North Carolina § 90-106 - Prescriptions and labeling.

§ 90-106. Prescriptions and labeling.

Definitions. - As used in this section, the following terms have the following meanings: Acute pain. - Pain, whether resulting from disease, accident, intentional trauma, or other cause, that the practitioner reasonably expects to last for three months or less. The term does not include chronic pain or pain being treated as part of cancer care, hospice care, palliative care, or medication-assisted treatment for a substance use disorder. The term does not include pain being treated as part of cancer care, hospice care, or palliative care provided by a person licensed to practice veterinary medicine pursuant to Article 11 of this Chapter. Chronic pain. - Pain that typically lasts for longer than three months or that lasts beyond the time of normal tissue healing. Surgical procedure. - A procedure that is performed for the purpose of structurally altering the human body by incision or destruction of tissues as part of the practice of medicine or a procedure that is performed for the purpose of structurally altering the animal body by incision or destruction of tissues as part of the practice of veterinary medicine. This term includes the diagnostic or therapeutic treatment of conditions or disease processes by use of instruments such as lasers, ultrasound, ionizing, radiation, scalpels, probes, or needles that cause localized alteration or transportation of live human tissue, or live animal tissue in the practice of veterinary medicine, by cutting, burning, vaporizing, freezing, suturing, probing, or manipulating by closed reduction for major dislocations and fractures, or otherwise altering by any mechanical, thermal, light-based, electromagnetic, or chemical means. Electronic Prescription Required; Exceptions. - Unless otherwise exempted by this subsection, a practitioner shall electronically prescribe all targeted controlled substances. This subsection does not apply to prescriptions for targeted controlled substances issued by any of the following: A practitioner, other than a pharmacist, who dispenses directly to an ultimate user. A practitioner who orders a controlled substance to be administered in a hospital, nursing home, hospice facility, outpatient dialysis facility, or residential care facility, as defined in G.S. 14-32.2(i). A practitioner who experiences temporary technological or electrical failure or other extenuating circumstance that prevents the prescription from being transmitted electronically. The practitioner, however, shall document the reason for this exception in the patient's medical record. A practitioner who writes a prescription to be dispensed by a pharmacy located on federal property. The practitioner, however, shall document the reason for this exception in the patient's medical record. A person licensed to practice veterinary medicine pursuant to Article 11 of this Chapter. A person licensed to practice veterinary medicine pursuant to Article 11 of this Chapter may continue to prescribe targeted controlled substances from valid written, oral, or facsimile prescriptions that are otherwise consistent with applicable laws. Verification by Dispenser Not Required. - A dispenser is not required to verify that a practitioner properly falls under one of the exceptions specified in subsection (a1) of this section prior to dispensing a targeted controlled substance. A dispenser may continue to dispense targeted controlled substances from valid written, oral, or facsimile prescriptions that are otherwise consistent with applicable laws. Limitation on Prescriptions Upon Initial Consultation for Acute Pain. - A practitioner shall not prescribe more than a five-day supply of any targeted controlled substance upon the initial consultation and treatment of a patient for acute pain, unless the prescription is for post-operative acute pain relief for use immediately following a surgical procedure. A practitioner shall not prescribe more than a seven-day supply of any targeted controlled substance for post-operative acute pain relief immediately following a surgical procedure. Upon any subsequent consultation for the same pain, the practitioner may issue any appropriate renewal, refill, or new prescription for a targeted controlled substance. This subsection does not apply to prescriptions for controlled substances issued by a practitioner who orders a controlled substance to be wholly administered in a hospital, nursing home licensed under Chapter 131E of the General Statutes, hospice facility, or residential care facility, as defined in G.S. 14-32.2(i). This subsection does not apply to prescriptions for controlled substances issued by a practitioner who orders a controlled substance to be wholly administered in an emergency facility, veterinary hospital, or animal hospital, as defined in G.S. 90-181.1. A practitioner who acts in accordance with the limitation on prescriptions as set forth in this subsection is immune from any civil liability or disciplinary action from the practitioner's occupational licensing agency for acting in accordance with this subsection. Repealed by Session Laws 2019-76, s. 12(b) effective January 1, 2020, and applicable to offenses committed on or after that date. Dispenser Immunity. - A dispenser is immune from any civil or criminal liability or disciplinary action from the Board of Pharmacy for dispensing a prescription written by a prescriber in violation of this section. Dispensing of Schedule II Controlled Substances. - No Schedule II substance shall be dispensed pursuant to a written or electronic prescription more than six months after the date it was prescribed. In emergency situations, as defined by rule of the Commission, Schedule II controlled substances may be dispensed upon oral prescription of a practitioner, reduced promptly to writing and filed by the dispensing agent. Prescriptions shall be retained in conformity with the requirements of G.S. 90-104. No prescription for a Schedule II substance shall be refilled. Dispensing of Schedule III and IV Controlled Substances. - Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance included in Schedules III or IV, except