reglab/housing_qa huggingface dataset:
MT Code § 50-31-301 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-301. Definitions

  50-31-301. Definitions. 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 solution (including the chemically synthesized equivalent of such a substance).   (2) "Code imprint" means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, marks or monograms unique to the manufacturer or distributor of the drug, or both.   (3) "Distributor" means a person who distributes for resale a drug in solid dosage form under the person's own label whether or not the person is the manufacturer of the drug.   (4) "Established name", with respect to a drug or ingredient of the drug, means:   (a) the applicable official name designated pursuant to section 508 of the federal act (21 U.S.C. 358);   (b) if there is no official name and the drug or the ingredient is an article recognized in an official compendium, then the official title of the drug or ingredient in the compendium. If this subsection (4)(b) applies to an article recognized in the United States Pharmacopoeia, the official title used in the United States Pharmacopoeia applies.   (c) if neither subsection (4)(a) nor (4)(b) applies, then the common or usual name, if any, of the drug or of the ingredient.   (5) "Legend drug" means any drug defined by section 503(b) of the federal act (21 U.S.C. 353(b)), as amended on January 15, 1980, under which its label is required to bear the statement: "Caution: Federal law prohibits dispensing without prescription."   (6) "Manufacturer" means a person who mixed the final ingredients and prepared the final drug product.   (7) "Solid dosage form" means capsules or tablets intended for oral use.   History: En. Sec. 15, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-715(part); amd. Sec. 1, Ch. 403, L. 1979; amd. Sec. 1, Ch. 95, L. 1981; amd. Sec. 1, Ch. 239, L. 1983; amd. Sec. 213, Ch. 42, L. 1997.
MT Code § 50-31-302 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-302. Antiseptics considered to be germicides

  50-31-302. Antiseptics considered to be germicides. 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, or other use which involves prolonged contact with the body.   History: En. Sec. 2, Ch. 307, L. 1967; amd. Sec. 1, Ch. 171, L. 1971; amd. Sec. 1, Ch. 114, L. 1974; amd. Sec. 3, Ch. 349, L. 1974; R.C.M. 1947, 27-702(n).
MT Code § 50-31-303 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-303. Certain drug advertisements considered false

  50-31-303. Certain drug advertisements considered false. (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, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or a sexually transmitted disease shall also be deemed to be false, except that no advertisement not in violation of 50-31-107(1) shall be deemed to be false under this section if it is disseminated only to members of the medical, dental, or veterinary professions or appears only in the scientific periodicals of these professions or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs or devices.   (2) Whenever the department determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, the department shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the department may deem necessary in the interests of public health.   (3) This section shall not be construed as indicating that self-medication for diseases other than those named herein is safe or efficacious.   History: En. Sec. 20, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-720(b); amd. Sec. 10, Ch. 37, L. 1979; amd. Sec. 17, Ch. 440, L. 1989.
MT Code § 50-31-304 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-304. Certain drugs and devices exempt from labeling requirements of chapter

  50-31-304. Certain drugs and devices exempt from labeling requirements of chapter. 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 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.   History: En. Sec. 15, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-715(part).
MT Code § 50-31-305 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-305. When drug or device adulterated

  50-31-305. When drug or device adulterated. 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 injurious to health;   (3) is a drug and the methods used in or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess;   (4) is a drug and its container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health;   (5) is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act or it is a color additive, the intended use of which in or on drugs is for purposes of coloring only, and is unsafe within the meaning of the federal act;   (6) purports to be or is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from or its quality or purity falls below the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium or, in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity therefor set forth in such compendium if its difference in strength, quality, or purity from such standard is plainly stated on its label.   (7) is not subject to the provisions of subsection (6) of this section and its strength differs from or its purity or quality falls below that which it purports or is represented to possess; or   (8) is a drug and any substance has been:   (a) mixed or packed therewith so as to reduce its quality or strength; or   (b) substituted wholly or in part therefor.   History: En. Sec. 14, Ch. 307, L. 1967; R.C.M. 1947, 27-714; amd. Sec. 11, Ch. 37, L. 1979.
MT Code § 50-31-307 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-307. Dispensing of prescription drugs

