Drugs limited to dispensing on prescription

N.D.C.C. § 19-02.1-15 — under North Dakota Food, Drug, and Cosmetic Act.

N.D.C.C. § 19-02.1-15

1. Except as authorized and provided in chapter 19-03.1, a depressant, stimulant, or hallucinogenic drug; or a drug intended for use by man which is a habit-forming drug to which subsection 4 of section 19-02.1-14 applies; or a drug that, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner; or a drug limited by an approved application under section 505 of the federal act or section 19-02.1-16 to use under the professional supervision of a practitioner, must be dispensed by prescription of a practitioner, and such prescription may not be filled or refilled after one year from the date on which such prescription was issued; except that nothing herein may be construed as preventing a practitioner from issuing a new prescription for the same drug either in writing or orally. Any oral prescription for such drug must be promptly reduced to writing and filed by the pharmacist. 2. Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug is exempt from the requirements of section 19-02.1-14, except subsection 1, subdivisions b and c of subsection 10, subsections 12 and 13, and the packaging requirements of subsections 8 and 9 of section 19-02.1-14, if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption does not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or electronic means, or to a drug dispensed in violation of subsection 1. 3. The department may, by regulation, remove drugs subject to subsection 4 of section 19-02.1-14 and section 19-02.1-16 from the requirements of subsection 1 when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regulations issued thereunder

may also, by regulations issued by the department, be removed from the requirements of subsection 1. 4. A drug which is subject to subsection 1 must be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal Law Prohibits Dispensing Without Prescription", "Rx Only", or "Caution: State Law Prohibits Dispensing Without Prescription". A drug to which subsection 1 does not apply must be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence. 5. Nothing in this section may be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications of narcotic drugs or marijuana as defined in the applicable federal and state laws relating to narcotic drugs and marijuana.

19-02.1-15.1. Requirements for dispensing controlled substances and specified drugs - Penalty. 1. As used in this section: a. "Controlled substance" has the meaning set forth in section 19-03.1-01. b. "Deliver, distribute, or dispense by means of the internet" refers, respectively, to delivery, distribution, or dispensing of a controlled substance or specified drug that is caused or facilitated by means of the internet. c. "In-person medical evaluation" means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other practitioners, and must include one of the following actions: (1) The prescribing practitioner examines the patient at the time the prescription or drug order is issued; (2) The prescribing practitioner has performed a prior examination of the patient within twelve months; (3) Another prescribing practitioner practicing within the same health system, group, or clinic as the prescribing practitioner has examined the patient within twelve months; (4) A consulting practitioner to whom the prescribing practitioner has referred the patient has examined the patient within twelve months; or (5) The referring practitioner has performed an examination in the case of a consultant practitioner issuing a prescription or drug order when providing services by means of telemedicine. d. "Internet" and "practice of telemedicine" have the meanings set forth in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 [Pub. L. 110-425; 21 U.S.C. 802-803]. e. "Specified drugs" mean: (1) A skeletal muscle relaxant containing carisoprodol, chlorphenesin, chlorzoxazone, metaxalone, or methocarbamol; (2) A centrally acting analgesic with opioid activity such as tapentadol or tramadol; (3) A drug containing butalbital; and (4) Phosphodiesterase type 5 inhibitors when used to treat erectile dysfunction. f. "Valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted an in-person medical evaluation of the patient. 2. A controlled substance or specified drug may not be delivered, distributed, or dispensed without a valid prescription. It is also unlawful for a person to knowingly or intentionally aid or abet in these activities. An example of such an activity includes knowingly or intentionally serving as an agent, intermediary, or other entity that causes the internet to be used to bring together a buyer and seller to engage in the dispensing of a controlled substance or specified drug.

3. This section applies to the delivery, distribution, and dispensing of a controlled substance or specified drug by means of the internet or any other electronic means from a location whether within or outside this state to a person or an address in this state. 4. Nothing in this section may be construed: a. To apply to the delivery, distribution, or dispensing of a controlled substance or specified drug by a practitioner engaged in the practice of telemedicine in accordance with applicable federal and state laws; b. To prohibit or limit the use of electronic prescriptions for a controlled substance or any other drug; c. To prohibit a physician from prescribing a controlled substance or specified drug through the use of a guideline or protocol established with an allied health professional, resident, or medical student under the direction and supervision of the physician; d. To prohibit a practitioner from issuing a prescription or dispensing a controlled substance or specified drug in accordance with administrative rules adopted by a state agency authorizing expedited partner therapy in the management of a sexually transmitted disease; or e. To limit prescription, administration, or dispensing of a controlled substance or specified drug through a distribution mechanism approved by the state health officer in order to prevent, mitigate, or treat a pandemic illness, infectious disease outbreak, or intentional or accidental release of a biological, chemical, or radiological agent. 5. A person who violates this section is guilty of a class C felony.