Sec. 4. A drug or device is considered to be misbranded under any of the following conditions:
(1) If the labeling of the drug or device is false or misleading in any way.
(2) If the drug or device is in package form unless the drug or device 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.
However, under clause (B) reasonable variations shall be permitted and exemptions as to small packages shall be established by rules adopted by the state department.
(3) If any word, statement, or other information required to appear on the label or labeling, under this chapter or a rule adopted under IC 16-42-1-2 is not prominently placed on the drug or device with conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms that make the label likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(4) If the drug or device:
(A) is for use by humans; and
(B) 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, methamphetamine, or sulphonmethane, or any chemical derivative of such substance, which derivative after investigation has been found to be and is designated as habit forming, by rules adopted by the state department under IC 16-42-1 through IC 16-42-4 or by regulations issued under 21 U.S.C. 352(d);
unless the label on the drug or device bears the name and quantity or proportion of that substance or derivative and the statement "Warning ─ May Be Habit Forming".
(5) If a drug, unless the following conditions are met:
(A) The label on the drug bears, to the exclusion of any other nonproprietary name except the applicable systematic chemical name or the chemical formula, the following:
(i) The established name of the drug, if any.
(ii) If the drug is fabricated from at least two (2) ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol and, 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 those 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 subdivision, applies only to prescription drugs.
(B) If a prescription drug, the established name of the drug or ingredient on the label (and on any labeling on which a name for the drug or ingredient is used) is printed prominently and in type at least half as large as that used for any proprietary name or designation for the drug or ingredient.
However, to the extent that compliance with the requirements of clause (A)(ii) or clause (B) is impracticable, exemptions shall be allowed under rules adopted by the state department or by regulations promulgated under the Federal Act.
(6) Unless the drug's or device's labeling bears:
(A) adequate directions for use; and
(B) adequate warnings against use in those pathological conditions or by children where the drug's or device's use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in the manner and form that is necessary for the protection of users.
However, if any requirement of clause (A) as applied to any drug or device is not necessary for the protection of the public health, the state department shall adopt rules exempting the drug or device from that requirement.
(7) If a drug purports to be a drug the name of which is recognized in an official compendium, unless the drug is packaged and labeled as prescribed in the compendium. However, the method of packing may be modified with the consent of the state department in accordance with regulations promulgated by the federal security administrator under the Federal Act. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, the drug is subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless the drug is labeled and offered for sale as a homeopathic drug. In that case the drug is subject to the Homeopathic Pharmacopoeia of the United States and not to the United States Pharmacopoeia.
(8) If a drug or device has been found by the federal security administrator or the state department to be a drug liable to deterioration, unless the drug or device is packaged in a form and manner and the drug's or device's label bears a statement of such precautions as the federal security administrator or the state department requires by rule or regulation as necessary for the protection of the public health. A rule or regulation may not be established for any drug recognized in an official compendium until the federal security administrator or the state department informs the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements and that body fails within a reasonable time to prescribe requirements.
(9) If a drug's container is made, formed, or filled as to be misleading.
(10) If a drug is an imitation of another drug.
(11) If a drug is offered for sale under the name of another drug.
(12) If a drug is or purports to be or is represented to be a drug composed wholly or partly of insulin, unless:
(A) the drug is from a batch with respect to which a certificate or release has been issued under Section 506 of the Federal Act; and
(B) the certificate or release is in effect with respect to the drug.
(13) If a drug is or purports to be or is represented to be a drug composed wholly or partly of any kind of penicillin, streptomycin, chloretetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative of those drugs, unless:
(A) the drug is from a batch with respect to which a certificate or release has been issued under Section 507 of the Federal Act; and
(B) the certificate or release is in effect with respect to that drug.
However, this subdivision does not apply to any drug or class of drugs exempted by regulations promulgated under Section 507(c) or 507(d) of the Federal Act.
(14) If a drug or device is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling of the drug or device.
(15) Under the conditions described in section 6 of this chapter.
[Pre-1993 Recodification Citations: 16-1-30-5; 16-1-30-6; 16-1-30-7; 16-1-30-8 part; 16-1-30-9; 16-1-30-10; 16-1-30-11; 16-1-30-12 part; 16-1-30-13; 16-1-30-15 part.]
As added by P.L.2-1993, SEC.25. Amended by P.L.17-2001, SEC.3.
