Petition for Writ of Certiorari — Hasna Bashir Iwas, Petitioner v. United States
Supreme Court briefMar 11, 2026
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No. ___________
IN THE SUPREME COURT OF THE UNITED STATES
________________________
HASNA BASHIR IWAS,
Petitioner,
V.
UNITED STATES OF AMERICA,
Respondent.
________________________
On Petition for Writ of Certiorari to the United
States Court of Appeals for the Sixth Circuit
________________________
PETITION FOR WRIT OF CERTIORARI
________________________
Beau B. Brindley
COUNSEL OF RECORD
For Petitioner Hasna Bashir Iwas
Law Offices of Beau B. Brindley
53 W Jackson Blvd. Ste 1410
Chicago IL 60604
(312)765-8878
bbbrindley@gmail.com
QUESTIONS PRESENTED
I.
Is authorization under the Controlled Substances Act defined in terms of
the regulatory definition of an effective prescription or by the plain meaning
of the statutory text?
II.
Does the mens rea required under 21 U.S.C. § 841(a) and this Court’s
opinion in Ruan attach to the fact of non-authorization or to the regulatory
standard for an effective prescription contained in 21 C.F.R. § 1306.04?
LIST OF PARTIES TO THE PROCEEDINGS
Petitioner, defendant-appellant below, Hasna Bashir Iwas.
Respondent is the United States of America, appellee below.
RELATED PROCEEDINGS
Ninth Circuit Court of Appeals:
United States v. Iwas, No. 24-1234, 2025 WL 2955197, at *1 (6th Cir. Oct. 20,
2025)
Mandate Issued December 11, 2025.
United States District Court for the Eastern District of Michigan:
United States v. Iwas, No 2:18-cr-20769LJM-RSW-5.
Judgement and conviction entered March 19, 2024.
2
TABLE OF CONTENTS
Question Presented........................................................................................................ 2
Parties to the Proceedings ............................................................................................. 2
Related Proceedings....................................................................................................... 2
Table of Contents ........................................................................................................... 3
Table of Authorities ....................................................................................................... 4
Opinions and Rulings Below ......................................................................................... 6
Jurisdiction .................................................................................................................... 6
Statement ....................................................................................................................... 6
Factual Background ...................................................................................................... 8
Reasons for Granting Review ...................................................................................... 12
Conclusion .................................................................................................................... 31
INDEX TO APPENDICES
APPENDIX A – Court of Appeals Opinion Affirming Judgment ..............................A1
APPENDIX B - District Court Judgment Order ......................................................A14
3
TABLE OF AUTHORITIES
Cases
Allison Engine Co. v. U.S. ex rel. Sanders, 553 U.S. 662 (2008) ................................ 24
Barnhart v. Sigmon Coal Co., 534 U.S. 438 (2002) .................................................... 24
Bond v. United States, 572 U.S. 844 (2014) ................................................................ 26
Fischer v. United States, 603 U.S. 480 (2024) ............................................................ 26
Gonzales v. Oregon, 546 U.S. 243 (2006) .............................................................. 25, 27
Grayned v. City of Rockford, 408 U.S. 104 (1972) ...................................................... 26
Hill v. Colorado, 530 U.S. 703 (2000) ......................................................................... 26
Hoffman Estates v. Flipside, Hoffman Estates, 455 U.S. 489 (1982) ......................... 26
Kolender v. Lawson, 461 U.S. 352 (1983) ................................................................... 27
Liparota v. United States, 471 U.S. 419 (1985) .................................................... 14, 18
United States v. Anderson, 67 F.4th 755 (6th Cir. 2023) ................................. 11,18,19
United States v. Bek, 493 F.3d 790 (7th Cir. 2007) .................................................... 12
United States v. Cristobal, No. 23-6107, 2024 WL 1506750 (2d Cir. Apr. 8, 2024) .. 14
United States v. Davis, 588 U.S. 445 (2019) ......................................................... 26, 29
United States v. Feingold, 454 F.3d 1101 (9th Cir. 2006) .......................................... 12
United States v. Hudson, 7 Cranch 32, 3 L.Ed. 259 (1812) .................................. 19, 26
United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) ............................................. 13
United States v. Jones, 825 F. App'x 335 (6th Cir. 2020); .......................................... 13
United States v. Kahn, 17-cr-00029-ABJ, U.S. Dist. Wyoming (2017) ...................... 16
United States v. Kahn, 989 F.3d 806 (10th Cir. 2021) ............................................... 12
4
United States v. Kohli, 847 F.3d 483 (7th Cir. 2017) ................................................. 12
United States v. Li, 819 F. App'x 111 (3d Cir. 2020) .................................................. 13
United States v. Lubetsky, No. 23-10142, 2024 WL 577543 (11th Cir. Feb. 13, 2024)
................................................................................................................................... 13
United States v. Merrill, 513 F.3d 1293 (11th Cir. 2008) ........................................... 12
United States v. Moore, 423 U.S. 122 (1975) ............................................. 21,22, 23, 25
United States v. Nelson, 383 F.3d 1227 (10th Cir. 2004) ........................................... 12
United States v. Nichols, 784 F.3d 666 (10th Cir. 2015) ............................................ 29
United States v. Norris, 780 F.2d 1206 (5th Cir. 1986) .............................................. 12
United States v. Pham, 120 F.4th 1368 (9th Cir. 2024) ............................................. 17
United States v. Ruan, 966 F.3d 1101 (11th Cir. 2020) ............................................. 12
United States v. Sabean, 885 F.3d 27 (1st Cir. 2018) ................................................. 13
United States v. Smith, 573 F.3d 639 (8th Cir. 2009) .......................................... 12, 13
United States v. Smithers, 92 F.4th 237, 247 (4th Cir. 2024) .................................... 17
United States v. Titus, 78 F.4th 595 (3d Cir. 2023) .................................................... 12
United States v. Tobin, 676 F.3d 1264 (11th Cir. 2012) ............................................. 12
United States v. Vamos, 797 F.2d 1146 (2d Cir. 1986) ............................................... 12
United States v. Wexler, 522 F.3d 194 (2d Cir. 2008) ................................................. 13
W. Virginia v. Env't Prot. Agency, 597 U.S. 697 (2022) ............................................. 26
Whitman v. United States, 574 U.S. 1003 (2014) ....................................................... 29
Statutes
21 U.S.C. § 802 ............................................................................................................. 21
5
21 U.S.C. § 822 ............................................................................................................. 21
21 U.S.C. § 841(a) ........................................................................................................ 21
21 U.S.C.S. § 829 ......................................................................................................... 22
Regulations
21 CFR §1306.04 .......................................................................................................... 11
OPINIONS AND RULINGS BELOW
United States v. Iwas, No. 24-1234, 2025 WL 2955197, at *1 (6th Cir. Oct. 20, 2025)
JURISDICTION
This is a federal criminal case involving an appeal from a final judgment
entered in the Western District of Michigan. The Sixth Circuit of Appeals entered
judgement on December 11, 2025. This Court's jurisdiction is invoked under 28
U.S.C. § 1254(1).
