6th Cir. Pattern Crim. Jury Instr. 14.02B

(1) The defendant is charged with the crime of dispensing [distributing] [name controlled substance]. [Name controlled substance] is a controlled substance. For you to find the defendant guilty of this crime, you must find that the government has proved each and every one of the following elements beyond a reasonable doubt:

(A) The defendant knowingly [or intentionally] dispensed [distributed] [name controlled substance];

(B) The defendant knew at the time of dispensing [distribution] that the substance was a controlled substance;

(C) The defendant’s dispensing [distribution] was unauthorized, that is to say the dispensing [distribution] was not for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice; and

(D) The defendant knew [or intended] that his dispensing [distribution] was unauthorized.

(2) Now I will give you more detailed instructions on some of these terms.

(A) The term “dispense” means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term “dispenser” means a practitioner who so delivers a controlled substance to an ultimate user or research subject.

(B) The term “distribute” means to deliver (other than by administering or dispensing) a controlled substance. [The term “distributor” means a person who so delivers a controlled substance.] [The term “distribute” includes the actual, constructive, or attempted transfer of a controlled substance.] [The term “distribute” includes the sale of a controlled substance.]

(C) The phrase “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” means acting in accordance with generally recognized and accepted professional standards in the field in which the individual practices. In considering whether the defendant acted for a legitimate medical purpose in the usual course of professional practice, you may consider all of the defendant’s actions and the circumstances surrounding them.

[(D) The term “practitioner” means a physician [dentist, veterinarian, scientific investigator, pharmacy, hospital or other person] 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.]

(3) If you are convinced that the government has proved all of these elements, say so by returning a guilty verdict on this charge. If you have a reasonable doubt about any one of these elements, then you must find the defendant not guilty of this charge.

Use Note

This instruction covers dispensing or distributing a controlled substance by a practitioner; if the defendant is not a practitioner, use Inst. 14.02A Distribution of a Controlled Substance.

This instruction covers simple dispensing or distributing of a controlled substance by a practitioner. If the charges include increased penalties based on the amount of the controlled substance, see also Inst. 14.07A. If the conduct charged includes distributing with death or serious bodily injury resulting, see also Instruction 14.07C.

This instruction should be given only after the defendant produces evidence that he or she was authorized as a practitioner to dispense or distribute controlled substances; this burden on the defendant to produce evidence is discussed below in the commentary.

If the bracketed sentence in paragraph (2)(B) defining distribution to include the actual, constructive and attempted transfer is given, the court should further define the terms actual, constructive, or attempted transfer. The terms “actual” and “constructive” are defined in the context of possession in Instructions 2.10 and 2.10A. The term “attempt” is defined in Instruction 5.01.

In paragraph (2)(C), the instruction refers to an individual practitioner “acting in accordance with generally recognized and accepted professional standards in the field in which the individual practices.” Standards for the different kinds of professional practice are set by various organizations. The law applicable to this offense does not define this phrase further.

The definition of “practitioner” in paragraph (2)(D) is based on the statutory definition in § 802(21); if the case involves a type of practitioner not specifically listed, the definition may be modified to cover a qualifying “other person.”

Brackets indicate options for the court. Bracketed italics are notes to the court.

Committee Commentary Instruction 14.02B

(current through May 29, 2026)

Title 21 U.S.C. § 841(a)(1) provides, “Except as authorized . . . , it shall be unlawful for any person knowingly or intentionally-- (1) to . . . distribute, or dispense . . . a controlled substance . . . .” Practitioners may be prosecuted under this provision if their conduct is unauthorized, i.e., not for a legitimate medical purpose in the usual course of professional practice. 21 C.F.R. § 1306.04(a); United States v. Ruan, 142 S. Ct. 2370, 2374 (2022); United States v. Moore, 96 S. Ct. 335, 337 (1975); see also United States v. Godofsky, 943 F.3d 1011, 1017, 1029 (6th Cir. 2019); United States v. Chaney, 921 F.3d 572, 589 (6th Cir. 2019) (quoting United States v. Johnson, 71 F.3d 539, 542 (6th Cir. 1995) (cleaned up)); and United States v. Kirk, 584 F.2d 773, 784 (6th Cir. 1978). The instruction uses “dispense” as the primary term and offers “distribute” as an option in brackets. Sixth Circuit cases can be found to support the use of either term, see, e.g., United States v. Seelig, 622 F.2d 207, 211 (6th Cir. 1980) (approving use of term “distribute” in instruction but finding error on other grounds) and United States v. Voorhies, 663 F.2d 30, 33 (6th Cir. 1981) (approving instruction that used term “dispense”). The Committee decided to use “dispensing” as the primary term based on this term’s repeated use by the Supreme Court in Ruan, see, e.g., 142 S. Ct. 2370, 2375; see also United States v. Fabode, 2022 WL 16825408, 6-7 (6th Cir. 2022) (unpublished).

