Missouri Revised Statutes
Chapter 196
Food, Drugs and Tobacco
←196.095
Section 196.100.1
196.105→
August 28, 2015
When drug or device misbranded.
196.100. 1. Any manufacturer, packer, distributor or seller of drugs or
devices in this state shall comply with the current federal labeling
requirements contained in the Federal Food, Drug and Cosmetic Act, as
amended, and any federal regulations promulgated thereunder. Any drug or
device which contains labeling that is not in compliance with the provisions
of this section shall be deemed misbranded.
2. A drug dispensed on a written prescription signed by a licensed
physician, dentist, or veterinarian, except a drug dispensed in the course of
the conduct of a business of dispensing drugs pursuant to a diagnosis by
mail, shall be exempt from the requirements of this section if such physician,
dentist, or veterinarian is licensed by law to administer such drug, and such
drug bears a label containing the name and place of business of the
dispenser, the serial number and date of such prescription, and the name of
such physician, dentist, or veterinarian.
3. The department is hereby directed to promulgate regulations exempting
from any labeling or packaging requirement of sections 196.010 to 196.120,
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, on
condition that such drugs and devices are not adulterated or misbranded under
the provisions of said sections upon removal from such processing, labeling,
or repacking establishment.
(L. 1943 p. 559 § 9870, A.L. 2001 H.B. 796 merged with S.B. 514)
1991
1991
1991
196.100. 1. A drug or device shall be deemed to be
misbranded:
(1) If its labeling is false or misleading in any
particular;
(2) If 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
under paragraph (b) of this subdivision reasonable variations
shall be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the department of
health;
(3) If any word, statement, or other information required by
or under authority of sections 196.010 to 196.120 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) If it is for use by man and contains any quantity of the
narcotic or hypnotic substance alphaeucaine, barbituric acid,
betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine,
codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote,
or sulphonmethane, or any chemical derivative of such substance,
which derivative has been by the department after investigation,
found to be, and by regulations under sections 196.010 to
196.120, designated as, habit forming, 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";
(5) If it is a drug and is not designated solely by a name
recognized in an official compendium unless its label bears:
(a) The common or usual name of the drug, if such there be;
and
(b) In case it is fabricated from two or more ingredients,
the common or usual name of each active ingredient, including the
kind and quantity or proportion of any alcohol, and also
including, whether active or not, the name and quantity or
proportion of any bromides, ether, chloroform, acetanilid,
acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,
ouabain, strophantin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein; provided,
that to the extent that compliance with the requirements of
paragraph (b) of this subdivision is impracticable, exemptions
shall be established by regulations promulgated by the department
of health;
(6) Unless its labeling bears:
(a) Adequate directions for use; and
(b) Such 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 duration of
administration or application, in such manner and form, as are
necessary for the protection of users; provided, that where any
requirement of paragraph (a) of this subdivision, as applied to
any drug or device, is not necessary for the protection of the
public health, the department shall promulgate regulations
exempting such drug or device from such requirements;
(7) 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 therein; provided, that the method of
packing may be modified with the consent of the department.
Whenever a drug is recognized in both the United States
Pharmacopoeia and the Homeopathic Pharmacopoeia of the United
States, it shall be subject to the requirements of the United
States Pharmacopoeia with respect to packaging and labeling
unless it is labeled and offered for sale as a homeopathic drug,
in which case it shall be subject to the provisions of the
Homeopathic Pharmacopoeia of the United States, and not to those
of the United States Pharmacopoeia;
(8) If it has been found by the department to be a drug
liable to deterioration, unless it is packaged in such form and
manner, and its label bears a statement of such precautions, as
the department shall by regulations require as necessary for the
protection of public health. No such regulation shall be
established for any drug recognized in an official compendium
until the department shall have informed the appropriate body
charged with the revision of such compendium of the need for such
packaging or labeling requirements and such body shall have
failed within a reasonable time to prescribe such requirements;
(9) If it is a drug and its container is so made, formed, or
filled as to be misleading; or if it is an imitation of another
drug; or if it is offered for sale under the name of another
drug;
(10) If it is dangerous to health when used in the dosage,
or with the frequency or duration prescribed, recommended, or
suggested in the labeling thereof;
(11) If it purports to be, or is represented as a drug
composed wholly or in part of insulin, unless it is from a batch
with respect to which a certificate or release has been issued
pursuant to 21 U.S.C.A. { 356 and, such certificate or release is
in effect with respect to such drug.
