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21 U.S.C. 821, 823(k), 829, 831, 871(b), unless otherwise noted.
36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
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This part sets forth the process and procedures for dispensing, by way of prescribing and administering controlled substances to ultimate users. The purpose of such procedures is to provide safe and efficient methods for dispensing controlled substances while providing effective controls against diversion.
[91 FR 5242, Feb. 5, 2026]
Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13964, Mar. 24, 1997]
(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:
(1) Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and
(2) Either registered or exempted from registration pursuant to §§ 1301.22(c) and 1301.23 of this chapter.
(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, Mar. 24, 1997]
(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]
(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]
A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy, a registered central fill pharmacy, or registered institutional practitioner.
[68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005]
(a) A practitioner may administer or dispense directly (but not prescribe) a narcotic drug in Schedule II to a narcotic dependent person for the purpose of maintenance or detoxification treatment if the practitioner meets both of the following conditions:
(1) The practitioner is separately registered with DEA as a narcotic treatment program.
(2) The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the Act.
(b) Nothing in this section shall prohibit a practitioner, who is not specifically registered to conduct a narcotic treatment program, from dispensing (but not prescribing) narcotic drugs, in accordance with applicable Federal, State, and local laws relating to controlled substances, to one person or for one person's use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both). Not more than a three-day supply of such medication may be dispensed to the person or for the person's use at one time while arrangements are being made for referral for treatment. Such emergency treatment may not be renewed or extended.
(c) This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.
(d) A practitioner may administer or dispense (including prescribe) any Schedule III, IV, or V narcotic drug for use in maintenance or detoxification treatment to a narcotic dependent person.
(e) [Reserved]
(f) Notwithstanding the definition of dispense under section 102(10) of the Act (21 U.S.C 802(10)), a pharmacy may deliver a controlled substance to a practitioner, pursuant to a prescription that meets the requirements under § 1306.04 for the purpose of administering the controlled substance by the practitioner if:
(1) The controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance (in this paragraph (f) referred to as the “administering practitioner”), as applicable, at the location listed on the practitioner's DEA certificate of registration;
(2) The controlled substance is a narcotic drug in schedule III, IV, or V to be administered for the purpose of maintenance or detoxification treatment and is to be administered by injection or implantation;
(3) The pharmacy, the prescribing practitioner, and the administering practitioner (as applicable) are authorized to conduct such activities specified in this paragraph (f) under the law of the State in which such activities take place;
(4) The prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;
(5) The controlled substance is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the controlled substance by the practitioner; and
(6) Notwithstanding any exceptions under section 307 of the Act (21 U.S.C. 827), the prescribing practitioner and the administering practitioner, as applicable, shall maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this paragraph (f), including the persons to whom the controlled substances were delivered and such other information as may be required under this chapter. Recordkeeping requirements for prescriptions are addressed in §§ 1304.03(c) and 1304.06 of this chapter.
(g) An emergency medical services professional of a registered emergency medical services agency may administer directly (but not prescribe) controlled substances in schedules II-V outside the physical presence of a medical director or authorizing medical professional while providing emergency medical services if the administration is authorized by law of the State in which it occurs, and is pursuant to:
(1) A standing order that is issued and adopted by one or more medical directors of the agency, including any such order that may be developed by a specific State's authority; or
(2) A verbal order that is:
(i) Issued in accordance with a policy of the agency; and
(ii) Provided by a medical director or an authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient --
(A) In the case of a mass casualty incident; or
(B) To ensure the proper care and treatment of a specific patient.
(h) An emergency medical services agency shall maintain, at a registered location of the agency, a record of the standing or verbal orders issued or adopted in accordance with § 1304.13 of this chapter.
