Document ID: ./input/supremecourt_opinions/opinions/21pdf/20-1410_1an2.pdf
Page Number: 7

Cite as:  597 U. S. ____ (2022) 

3 

Opinion of the Court 

dividual practitioner acting in the usual course of his pro-
fessional practice.”  21 CFR §1306.04(a).  We assume, as did 
the courts below and the parties here, that a prescription is
“authorized” and therefore lawful if it satisfies this stand-
ard.  At Ruan’s and Kahn’s trials, the Government argued 
that  the  doctors’  prescriptions  failed  to  comply  with  this
standard.  The doctors argued that their prescriptions did 
comply, and that, even if not, the doctors did not knowingly
deviate or intentionally deviate from the standard.

Ruan,  for  example,  asked  for  a  jury  instruction  that
would have required the Government to prove that he sub-
jectively knew that his prescriptions fell outside the scope of 
his prescribing authority.  The District Court, however, re-
jected this request.  The court instead set forth a more ob-
jective standard, instructing the jury that a doctor acts law-
fully when he prescribes “in good faith as part of his medical
treatment of a patient in accordance with the standard of
medical practice generally recognized and accepted in the
United  States.”    App.  to  Pet.  for  Cert.  in  No.  20–410,  p. 
139a.  The court further instructed the jury that a doctor 
violates §841 when “the doctor’s actions were either not for 
a  legitimate  medical  purpose  or  were  outside  the  usual 
course of professional medical practice.”  Ibid.  The jury con-
victed Ruan, and the trial court sentenced him to over 20 
years in prison and ordered him to pay millions of dollars
in restitution and forfeiture. 

The  Eleventh  Circuit  affirmed  Ruan’s  convictions.    See 
966 F. 3d 1101, 1120, 1166–1167 (2020).  The appeals court 
held that a doctor’s “subjectiv[e] belie[f] that he is meeting 
a patient’s  medical needs by prescribing a controlled sub-
stance”  is  not  a  “complete  defense”  to  a  §841 prosecution. 
Id., at 1167.  Rather, the court said, “ ‘[w]hether a defendant 
acts in the usual course of his professional practice must be
evaluated based on an objective standard, not a subjective
standard.’ ”  Id., at 1166 (quoting United States v. Joseph,