A doctor who prescribes controlled substances, such as opiates, will only violate the Controlled Substances Act (CSA), 21 U.S.C. §841, if the government proves beyond a reasonable doubt that he knew his conduct was not authorized under related regulations. In late June 2022, the U.S. Supreme Court in Ruan v. the United States, 142 S.Ct. 2370, imposed this "strong scienter requirement" in holding that when prescribing controlled substances in violation of the CSA, the mens rea requirement of "knowingly or intentionally" applies to the statute's "except as authorized" clause. The CSA makes it unlawful, "except as authorized," to "knowingly or intentionally" distribute, dispense, or manufacture controlled substances. When a criminal defendant presents evidence that he was statutorily authorized to prescribe, a jury must focus on the defendant's mental state at the time the relevant drug was prescribed, rather than the mental state of a hypothetical reasonable doctor.

This article reviews the Ruan decision and how district courts are applying it in practice. Next, the article explores enforcement trends following the Ruan decision. This article concludes by suggesting how Ruan might inform prescribing practices and prosecutors' charging decisions.

The 'Ruan' Decision

Ruan arose from a challenge to jury instructions in two separate prosecutions of doctors accused of prescribing a Schedule II drug, fentanyl, and Schedule III drugs allegedly outside ordinary medical practice.