Section 19-02.1-14 - Drugs and devices - Misbranding definedA drug or device must be deemed to be misbranded:
1. If its labeling is false or misleading in any particular.2. If in package form unless it bears a label containing:a. The name and place of business of the manufacturer, packer, or distributor; and b. An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under this subdivision reasonable variations must be permitted, and exemptions as to small packages must be allowed, in accordance with regulations prescribed by the department or issued under the federal act.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 thereon 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 man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any chemical derivative of such substance, which derivative, after investigation, has been found to be and designated as, habit-forming, by regulations issued by the department under this chapter, or by regulations issued pursuant to section 502(d) of the federal act, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning - May be habit-forming".5. If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula: a. The established name, as defined in subsection 6, of the drug, if such there be; and b. The established name and quantity of each active ingredient, in case it is fabricated from two or more ingredients, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein. Provided, that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subsection applies only to prescription drugs; provided, further, that to the extent that compliance with the requirements of subdivision b of subsection 6 is impracticable, exemptions must be allowed under regulations promulgated by the department, or under the federal act.
6. As used in subsections 5 and 6, the term "established name", with respect to a drug or ingredient thereof, means: a. The applicable official name designated pursuant to section 508 of the federal act;b. If there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium; or c. If neither subdivision a nor b applies, then the common or usual name, if any, of such drug or of such ingredient. Provided, further, that when subdivision b applies to an article recognized in the United States pharmacopeia and in the homeopathic pharmacopeia under different official titles, the official title used in the United States pharmacopeia applies unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the homeopathic pharmacopeia applies.
7. Unless its labeling bears: a. Adequate directions for use; and b. Such adequate warnings against use in those pathological conditions or by children when its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. Provided, that if any requirement of subdivision a, as applied to any drug or device, is not necessary for the protection of the public health, the department shall promulgate regulations exempting such drug or device from such requirements; provided, further, that articles exempted under regulations issued under section 502(f) of the federal act may also be exempt.
8. 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 therein; provided, that the method of packing may be modified with the consent of the department, or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States pharmacopeia and the homeopathic pharmacopeia of the United States, it is subject to the requirements of the United States pharmacopeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it is subject to the provisions of the homeopathic pharmacopeia of the United States and not to those of the United States pharmacopeia; provided, further, that in the event of inconsistency between the requirements of this subsection and those of subsections 5 and 6 as to the name by which the drug or its ingredients must be designated, the requirements of subsections 5 and 6 must prevail.9. If it has been found by the department or under the federal act to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the regulations issued by the department or under the federal act require as necessary for the protection of public health. No such regulation may be established for any drug recognized in an official compendium until the department shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements.10. If it is a drug and:a. Its container is so made, formed, or filled as to be misleading;b. If it is an imitation of another drug; or c. If it is offered for sale under the name of another drug.11. If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.12. If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is from a batch with respect to which a certificate or release has been issued pursuant to section 506 of the federal act, and such certificate or release is in effect with respect to such drug.13. If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless it is from a batch with respect to which a certificate or release has been issued pursuant to section 507 of the federal act, and such certificate or release is in effect with respect to such drug; provided, that this subsection does not apply to any drug or class of drugs exempted by regulations promulgated under section 507(c) or (d) of the federal act. For the purpose of this subsection, the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution, including the chemically synthesized equivalent of any such substance.14. If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, prescribed under the provisions of subsection 2 of section 19-02.1-12 or of the federal act.15. In the case of any prescription drug distributed or offered for sale in this state, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of the established name as defined in subsection 6, the formula showing quantitatively each ingredient of such drug to the extent required for labels under section 502(e) of the federal act, and such other information in brief summary relating to side effects, contraindications, and effectiveness as are required in regulations issued under the federal act.16. If a trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud.17. Drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed are exempt from any labeling or packaging requirements of this chapter; provided, that such drugs and devices are being delivered, manufactured, processed, labeled, repacked, or otherwise held in compliance with regulations issued by the department, or under the federal act.18. If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name, as defined in subsection 6, prominently printed in type at least half as large as that used thereon for any proprietary name or designation for the device, except that to the extent compliance with the requirements of this subsection is impracticable, exemptions will be established by rules adopted by the department. As used in this subsection, the term "established name" with respect to a device means: a. The applicable official name of the device designated pursuant to federal law.b. If there is no official name of the device designated pursuant to federal law and the device is an article recognized in an official compendium, then the official title of the device in the compendium.c. If neither subdivision a nor subdivision b applies, then any common or usual name of the device.19. If it is a device subject to a performance standard established under federal law, unless it bears labeling prescribed in the performance standard.