STATEMENT
This case involves a registered pharmacist’s petition for relief from criminal
conviction under 21 USC § 841 based on this Court’s holding in Ruan v. United States,
597 U.S. 450 (2022). In Ruan, this Court held that 21 U.S.C. § 841’s “‘knowingly or
6
intentionally’ mens rea applies to authorization.” Ruan v. United States, 597 U.S. 450,
454 (2022). “[F]or purposes of a criminal conviction under § 841, this requires proving
that a defendant knew or intended that his or her conduct was unauthorized.” Id. at
467.
Petitioner was charged with one count of conspiracy to distribute a controlled
substance in violation of 21 U.S.C. § 841(a)(1), one count of maintaining a drug
involved premises in violation of 21 U.S.C. 856(a)(1), and several counts for specific
acts of distribution. Each count stemmed from allegations that Petitioner, a licensed
pharmacist, filled prescriptions that were written for no legitimate medical purpose
and outside the usual course of professional practice, or that were, in fact, forgeries.
Ms. Iwas did not deny filling the charged prescriptions. The question at trial
was whether the defendant knew that the charged prescriptions were fraudulent or
whether she filled them outside the usual course of her professional practice. The
relevant portion of the jury instructions defining mens rea required only that the
government prove “That the defendant knowingly or intentionally distributed an
unauthorized prescription, that is, one not issued for a legitimate medical purpose
in the usual course of professional practice.”
Since this Court’s decision in Ruan, a circuit split has developed as to the
correct mens rea under § 841. The Tenth Circuit, on remand from one of the
companion cases in Ruan, construed the Ruan opinion as requiring the government
to prove a defendant’s subjective knowledge or intent as it pertains to the fact of nonauthorization. Other circuits have continued to rely on the regulatory language to
7
define authorization and the statute’s mens rea. Even among these circuits, however,
there remain substantial variations in how they apply the statute. This Court’s
review is necessary to resolve the split.
FACTUAL BACKGROUND
Petitioner owned and operated Beacon Pointe Pharmacy in Grosse Pointe
Park, Michigan. R. 183 at 18–19. Between August 2013 and November 2018,
Petitioner filled nearly 1,300 forged prescriptions for controlled substances—
primarily oxymorphone, oxycodone with acetaminophen, promethazine with codeine,
and alprazolam. R. 258 at 57, 63–65. The forged prescriptions were issued in the
names of fifty-eight “patients” associated with one individual, Rochelle Edwards. Id.
at 110. The forged prescriptions were labeled as being issued by eight different
prescribers to whom patients “migrate[d]” in groups. R. 258 at 109.
Some of the forged prescriptions contained on their faces incorrect phone
numbers and addresses for the named prescribers; labels on the backs that were
printed and affixed by Beacon Pointe Pharmacy staff, however, displayed the
correct phone numbers and addresses, indicating that the pharmacy system
contained the correct information. See, e.g., R. 166 at 33–34; R. 258 at 101–02.
Other forged prescriptions displayed the correct phone numbers for the prescribers.
See, e.g., R. 166 at 69–70, 74–75. In some instances, Petitioner handwrote notes on
the back of prescriptions indicating that they had been verified with the prescriber.
See, e.g., id. at 77–80; R. 169 at 71–73; R. 183 at 69–70, 81. The prescribers or their
8
agents testified that those prescriptions were not in fact verified, and in most cases
verification would have been impossible because the supposed patient was not
actually a patient of the prescriber. See, e.g., R. 166 at 33, 73–81, 123; R. 168 at 28–
33; R. 259 at 174–77.
Additionally, Petitioner filled many prescriptions issued by Dr. Otis
Crawford. Dr. Crawford wrote controlled-substance prescriptions for patients whom
he never examined, see, e.g., R. 172 at 99–110), and, sometimes, for patients who
had never even been to his clinic, see, e.g., R. 173 at 23. Petitioner filled controlledsubstance prescriptions from Dr. Crawford, despite acknowledging in a text, “I
always don’t feel good filling his scripts.” Id. at 47
Petitioner testified that she did not know that any of the charged
prescriptions were fraudulent, R. 183 at 34, or that Dr. Crawford was, in any way,
operating outside the usual course of professional practice or that she was not
authorized to fill prescriptions issued by his office. R. 183 at 47.