  50-31-307. Dispensing of prescription drugs. (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 pharmacy by electronic means or directly dispenses the drug pursuant to 37-2-104;   (c) provides an oral prescription that is reduced promptly to writing and filed by the pharmacist or practitioner, if the practitioner dispenses the drug; or   (d) authorizes the refilling of a written, electronic, or oral prescription either in the original prescription or by an oral order that is reduced promptly to writing and filed by the pharmacist or practitioner, if the practitioner fills the prescription.   (2) A drug must be dispensed as provided in subsection (1) if the drug:   (a) is a habit-forming drug to which 50-31-306(1)(d) applies;   (b) because of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer or prescribe the drug; or   (c) is limited by an approved application under section 505 of the federal act (21 U.S.C. 355) or 50-31-311 to use under the professional supervision of a practitioner licensed by law to administer or prescribe the drug.   (3) If the drug is a factory prepackaged contraceptive, other than mifepristone, it may be dispensed as provided in subsection (1) or by a registered nurse employed by a family planning clinic under contract with the department of public health and human services pursuant to a physician's written protocol specifying the circumstances under which dispensing is appropriate and pursuant to the board of pharmacy's rules concerning labeling, storage, and recordkeeping of drugs.   (4) The act of dispensing a drug contrary to the provisions of this section is considered an act that results in a drug being misbranded while held for sale.   History: En. Sec. 16, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-716(a); amd. Sec. 3, Ch. 472, L. 1989; amd. Sec. 130, Ch. 418, L. 1995; amd. Sec. 308, Ch. 546, L. 1995; amd. Sec. 215, Ch. 42, L. 1997; amd. Sec. 3, Ch. 125, L. 2007; amd. Sec. 1, Ch. 206, L. 2015; amd. Sec. 4, Ch. 454, L. 2021.
MT Code § 50-31-308 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-308. Prescription drugs exempt from certain provisions of chapter

  50-31-308. Prescription drugs exempt from certain provisions of chapter. (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 packaging requirements of subsections (1)(g) and (1)(h), if the drug bears a label containing:   (a) the name and address of the dispenser;   (b) the serial number and date of the prescription or the date it was filled;   (c) the name of the prescriber; and   (d) if stated in the prescription, the name of the patient and the directions for use and cautionary statements, if any, contained in the prescription.   (2) This exemption does not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of 50-31-307.   History: En. Sec. 16, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-716(b); amd. Sec. 2, Ch. 206, L. 2015.
MT Code § 50-31-309 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-309. Removal of drugs from prescription requirement

  50-31-309. Removal of drugs from prescription requirement. 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 regulations issued thereunder may also, by regulations issued by the department, be removed from the requirements of 50-31-307.   History: En. Sec. 16, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-716(c).
MT Code § 50-31-310 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-310. Narcotic and marijuana laws not affected

  50-31-310. Narcotic and marijuana laws not affected. 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, marijuana, or synthetic cannabinoids, as defined in the applicable federal and state laws relating to narcotic drugs, marijuana, and synthetic cannabinoids.   History: En. Sec. 16, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-716(e); amd. Sec. 6, Ch. 156, L. 2011.
MT Code § 50-31-311 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-311. New drug application required

  50-31-311. New drug application required. (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 act (21 U.S.C. 355); or   (b) when not subject to the federal act, the drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended, or suggested in the labeling of the drug and, prior to selling or offering for sale the drug, there has been filed with the department an application setting forth:   (i) full reports of investigations that have been made to show whether or not the drug is safe for use and whether the drug is effective in use;   (ii) a full list of the articles used as components of the drug;   (iii) a full statement of the composition of the drug;   (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug;   (v) samples of the drug and of the articles used as components of the drug that the department may require; and   (vi) specimens of the labeling proposed to be used for the drug.   (2) An application provided for in subsection (1)(b) becomes effective on the 180th day after the filing of the application. However, if the department finds, after due notice to the applicant and giving the applicant an opportunity for a hearing, that the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling of the drug, the department shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective.   (3) An order refusing to permit an application under this section to become effective may be revoked by the department.   History: En. Sec. 17, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-717(a) thru (c); amd. Sec. 1, Ch. 333, L. 1981; amd. Sec. 216, Ch. 42, L. 1997.
MT Code § 50-31-312 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-312. Exemptions from new drug application requirement