In paragraph (1), the elements are based on the statute, regulation and cases cited in the paragraph above. In paragraph (1)(A), the requirement that the defendant “knowingly [or intentionally]” distributed a controlled substance is based on § 841(a)(1) and Sixth Circuit case law. The instruction requires a mens rea of knowingly, and then offers in brackets the option of adding an alternative mens rea of intentionally. As quoted above, the statute states that the defendant must “knowingly or intentionally” distribute a controlled substance. However, as noted in the commentary to Instruction 14.01 on possession with intent to distribute, the Sixth Circuit often omits the optional term “intentionally” from the list of elements for that crime. Based on these cases construing the same statute, the instruction for dispensing or distribution by a practitioner uses the term knowingly, and then provides the phrase “or intentionally” in brackets as an option for inclusion based on the language in § 841(a) and for cases where the government used that term in the indictment.

In paragraph (1)(B), the language requiring the defendant to know at the time of dispensing or distribution that the substance was a controlled substance is supported by United States v. Godofsky, 943 F.3d 1011, 1017 & 1029 (6th Cir. 2019). See also United States v. Harris, 293 F.3d 970, 974 (6th Cir. 2002) (requiring this knowledge for distribution by non-practitioners) and United States v. Gibbs, 182 F.3d 408 (6th Cir. 1999) (same).

In paragraph (1)(C), the requirement that the defendant’s dispensing or distribution was unauthorized, that is to say the dispensing [distribution] was not for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice, is based on 21 C.F.R. § 1306.04(a), United States v. Ruan, 142 S. Ct. 2370 (2022), and United States v. Moore, 96 S. Ct. 335, 337 (1975); see also United States v. Campbell, 135 F.4th 376, 386 (6th Cir. 2025) (discussing Ruan); United States v. Godofsky, 943 F.3d 1011, 1017, 1029 (6th Cir. 2019); United States v. Chaney, 921 F.3d 572, 589 (6th Cir. 2019) (quoting United States v. Johnson, 71 F.3d 539, 542 (6th Cir. 1995) (cleaned up)); and United States v. Kirk, 584 F.2d 773, 784 (6th Cir. 1978).

In paragraph (1)(D), the requirement that the defendant knew or intended that his dispensing or distribution was unauthorized is based on Ruan, 142 S. Ct. 2370, 2382; see also United States v. Campbell, 135 F.4th 376, 386 (6th Cir. 2025).

In paragraph (2), the definitions of dispense, distribute, and practitioner in paragraphs (A), (B), and (D) are drawn primarily from the definitions in 18 U.S.C. §§ 802(10); 802(11) and 802(8); and 802(21), respectively. Some of these definitions have been edited to use plain English and to fit the usual case.

The definition of “dispense” in paragraph (2)(A) uses the language of § 802(10) verbatim. The definition of “distribute” in paragraph (2)(B) is based on §§ 802(11) and 802(8). Section 802(11) defines “distribute” as “to deliver (other than by administering or dispensing) a controlled substance.” Section 802(8) then defines the terms “deliver” and “delivery” as “the actual, constructive, or attempted transfer of a controlled substance . . . .” The first bracketed sentence (defining “distributor”) is drawn from § 802(11), and the second bracketed sentence (defining “distribute” to include actual, constructive, or attempted transfers of a controlled substance) is drawn from § 802(8). The third bracketed sentence (defining distribution to include the sale of a controlled substance) is based on United States v. Robbs, 75 F. App’x 425, 431 (6th Cir. 2003) (unpublished). Sixth Circuit authority recognizes that the term “distribute” includes the act of writing a prescription, see United States v. Johnson, 831 F.2d 124, 128 (6th Cir. 1987) and United States v. Flowers, 818 F.2d 464, 467 (6th Cir. 1987). The instruction covers the conduct of writing prescriptions under the definition of “dispense.”