Petitioner argued below that the jury instructions issued in this case failed to
fully capture either the mens rea or the actus reus required by Ruan v. United
States, 597 U.S. 450, 478 (2022).
The instructions on the substantive counts defined the elements of a § 841
offense as follows:
In order to find the defendant guilty of a violation of 21 U.S.C.
841(a)(1), the government must prove beyond a reasonable doubt each
of the following elements:
(1) That the defendant knowingly or intentionally distributed to
another person a controlled substance by filling a prescription in the
name of the person listed in a particular count, for the controlled
9
substance alleged in that count, either personally or in concert with an
employee or agent;
(2) That the particular prescription was unauthorized, that is, not
issued for a legitimate medical purpose in the usual course of
professional practice; and
(3) That the defendant knowingly or intentionally distributed an
unauthorized prescription, that is, one not issued for a legitimate
medical purpose in the usual course of professional practice.
R. 177, Page ID 1949.
The jury instructions issued in this case define the words “usual course of
professional practice” in purely objective terms:
“(6) The term “usual course of professional practice” is defined by
reference to an objective standard of medical and pharmacy practice
generally recognized and accepted by the medical and pharmacy
professions in the United States. This standard is not violated by mere
negligence. This standard is breached when the doctor acts contrary to
what a legitimate doctor would do in a medically valid effort to help
patients.”
R. 177, Page ID, 1950-51.
Based on the language from 21 C.F.R. § 1306.04, the district court placed
upon pharmacists the “corresponding responsibility” to ensure that the doctor who
issued a given prescription was acting within “generally recognized and accepted”
standards of practice:
“(5) A prescription for a controlled substance must be issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his or her professional practice. The responsibility for
the proper prescribing and dispensing of controlled substances is upon
the prescribing practitioner, but a corresponding responsibility rests
with the pharmacist to not fill an unauthorized prescription.
R. 177, Page ID 1950.
10
Petitioner was convicted on all counts except the drug-involved premises
charge. R. 223. The district court sentenced Iwas to a term of imprisonment of 100
months.
On appeal, Petitioner argued that, under Ruan, it is insufficient for the
government to prove that a defendant knowingly or intentionally acted in a
manner that was objectively unauthorized, even if one knows the facts that could
render a prescription unauthorized. App.R.29 at 11-12. Rather, the government
must prove knowledge or intent as it relates to the fact of non-authorization. Id.
Petitioner asserted that the definition of authorization must be a matter of
statutory construction, rather than simply deferring to the regulatory language. Id.
at 17-19.
The appellate court disagreed. Relying on United States v. Anderson, 67
F.4th 755 (6th Cir. 2023), the Sixth Circuit held that the district court comported
with Ruan because it “juxtaposed knowledge with lesser levels of culpability.”
Cert.Appx. at 11. The jury instructions were sufficient, it found, because “[i]n
defining ‘knowingly,’ the district court instructed the jury that ‘[c]arelessness,
negligence, incompetence, or foolishness on [Iwas’s] part are not the same as
knowledge and are not enough to find [Iwas] guilty on’ the § 841(a)(1) counts.” Id.
It thus affirmed the conviction.
11
REASONS FOR GRANTING REVIEW
I.
THE CIRCUITS
PRESENTED.
ARE
DIVIDED
ON
THE
QUESTION
The regulation relied upon in the court below, 21 CFR §1306.04, states that
in order for “[a] prescription for a controlled substance to be effective [it] must be
issued for a legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.” Prior to Ruan, the Circuits held that any
prescription that is not “effective” as defined by CFR § 1306.04 is not “authorized”
under § 841. The elements were, therefore, dependent upon the circuit’s
interpretation of the meaning of the language of the CFR.
Prior to Ruan, most of the circuits interpreted “medical purpose” and “usual
course of professional practice” to provide two different theories of guilt that could
be proven in the disjunctive. Under the circuits’ interpretation of the CFR, “medical
purpose” is a subjective question regarding whether the doctor intended the
prescription to alleviate what she believed to be a bona fide medical condition. By
contrast “usual course of professional practice” turns on a doctor’s compliance with
“medical norms” or “the standards of medical practice generally recognized
throughout the United States.” United States v. Vamos, 797 F.2d 1146, 1153 (2d Cir.
1986); United States v. Hurwitz, 459 F.3d 463, 480 (4th Cir. 2006); United States v.
Norris, 780 F.2d 1206, at 1209 (5th Cir. 1986); United States v. Smith, 573 F.3d 639,
647-48 (8th Cir. 2009); United States v. Bek, 493 F.3d 790, 798 (7th Cir. 2007);
12
United States v. Feingold, 454 F.3d 1101, 1011 n.3 (9th Cir. 2006); United States v.
Nelson, 383 F.3d 1227, 1233 (10th Cir. 2004); United States v. Merrill, 513 F.3d
1293, 1306 (11th Cir. 2008).
Prior to Ruan, a circuit split had developed as to the mens rea the
government must establish when it seeks to convict a defendant under the theory
that the charged prescriptions were issued outside the “usual course of professional
practice.” While all circuits agreed that “medical purpose” was a subjective
question, some circuits held that “usual course of professional practice” was an
entirely objective one. United States v. Tobin, 676 F.3d 1264 (11th Cir. 2012);
United States v. Kahn, 989 F.3d 806, 825 (10th Cir. 2021); United States v. Ruan,
966 F.3d 1101 (11th Cir. 2020). Others held that the government is required to
prove that the defendant knew that the charged prescription was outside the “usual
course of professional practice.” United States v. Kohli, 847 F.3d 483, 490 (7th Cir.
