(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his 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 who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.
(c) A prescription may be issued by a practitioner for a controlled substance in Schedule III, IV, or V for use in detoxification treatment or maintenance treatment.
(d) A prescription may be issued by a practitioner in accordance with § 1306.05 for a Schedule III, IV, or V controlled substance for the purpose of maintenance or detoxification treatment for the purposes of administration in accordance with section 309A of the Act (21 U.S.C. 829a) and § 1306.07(f). Such prescription shall not be used to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients.
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005; 85 FR 69167, Nov. 2, 2020; 91 FR 34768, June 9, 2026]
Notes of Decisions
Cited in
242
cases (
79 in the last 5 years), 1975–2026 · leading case:
Gonzales v. Oregon, 546 U.S. 243 (2006).
Gonzales v. Oregon, 546 U.S. 243 (2006).
· cites it 20× “" 21 CFR § 1306.04 (a) (2005). To prevent diversion of controlled substances with medical uses, the CSA regulates the activity of physicians.”
United States v. Smith, 573 F.3d 639 (8th Cir. 2009).
· cites it 19× “First, he alleges that the district court erred in instructing the jury that a prescription's validity under 21 C.F.R. § 1306.04 is determined by generally accepted medical practices rather than the specific, regular practice of the issuing doctor.”
Xiulu Ruan v. United States, 597 U.S. 450 (2022).
· cites it 6× “” 21 CFR §1306.04 (a). At issue in Ruan’s and Kahn’s trials was the mens rea required to convict under §841 for distributing controlled substances not “as authorized.”
United States v. Tobin, 676 F.3d 1264 (11th Cir. 2012).
· cites it 9× “§ 802(6), (10), (11), (21), or by regulation, see 21 C.F.R. § 1306.04 (a). In particular, the regulations promulgated by the Attorney General specify that a “prescription” is one that must be “issued for a legitimate medical purpose by an individual practitioner acting in the…”
United States v. Jack Kelly Joseph, 709 F.3d 1082 (11th Cir. 2013).
· cites it 6× “Practitioners may issue prescriptions for controlled substances so long as the prescriptions are issued 4 “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), and the indictment charged…”
United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008).
· cites it 6× “” 21 C.F.R. § 1306.04 (a). The Supreme Court held in Moore, 423 U.”
United States v. Sabean, 885 F.3d 27 (1st Cir. 2018).
· cites it 5× “§ 841 (a)(1) ; 21 C.F.R. § 1306.04 (a). Finally, the indictment charged the defendant, in a single count, with committing health-care fraud by writing certain prescriptions meant for S.”
Ryan v. Dan's Food Stores, Inc., 972 P.2d 395 (Utah 1998).
· cites it 8× “In this case, Ryan argues that he was following a clear and substantial public policy set out by 21 C.F.R. § 1306.04 and 21 U.S.C. § 801 .”
Oregon v. Ashcroft, 368 F.3d 1118 (9th Cir. 2004).
· cites it 21× “the Act and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”
United States v. Lovern, 590 F.3d 1095 (10th Cir. 2009).
· cites it 6× “" 21 C.F.R. § 1306.04 (a). While the responsibility for meeting this test rests in the first instance with the prescribing doctor, "a corresponding responsibility rests with the pharmacist who fills the prescription.”
United States v. Lamartiniere, 100 F.4th 625 (5th Cir. 2024).
· cites it 10× “”22 In turn, § 822(b) provides that medical practitioners registered with the Attorney General “are authorized to possess, manufacture, distribute, or dispense” controlled substances “to the extent authorized by their registration and in conformity with the other provisions” of…”
United States v. Brown, 553 F.3d 768 (5th Cir. 2008).
· cites it 3× “The “corresponding responsibility” of pharmacists derives from 21 C.F.R. § 1306.04 , and the district court’s instruction largely mirrors this regulation.”
— 21 C.F.R. § 1306.04(a) — 8 cases
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