FDA Warns Medical Practices of Risks to Patients with Drugs Purchased from Foreign and Unlicensed Sources

Topics: Counterfeit drugs and Practitioner prescriber

Food and Drug Administration (FDA) sent letters to medical practices in several states requesting that they stop administering drugs purchased from any foreign or unlicensed source. FDA’s letters were sent in response to the discovery that the medical practices purchased medications from foreign or unlicensed suppliers that sold illegal prescription medications. FDA has advised that these medical practices are putting patients at risk of exposure to medications that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous.

In an FDA statement, the agency urges the health care community “to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States.” Further, FDA reminds health care providers, pharmacies, and wholesalers/distributors that they are valuable partners in protecting consumers from the threat of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. FDA advises that the receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering such offers.

FDA notes that the “Verify Wholesale Drug Distributor Licenses” FDA Web page may be used to verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business. Also, suspected criminal activity can be reported to FDA's Office of Criminal Investigations (OCI) by calling 800/551-3989 or completing the online form on the OCI Web Site.