2017); United States v. Feingold, 454 F.3d 1001, 1008 (9th Cir. 2006). Still others
imposed something close to a negligence standard. United States v. Sabean, 885
F.3d 27, 45 (1st Cir. 2018); United States v. Wexler, 522 F.3d 194, 206 (2d Cir. 2008);
United States v. Li, 819 F. App'x 111, 118 (3d Cir. 2020) (unpublished); United
States v. Hurwitz, 459 F.3d 463, 478, 480 (4th Cir. 2006); United States v. Jones,
825 F. App'x 335, 339 (6th Cir. 2020); United States v. Kohli, 847 F.3d 483, 490 (7th
Cir. 2017); United States v. Smith, 573 F.3d 639, 649–50 n.4 (8th Cir. 2009).
Each circuit based its ruling on a parsing of the language of 21 CFR §
1306.04, without reference to the plain meaning or intent of the drafters of the CSA.
13
In the opinion below, the Sixth Circuit necessarily assumed that Ruan did
nothing more than apply § 841’s mens rea to the regulatory standard articulated in
§ 1306.04.
The Fifth, Seventh, Ninth, and Eleventh Circuits agree. In those circuits,
CFR §1306.04 continues to define the elements of the offense. United States v.
Lamartiniere, 100 F.4th 625, 638 (5th Cir. 2024). (“As to the third element, we
acknowledged that it was ‘not expressly required by the text of § 841, but relevant
regulations [21 C.F.R. § 1306.04(a)] provide’…”); Anderson, 67 F.4th at 764; Heaton,
59 F.4th at 1240 (“As the government points out, the plain language of 21 C.F.R. §
1306.04(a) demonstrates that the jury instruction here correctly used “or” in
defining the elements of a § 841(a) offense.” … Thus, both requirements must be
satisfied to make a prescription authorized.”); United States v. Lubetsky, No. 2310142, 2024 WL 577543, at 1 (11th Cir. Feb. 13, 2024) (unpublished) (“Because the
government did not prove a lack of legitimate medical purpose, the argument goes,
the government did not prove the prescriptions were unauthorized. …[defendants]
first argument is squarely foreclosed by circuit precedent.”) (unpublished); see also,
United States v. Cristobal, No. 23-6107, 2024 WL 1506750, at 4 (2d Cir. Apr. 8,
2024) (upholding jury instructions that rest on the language of CFR § 1304.06
requiring that the defendant “act[] in accordance with a standard of medical
practice generally recognized and accepted in the State of New York.”); United
States v. Titus, 78 F.4th 595, 598–99 (3d Cir. 2023) (“Here, the instructions required
the jury to find that Titus had knowingly or intentionally distributed controlled
14
substances outside “the usual course of professional practice and not for a
legitimate medical purpose.”).
The Tenth Circuit’s interpretation of the scope and breadth of Ruan is vastly
different. The Tenth Circuit interpreted Ruan as imposing something close to
specific intent, which a plain reading of Ruan’s text supports. In the Tenth Circuit,
the government is required to prove “that petitioner knew that his conduct was
unauthorized or illegal.” Kahn II, 58 F.4th at 1315 (quoting Liparota, 471 U.S. at
434); id. at 1317 (jury instructions did not require the government to prove that
“[the defendant] intended to act without authorization”). In the Tenth Circuit, “it [is
not] enough that the jury accepted that [the defendant] subjectively knew a
prescription was issued not for a legitimate medical purpose, and/or issued a
prescription that was objectively not in the usual course of professional practice.
Both approaches run counter to Ruan.” Id. at 1320.
Following Ruan, in the Tenth Circuit the language of CFR §1306.04 does not
serve “as distinct bases to support a conviction, but as ‘reference to objective
criteria’ that may serve as circumstantial evidence of a defendant's subjective intent
to act in an unauthorized manner.” Kahn II, 58 F.4th at 1316 (quoting Ruan, 597
U.S. at 455). In the Tenth Circuit, a defendant stepping outside of the bounds of
medical practice is a data point a jury may consider when deciding whether she
knew a given prescription to be outside of her authorization under the CSA. By
contrast, under the instructions approved of by the Fifth, Sixth, Seventh, and
Eleventh circuits, stepping outside of the “usual course of professional practice” as
15
defined by medical “norms” or “generally accepted standards of practice” or the
“standard of care” is, itself, the crime. Lamartiniere, 100 F.4th at 638; Anderson, 67
F.4th at 764; Heaton, 59 F.4th at 1240.
This is not a minor or technical disagreement. The Tenth Circuit denounced
as insufficient to capture the mens rea required by Ruan an elements instruction
that is materially indistinguishable from that which the Sixth Circuit upheld in the
instant case. On remand from Kahn II, the district court issued a jury instruction
defining authorization that is materially aligned with the interpretation Petitioner
argued below. 1 That instruction defined an “authorized” prescription as one issued
with the aim to “prevent, cure, or alleviate the symptoms of a disease or injury.”
1 The instruction issued in defendant Kahn’s retrial following remand from the
Tenth Circuit stated in part:
“To be authorized under the law, a controlled substances
prescription must be issued by an individual practitioner acting in the
course of professional practice. For purposes of a registered practitioner,
to act in the course of professional practice means to practice medicine.
