The US Supreme Court has handed down a major decision discussing 21 U.S.C. §841, which makes it a federal crime, “[e]xcept as authorized[,]
. . . for any person knowingly or intentionally . . . to manufacture, dis- tribute, or dispense . . . a controlled substance.” A federal regulation authorizes registered doctors to dispense controlled substances via prescription, but 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).
At issue in two doctors’ trials was the mens rea required to convict under section 841 for distributing controlled substances not “as authorized.” Each doctor contested the jury instructions pertaining to mens rea given at their trials, and each was ultimately convicted under §841 for prescribing in an unauthorized manner. Their convictions were sepa- rately affirmed by the Courts of Appeals. The court has ruled that “section 841’s “knowingly or intentionally” mens rea applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his or her conduct was “authorized,” the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. ”
“And in §841 prosecutions, authorization plays a “crucial” role in separating innocent conduct from wrongful conduct. Regulatory language defining an authorized prescription is “ambiguous” and “open to varying constructions,” meaning that prohibited conduct (issuing invalid prescriptions) is “often difficult to distinguish” from acceptable conduct (issuing valid prescriptions). A strong scienter requirement helps reduce the risk of “over-deterrence,” i.e., punishing conduct that lies close to, but on the permissible side of, the criminal line. Ibid.
“The statutory provisions at issue here are also not the kind to which the Court has held the presumption of scienter does not apply. Section 841 does not define a regulatory or public welfare offense that carries only minor penalties. Nor is the “except as authorized” clause a jurisdictional provision. In a §841 prosecution, once the defendant satisfies the initial burden of production by producing evidence of authorization, the burden of proving a lack of authorization shifts back to the Government.
In summary, the court concludes that §841’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause. This means that in a §841 prosecution in which a defendant meets his burden of production under §885, the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.