Title 19, Foods, Drugs, Oils, and Compounds

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…

1. A person may not advertise, offer for sale, sell, or misrepresent cell-cultured protein as a meat food product. A cell-cultured food product: a. May not be packaged in the same, or deceptively similar, packaging as a meat food product; and b. Must be labeled as a cell-cultured…

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. As used in this section, unless the subject matter or context otherwise requires: a. "Brand name" means the registered trademark name given to a drug or medicine by its manufacturer, labeler, or distributor. b. "Code imprint" means a series of letters or numbers assigned by th…

1. For the purposes of this section: a. "Determination" means a decision that settles and ends a controversy or the resolution of a question through appeal. b. "Maximum allowable cost price" means a maximum reimbursement amount for a group of therapeutically equivalent and pharma…

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. As used in this section: a. "Controlled substance" has the meaning set forth in section 19-03.1-01. b. "Deliver, distribute, or dispense by means of the internet" refers, respectively, to delivery, distribution, or dispensing of a controlled substance or specified drug that is…

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. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. b. "Plan sponsor" has the same meaning as in section 19-03.6-01. c. "Third-party payer" has the same meaning as in section 19-03.6-01. 2. A pharmacy benefits manager or third…

1. As used in this section: a. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. b. "Plan sponsor" has the same meaning as in section 19-03.6-01. c. "Specialty drug" means a prescription drug that: (1) Is not available for order or purchase by a retail co…

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…

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 license expires on June thirtieth of each year. The department may adopt rules establishing the amount and the procedures for the c…

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…