For a practitioner to practice medicine, he or she must act for a medical
purpose—which means aiming to prevent, cure, or alleviate the
symptoms of a disease or injury—and must believe that the treatment
is a medically legitimate means of treating the relevant disease or
injury. Conversely, a prescription is not authorized when it is issued for
a purpose foreign to medicine, such as facilitating addiction,
recreational abuse, or unlawful distribution.
However, issuing an unauthorized prescription (that is, a
prescription not issued for a medical purpose while acting in the course
of professional practice) is not, by itself, a crime. A registered
practitioner only violates 21 U.S.C. § 841(a)(1) if he or she knowingly or
intentionally issues an unauthorized prescription and, at the time,
knew the prescription was unauthorized or intended it to be
unauthorized.”
United States v. Kahn, 17-cr-00029-ABJ, U.S. Dist. Crt. Wyoming, Dkt. No. 1301,
pp. 25-26 (2017).
16
United States v. Kahn, 17-cr-00029-ABJ, U.S. Dist. Wyoming, Dkt. No. 1301, pp. 25
(2017). A prescription is not authorized, by contrast “when it is issued for a purpose
foreign to medicine, such as facilitating addiction, recreational abuse, or unlawful
distribution.” Id. The instruction went on to state that:
“A registered practitioner only violates 21 U.S.C. § 841(a)(1) if he
or she knowingly or intentionally issues an unauthorized prescription
and, at the time, knew the prescription was unauthorized or intended
it to be unauthorized.”
Id. (emphasis in original). These instructions are consistent with Petitioner’s
argument below.
The Fourth Circuit has adopted a similar interpretation of Ruan. See United
States v. Smithers, 92 F.4th 237, 247 (4th Cir. 2024). Defendants in the Tenth and
Fourth Circuits are therefore now tried based on a radically different mens rea (and
as argued below radically different actus reus) than are defendants in the Fifth,
Sixth, Seventh, Ninth and Eleventh Circuits. Both sides of the circuit split rest
their positions on this Court’s language in Ruan. Someone is wrong.
It is difficult to see how this circuit split can resolve itself in the absence of
review from this Court. The government will not be able to appeal from acquittals
in the Tenth or Fourth Circuit cases where instructions require the government to
prove specific intent. Circuits that attach the knowledge element to the two theories
of guilt under CFR §1306.04 do so in reliance on this Court’s assumption that the
scope of authorization under §841 is defined by 21 C.F.R. § 1306.04(a). See, e.g.,
17
Pham, 120 F.4th at 1371; Hofschulz, 105 F.4th at 929, Lamartiniere, 100 F.4th at
641; Heaton, 59 F.4th at 1240. They Court must clarify its Ruan language, which is
necessarily being misinterpreted by two or more Courts of Appeal, and put an end
to the Circuit split to make uniform the application of the law nationwide.
II.
THE SIXTH CIRCUIT’S OPINION BELOW IS WRONG.
a. The Opinion Below is Based on a Fundamental Misreading of
Ruan.
The Sixth Circuit’s opinion below was explicitly based on its analysis in
United States v. Anderson, 67 F.4th 755 (6th Cir. 2023), where it held that “[a]
doctor's prescription is authorized within the meaning of § 841(a) when it is made
‘for a legitimate medical purpose ... in the usual course of his professional practice.’”
Id. at 764 (citing 21 C.F.R. § 1306.04(a)). In Anderson, the Sixth Circuit
acknowledged this Court’s holding in Ruan, but still somehow upheld the
Defendant-Appellant’s conviction because “a rational juror could conclude that
Anderson knowingly prescribed controlled substances without a legitimate medical
purpose and outside the usual course of professional practice.” 67 F.4th at 769.
That understanding is incorrect both in regard to what this Court decided in
Ruan and in regard to the meaning of the regulation. Whether the regulation does
or does not define authorization was not at issue in Ruan. Because the cases below
did not challenge the regulation, the Court assumed its applicability:
18
As noted above, a regulation provides that, “to be effective,” a
prescription “must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.” 21 C.F.R. § 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 standard.
Ruan, 597 U.S. at 455 (emphasis added). While the Court assumed the applicability
of the regulation, it continuously spoke in terms of “statutory provisions,” id. at 459,
and “the mental state that applies to a statutory clause (‘[e]xcept as authorized’) . . .
.” Id. at 461 (emphasis added). The repeated reference to the text of the statute
itself is consistent with the Court’s long-held understanding that “[t]he definition of
the elements of a criminal offense is entrusted to the legislature, particularly in the
case of federal crimes, which are solely creatures of statute.” Liparota v. United
States, 471 U.S. 419, 424 (1985) (citing United States v. Hudson, 7 Cranch 32, 3
L.Ed. 259 (1812)).
Presumably, if the Court intended to depart from that paradigm of criminal
statutory construction and instead rely on the regulation to define the mens rea
required by the statutory provisions rather than the text of the statute itself, it
would have said so clearly. Indeed, the petitioner in Kahn invited the Court to adopt
a standard similar to that established in a prior Ninth Circuit case. If the Court had
accepted the invitation, it simply could have resolved the circuit split in favor of the
Ninth Circuit’s interpretation. But it did not. It took what Justice Alito’s
19
concurrence described as “a radical new course” and held “that the mental state
expressed by the terms ‘knowingly or intentionally’ in § 841(a) applies to the
‘[e]xcept as authorized’ proviso.” Ruan, 597 U.S. at 469 (Alito, J., concurring). Had
Ruan adopted the standard in the Ninth Circuit, there would be nothing radical or
new about its holding.