[39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005; 85 FR 69167, Nov. 2, 2020; 88 FR 53382, Aug. 8, 2023; 91 FR 5242, Feb. 5, 2026; 91 FR 16167, Apr. 1, 2026; 91 FR 34768, June 9, 2026]
(a) An individual practitioner may sign and transmit electronic prescriptions for controlled substances provided the practitioner meets all of the following requirements:
(1) The practitioner must comply with all other requirements for issuing controlled substance prescriptions in this part;
(2) The practitioner must use an application that meets the requirements of part 1311 of this chapter; and
(3) The practitioner must comply with the requirements for practitioners in part 1311 of this chapter.
(b) A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter.
(c) To annotate an electronic prescription, a pharmacist must include all of the information that this part requires in the prescription record.
(d) If the content of any of the information required under § 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance.
(e) The transfer for initial dispensing of an electronic prescription for a controlled substance in Schedule II-V is permissible between retail pharmacies, upon request from the patient, on a one-time basis only. If the transferred prescription is for a controlled substance in Schedule III, IV, or V and includes authorized refills, the refills are transferred with the initial prescription to the pharmacy receiving the transfer.
(f) The transfer of an electronic prescription for a controlled substance in Schedule II-V between retail pharmacies for the purpose of initial dispensing is subject to the following requirements:
(1) The prescription must be transferred from one retail pharmacy to another retail pharmacy in its electronic form. At no time may an intermediary convert an electronic prescription to another form (e.g., facsimile) for transmission.
(2) The contents of the prescription required by this part must not be altered during transfer between retail pharmacies. Any change to the content during transfer, including truncation or removal of data, will render the electronic prescription invalid.
(3) The transfer must be communicated directly between two licensed pharmacists.
(4) The transferring pharmacist must add the following to the electronic prescription record:
(i) Information that the prescription has been transferred.
(ii) The name, address, and DEA registration number of the pharmacy to which the prescription was transferred and the name of the pharmacist receiving the prescription information.
(iii) The date of the transfer and the name of the pharmacist transferring the prescription information.
(5) The receiving pharmacist must do the following:
(i) Add the word “transfer” to the electronic prescription record at the receiving pharmacy.
(ii) Annotate the prescription record with the name, address, and DEA registration number of the pharmacy from which the prescription was transferred and the name of the pharmacist who transferred the prescription.
(iii) Record the date of the transfer and the name of the pharmacist receiving the prescription information.
(6) In lieu of manual data entry, the transferring or receiving pharmacy's prescription processing software may, if capable, capture the information required, as outlined in this paragraph (f), from the electronic prescription and automatically populate the corresponding data fields to document the transfer of an electronic controlled substance prescription between pharmacies. The transferring or receiving pharmacist, as applicable, must ensure that the populated information is complete and accurate.
(g) The transfer of an electronic prescription for a controlled substance in Schedule II-V for the purpose of initial dispensing is permissible only if allowable under existing State or other applicable law.
(h) The electronic records documenting the transfer of the electronic prescription must be maintained for a period of two years from the date of the transfer by both the pharmacy transferring the electronic prescription and the pharmacy receiving the electronic prescription.
(i) A pharmacy may transfer electronic prescription information for a controlled substance in Schedule III, IV, and V to another pharmacy for the purpose of refill dispensing pursuant to § 1306.25.
[75 FR 16307, Mar. 31, 2010, as amended at 88 FR 48379, July 27, 2023]
(a) No controlled substance that is a prescription drug may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.
(b) In accordance with the Act, it is unlawful for any person to knowingly or intentionally fill a prescription for a controlled substance that was issued in a manner that constitutes dispensing by means of the Internet unless such person is a pharmacist who is acting in the usual course of his professional practice and is acting on behalf of a pharmacy whose registration has been modified under sections 1301.13 and 1301.19 of this chapter to authorize it to operate as an online pharmacy.
(c) Any online pharmacy that participates in the transfer between pharmacies of prescription information must do so in accordance with the requirements of §§ 1306.15 and 1306.25 of this part.
[74 FR 15624, Apr. 6, 2009]