Title 19 — Foods, Drugs, Oils, and Compounds

Every closed package containing potatoes to be sold or offered for sale at retail by any person must bear conspicuously on the top or side, or both, thereof in plain words the grade. An attached tag may substitute for the grade print on closed packages. Inspections under this cha…

Grades must be those established by the United States department of agriculture, the North Dakota state seed department, or any grade approved by the North Dakota agriculture commissioner. Culls or pickouts must be labeled as "culls".

Any person who violates any of the provisions of this chapter is guilty of a class B misdemeanor.

1. Except as provided in subsection 2, a producer, processor, manufacturer, packer, distributor, carrier, holder, seller, marketer, trade association, or advertiser of a food, as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(f)], or an assoc…

1. In any action commenced under this chapter, the complaint or petition must state with particularity the following: a. The statute, rule, regulation, ordinance, or other law that was allegedly violated; b. The facts that are alleged to constitute a material violation of the sta…

1. In any action commenced under this chapter, all discovery and other proceedings must be stayed during the pendency of any motion to dismiss unless the court finds upon the motion of any party that particularized discovery is necessary to preserve evidence or to prevent undue p…

For the purpose of this chapter: 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…

The following acts and the causing thereof within the state of North Dakota are hereby prohibited: 1. The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded. 2. The adulteration or misbranding of a…

In addition to the remedies hereinafter provided, the department is hereby authorized to apply to the district court of Burleigh County for, and such court shall have jurisdiction upon hearing and for cause shown to grant, a temporary or permanent injunction restraining any perso…

1. Any person who violates any of the provisions of subsections 1 through 16 of section 19-02.1-02 is guilty of a class B misdemeanor. 2. No person shall be subject to the penalties of subsection 1, for having violated subsection 1 or 3 of section 19-02.1-02 if the person establi…

1. Whenever a duly authorized agent of the department finds or has probable cause to believe that any food, drug, device, or cosmetic is adulterated or so misbranded as to be dangerous or fraudulent, within the meaning of this chapter, the authorized agent shall affix to such art…

It is the duty of each state's attorney, to whom the department or state board of pharmacy reports any violation of this chapter occurring in the state's attorney's county, to cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted i…

Nothing in this chapter may be construed as requiring the department or the state board of pharmacy to report minor violations of this chapter for the institution of proceedings under this chapter whenever the department or the state board of pharmacy believes that the public int…

Whenever in the judgment of the department such action will promote honesty and fair dealing in the interest of consumers, the department shall promulgate regulations fixing and establishing for any food or class of food a reasonable definition and standard of identity or reasona…

A food must be deemed to be adulterated for any of the following reasons: 1. If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food may not be considered adulterated und…

A food must be deemed to be misbranded: 1. If its labeling is false or misleading in any particular. 2. If it is offered for sale under the name of another food. 3. If it is an imitation of another food for which a definition and standard of identity has been prescribed by regula…

The department may adopt appropriate rules under chapter 28-32 to establish standards for proper labeling and temperature during the retail storage and sale of shell eggs. As used in this section, "eggs" means eggs in the shell which are the product of a domesticated chicken.

Whenever the department finds after investigation that the distribution in the state of North Dakota of any class of food may, by reason of contamination with micro-organisms during manufacture, processing, or packing thereof in any locality, be injurious to health and that such …

1. Any added poisonous or deleterious substance, any food additive, any pesticide chemical in or on a raw agricultural commodity, or any color additive shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of subsection 2 of sect…

A drug or device must be deemed to be adulterated: 1. If it consists in whole or in part of any filthy, putrid, or decomposed substance. 2. If it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby …

A 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 …

1. In this section: a. "Biological product", "biosimilar", "interchangeable", "interchangeable biological product", "license", and "reference product" mean the same as these terms mean under section 351 of the federal Public Health Service Act [42 U.S.C. 262]. b. "Prescription" m…

1. Except as authorized and provided in chapter 19-03.1, a depressant, stimulant, or hallucinogenic drug; or a drug intended for use by man which is a habit-forming drug to which subsection 4 of section 19-02.1-14 applies; or a drug that, because of its toxicity or other potentia…

1. No person may sell, deliver, offer for sale, hold for sale, or give away any new drug unless: a. An application with respect thereto has been approved and said approval has not been withdrawn under section 505 of the federal act; or b. When not subject to the federal act, unle…

1. As used in this section: a. "Metastatic cancer" means cancer that has spread from the primary or original site to lymph nodes, nearby tissues, or other parts of the body. b. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. c. "Step therapy protocol" m…

