§ 106-134.1. Prescriptions required; label requirements; removal of certain drugs from requirements of this section.
§ 106‑134.1. Prescriptions required; label requirements; removal of certain drugs fromrequirements of this section.
(a) A drug intended for use by man which:
(1) Is a habit‑forming drug to which G.S. 106‑134(4)applies; or
(2) Because of its toxicity or other potentiality for harmfuleffect, or the method of its use, or the collateral measures necessary to itsuse, is not safe for use except under the supervision of a practitionerlicensed by law to administer such drug in the course of his normal practice;or
(3) Is limited by an approved application under section 505 ofthe federal act to use under the professional supervision of a practitionerlicensed by law to administer such drug; or
(4) Is a drug the label of which bears the statement"Caution: Federal law prohibits dispensing without a prescription,"shall be dispensed only
a. Upon a written prescription of a practitioner licensed bylaw to administer such drug, or authorized to issue orders pursuant to G.S. 90‑87(23)(a),provided that the written prescription must bear the printed or stamped name,address, telephone number and DEA number of the prescriber in addition to hislegal signature, or
b. Upon an oral prescription of such practitioner which isreduced promptly to writing and filed by the pharmacist, or
c. By refilling any such written or oral prescription if suchrefilling is authorized by the prescriber either in the original prescriptionor by oral order which is reduced promptly to writing and filed by thepharmacist. If any prescription for such drug does not indicate the times itmay be refilled, if any, such prescription may not be refilled unless thepharmacist is subsequently authorized to do so by the practitioner.
The act of dispensing a drug contrary to the provisions ofthis subdivision shall be deemed to be an act which results in a drug beingmisbranded while held for sale.
(b) Any drug dispensed by filling or refilling a written or oralprescription of a practitioner licensed by law to administer such drug shall beexempt from the requirements of G.S. 106‑134, except subsections (1),(9)b and c, (13) and (14), and the packaging requirements of subsections (7)and (8), if the drug bears an affixed label containing the name of the patient,the name and address of the pharmacy, the phrase "Filled by__________________" or "Dispensed by_________________," with thename of the practitioner who dispenses the prescription appearing in the blank,the serial number and date of the prescription or of its filling, the name ofthe prescriber, the directions for use, and unless otherwise directed by theprescriber of such drug, the name and strength of such drug. This exemptionshall not apply to any drugs dispensed in the course of the conduct of abusiness of dispensing drugs pursuant to diagnosis by mail, or to a drugdispensed in violation of subsection (a) of this section.
Any tranquilizer or sedative dispensed by filling or refilling awritten or oral prescription of a practitioner licensed by law to administersuch drug shall be labelled by the pharmacist, if the prescriber so directs onthe prescription, with a warning that: "The consumption of alcoholicbeverages while on this medication can be harmful to your health."
(c) The Board may, by regulation, remove drugs subject to G.S.106‑134(4) and G.S. 106‑135 from the requirements of subsection (a)of this section when such requirements are not necessary for the protection ofthe public health. Drugs removed from the prescription requirements of thefederal act by regulations issued thereunder shall also, by regulations issuedby the Board, be removed from the requirement of subsection (a).
(d) A drug which is subject to subsection (a) of this sectionshall be deemed to be misbranded if at any time prior to dispensing its labelfails to bear the statement "Caution: Federal Law Prohibits DispensingWithout Prescription." A drug to which subsection (a) of this section doesnot apply shall be deemed to be misbranded if at any time prior to dispensingits label bears the caution statement quoted in the preceding sentence.
(e) Nothing in this section shall be construed to relieve anyperson from any requirement prescribed by or under authority of law withrespect to drugs now included or which may hereafter be included within theclassification of "controlled substances" as this term is defined inapplicable federal and State controlled substance acts. (1975, c. 614, s. 29; 1977, c. 421; 1979, c. 626;1981, c. 75, s. 2.)