ot later than 30 days after the date of the initial notification in paragraph (b)(1) of this section
Reporting 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. Learn how to identify these problems. The following links provide information on how to report these problems 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.