  50-31-312. Exemptions from new drug application requirement. (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 by the department or pursuant to section 505(i) or 507(d) of the federal act (21 U.S.C. 355(i) or 357(d));   (b) a drug sold in this state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act;   (c) any drug that is manufactured by an establishment licensed under 42 U.S.C. 262; or   (d) any drug that is subject to 50-31-306(1)(n).   (2) The provisions of 50-31-103(24) do not apply to any drug, when the drug is intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to the drug, that on October 9, 1962, or on the date immediately preceding July 1, 1967:   (a) was commercially sold or used in this state or in the United States;   (b) was not a new drug as defined by 50-31-103(24) as then in force; and   (c) was not covered by an effective application under 50-31-311 or under section 505 of the federal act (21 U.S.C. 355).   History: En. Sec. 17, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-717(d), (e); amd. Sec. 2, Ch. 456, L. 1979; amd. Sec. 7, Ch. 169, L. 1989; amd. Sec. 217, Ch. 42, L. 1997; amd. Sec. 4, Ch. 373, L. 2003; amd. Sec. 5, Ch. 186, L. 2019.
MT Code § 50-31-313 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-313. Code imprint required on legend drugs

  50-31-313. Code imprint required on legend drugs. 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.   History: En. Sec. 2, Ch. 95, L. 1981.
MT Code § 50-31-314 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-314. Exemptions from code imprint requirement

  50-31-314. Exemptions from code imprint requirement. 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 provisions of 50-31-313 impractical or impossible. Any exemption granted must be included in the list required by 50-31-315 and must describe the physical characteristics and type of drug covered by the exemption.   History: En. Sec. 3, Ch. 95, L. 1981; amd. Sec. 1, Ch. 247, L. 1983.
MT Code § 50-31-315 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 3. Drugs and Devices|50-31-315. List of code imprints to be provided

  50-31-315. List of code imprints to be provided. 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 each drug by code imprint.   History: En. Sec. 4, Ch. 95, L. 1981; amd. Sec. 1, Ch. 247, L. 1983.
MT Code § 50-31-401 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 4. Cosmetics|50-31-401. When cosmetic adulterated

  50-31-401. When cosmetic adulterated. 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 or usual;   (2) it consists in whole or in part of any filthy, putrid, or decomposed substance;   (3) it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth or rendered injurious to health;   (4) its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;   (5) it is not a hair dye and it is or it bears or contains a color additive which is unsafe within the meaning of the federal act.   History: En. Sec. 18, Ch. 307, L. 1967; R.C.M. 1947, 27-718(part).
MT Code § 50-31-402 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 4. Cosmetics|50-31-402. When cosmetic misbranded

  50-31-402. When cosmetic misbranded. 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 quantity of the contents in terms of weight, measure, or numerical count; provided that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the department;   (3) 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) its container is so made, formed, or filled as to be misleading;   (5) it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive prescribed under the provisions of the federal act.   History: En. Sec. 19, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-719(part).
MT Code § 50-31-403 (2021)
2021 Montana Code Annotated|Title 50. Health and Safety|Chapter 31. Montana Food, Drug, and Cosmetic Act|Part 4. Cosmetics|50-31-403. Exceptions for hair dyes

  50-31-403. Exceptions for hair dyes. (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 accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness", and the labeling of which bears adequate directions for such preliminary testing.   (2) Section 50-31-402(5) shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in 50-31-404).   History: (1)En. Sec. 18, Ch. 307, L. 1967; Sec. 27-718, R.C.M. 1947; (2)En. Sec. 19, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; Sec. 27-719, R.C.M. 1947; R.C.M. 1947, 27-718(part), 27-719(part).