Montana Code Annotated
Part 3. Drugs and Devices
50-31-306. When drug or device misbranded

50-31-306. When drug or device misbranded. (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 drug must contain the name and place of business of the manufacturer as well as the packer or distributor; and
(ii) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided that reasonable variation may be permitted and exemptions as to small packages may be allowed in accordance with regulations prescribed by the department or issued under the federal act;
(c) if 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 on the label or labeling with conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in terms that render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(d) if it is for use by humans and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, Salvia divinorum, sulfonmethane, synthetic cannabinoids, or any chemical derivative of the substance that, after investigation, has been found to be and designated as habit-forming by regulations issued by the department under this chapter or by regulations issued pursuant to section 502(d) of the federal act (21 U.S.C. 352(d)), unless its label bears the name and quantity or proportion of the substance or derivative in juxtaposition to the statement "Warning--May be habit-forming";
(e) if it is a drug, unless its label bears to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula):
(i) the established name (as defined in 50-31-301) of the drug, if there is one; and
(ii) in case the drug is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances contained in the drug. However, the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subsection (1)(e)(ii), applies only to prescription drugs, and to the extent that compliance with the requirements of this subsection (1)(e)(ii) is impracticable, exemptions may be allowed under regulations promulgated by the department or under the federal act.
(f) unless its labeling bears:
(i) adequate directions for use; however, if any requirement of this subsection (1)(f)(i), as applied to any drug or device, is not necessary for the protection of the public health, the department shall promulgate regulations exempting the drug or device from the requirements, and articles exempted under regulations issued under section 502(f) of the federal act (21 U.S.C. 352(f)) may also be exempt; and
(ii) adequate warnings against use in those pathological conditions or by children when its use may be dangerous to health or adequate warnings against unsafe dosage or methods or duration of administration or application, in a manner and form that are necessary for the protection of users;
(g) if it purports to be a drug, the name of which is recognized in an official compendium unless it is packaged and labeled as prescribed in the compendium. The method of packing may be modified with the consent of the department or if consent is obtained under the federal act. In the event of inconsistency between the requirements of this subsection (1)(g) and those of subsection (1)(e) as to the name by which the drug or its ingredients must be designated, the requirements of subsection (1)(e) prevail.
(h) if it has been found by the department or under the federal act to be a drug liable to deterioration, unless it is packaged in a form and manner and its label bears a statement of precautions that the regulations issued by the department or under the federal act require as necessary for the protection of public health. A regulation may not be established for any drug recognized in an official compendium until the department has informed the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements and the body has failed within a reasonable time to prescribe the requirements.
(i) if it is a drug and its container is made, formed, or filled in a way that is misleading;
(j) if it is an imitation of another drug;
(k) if it is offered for sale under the name of another drug;
(l) if it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling;
(m) if it is, purports to be, or is represented as a drug composed wholly or partly of insulin, unless:
(i) it is from a batch with respect to which a certificate or release has been issued pursuant to section 506 of the federal act (21 U.S.C. 356); and
(ii) the certificate or release is in effect with respect to the drug;
(n) if it is, purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, any other antibiotic drug, or any derivative thereof unless:
(i) it is from a batch with respect to which a certificate or release has been issued pursuant to section 507 of the federal act (21 U.S.C. 357); and
(ii) the certificate or release is in effect with respect to the drug. This subsection (1)(n) does not apply to any drug or class of drugs exempted by regulations promulgated under section 507(c) or (d) of the federal act (21 U.S.C. 357(c) or (d)).
(o) if it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with the packaging and labeling requirements applicable to the color additive prescribed under the provisions of 50-31-108 or of the federal act;
(p) in the case of any prescription drug distributed or offered for sale in this state, unless the manufacturer, packer, or distributor of the drug includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of:
(i) the established name, as defined in 50-31-301;
(ii) the formula showing quantitatively each ingredient of the drug to the extent required for labels under section 502(e) of the federal act (21 U.S.C. 352(e)); and
(iii) other information in brief summary relating to side effects, contraindications, and effectiveness that is required in regulations issued under the federal act; or
(q) if a trademark, trade name, or other identifying mark, imprint, or device or another or any likeness of the foregoing has been placed on the drug or upon its container with intent to defraud.
(2) A drug that is subject to 50-31-307 is considered to be misbranded if, at any time prior to dispensing, its label fails to bear the statement "Caution: Federal Law Prohibits Dispensing Without Prescription", or "Caution: State Law Prohibits Dispensing Without Prescription". A drug to which 50-31-307 does not apply is considered to be misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in the preceding sentence.
History: En. Secs. 15, 16, Ch. 307, L. 1967; amd. Sec. 107, Ch. 349, L. 1974; R.C.M. 1947, 27-715(part), 27-716(d); amd. Sec. 12, Ch. 37, L. 1979; amd. Sec. 2, Ch. 403, L. 1979; amd. Sec. 214, Ch. 42, L. 1997; amd. Sec. 5, Ch. 156, L. 2011.