The U.S. drug supply is among the safest in the world. In the United States, we have federal and state laws that creates a “closed” drug distribution system to help ensure that the domestic drug supply is safe.
Counterfeit medicine is fake medicine and may be harmful to your health. However, incidence of counterfeit drugs in the U.S. is rare relative to the large number of prescription drugs used. FDA remains vigilant to protect the U.S. drug supply from counterfeits and other substandard drugs that often originate from outside our boarders.
FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits.
FDA has a global perspective on a safe and secure supply chain.
Since many counterfeits are made abroad and can arrive in the U.S. through the mail or are smuggled in, FDA works with U.S. Customs and Border Protection, and using a risk-based approach focuses on areas that present the most threat to our drug supply.
Drug safety and quality no longer begin or end at our border. The U.S. government works with foreign regulatory counterparts when possible to disrupt or close illegal operations involving the production and distribution of counterfeits.
FDA works to protect consumers against counterfeit drugs
Health care providers and consumers need to be aware of how they could be exposed to counterfeit medicines. Watch out for possible signs of a counterfeit drug:
- Does the drug or packaging look different than what you normally receive?
- Has the consumer experienced a new or unusual side effect after using the drug?
- Did the consumer buy the drug from an internet seller?
Purchasing unapproved drugs is risky business. Health care providers and supply chain stakeholders need to only buy from authorized and licensed entities to help ensure they are getting safe and effective drugs that have been approved by FDA. See BeSafeRx for more information about the potential dangers of buying medicine from online pharmacies.
News on counterfeit medicines
- Janssen alerts counterfeit Symtuza is being distributed in the United States (December 24, 2020)
- DEA Considers Fentanyl-Containing Counterfeit Medications a Global Threat (August 1, 2016)
- FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries (May 12, 2016)
- Counterfeit Version of Botox Found in the United States
- Counterfeit Versions of Cialis tablets identified entering the United States (January 21, 2015)
- Health Care Provider Alert: Another Counterfeit Cancer Medicine Found in United States (February 5, 2013)
Do you suspect you have a counterfeit drug?
If you believe you have a counterfeit medicine, talk to the pharmacist where you bought the medicine or contact your health care professional for medical advice.
After your safety is assured, FDA needs your help in protecting the safety of others. FDA relies on the voluntary reporting of suspect counterfeit drugs from consumers, health care professionals and other drug supply chain partners to ensure that only safe and effective drugs are available on the market.
FDA asks health care professionals to report a suspect counterfeit drug to FDA’s MedWatch office. Contact FDA's Office of Criminal Investigations if you are aware of suspicious activity that may be associated with counterfeit prescription drugs.
If you find a website you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics, please follow one of the three options below to report to FDA. If your report:
- involves a life-threatening situation due to an FDA-regulated product you purchased from a website, call 1-866-300-4374 or 301-796-8240 immediately. Also, contact your health professional for medical advice.
- involves a serious reaction or problem with an FDA-regulated product, fill out FDA's MedWatch reporting form. Also, contact your health professional for medical advice.
- for problem websites that do not involve a life-threatening or otherwise serious reaction, fill out this form (En Español). To report emails promoting medical products that you think might be illegal, forward the email to firstname.lastname@example.org.
- How to Buy Medicines Safely From an Online Pharmacy
- Health Fraud Awareness
- Flickr -- Counterfeit Drugs Photos
- Counterfeit Alert Network
Guidance Documents and Reports
- FDA Guidance on Standards Development for Prescription Drug Supply Chain Security
- FDA Draft Guidance for Industry on Anticounterfeiting
- FDA Global Strategic Framework for SSFFC Medical Products
Additional Government Resources
- Federal Trade Commission: Buying Prescription Drugs Online
- Drug Enforcement Administration: Buying Prescription Drugs Online