TITLE 21
Food And Drugs

CHAPTER 21-31
Rhode Island Food, Drugs, and Cosmetics Act

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 of weight, measure, or numerical count; provided, that under paragraph (ii) of this subdivision reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the director of health.

(3) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed on it with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(4) If it is for use by humans and contains any quantity of the 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 any chemical derivative of any of those substances, which derivative has been by the director of health after investigation found to be, and by regulations under this chapter designated as, habit forming, unless its label bears the name and quantity of the proportion of the substance or derivative and in juxtaposition with it the statement "Warning – May be habit forming."

(5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears: (i) the common or usual name of the drug, if there is one; and (ii) in case it is fabricated from two (2) or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, anti-pyrine, atropine, hysoeine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of those substances contained in it; provided, that to the extent that compliance with the requirements of paragraph (ii) of this subdivision is impracticable, exemptions shall be established by regulations promulgated by the director of health.

(6) Unless its labeling bears: (i) adequate directions for use; and (ii) adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in the manner and form that are necessary for the protection of users; provided, that where any requirement of paragraph (i) of this subdivision, as applied to any drug or device, is not necessary for the protection of the public health, the director of health shall promulgate regulations exempting the drug or device from those requirements.

(7) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed in the compendium; provided, that the method of packing may be modified with the consent of the director of health. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the United States Pharmacopoeia.

(8) If it has been found by the director of health to be a drug liable to deterioration, unless it is packaged in the form and manner, and its label bears a statement of the precautions, that the director of health shall by regulations require as necessary for the protection of public health. No regulation shall be established for any drug recognized in an official compendium until the director of health shall have informed the appropriate body charged with the revision of the compendium of the need for packaging or labeling requirements and that body shall have failed within a reasonable time to 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, or with the frequency or duration prescribed, recommended, or suggested in its labeling.

(11)(i) A drug intended for use by humans which: (A) is a habit forming drug to which subdivision (a)(4) of this section applies; (B) because of 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 except under the supervision of a practitioner licensed by law to administer that drug; or (C) is limited by an effective application under § 21-31-16 to use under the professional supervision of a practitioner licensed by law to administer that drug shall be dispensed only: (I) upon a written prescription of a practitioner licensed by law to administer the drug, (II) upon an oral prescription of the practitioner which is reduced promptly to writing and filed by the pharmacist, or (III) by refilling any written or oral prescription if the refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this subdivision shall be deemed to be an act that results in the drug being misbranded while held for sale.

(ii) The director of health may by regulation remove drugs subject to subdivision (a)(4) of this section and § 21-31-16 from the requirements of paragraph (i) of this subdivision when those requirements are not necessary for the protection of the public health.

(iii) A drug which is subject to paragraph (i) of this subdivision shall 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." A drug to which paragraph (i) of this subdivision does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

(iv) No prescription for any of the drugs described in this subdivision shall be refilled if marked "non-repeat" or "N.R."

(12) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to § 23-24.1-3 or 23-24.1-4 of the Poison Prevention Packaging Act.

(b)(1) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to prescribe the drug, and any drug dispensed to an ultimate user by a practitioner, shall be exempt from the requirements of this section except subdivisions (a)(1), (9), and (11) of this 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 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 the prescription. When a practitioner prescribes a drug by brand name, oral, written or electronic, he or she shall, in each prescription, authorize a less expensive generic equivalent drug product by signing the prescription. Pursuant to § 42-127.1-7 and chapter (19.1 of title 5) an electronic signature shall satisfy this requirement. If in the professional judgment 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 the generic name and manufacturer, and/or distributor, of the chosen product.

(3) The requirements of subdivision (2) of this subsection only apply to single entity, multiple-source drugs.

(4) When dispensing a single entity, single source drug, the trade name of the prescribed drug will also appear on the label, and the generic name of the prescribed drug may also appear on the label.

(5) When dispensing a fixed combination product, the United States Pharmacopoeia's publication of Pharmacy Equivalent Names (PEN Names) for fixed combination products is the official list of abbreviations for that labeling, and will be the approved abbreviation for identifying the combination product dispensed. If no PEN name has been officially issued by the USP, the practitioner or pharmacist will label the medication secundum artem.

(6) Subdivisions (2) – (5) of this subsection apply in all cases of dispensing by practitioners or pharmacists.

(7) Nothing in this section shall 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 subsequently be included within the classifications stated in chapters 28 and 30 of this title.

History of Section.
(P.L. 1959, ch. 56, § 1; P.L. 1977, ch. 90, § 4; P.L. 1990, ch. 68, § 1; P.L. 1994, ch. 335, § 1; P.L. 1999, ch. 110, § 2; P.L. 2002, ch. 292, § 64; P.L. 2003, ch. 47, § 2; P.L. 2003, ch. 405, § 2.)