Justia Opinion Summary and Annotations

Two medical doctors, licensed to prescribe controlled substances, were convicted for violating 21 U.S.C. 841, which makes it a crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” Registered doctors may dispense controlled substances via prescription only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a).

The Supreme Court vacated their convictions. Section 841’s “knowingly or intentionally” mental state applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his conduct was “authorized,” the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. Section 885 does not provide a basis for inferring that Congress intended to do away with, or weaken ordinary and longstanding scienter requirements but supports applying normal scienter principles to the “except as authorized” clause. The Court of Appeals in both cases evaluated the jury instructions relating to “mens rea” under an incorrect understanding of section 841’s scienter requirements.

Annotation

Primary Holding

In prosecutions of medical doctors for the distribution of controlled substances, the “knowingly or intentionally” mental state requirement applies to the “except as authorized” clause.