Code of Federal Regulations · Section

§ 1306.07 — Administering Or Dispensing Of Narcotic Drugs

21 C.F.R. § 1306.07

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(a) A practitioner may administer or dispense directly (but not prescribe) a narcotic drug listed in any schedule to a narcotic dependant 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 approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to a narcotic dependent person if the practitioner complies with the requirements of § 1301.28 of this chapter.

(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, as applicable, at the location, listed on the practitioner's certificate of registration;

(2) The controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2)(G)(iii) of the Act (21 U.S.C. 823(g)(2)(G)(iii)); and

(i) The practitioner who issued the prescription is a qualifying practitioner as defined in section 303(g) of the Act (21 U.S.C. 823(g)); and

(ii) The controlled substance is to be administered by injection or implantation;

(3) The pharmacy and the practitioner 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 14 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 practitioner administering the controlled substance, 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.

(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.

Authorizing Statute