In paragraph (2)(C), the phrase “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” is defined to mean “acting in accordance with generally recognized and accepted standards of that individual’s professional practice.” See United States v. Campbell, 135 F.4th 376, 394 (6th Cir. 2025):

The government can prove knowledge of a lack of authorization “by reference to objective criteria,” such as “objective standard[s] [of] medicine” and “accepted limits” of medical practice. Ruan, 597 U.S. at 467, 142 S.Ct. 2370 (quotations omitted). Indeed, it is “impossible” for the government to prove that a defendant was “acting outside the usual course of professional practice . . . without mentioning the usual standard of care.” United States v. Volkman, 736 F.3d 1013, 1023 (6th Cir. 2013) (quotations omitted), vacated on other grounds, 574 U.S. 955, 135 S.Ct. 13, 190 L.Ed.2d 286 (2014).

As stated in the Use Note, standards for the different kinds of professional practice are set by various organizations.

In United States v. Chaney, 921 F.3d 572 (6th Cir. 2019) the three defendants (a physician, a clinic, and the CEO of the clinic) were convicted of distribution under § 841(a) and § 2. The defendants argued that the evidence they acted without a “legitimate medical purpose” was insufficient because the patients who received the drugs had various serious underlying conditions that justified the prescription of drugs. The trial court rejected this argument, and the Sixth Circuit affirmed, explaining:

[The defendants’] arguments are incorrect.

. . . .

Instead, as the word “purpose” implies, we look at a provider's reason for issuing the prescription when determining whether it was issued for a legitimate medical purpose, rather than the patient's underlying conditions. As the district court made abundantly clear, a doctor prescribing opioid painkillers to anyone walking through the door is not saved if a person happens to have an underlying condition that could justify the prescription; likewise, a doctor who acts in good faith and with all due care but nevertheless issues a prescription to a patient who was merely faking symptoms is nevertheless acting with a legitimate medical purpose. To say otherwise would be absurdity.

. . . .

Evidence of the circumstances surrounding a prescription allows juries to infer that a physician's purpose was something other than legitimate medical treatment; the underlying conditions a patient may have had are not dispositive.

The minimum mens rea for this crime is knowingly, so the provisions of Inst. 2.09 Deliberate Ignorance are properly given in cases under Inst. 14.02B. See United States v. Bauer, 82 F.4th 522, 530-531 (6th Cir. 2023) (approving a jury instruction that was substantially the same as pattern Inst. 2.09 Deliberate Ignorance); United States v. Anderson, 67 F.4th 755, 766 (6th Cir. 2023) (same).

In United States v. Campbell, 135 F.4th 376, 387-388 (6th Cir. 2025), the court affirmed convictions of a doctor and a nurse practitioner for conspiracy to distribute drugs although the instructions did not specifically address the Ruan requirement that they knew their conduct was unauthorized. The court explained that the “instructions on the elements of unlawful distribution pointedly omit any reference to knowledge of a lack of authorization,” so it was “doubtful” that the instructions “fully comported” with the Ruan requirements. Id. However, based on three cases holding that Ruan was satisfied when the court provided a deliberate ignorance instruction like Inst. 2.09, the court concluded it was bound to affirm the convictions. Campbell at 387-388, citing United States v. Stanton, 103 F.4th 1204 (6th Cir. 2024); United States v. Bauer, 82 F.4th 522 (6th Cir. 2023); and United States v. Anderson, 67 F.4th 755 (6th Cir. 2023). The Campbell court recognized that although it was compelled to affirm, these cases did not use the instructions that should be used in prosecuting practitioners for unauthorized distribution cases going forward. Campbell at 388 note 2, quoting United States v. Bauer, 82 F.4th 522, 533 (6th Cir. 2023).

This instruction is properly given only after the defendant meets the burden of producing evidence that he or she was authorized as a practitioner to dispense or distribute controlled substances. As the Ruan Court stated, “[O]nce 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.” Ruan, 142 S. Ct. 2370, 2376 (2022). The Court did not define the burden on the defendant to produce evidence further; the concurring opinion noted that cert. was not granted on that question and no party briefed it. Ruan, supra at 2384 (Alito, Thomas, and Barrett, JJ., concurring in the judgment).

The instruction does not include a good faith defense and does not use the term good faith. See United States v. Bauer, 82 F.4th 522, 532 (6th Cir. 2023) (describing the good faith defense as one that “Ruan likely makes obsolete”).