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2 

XIULU RUAN v. UNITED STATES 

Opinion of the Court 

In each of these two consolidated cases, a doctor was con-
victed under §841 for dispensing controlled substances not 
“as authorized.”  The question before us concerns the state 
of mind that the Government must prove to convict these 
doctors of violating the statute.  We hold that the statute’s 
“knowingly or intentionally” mens rea applies to authoriza-
tion.  After  a  defendant  produces  evidence  that  he  or  she 
was authorized to dispense controlled substances, the Gov-
ernment must prove beyond a reasonable doubt that the de-
fendant knew that he or she was acting in an unauthorized 
manner, or intended to do so. 

I 
The question we face concerns §841’s exception from the
general  prohibition  on  dispensing  controlled  substances
contained in the phrase “[e]xcept as authorized.”  In partic-
ular, the question concerns the defendant’s state of mind. 
To prove that a doctor’s dispensation of drugs via prescrip-
tion  falls  within  the  statute’s  prohibition  and  outside  the 
authorization exception, is it sufficient for the Government
to prove that a prescription was in fact not authorized, or 
must  the  Government  prove  that  the  doctor  knew  or  in-
tended that the prescription was unauthorized? 

Petitioners Xiulu Ruan and Shakeel Kahn are both doc-
tors who actively practiced medicine.  They both possessed
licenses  permitting  them  to  prescribe  controlled  sub-
stances.  The  Government  separately  charged  them  with 
unlawfully dispensing and distributing drugs in violation of 
§841.  Each  proceeded  to  a  jury  trial,  and  each  was  con-
victed of the charges. 

At their separate trials, Ruan and Kahn argued that their 
dispensation  of  drugs  was  lawful  because  the  drugs  were 
dispensed pursuant to valid prescriptions.  As noted above, 
a regulation provides that, “to be effective,” a prescription 
“must be issued for a legitimate medical purpose by an in-