Title 50, Title 50

The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession, and holding of these articles for sale; the sale, dispensing, and giving of the…

Unless the context requires otherwise, in this chapter, the following definitions apply: (1) "Advertisement" means representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing or that are likely to induce, directly or indirectly,…

(1) The department may adopt rules for the efficient enforcement of this chapter. The department may adopt by reference the regulations adopted by the food and drug administration under the federal act and the Fair Packaging and Labeling Act (15 U.S.C. 1451, et seq.). (2) No hear…

(1) 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. (2) The department may also cause to be dissemi…

(1) The department or its authorized agents have 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 any vehicle being used t…

(1) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular. (2) 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 misle…

(1) The department, upon its own motion or upon the petition of any interested party requesting that a rule be established, whenever public health or other considerations in the state require, is authorized to adopt, amend, or repeal rules, whether or not in accordance with regul…

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 50-31-202(2) with res…

Subsections (5) and (6) of 50-31-103 do not apply to a pesticide chemical, soil or plant nutrient, or other agricultural chemical that affects the color of produce of the soil, whether before or after harvest, solely because of its effect in aiding, retarding, or otherwise affect…

A requirement made by or under authority of this chapter that a word, statement, or other information shall appear on the label is not complied with unless the word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail p…

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

A food is considered to be adulterated if: (1) it bears or contains any poisonous or deleterious substance that may render it injurious to health. If the poisonous or deleterious substance is not an added substance, the food may not be considered adulterated under this subsection…

A food is considered to be misbranded if: (1) its labeling is false or misleading in any particular; (2) it is offered for sale under the name of another food; (3) it is an imitation of another food for which a definition and standard of identity has been prescribed by regulation…

(1) Any product sold in semblance of honey which is a blend or mixture of honey and other ingredients must be labeled in such a way that the name of the main ingredient added to the honey will be printed so that it will be as prominent and conspicuous as the word "honey". The wor…

(1) A food service establishment or retail meat establishment may not use the terms "hamburger", "burger", or other similar term in any advertisement or menu to refer to any beef patty mix. A food service establishment or retail meat establishment selling or serving beef patty mi…

Claims of medicinal or health-giving properties on labels or in advertisements for bottled water are prohibited.

(1) Unless authorized as a food or drug by the United States food and drug administration, a hemp product containing total delta-9 tetrahydrocannabinol (THC) may not be sold to a consumer in the state. (2) For the purposes of this section, the following definitions apply: (a) "Co…

As used in this part, the following definitions apply: (1) "Antibiotic drug" means any drug intended for use by humans containing any quantity of any chemical substance that is produced by a microorganism and that has the capacity to inhibit or destroy microorganisms in dilute so…

The representation of a drug in its labeling or advertisement as an antiseptic is 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,…

(1) For the purpose of this chapter, the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas,…

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 shall be exempt from any labeling or packaging requirements of this c…

A drug or device shall be deemed to be adulterated if it: (1) consists in whole or in part of any filthy, putrid, or decomposed substance; (2) has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth or rendered inj…

(1) A drug or device is considered to be misbranded: (a) if its labeling is false or misleading in any particular; (b) if in package form unless it bears a label containing: (i) the name and place of business of the manufacturer, packer, or distributor, except that a prescription…

(1) A drug intended for use by humans that is included in one of the categories in subsection (2) may be dispensed only if a practitioner licensed by law to administer or prescribe the drug: (a) provides a written prescription; (b) transmits the prescription directly to the pharm…

(1) Any drug dispensed by filling or refilling a written, electronic, or oral prescription of a practitioner licensed by law to administer or prescribe the drug is exempt from the requirements of 50-31-306, except subsections (1)(a), (1)(j), (1)(k), (1)(m), (1)(n), and the packag…

The department may by regulation remove drugs subject to 50-31-306(1)(d) and 50-31-311 from the requirements of 50-31-307 when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the federal act by regul…

Nothing in 50-31-306(2), 50-31-307, 50-31-308, or 50-31-309 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 hereafter be included within the classifications of narcotic drugs, ma…

(1) Except as provided in Title 50, chapter 42, a person may not sell, deliver, offer for sale, hold for sale, or give away any new drug unless: (a) an application with respect to the drug has been approved and the approval has not been withdrawn under section 505 of the federal …

(1) Section 50-31-311 does not apply to: (a) a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs, provided the drug is plainly labeled in compliance with regulations issued …

No legend drug in solid dosage form may be manufactured or distributed in this state unless it is clearly marked or imprinted with a code imprint identifying the drug and the manufacturer or distributor of the drug.

The board of pharmacy may grant exemptions from the requirements of 50-31-313 and 50-31-315 upon a showing by a drug manufacturer or distributor that size, physical characteristics, or other compelling reasons render application of a code imprint on a legend drug subject to the p…

Upon request of the board of pharmacy, all manufacturers and distributors of legend drugs in solid dosage form who produce or distribute legend drugs in Montana must provide and keep current a list of those drugs, which list identifies the manufacturer and the specific type of ea…

A cosmetic shall be deemed to be adulterated if: (1) 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 shall be deemed to be misbranded if: (1) its labeling is false or misleading in any particular; (2) 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 …

(1) Section 50-31-401 shall not apply to coal tar hair dye, the label of which bears the following legend conspicuously displayed thereon: "Caution--This product contains ingredients which may cause skin irritation on certain individuals, and a preliminary test according to accom…

For the purpose of 50-31-401(5) and 50-31-403, the term "hair dye" shall not include eyelash dyes or eyebrow dyes.

The following acts and the causing of the acts within the state of Montana are 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 any foo…

It is unlawful for any person to sell or offer for sale any product which is in semblance of honey and which is labeled, advertised, or otherwise represented to be honey if it is not honey.

Nothing in this chapter shall be construed as requiring the department to report for the institution of proceedings under this chapter minor violations of this chapter whenever the department believes that the public interest will be adequately served in the circumstances by a su…

Before a violation of this chapter is reported to a state or county attorney for the institution of a criminal proceeding, the person against whom the proceeding is contemplated must be given appropriate notice and an opportunity to present the person's views before the departmen…

Each state attorney or county attorney to whom the department reports a violation of this chapter shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.

(1) Any person who violates any of the provisions of 50-31-204, 50-31-208, 50-31-313, 50-31-315, 50-31-501, or 50-31-502 is guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than 3 months, a fine of not more than $250, or both such im…

(1) A person is not subject to the penalties of 50-31-506 for having violated 50-31-501(1) or (3) if the person establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the state of Montana from whom the person received in good…

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

(1) If an 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 agent shall affix to the article a tag or other appropriate m…

Whenever the department or any of its authorized agents find in any room, building, vehicle of transportation, or other structure any meat, seafood, poultry, vegetable, fruit, or other perishable article which is unsound or contains any filthy, decomposed, or putrid substance or …