§ 21-31-15 - Misbranded drug or device.
SECTION 21-31-15
§ 21-31-15 Misbranded drug or device.– (a) A drug or device shall be deemed to be misbranded:
(1) If its labeling is false or misleading in any way.
(2) If in package form unless it bears a label containing:(i) the name and place of business of the manufacturer, packer, or distributor;and (ii) an accurate statement of the quantity of the contents in terms ofweight, measure, or numerical count; provided, that under paragraph (ii) ofthis subdivision reasonable variations shall be permitted, and exemptions as tosmall packages shall be established, by regulations prescribed by the directorof health.
(3) If any word, statement, or other information required byor under authority of this chapter to appear on the label or labeling is notprominently placed on it with such conspicuousness (as compared with otherwords, statements, designs, or devices in the labeling) and in such terms as torender it likely to be read and understood by the ordinary individual undercustomary conditions of purchase and use.
(4) If it is for use by humans and contains any quantity ofthe narcotic or hypnotic substance alpha-eucaine, barbituric acid, betaeucaine,bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin,marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or anychemical derivative of any of those substances, which derivative has been bythe director of health after investigation found to be, and by regulationsunder this chapter designated as, habit forming, unless its label bears thename and quantity of the proportion of the substance or derivative and injuxtaposition with it the statement "Warning – May be habit forming."
(5) If it is a drug and is not designated solely by a namerecognized in an official compendium unless its label bears: (i) the common orusual name of the drug, if there is one; and (ii) in case it is fabricated fromtwo (2) or more ingredients, the common or usual name of each activeingredient, including the kind and quantity or proportion of any alcohol, andalso including, whether active or not, the name and quantity or proportion ofany bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine,anti-pyrine, atropine, hysoeine, hyoscyamine, arsenic, digitalis, glucosides,mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative orpreparation of those substances contained in it; provided, that to the extentthat compliance with the requirements of paragraph (ii) of this subdivision isimpracticable, exemptions shall be established by regulations promulgated bythe director of health.
(6) Unless its labeling bears: (i) adequate directions foruse; and (ii) adequate warnings against use in those pathological conditions orby children where its use may be dangerous to health, or against unsafe dosageor methods or duration of administration or application, in the manner and formthat are necessary for the protection of users; provided, that where anyrequirement of paragraph (i) of this subdivision, as applied to any drug ordevice, is not necessary for the protection of the public health, the directorof health shall promulgate regulations exempting the drug or device from thoserequirements.
(7) If it purports to be a drug the name of which isrecognized in an official compendium, unless it is packaged and labeled asprescribed in the compendium; provided, that the method of packing may bemodified with the consent of the director of health. Whenever a drug isrecognized in both the United States Pharmacopoeia and the HomeopathicPharmacopoeia of the United States, it shall be subject to the requirements ofthe United States Pharmacopoeia with respect to packaging and labeling unlessit is labeled and offered for sale as a homeopathic drug, in which case itshall be subject to the provisions of the Homeopathic Pharmacopoeia of theUnited States, and not to those of the United States Pharmacopoeia.
(8) If it has been found by the director of health to be adrug liable to deterioration, unless it is packaged in the form and manner, andits label bears a statement of the precautions, that the director of healthshall by regulations require as necessary for the protection of public health.No regulation shall be established for any drug recognized in an officialcompendium until the director of health shall have informed the appropriatebody charged with the revision of the compendium of the need for packaging orlabeling requirements and that body shall have failed within a reasonable timeto prescribe those requirements.
(9) If: (i) it is a drug and its container is made, formed,or filled as to be misleading; (ii) it is an imitation of another drug; or(iii) it is offered for sale under the name of another drug.
(10) If it is dangerous to health when used in the dosage, orwith the frequency or duration prescribed, recommended, or suggested in itslabeling.
