126.10 - DRUGS AND DEVICES -- MISBRANDING -- LABELING.
126.10 DRUGS AND DEVICES -- MISBRANDING --
LABELING.
1. A drug or device is misbranded under any of the following
circumstances:
a. If its labeling is false or misleading in any particular.
b. (1) If in a package form unless it bears a label
containing both of the following:
(a) The name and place of business of the manufacturer, packer,
or distributor.
(b) An accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count.
(2) However, under subparagraph (1), subparagraph division (a),
reasonable variations shall be permitted, and exemptions as to small
packages shall be allowed, in accordance with rules adopted by the
board.
c. If any word, statement, or other information required by
or under the 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.
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, or
sulphonmethane; or any chemical derivative of such a substance, which
derivative, after investigation, has been designated as habit
forming, by rules adopted by the board under this chapter or by
regulations adopted by the secretary pursuant to section 502(d) of
the federal Act; unless its label bears the name and quantity or
proportion of such substance or derivative and in juxtaposition
therewith the statement "Warning -- May Be Habit Forming."
e. (1) If it is a drug, unless both of the following apply:
(a) 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 of the drug, as specified in
subparagraph (3), if such exists; and
(ii) If the drug is fabricated from two or more ingredients, the
established name and quantity of each active ingredient, including
the quantity, kind, and proportion of any alcohol, and also
including, whether active or not, the established name and quantity
or proportion of any bromides, ether, chloroform, acetanilide,
acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,
ouabain, strophanthin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein. However, the
requirement for stating the quantity of the active ingredients, other
than the quantity of those specifically named in this subparagraph
subdivision, applies only to prescription drugs.
(b) For a prescription drug, the established name of the
prescription drug or of an ingredient is printed, on the label and on
any labeling on which a name for the prescription drug or an
ingredient is used, prominently and in type at least half as large as
that used thereon for any proprietary name or designation for the
prescription drug or ingredient. However, to the extent that
compliance with subparagraph division (a), subparagraph subdivision
(ii), or this subparagraph division is impracticable, exemptions
shall be allowed under rules or regulations adopted by the board or
the secretary under the federal Act.
(2) If it is a device and it has an established name, unless its
label bears, to the exclusion of any other nonproprietary name, its
established name, as defined in subparagraph (4), prominently printed
in type at least half as large as that used thereon for any
proprietary name or designation for the device, except that to the
extent compliance with this subparagraph is impracticable, exemptions
shall be allowed under rules or regulations adopted by the board or
the secretary under the federal Act.
(3) As used in subparagraph (1), the term "established name",
with respect to a drug or ingredient thereof, means one of the
following:
(a) The applicable official name designated pursuant to section
508 of the federal Act.
(b) If no such official name exists and the drug or ingredient is
an article recognized in an official compendium, then its official
title in the compendium.
(c) If neither subparagraph division (a) nor (b) applies, then
the common or usual name, if any, of the drug or ingredient.
However, if subparagraph division (b) applies to an article
recognized in the United States Pharmacopoeia National Formulary and
in the Homeopathic Pharmacopoeia of the United States under different
official titles, the official title used in the United States
Pharmacopoeia National Formulary applies unless it is labeled and
offered for sale as a homeopathic drug, in which case the official
title used in the Homeopathic Pharmacopoeia of the United States
applies.
(4) As used in subparagraph (2), the term "established name"
with respect to a device means one of the following:
(a) The applicable official name of the device pursuant to
section 508 of the federal Act.
(b) If no such official name exists and the device is an article
recognized in an official compendium, then its official title in the
compendium.
(c) If neither subparagraph division (a) nor (b) applies, then
any common or usual name of the device.
f. (1) Unless its labeling bears both of the following:
(a) Adequate directions for use.
(b) Adequate warnings against use in those pathological
conditions, or by children, where its use may be dangerous to health,
or against unsafe dosage or methods or durations of administration or
application, in the manner and form necessary for the protection of
users.
(2) However, if a requirement of subparagraph (1), subparagraph
division (a), as applied to a drug or device, is not necessary for
the protection of the public health, the board or the secretary shall
adopt rules or regulations exempting the drug or device from that
requirement.
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 official compendium. However, the
method of packing may be modified with the consent of the board or
the secretary. If a drug is recognized in both the United States
Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of
the United States, it is subject to the requirements of the United
States Pharmacopoeia National Formulary with respect to packaging and
labeling unless it is labeled and offered for sale as a homeopathic
drug, in which case it is subject to the Homeopathic Pharmacopoeia of
the United States, and not to the United States Pharmacopoeia
National Formulary. However, if an inconsistency exists between this
paragraph and paragraph "e" as to the name by which the drug or
its ingredients shall be designated, paragraph "e" prevails.
h. If it has been found by the board or the secretary to be a
drug liable to deterioration, unless it is packaged in the form and
manner, and its label bears a statement of the precautions that the
board or the secretary by rule or regulation requires as necessary
for the protection of public health. Such a rule or regulation shall
not be established for a drug recognized in an official compendium
until the board or the secretary has informed the appropriate body
charged with the revision of the official compendium of the need for
such packaging or labeling requirements and that body has failed
within a reasonable time to prescribe such requirements.
i. (1) If it is a drug and its container is so made, formed,
or filled as to be misleading.
