§ 16-42-3-4 — Misbranded drug or device

Indiana § 16-42-3-4

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 3: Uniform Food, Drug, and Cosmetic Act: Adulteration

Text

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.]

Legislative History

As added by P.L.2-1993, SEC.25. Amended by P.L.17-2001, SEC.3.