Counterfeit Medicine

Medicine approved for use in the United States has been reviewed for safety, effectiveness and quality by FDA. The U.S. drug supply is among the safest in the world. In the United States, we have federal and state laws that create a “closed” drug distribution system to help ensure that the domestic drug supply is safe. FDA remains vigilant in protecting the U.S. drug supply from counterfeits and other substandard drugs.

Illicit, counterfeit medicine is fake medication and may be harmful to your health. One way U.S. consumers could be exposed to potential counterfeit drugs is through illegal online sales. Americans can protect themselves and their families by purchasing medicines only from state licensed pharmacies in the United States. FDA is actively working to remove illegal products sold online.

FDA takes 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.

What is FDA doing to maintain the safety of the legitimate U.S. drug supply chain?

Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public.

FDA is implementing key provisions of the Drug Supply Chain Security Act (DSCSA), which outlines steps to achieve interoperable, electronic tracing of product 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 drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Learn more about the Drug Supply Chain Security Act law and policies.

Additionally, all imported shipments of FDA-regulated products are reviewed by the FDA. Imported drugs must meet FDA’s standards for quality, safety and effectiveness. FDA verifies compliance with the following requirements as applicable: registration, listing, drug application, drug labeling and drug current good manufacturing practices (cGMPs). FDA also randomly samples and tests imported products.

FDA issued a draft guidance for industry on anti-counterfeiting for pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs). A PCID is a substance or combination of substances possessing a unique physical or chemical property that unequivocally identifies and authenticates a drug product or dosage form.

What is FDA doing to shield consumers from illegal and illicit fake medicine they may encounter on the internet?

FDA is maximizing the scope of our continued efforts to the protect the American public. FDA remains dedicated to preventing dangerous drugs from reaching and harming U.S. consumers, including through illegal online sales. Examples of FDA efforts to protect patients, include but are not limited to the following:

FDA’s Office of Criminal Investigations conducts criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution. This includes cyber crime and distribution of counterfeit, unapproved, and misbranded medical products. View OCI press releases.
FDA issues warning letters informing website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic Act. Examples of unapproved and misbranded drugs cited in these letters include, but are not limited to opioids, benzodiazepines, and those purported to treat COVID-19, HIV, and cancer. Learn about internet pharmacy warning letters.
FDA held three Online Opioid Summits to collaborate with stakeholders in the internet ecosystem, government, academia, and other important partners to reduce the illegal availability of opioids online. Learn more about the summits:
- FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online
- Online Opioid Summit
FDA’s Forensic Chemistry Center provides rapid response and specialized analytical services in forensic chemistry and molecular/microbiology related to product tampering, counterfeiting, and adulteration/contamination.
FDA and U.S. Customs and Border Protection (CBP) leaders signed an agreement to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation’s International Mail Facilities (IMFs) and Ports of Entry that pose a threat to public health

How can consumers protect themselves and their families?

Americans can protect themselves and their families by purchasing medicines only from state licensed pharmacies that are located in the U.S.

One way U.S. consumers could be exposed to potential counterfeit drugs is through illegal online sales. Counterfeits may be sold on the internet or by unsafe websites posing as online pharmacies.

Consumers may turn to online pharmacies because of convenience, privacy and cost savings; however, some websites sell medicines that are dangerous or even deadly. Protect your health by recognizing the signs of safe and unsafe online pharmacies.

Checking an online pharmacy’s license through the state board of pharmacy is an important step in knowing whether you are using a safe pharmacy. Click on your state to look for your pharmacy in the state’s board of pharmacy license database. If your online pharmacy is not listed, you should not use that pharmacy.

If your pharmacy is listed, please also confirm that the pharmacy:

Requires a doctor’s prescription
Provides a physical address and telephone number in the United States
Has a licensed pharmacist to answer your questions

Additionally, you should watch out for possible signs of a counterfeit drug and ask:

Was this drug purchased from an internet seller?
Does the drug or packaging look different than what you normally receive?
Have you experienced a new or unusual side effect after using the drug?

Purchasing unapproved drugs is risky business. See BeSafeRx for more information about the potential dangers of buying medicine from online pharmacies.

U.S. Food and Drug Administration

Counterfeit Medicine

What is FDA doing to maintain the safety of the legitimate U.S. drug supply chain?

What is FDA doing to shield consumers from illegal and illicit fake medicine they may encounter on the internet?

How can consumers protect themselves and their families?

How do I report suspected illegal products to FDA?

Related FDA Consumer Information

Additional Government Resources

Questions

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