(11) A drug intended for use by humans which: (A) is a habitforming drug to which subdivision (a)(4) of this section applies; (B) becauseof its toxicity or the potential for harmful effect, or the method of its use,or the collateral measures necessary to its use, is not safe for use exceptunder the supervision of a practitioner licensed by law to administer thatdrug; or (C) is limited by an effective application under § 21-31-16 touse under the professional supervision of a practitioner licensed by law toadminister that drug shall be dispensed only: (I) upon a written prescriptionof a practitioner licensed by law to administer the drug, (II) upon an oralprescription of the practitioner which is reduced promptly to writing and filedby the pharmacist, or (III) by refilling any written or oral prescription ifthe refilling is authorized by the prescriber either in the originalprescription or by oral order which is reduced promptly to writing and filed bythe pharmacist. The act of dispensing a drug contrary to the provisions of thissubdivision shall be deemed to be an act that results in the drug beingmisbranded while held for sale.
(ii) The director of health may by regulation remove drugssubject to subdivision (a)(4) of this section and § 21-31-16 from therequirements of paragraph (i) of this subdivision when those requirements arenot necessary for the protection of the public health.
(iii) A drug which is subject to paragraph (i) of thissubdivision shall be deemed to be misbranded if at any time prior to dispensingits label fails to bear the statement "Caution: Federal law prohibitsdispensing without prescription." A drug to which paragraph (i) of thissubdivision does not apply shall be deemed to be misbranded if at any timeprior to dispensing its label bears the caution statement quoted in thepreceding sentence.
(iv) No prescription for any of the drugs described in thissubdivision shall be refilled if marked "non-repeat" or "N.R."
(12) If it is a drug and its packaging or labeling is inviolation of an applicable regulation issued pursuant to § 23-24.1-3 or23-24.1-4 of the Poison Prevention Packaging Act.
(b) Any drug dispensed by filling or refilling a written ororal prescription of a practitioner licensed by law to prescribe the drug, andany drug dispensed to an ultimate user by a practitioner, shall be exempt fromthe requirements of this section except subdivisions (a)(1), (9), and (11) ofthis section, and the packaging requirements of subdivisions (a)(7), (8), and(12) of this section, if the drug bears a label containing the name and addressof the dispenser, the serial number and date of the prescription or of itsfilling, the name of the prescriber, and, if stated in the prescription, thename of the patient, and the directions for use and cautionary statements, ifany, contained in the prescription. When a practitioner prescribes a drug bybrand name, oral, written or electronic, he or she shall, in each prescription,authorize a less expensive generic equivalent drug product by signing theprescription. Pursuant to § 42-127.1-7 and chapter (19.1 of title 5) anelectronic signature shall satisfy this requirement. If in the professionaljudgment of the prescribing practitioner the brand name is medically necessary,the practitioner shall indicate "Brand name necessary" on the prescription.This exemption shall not apply to any drug dispensed in violation of paragraph(a)(11)(i) of this section.
(2) When dispensing a generic drug product, the word"INTERCHANGE" or the letters "IC" must appear on the label followed by thegeneric name and manufacturer, and/or distributor, of the chosen product.
(3) The requirements of subdivision (2) of this subsectiononly apply to single entity, multiple-source drugs.
(4) When dispensing a single entity, single source drug, thetrade name of the prescribed drug will also appear on the label, and thegeneric name of the prescribed drug may also appear on the label.
(5) When dispensing a fixed combination product, the UnitedStates Pharmacopoeia's publication of Pharmacy Equivalent Names (PEN Names) forfixed combination products is the official list of abbreviations for thatlabeling, and will be the approved abbreviation for identifying the combinationproduct dispensed. If no PEN name has been officially issued by the USP, thepractitioner or pharmacist will label the medication secundum artem.
(6) Subdivisions (2) – (5) of this subsection apply inall cases of dispensing by practitioners or pharmacists.
(7) 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 subsequently be included within theclassifications stated in chapters 28 and 30 of this title.