The Sixth Circuit has ignored Ruan’s strong reliance on Liparota, which
interpreted a similarly worded statute to require knowledge of the fact of nonauthorization, not merely knowledge that an action taken meets the criteria for
what would make the action unauthorized.
b. Using the Regulatory Language to Define § 841’s Mens Rea is
Inconsistent with the Text, Structure, and History of the CSA.
The Sixth Circuit’s application of § 841’s mens rea to the regulatory language
defining an effective prescription cannot be squared with the text, structure, and
history of the Controlled Substances Act. Section 841 states: “Except as authorized
by this subchapter, it shall be unlawful for any person knowingly or intentionally . .
. to distribute[] or dispense . . . a controlled substance . . . .” 21 U.S.C. § 841(a).
Section 822(b) outlines the scope of a registrant’s authorization under the CSA:
Persons registered by the Attorney General under this subchapter to
manufacture, distribute, or dispense controlled substances or list I
chemicals are authorized to possess, manufacture, distribute, or
dispense such substances or chemicals (including any such activity in
20
the conduct of research) to the extent authorized by their registration
and in conformity with the other provisions of this subchapter.
21 U.S.C. § 822(b). Though this definition of authority may seem somewhat
“circular,” an examination of the text and structure of the CSA and the regulatory
regime for registration elucidates the authority conferred by registration.
Section 802(21) defines the term “practitioner” for purposes of the CSA and
the type of registration contemplated by the Act. United States v. Moore, 423 U.S.
122, 141 (1975). That provision provides:
“The term ‘practitioner’ means a physician . . . licensed, registered, or
otherwise permitted, by the United States or the jurisdiction in which
he practices . . . to distribute[ or] dispense . . . a controlled substance in
the course of professional practice or research.”
21 U.S.C. § 802(21). Thus, the text of the statute contemplates that the
authorization conferred by registration extends to acts taken in the course of
professional practice. Moore, 423 U.S. at 141.
The regulatory requirement that a prescription may only be written in the
usual course of professional practice is narrower than the scope of authority
provided for in the text of the CSA. Not only is the regulatory language narrower in
scope than the statute, but it is also significantly less clear than the statutory
language. The language, “usual course of professional practice” carries the
implication that one can act within the course of professional practice while
simultaneously acting outside the scope of their authority under the CSA. While it
21
is clear that one who acts “for a purpose foreign to medicine—such as facilitating
addiction or recreational drug abuse”—has not acted in the course of professional
practice, Ruan, 142 S. Ct. at 2389 (Alito, J., concurring), neither courts nor the
government have been able to provide clear guidance as to what distinguishes the
usual course of professional practice from the practice generally. How unusual must
one’s practice be to cross the line into criminal conduct? The regulation provides no
answers.
Similarly, the text of the CSA only requires that there be a medical purpose
for the distribution or dispensation of a controlled substance. 21 U.S.C.S. § 829(c)
(“No controlled substance in schedule V which is a drug may be distributed or
dispensed other than for a medical purpose.”); cf. Moore, 423 U.S. at 137 n.13 (“The
medical purpose requirement explicit in subsection (c) could be implicit in
subsections (a) and (b).”). The regulation’s requirement that there be a legitimate
medical purpose is, once again, inconsistent with the text of the CSA itself. One
need not strain to see the inconsistency. Certain schedule V controlled substances
are prescription drugs. 2 Hence, one could satisfy the demands of the statute by
issuing a prescription for a medical purpose. The regulation, however, imposes an
undefined legitimacy requirement, and it again injects ambiguity into the scope of a
registrant-physician’s prescribing authority.
2 There is no indication in the text of the CSA that there is a higher standard
required for issuing a prescription for prescription drugs listed in schedules II-IV.
Moreover, the text of CFR § 1306.04 does not limit the regulations application to
prescriptions issued for controlled substances in any particular schedule.
22
Moreover, the most logical reading of the statute does not lead to the
conclusion that § 829’s use of the term “medical purpose” was intended to limit the
scope of a practitioner’s authority. Moore, 423 U.S. at 138 (“On its face s 829
addresses only the form that a prescription must take. . . . [Section] 829 by its terms
does not limit the authority of a practitioner.”). But the regulatory language has led
to significant variation regarding whether there are two distinct means to secure a
conviction under § 841.
Further textual evidence makes clear, however, that the authorization
contemplated by §§ 841 and 822(b) does not contemplate regulatory restrictions on
the scope of a practitioner’s authority. Of particular note, both provisions refer back
to the statute itself, rather than indicating that authorization requires compliance
with the Attorney General’s regulations. Section 822 contains other provisions that
explicitly require one to act “in accordance with the rules and regulations
promulgated by [the Attorney General].” § 822(a)(1), (a)(2). The inclusion of the
requirement to act in accordance with the rules and regulations in subsection (a)(1)
and (a)(2), combined with the absence of similar language in subsection (b) suggests
that Congress did not intend for a practitioner’s authorization to be dependent on
compliance with implementing regulations. See Allison Engine Co. v. U.S. ex rel.
Sanders, 553 U.S. 662, 671 (2008). “[W]hen Congress includes particular language
in one section of a statute but omits it in another section of the same Act, it is
generally presumed that Congress acts intentionally and purposely in the disparate
23
inclusion or exclusion.” Id. (quoting Barnhart v. Sigmon Coal Co., 534 U.S. 438, 452
(2002)) (alteration in original).
A similar rationale applies with respect to § 823(d), which expressly limits
the authority of registrant manufacturers and dispensers of schedule I and II
controlled substances and, in conjunction with § 826, permits the Attorney General
to impose limitations on such registrants’ authority. 21 U.S.C. §§ 823(d), 826. No
similar restriction is imposed on registrant practitioners, and there is no
authorization for the Attorney General to impose limitations on such registrants.