1. If a pharmacy offers a prescription through home delivery or mail order delivery services, the pharmacy may not initiate delivery of a refill unless: a. The pharmacy obtains prior consent from the patient or the patient's authorized representative; or b. The pharmacy provides …

1. As used in this section: a. "Pharmacy" means a pharmacy licensed under the laws of this state. b. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. 2. A pharmacy benefits manager may not discriminate against or interfere with a covered entity participa…

1. As used in this section: a. "Clinician-administered drug" means an outpatient prescription drug other than a: (1) Vaccine that cannot be reasonably self-administered by the patient to whom the drug is prescribed; (2) Vaccine that typically is administered: (a) By a health care…

A cosmetic must be deemed to be adulterated: 1. If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary …

A cosmetic 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 qu…

1. An advertisement of a food, drug, device, or cosmetic is false if it is false or misleading in any particular. 2. For the purpose of this chapter, the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poi…

The authority to adopt rules for the efficient enforcement of this chapter is hereby vested in the department. The department is hereby authorized to make the rules adopted under this chapter conform, insofar as practicable, with those adopted under the federal act. Rules must co…

The department has free access at all reasonable hours to any factory, warehouse, or establishment in which foods, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or to enter any vehicle being used to transport or hold suc…

The department may cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof. The department may also cause to be disseminated su…

Repealed by S.L. 1971, ch. 235, § 49. 19-02.1-24. Sale of prepackaged food from vending machines - License - Rules - Inspections. 1. An establishment may not sell any type of prepackaged food from a food vending machine without first obtaining a license from the department. The l…

Each retailer shall indicate, by label, to customers the country of origin of fresh beef, lamb, and pork available for sale to customers. For purposes of this section, a label means a clearly visible printed or written indication that is placed in the immediate vicinity of the fo…

1. Exemplary damages may not be awarded against the manufacturer or seller of a product or device that caused the harm claimed by the plaintiff if: a. The product or device was subject to approval under 21 U.S.C. 355 or premarket approval under 21 U.S.C. 360e by the food and drug…

As used in this chapter and in chapters 19-03.2 and 19-03.4, unless the context otherwise requires: 1. "Administer" means to apply a controlled substance, whether by injection, inhalation, ingestion, or any other means, directly to the body of a patient or research subject by: a.…

1. In carrying out its duties under this chapter, the board shall consult with representatives of each of the following interests: North Dakota board of medicine, board of dental examiners, board of registry in podiatry, board of veterinary medical examiners, board of nursing, th…

1. The board shall administer this chapter and may add substances to or delete or reschedule all substances enumerated in the schedules in sections 19-03.1-05, 19-03.1-07, 19-03.1-09, 19-03.1-11, or 19-03.1-13 pursuant to the procedures of chapter 28-32. In making a determination…

The controlled substances listed or to be listed in the schedules in sections 19-03.1-05, 19-03.1-07, 19-03.1-09, 19-03.1-11, and 19-03.1-13 are included by whatever official, common, usual, chemical, or trade name designated.

The board shall place a substance in schedule I if it finds that the substance: 1. Has high potential for abuse; and 2. Has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.

1. The controlled substances listed in this section are included in schedule I. 2. Schedule I consists of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 3. Opiates. Unless specifica…

The board shall place a substance in schedule II if it finds that: 1. The substance has high potential for abuse; 2. The substance has currently accepted medical use in treatment in the United States or currently accepted medical use with severe restrictions; and 3. The abuse of …

1. The controlled substances listed in this section are included in schedule II. 2. Schedule II consists of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 3. Substances, vegetable o…

The board shall place a substance in schedule III if it finds that: 1. The substance has a potential for abuse less than the substances listed in schedules I and II; 2. The substance has currently accepted medical use in treatment in the United States; and 3. Abuse of the substan…

1. The controlled substances listed in this section are included in schedule III. 2. Schedule III consists of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 3. Stimulants. Unless sp…

The board shall place a substance in schedule IV if it finds that: 1. The substance has a low potential for abuse relative to substances in schedule III; 2. The substance has currently accepted medical use in treatment in the United States; and 3. Abuse of the substance may lead …

1. The controlled substances listed in this section are included in schedule IV. 2. Schedule IV consists of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 3. Narcotic drugs. Unless …

The board shall place a substance in schedule V if it finds that: 1. The substance has low potential for abuse relative to the controlled substances listed in schedule IV; 2. The substance has currently accepted medical use in treatment in the United States; and 3. The substance …