North Dakota Code 19-02.1-01 – Definitions
For the purpose of this chapter:
Terms Used In North Dakota Code 19-02.1-01
- Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- following: when used by way of reference to a chapter or other part of a statute means the next preceding or next following chapter or other part. See North Dakota Code 1-01-49
- Individual: means a human being. See North Dakota Code 1-01-49
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- Person: means an individual, organization, government, political subdivision, or government agency or instrumentality. See North Dakota Code 1-01-49
- Process: means a writ or summons issued in the course of judicial proceedings. See North Dakota Code 1-01-49
- State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See North Dakota Code 1-01-49
- United States: includes the District of Columbia and the territories. See North Dakota Code 1-01-49
- written: include "typewriting" and "typewritten" and "printing" and "printed" except in the case of signatures and when the words are used by way of contrast to typewriting and printing. See North Dakota Code 1-01-37
1. “Advertisement” means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.
2. “Color” includes black, white, and intermediate grays.
3. “Color additive” means a material which:
a. Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; or
b. When added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable, alone or through reaction with other substance, of imparting color thereto, except that such term does not include any material which has been or hereafter is exempted under the Federal Act.
4. “Contaminated with filth” applies to any food, drug, device, or cosmetic not securely protected from dust, dirt, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations.
5. “Cosmetic” means:
a. Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or
b. Articles intended for use as a component of any such articles, except that such term does not include soap.
6. “Department” means the department of health and human services.
7. “Device”, except when used in the first paragraph following subsection 21 of this section and in subsection 10 of section 19-02.1-02, subsection 6 of section 19-02.1-10, subsections 3 and 16 of section 19-02.1-14, and subsection 3 of section 19-02.1-18, means instruments, apparatus and contrivances, including their components, parts, and accessories, intended:
a. For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or
b. To affect the structure or any function of the body of man or other animals.
8. “Drug” means:
a. Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary, or any supplement to any of them; b. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; c. Articles, other than food, intended to affect the structure or any function of the body of man or other animals; or
d. Articles intended for use as a component of any article specified in subdivision a, b, or c, but does not include devices or their components, parts, or accessories.
Provided, however, that “drug”, for the purpose of this chapter, and as defined by this subsection, does not include those controlled substances or drugs regulated by or under the authority of the Uniform Controlled Substances Act, with respect to such drugs, the Uniform Controlled Substances Act takes precedence over and supplants the provisions of this chapter only so far as its authority and control is synonymous with the provisions of this chapter.
9. “Federal Act” means the Federal Food, Drug, and Cosmetic Act, as amended [21 U.S.C. § 301 et seq.].
10. “Food” means:
a. Articles used for food or drink for man or other animals; b. Chewing gum; and
c. Articles used for components of any such article.
11. “Food additive” means any substance, the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use, if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures, or, in the case of a substance used in a food prior to January 1, 1958, through either scientific procedures or experience based on common use in food, to be safe under the conditions of its intended use, except that such term does not include:
a. A pesticide chemical in or on a raw agricultural commodity; b. A pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; c. A color additive; or
d. Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the Federal Act; the Poultry Products Inspection Act [21 U.S.C. § 451 et seq.]; or the Meat Inspection Act of March 4, 1907 [34 Stat. 1260, as amended and extended, 21 U.S.C. § 71 et seq.].
12. “Immediate container” does not include package liners.
13. “Label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appearing on the label may not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
14. “Labeling” means all labels and other written, printed, or graphic matter:
a. Upon an article or any of its containers or wrappers; or b. Accompanying such article.
15. “Manufacture, compound, or process” includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package in the furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer, and the term “manufacturers, compounders, and processors” must be deemed to refer to persons engaged in such defined activities.
16. “New drug” means:
a. Any drug the composition of which is such that such drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or
b. Any drug the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
17. “Official compendium” means the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, official national formulary, or any supplement to any of them.
18. “Person” includes individual, partnership, corporation, limited liability company, and association.
19. “Pesticide chemical” means any substance which, alone, in chemical combination, or in formulation with one or more other substances is a pesticide within the meaning of chapter 4.1-34, and which is used in the production, storage, or transportation of raw agricultural commodities.
20. “Practitioner” means an individual licensed, registered, or otherwise authorized by the jurisdiction in which the individual is practicing to prescribe drugs in the course of professional practice which are subject to this chapter.
21. “Raw agricultural commodity” means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.
If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading, there must be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.
The representation of a drug, in its labeling or advertisement, as an antiseptic must be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.
The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics must be considered to include the manufacture, production, processing, packing, exposure, offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving of any such article and the supplying or applying of any such articles in the conduct of any food, drug, or cosmetic establishment.
Nothing in subsection 21 may be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.