The historical context in which the CSA was passed provides further support
for the contention that the Attorney General does not have the authority to restrict
the prescribing authority of a registrant doctor beyond the restrictions imposed by
the CSA itself. In drafting the CSA, Congress sought to correct the fact that, under
the Harrison Act and its implementing regulations, “the appropriate method of the
practice of medicine” was effectively determined “through criminal prosecution of
physicians whose methods of prescribing narcotic drugs have not conformed to the
opinions of Federal prosecutors of what constitutes appropriate methods of
professional practice.” H.R. Rep. No. 91-1444, p. 15. Vague regulations permitted
prosecutors and narcotics authorities to target physicians who treated narcotics
addicts, leading many in the medical profession to fear accepting such persons as
patients would create an undue risk of prosecution:
The practicing physician has thus been confused as to when he may
prescribe narcotic drugs for an addict. Out of a fear of prosecution many
24
physicians refuse to use narcotics in the treatment of addicts except
occasionally in a withdrawal regimen lasting no longer than a few
weeks. In most instances they shun addicts as patients.
Id. (quoting Report of the President's Advisory Commission on Narcotic and Drug
Abuse, 57 (1963) (“Prettyman Report”).
Congress’s solution was to enact a provision “require[ing] the Secretary of
Health, Education, and Welfare, after consultation with the Attorney General and
national addict treatment organizations, to ‘determine the appropriate methods of
professional practice in the medical treatment of . . . narcotic addiction . . . .’” Moore,
423 U.S. at 144 (quoting Pub.L. 91-513, Title I, § 4, Oct. 27, 1970, 84 Stat. 1241
(current version at 42 U.S.C. § 290bb-2a)). That was the only area “in which
Congress set general, uniform standards of medical practice.” Gonzales v. Oregon,
546 U.S. 243, 271 (2006). The scope of a registrant’s prescribing powers is, at
bottom, a medical decision. The fact that Congress deliberately vested authority
over medical standards in the Secretary rather than the Attorney General indicates
the CSA does not empower the Attorney General to define the scope of a physician’s
prescribing powers. By relying on the regulatory language, the Ninth Circuit
adopted an interpretation “which is inconsistent with ‘the context from which the
statute arose.’” Fischer v. United States, 603 U.S. 480, 498 (2024) (quoting Bond v.
United States, 572 U.S. 844, 860 (2014)). The Court should take this opportunity to
correct the error.
25
c. Deferring to the Regulation to Define Authorization for §
841’s Criminal Prohibitions is Inconsistent with the
Constitutional Separation of Powers.
“Only the people's elected representatives in the legislature are authorized to
‘make an act a crime.’” United States v. Davis, 588 U.S. 445, 451 (2019) (quoting
United States v. Hudson, 7 Cranch 32, 34 (1812)). Despite this axiomatic command
of the constitutional separation of powers, prosecutions of medical professionals
under § 841 have turned not on the meaning of the statutory text, enacted through
the process of bicameralism and presentment. Instead, each case hinges on the caseby-case interpretation of vague regulatory language enacted by unelected
bureaucrats. Unsurprisingly, this has led to variation in the application of the
criminal law across jurisdictions, variation which has withstood this Court’s opinion
in Ruan.
Courts have assumed that the issuance of § 1306.04 was within the Attorney
General’s statutory under the CSA. But such assumptions are inconsistent with the
major questions doctrine. That doctrine stands for the proposition that “in certain
extraordinary cases, both separation of powers principles and a practical
understanding of legislative intent make [courts] reluctant to read into ambiguous
statutory text the delegation claimed to be lurking there.” W. Virginia v. Env't Prot.
Agency, 597 U.S. 697, 723 (2022). In such cases, “something more than a merely
plausible textual basis for the agency action is necessary. The agency instead must
point to ‘clear congressional authorization’ for the power it claims.” Id. (quoting Util.
Air Regulatory Grp. v. EPA, 573 U.S. 302, 324 (2014)).
26
Authority over the regulation of medicine, as previously discussed, was an
issue of major political and economic significance, and there is no textual basis
sufficient to support a construction under which the Attorney General has the
authority to define a registered practitioner’s prescribing authority. To the contrary,
“[t]he structure of the CSA, then, conveys unwillingness to cede medical judgments
to an executive official who lacks medical expertise.” Gonzales v. Oregon, 546 U.S.
243, 266 (2006). Moreover, the “regulation of health and safety is primarily, and
historically, a matter of local concern,” id. at 271 (quotation marks omitted), and
nothing in the statute shows a congressional intention to upset that balance. To the
contrary, “[t]he statute and [this Court’s] case law amply support the conclusion
that Congress regulates medical practice insofar as it bars doctors from using their
prescription-writing powers as a means to engage in illicit drug dealing and
trafficking as conventionally understood.” Id. at 269-270. “Beyond this, however, the
statute manifests no intent to regulate the practice of medicine generally.” Id. at
270.
Regulation 1306.04, however, is inconsistent with this principle. The
regulation makes the implicit judgment that some medical purposes are legitimate
while others are not. So too does it imply that one’s professional practice can become
so unusual that, while they have not yet abandoned the practice of medicine, they
entered the realm of drug trafficking. These unexplained assumptions are
ungrounded in the text of the statute and inconsistent with Congress’s delegation of
decisions that require medical judgment to the Secretary.