paregoric, U.S.P., as provided in G.S. 90-91(e)1., shall be dispensed without a prescription, and oral prescriptions shall be promptly reduced to writing and filed with the dispensing agent. The prescription shall not be filled or refilled more than six months after the date of the prescription or be refilled more than five times after the date of the prescription. Dispensing of Schedule V Controlled Substances. - No controlled substance included in Schedule V of this Article or paregoric, U.S.P., shall be distributed or dispensed other than for a medical purpose. Dispensing of Schedule VI Controlled Substances. - No controlled substance included in Schedule VI of this Article shall be distributed or dispensed other than for scientific or research purposes by persons registered under, or permitted by, this Article to engage in scientific or research projects. Labeling Requirements. - No controlled substance shall be dispensed or distributed in this State unless the substance is in a container clearly labeled in accord with regulations lawfully adopted and published by the federal government or the Commission. Copies. - When a copy of a prescription for a controlled substance under this Article is given as required by G.S. 90-70, the copy shall be plainly marked: "Copy - for information only." Copies of prescriptions for controlled substances shall not be filled or refilled. Fill Date. - A pharmacist dispensing a controlled substance under this Article shall enter the date of dispensing on the prescription order pursuant to which the controlled substance was dispensed. Distribution of Complimentary Samples. - A manufacturer's sales representative may distribute a controlled substance as a complimentary sample only upon the written request of a practitioner. The request must be made on each distribution and must contain the names and addresses of the supplier and the requester and the name and quantity of the specific controlled substance requested. The manufacturer shall maintain a record of each request for a period of two years. History (1971, c. 919, s. 1; 1973, c. 476, s. 128; c. 1358, s. 15; 1975, c. 572; 1977, c. 667, s. 3; 1981, c. 51, s. 9; 2007-248, s. 2; 2013-379, s. 5; 2017-74, s. 6; 2018-76, ss. 5, 7; 2019-76, s. 12(b).) Editor's Note. - Section 90-70, referred to in this section, along with certain other sections from Parts 1 and 1A of Article 4 of Chapter 90 , has been recodified in Article 4A of Chapter 90 . As to the preservation of prescription orders, see now G.S. 90-85.26 . As to the availability of pharmacy records, see now G.S. 90-85.36 . Session Laws 2017-74, s. 15(b), made amendments to subsection (a) as amended by Session Laws 2017-74, s. 6, and subsections (a1) and (a2) as added by Session Laws 2017-74, s. 6, effective January 1, 2020. Session Laws 2017-74, s. 15(c), made subsections (a3) and (a4), as added by Session Laws 2017-74, s. 6, effective January 1, 2018. Session Laws 2017-74, s. 15(e), made subsection (a5), as added by Session Laws 2017-74, s. 6, effective June 29, 2017, and applicable to acts committed 30 days after the date the State Chief Information Officer notifies the Revisor of Statutes that (i) the upgrades to the Controlled Substances Reporting System (CSRS) database described in subdivisions (1) and (2) of subsection (a) of Section 12F.7 of S.L. 2016-94 have been completed and (ii) the upgraded CSRS database is fully operational within the Department of Information Technology and connected to the statewide health information exchange. Session Laws 2017-74, provides in its preamble: "Whereas, the General Assembly recognizes the substantial impact the nationwide opioid epidemic continues to have on the State of North Carolina; and "Whereas, North Carolina has seen a 442% increase in overdose deaths caused by commonly prescribed opioids between 1999 and 2015; and "Whereas, the General Assembly fully recognizes the appropriate use of opioids in the treatment of acute and chronic pain; Now, therefore," Session Laws 2017-74, s. 1, provides: "This act shall be known and may be cited as the 'Strengthen Opioid Misuse Prevention Act of 2017' or the 'STOP Act.'" Session Laws 2019-76, s. 12(c) made the amendments by Session Laws 2019-76, s. 12(b), effective January 1, 2020, and applicable to offenses committed on or after that date. Session Laws 2019-76, s. 33, provides: "Parts I and II of this act do not affect the coverage, eligibility, rights, responsibilities, or provision of State or federal services or benefits for individuals who have been diagnosed with mental retardation and whose diagnosis has not been changed to a diagnosis of intellectual disability." Effect of Amendments. - Session Laws 2007-248, s. 2, effective July 20, 2007, substituted "on the prescription order" for "and shall write his own signature on the face of the prescription" in subsection (h). Session Laws 2013-379, s. 5, effective October 1, 2013, added the second sentence in subsection (a). For applicability, see Editor's note. Session Laws 2017-74, s. 6, effective January 1, 2020, in subsection (a) deleted the first sentence which formerly read: "Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance included in Schedule II of this Article may be dispensed without the written prescription of a practitioner.", inserted "or electronic" in the second sentence; and added subsections (a1) and (a2). For applicability, see editor's note. Session Laws 2017-74, s. 6, effective January 1, 2018, added subsections (a3) through (a4). For applicability, see editor's note. Session Laws 2017-74, s. 6, effective June 29, 2017, added subsection (a5). For applicability, see editor's note. Session Laws 2018-76, s. 5, effective January 1, 2020, added the last sentence in subdivision (a1)(5). Session Laws 2018-76, s. 7, effective June 25, 2018, added the penultimate sentence in subsection (a3); and in subsection (a4), added the last sentence in subdivision (a4)(1), rewrote the first sentence of subdivision (a4)(3), and inserted "or live animal tissue in the practice of veterinary medicine," in the second sentence of subdivision (a4)(3). Session Laws 2019-76, s. 12(b), rewrote this section. For effective date and applicability, see editor's note.