(2) If it is an imitation of another drug.
(3) If it is offered for sale under the name of another drug.
j. If it is dangerous to health when used in the dosage or
manner, or with the frequency or duration prescribed, recommended, or
suggested in its labeling.
k. If it is, or purports to be, or is represented as a drug
composed wholly or partly of insulin, unless both of the following
apply:
(1) It is from a batch with respect to which a certificate or
release has been issued pursuant to section 506 of the federal Act.
(2) The certificate or release is in effect with respect to the
drug.
l. (1) If it is, or purports to be, or is represented as a
drug, composed wholly or partly of any kind of penicillin,
streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any
other antibiotic drug, or any derivative thereof, unless both of the
following apply:
(a) It is from a batch with respect to which a certificate or
release has been issued pursuant to section 507 of the federal Act.
(b) The certificate or release is in effect with respect to the
drug.
(2) However, this paragraph "l" does not apply to any drug or
class of drugs exempted by regulations adopted under section 507(c)
or 507(d) of the federal Act.
m. If it is a color additive, the intended use of which is
for the purpose of coloring only, unless its packaging and labeling
are in conformity with the packaging and labeling requirements
applicable to that color additive, as contained in regulations
adopted under section 706 of the federal Act.
n. If it is a prescription drug distributed or offered for
sale in this state, unless the manufacturer, packer, or distributor
includes in all advertising and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to the prescription drug a true statement of
all of the following:
(1) The established name as defined in paragraph "e", printed
prominently and in type at least half as large as that used for any
trade or brand name thereof.
(2) The formula showing quantitatively each ingredient of the
prescription drug to the extent required for labels under paragraph
"e".
(3) Other information in brief summary relating to side effects,
contraindications, and effectiveness as required in regulations
adopted pursuant to section 701(e) of the federal Act.
o. If it was manufactured, prepared, propagated, compounded,
or processed in an establishment in this state not duly registered
under section 510 of the federal Act, if it was not included on a
list required by section 510(j) of the federal Act, if a notice or
other information respecting it was not provided as required by that
section or section 510(k) of the federal Act, or if it does not bear
the symbols from the uniform system for identification of devices
prescribed under section 510(e) of the federal Act that are required
by regulation.
p. If it is a drug and its packaging or labeling is in
violation of an applicable regulation adopted pursuant to section 3
or 4 of the federal Poison Prevention Packaging Act of 1970, 15
U.S.C. § 1471 et seq.
q. If a trademark, trade name, or other identifying mark,
imprint, or device of another trademark, trade name, mark, or imprint
or any likeness of the foregoing has been placed thereon or upon its
container with intent to defraud.
r. In the case of a restricted device distributed or offered
for sale in this state, if either of the following applies:
(1) Its advertising is false or misleading in any particular.
(2) It is sold, distributed, or used in violation of regulations
adopted pursuant to section 520(e) of the federal Act.
s. In the case of a restricted device distributed or offered
for sale in this state, unless the manufacturer, packer, or
distributor includes in all advertising and other descriptive printed
matter issued by the manufacturer, packer, or distributor with
respect to the device both of the following:
(1) A true statement of the device's established name as defined
in paragraph "e", printed prominently and in type at least half
as large as that used for any trade or brand name thereof.
(2) A brief statement of the intended uses of the device and
relevant warnings, precautions, side effects, and contraindications;
and in the case of a specific device made subject to regulations
adopted pursuant to the federal Act, a full description of the
components of the device or the formula showing quantitatively each
ingredient of the device to the extent required in regulations under
the federal Act.
t. If it is a device subject to a performance standard
established under section 514 of the federal Act, unless it bears
labeling as prescribed in that performance standard.
u. If it is a device and there was a failure or refusal to
comply with any requirement prescribed under section 518 of the
federal Act respecting the device, or to furnish material required by
or under section 519 of the federal Act respecting the device.
2. If an article is alleged to be misbranded because the labeling
or advertising is misleading, then in determining whether the
labeling or advertising is misleading, there shall be taken into
account, among other things, not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations,
or material with respect to consequences which may result from the
use of the article to which the labeling or advertising relates,
under the conditions of use prescribed in the labeling or advertising
or under customary or usual conditions of use.
3. The representation of a drug, in its labeling, as an
antiseptic shall be 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 such other use as involves prolonged
contact with the body. Section History: Recent Form
89 Acts, ch 197, § 10
CS89, § 203B.10
C93, § 126.10
2009 Acts, ch 41, §189
Referred to in § 126.11