21 C.F.R. § 1306.05

Manner of issuance of prescriptions

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(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.

(b) [Reserved]

(c) Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription.

(d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed.

(e) Electronic prescriptions shall be created and signed using an application that meets the requirements of part 1311 of this chapter.

(f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.

(g) An individual practitioner exempted from registration under § 1301.22(c) of this chapter shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in § 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each paper prescription shall have the name of the practitioner stamped, typed, or handprinted on it, as well as the signature of the practitioner.

(h) An official exempted from registration under § 1301.23(a) of this chapter must include on all prescriptions issued by him his branch of service or agency (e.g., “U.S. Army” or “Public Health Service”) and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each paper prescription shall have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer.

[75 FR 16307, Mar. 31, 2010, as amended at 91 FR 34768, June 9, 2026]
Notes of Decisions
Cited in 30 cases (9 in the last 5 years), 1976–2024 · leading case: United States v. Jack Kelly Joseph, 709 F.3d 1082 (11th Cir. 2013).
United States v. Jack Kelly Joseph, 709 F.3d 1082 (11th Cir. 2013). · cites it 5× “” 21 C.F.R. § 1306.05 . Dr. Straus testified that these regulations are designed to ensure that the doctor examines the patient before delivering the prescription and to ensure that there is a legitimate medical reason for delivering the prescription.”
United States v. Elechi Oti, 872 F.3d 678 (5th Cir. 2017). “]” 21 C.F.R. § 1306.05 . Because Texas and federal law state that it is unlawful to dispense the drugs Iwuoha was dispensing without a prescription signed on the same day they were prescribed, we conclude that there was no error here, plain or otherwise.”
United States v. Tull-Abreu, 921 F.3d 294 (1st Cir. 2019). · cites it 2× “2016), such prescriptions must be dated and signed on the day that they are issued, see 21 C.F.R. § 1306.05 (a). Tull-Abreu did not do that; he wrote in dates when he was in fact out of the country or traveling.”
Wedgewood Vill. Pharmacy v. Drug Enf't Admin., 509 F.3d 541 (D.C. Cir. 2007). · cites it 2× “04 (b) (prohibiting using prescriptions “for the purpose of general dispensing”); 21 C.F.R. § 1306.05 (“All prescriptions .”
United States v. Arman Abovyan, 988 F.3d 1288 (11th Cir. 2021). “” Second, appearing to reference 21 C.F.R. § 1306.05 , the district court properly instructed that prescriptions must “be dated as of, and signed on, the day when issued” and that “the prescribing practitioner is responsible in case the 39 USCA11 Case: 19-10676 Date Filed:…”
Norman Bridge Drug Co. v. Michael Banner, John R. Bartels, Jr., Adm'r, Drug Enf't Admin., 529 F.2d 822 (5th Cir. 1976). “04(d)(1); (5) That Norman Bridge Drug Company had filled prescriptions which had been issued in a manner violative of 21 CFR 1306.05(a); (6) That Norman Bridge Drug Company had failed to keep complete and accurate records of receipts of controlled substances in Schedules III, IV…”
United States v. Poulin, 926 F. Supp. 246 (D. Mass. 1996). · cites it 3× “21 C.F.R. § 1306.05 . The Controlled Substances Act imposes liability on pharmacists who fill invalid prescriptions.”
United States v. Wilson, 98 F.4th 1204 (10th Cir. 2024). “” 21 C.F.R. § 1306.05 . And Schedule IV-substance “prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.”
Earl A. Humphreys, M.D. v. Drug Enf't Admin., 96 F.3d 658 (3rd Cir. 1996). “We note that, although not cited by the Deputy Administrator, another regulation, 21 C.F.R. § 1306.05 (a), requires that all prescriptions for controlled substances shall bear the full name and address of the patient.”
Akhtar-Zaidi v. Drug Enf't Admin., 841 F.3d 707 (6th Cir. 2016). “” 21 C.F.R. § 1306.05 (a). In Ohio, chronic pain is defined as “pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months.”
William Hedrick v. State of Indiana, 124 N.E.3d 1273 (Ind. Ct. App. 2019). “See 21 C.F.R. § 1306.05 . [33] Hedrick argues, "there is no logical reason for [him] to sign his own name to a surrendered DEA number.”
United States v. Barbacoff, 416 F. Supp. 606 (D.D.C. 1976). “14 (1975), 21 C.F.R. § 1306.05 (a) (1975), and 21 C.”
— 21 C.F.R. § 1306.05(a) — 1 case
Norman Bridge Drug Co. v. Michael Banner, John R. Bartels, Jr., Adm'r, Drug Enf't Admin., 529 F.2d 822 (5th Cir. 1976). “04(d)(1); (5) That Norman Bridge Drug Company had filled prescriptions which had been issued in a manner violative of 21 CFR 1306.05(a); (6) That Norman Bridge Drug Company had failed to keep complete and accurate records of receipts of controlled substances in Schedules III, IV…”
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