27
Moreover, the requirement that a prescription be issued for a “legitimate
medical purpose in the usual course of professional practice” is impermissibly vague
as it provides no meaningful guidance to those enforcing the CSA. “It is a basic
principle of due process that an enactment is void for vagueness if its prohibitions
are not clearly defined.” Grayned v. City of Rockford, 408 U.S. 104, 108 (1972).
A statute can be impermissibly vague for either of two independent
reasons. First, if it fails to provide people of ordinary intelligence a
reasonable opportunity to understand what conduct it prohibits. Second,
if it authorizes or even encourages arbitrary and discriminatory
enforcement.
Hill v. Colorado, 530 U.S. 703, 732 (2000). While requiring knowledge of a lack of
authorization lessens the concerns that one may be punished without adequate
notice of the offense, see Hoffman Estates v. Flipside, Hoffman Estates, 455 U.S.
489, 499 (1982) (noting that “the scienter requirement may mitigate a law's
vagueness, especially with respect to the adequacy of notice to the complainant that
his conduct is proscribed” (emphasis added)), a scienter requirement does not
alleviate all vagueness concerns:
Although the doctrine focuses both on actual notice to citizens and
arbitrary enforcement, [the Supreme Court has] recognized . . . that the
more important aspect of the vagueness doctrine “is not actual notice,
but the other principal element of the doctrine -- the requirement that a
legislature establish minimal guidelines to govern law enforcement.”
28
Kolender v. Lawson, 461 U.S. 352, 357-58 (1983) (quoting Smith v. Goguen, 415 U.S.
566, 574 (1974)).
The second element of the vagueness doctrine is rooted in the understanding
that “[v]ague laws . . . undermine the Constitution’s separation of powers and the
democratic self-governance it aims to protect.” United States v. Davis, 588 U.S. at
451. “Vague statutes threaten to hand responsibility for defining crimes to
relatively unaccountable police, prosecutors, and judges, eroding the people’s ability
to oversee the creation of the laws they are expected to abide.” Id. The language of
the 21 CFR § 1306.04 is entirely deficient in this respect.
This is not the typical vagueness circumstance, where the statute itself
leaves gaps that are ripe for abuse. Here, it is a regulatory interpretation that
injects vagueness into a statute in a manner that invites arbitrary enforcement.
And the vague regulation has been issued under the claimed authority of the very
actor charged with enforcing the law. “If the separation of powers means anything,
it must mean that the prosecutor isn't allowed to define the crimes he gets to
enforce.” United States v. Nichols, 784 F.3d 666, 668 (10th Cir. 2015) (Gorsuch, J.,
dissenting from the denial of rehearing en banc); cf. “Deferring to the prosecuting
branch's expansive views of these statutes would turn their normal construction
upside-down, replacing the doctrine of lenity with a doctrine of severity.” Whitman
v. United States, 574 U.S. 1003 (2014) (Scalia, J., statement respecting the denial of
certiorari) (quotation marks, brackets, and ellipsis omitted)). Such an interpretation
29
is not compatible with the separation of powers, and has led to precisely the perils
Congress sought to correct in drafting the CSA.
And, while Petitioner contends that the ordinary tools of statutory
construction demonstrate the erroneousness of the Sixth Circuit and other Courts’
reliance on the regulations, should the Court find the statue ambiguous, it should
apply the rule of lenity.
III.
THE ISSUE PRESENTED IS OF VAST IMPORTANCE TO THE
MEDICAL COMMUNITY AND IS RECURRANT.
The CSA was not intended to interfere with the legitimate practice of
medicine. However, this is precisely what has occurred due to the lack of clear
standards delineating when a prescriber can issue prescriptions for controlled
substances and the due to the aggressive prosecution of prescribers. Rather than
fulfilling the purpose of the CSA, the DEA and United States Attorney’s Office have
acted as a de facto national medical board, curtailing practices it disagrees with
through criminal prosecutions of prescribing physicians. Congress witnessed a
similar situation under the Harrison Act, and it sought to prevent its recurrence in
drafting the CSA. However, reliance on the vague regulatory language has allowed
and encouraged exactly that which Congress sought to cure.
One area that has been disproportionately impacted is the field of pain
management. According to a 2019 report released by Health and Human Services, 3
3 U.S. Department of Health and Human Services (2019, May) (“HHS Report”).
Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps,
Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health
30
“[r]egulatory oversight has also led to fears of prescribing among clinicians, with
some refusing to prescribe opioids even to established patients who report relief and
demonstrate improved function on a stable opioid regimen.” HHS report at 12.
Fears of arbitrary enforcement have had a negative effect on proper prescribing:
“Clinicians who treat acute and chronic pain, particularly with opioids,
may experience stigma from colleagues and society in general that — in
addition to fear of scrutiny from state medical boards and the DEA —
may also dissuade them from using opioids appropriately.”
Id. at 57. Intervention from this Court is needed to clarify the standards applicable
to medical professionals under the CSA. This case provides an opportunity to clarify
the standards for the medical community so it can minimize the patient harms that
have resulted from the enduring uncertainty regarding the standards governing the
CSA.
CONCLUSION
For the foregoing reasons, Petitioner respectfully prays that this Honorable
Court grant her Petition for Certiorari.
and Human Services website: https://www.hhs.gov/sites/default/files/pmtf-finalreport-2019-05-23.pdf.
31
Respectfully Submitted,
Hasna Bashir Iwas
March 10, 2026
By: /s/ Beau B Brindley
Beau B. Brindley
COUNSEL OF RECORD
For Petitioner Hasna Bashir Iwas
Law Offices of Beau B. Brindley
53 W Jackson Blvd. Ste 1410
Chicago IL 60604
(312)765-8878
bbbrindley@gmail.com
32
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.