On August 7, 2020, the U.S. Department of Justice (“DOJ”) announced the indictment of a psychiatrist and his office manager for allegedly importing and selling drugs not approved by the U.S. Food & Drug Administration (“FDA”).  The DOJ alleges that for ten years, the psychiatrist and his office manager, who is also the psychiatrist’s wife, purchased disulfiram (used for alcohol dependence) and naltrexone (used for alcohol and opioid dependence) from Hong Kong.  Although certain forms of disulfiram and naltrexone are permitted, the forms of the medications allegedly purchased and distributed by the psychiatrist was not FDA approved.  The DOJ also alleges the psychiatrist falsified shipping documents by declaring the illegal medications as “plastic beads in plastic tubes” on shipment documents.

The psychiatrist and his wife were each indicted on one count of international money laundering conspiracy.  The psychiatrist was also indicted on conspiracy to defraud the United States, money laundering, receiving and delivering misbranded drugs with an intent to defraud or mislead, and importing merchandise contrary to law.  

This indictment reflects the continued efforts of government agencies to investigate improper medication purchase and distribution.  Since 2015, the Drug Supply Chain Security Act has required health care providers who dispense or administer prescription drugs to purchase medication from “authorized trading partners” licensed by or registered with the state or federal government.  21 U.S.C. § 360eee-1 (d)(3).  Providers may use the FDA’s database to locate and access state licensing agencies to verify authorized trading partners, which can found here.  

The attorneys at Chilivis Grubman represent clients of all types and sizes in connection with a wide variety of regulatory and compliance matters, including government investigations, audits, and litigation. If you need assistance with such a matter, please contact us today.