2. A drug dispensed on a written prescription signed by a
licensed physician, dentist, or veterinarian, except a drug
dispensed in the course of the conduct of a business of
dispensing drugs pursuant to a diagnosis by mail, shall be exempt
from the requirements of this section if such physician, dentist,
or veterinarian is licensed by law to administer such drug, and
such drug bears a label containing the name and place of business
of the dispenser, the serial number and date of such
prescription, and the name of such physician, dentist, or
veterinarian.
3. The department is hereby directed to promulgate
regulations exempting from any labeling or packaging requirement
of sections 196.010 to 196.120, 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, on
condition that such drugs and devices are not adulterated or
misbranded under the provisions of said sections upon removal
from such processing, labeling, or repacking establishment.
1991
196.100. 1. A drug or device shall be deemed to be
misbranded:
(1) If its labeling is false or misleading in any
particular;
(2) If 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
under paragraph (b) of this subdivision reasonable variations
shall be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the department of
health;
(3) If any word, statement, or other information required by
or under authority of sections 196.010 to 196.120 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) If it is for use by man and contains any quantity of the
narcotic or hypnotic substance alphaeucaine, barbituric acid,
betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine,
codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote,
or sulphonmethane, or any chemical derivative of such substance,
which derivative has been by the department after investigation,
found to be, and by regulations under sections 196.010 to
196.120, designated as, habit forming, 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";
(5) If it is a drug and is not designated solely by a name
recognized in an official compendium unless its label bears:
(a) The common or usual name of the drug, if such there be;
and
(b) In case it is fabricated from two or more ingredients,
the common or usual name of each active ingredient, including the
kind and quantity or proportion of any alcohol, and also
including, whether active or not, the name and quantity or
proportion of any bromides, ether, chloroform, acetanilid,
acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,
ouabain, strophantin, strychnine, thyroid, or any derivative or
preparation of any such substances, contained therein; provided,
that to the extent that compliance with the requirements of
paragraph (b) of this subdivision is impracticable, exemptions
shall be established by regulations promulgated by the department
of health;
(6) Unless its labeling bears:
(a) Adequate directions for use; and
(b) Such 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 duration of
administration or application, in such manner and form, as are
necessary for the protection of users; provided, that where any
requirement of paragraph (a) of this subdivision, as applied to
any drug or device, is not necessary for the protection of the
public health, the department shall promulgate regulations
exempting such drug or device from such requirements;
(7) 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 therein; provided, that the method of
packing may be modified with the consent of the department.
Whenever a drug is recognized in both the United States
Pharmacopoeia and the Homeopathic Pharmacopoeia of the United
States, it shall be subject to the requirements of the United
States Pharmacopoeia with respect to packaging and labeling
unless it is labeled and offered for sale as a homeopathic drug,
in which case it shall be subject to the provisions of the
Homeopathic Pharmacopoeia of the United States, and not to those
of the United States Pharmacopoeia;
(8) If it has been found by the department to be a drug
liable to deterioration, unless it is packaged in such form and
manner, and its label bears a statement of such precautions, as
the department shall by regulations require as necessary for the
protection of public health. No such regulation shall be
established for any drug recognized in an official compendium
until the department shall have informed the appropriate body
charged with the revision of such compendium of the need for such
packaging or labeling requirements and such body shall have
failed within a reasonable time to prescribe such requirements;
(9) If it is a drug and its container is so made, formed, or
filled as to be misleading; or if it is an imitation of another
drug; or if it is offered for sale under the name of another
drug;
(10) If it is dangerous to health when used in the dosage,
or with the frequency or duration prescribed, recommended, or
suggested in the labeling thereof;
(11) If it purports to be, or is represented as a drug
composed wholly or in part of insulin, unless it is from a batch
with respect to which a certificate or release has been issued
pursuant to 21 U.S.C.A. { 356 and, such certificate or release is
in effect with respect to such drug.
2. A drug dispensed on a written prescription signed by a
licensed physician, dentist, or veterinarian, except a drug
dispensed in the course of the conduct of a business of
dispensing drugs pursuant to a diagnosis by mail, shall be exempt
from the requirements of this section if such physician, dentist,
or veterinarian is licensed by law to administer such drug, and
such drug bears a label containing the name and place of business
of the dispenser, the serial number and date of such
prescription, and the name of such physician, dentist, or
veterinarian.
3. The department is hereby directed to promulgate
regulations exempting from any labeling or packaging requirement
of sections 196.010 to 196.120, 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, on
condition that such drugs and devices are not adulterated or
misbranded under the provisions of said sections upon removal
from such processing, labeling, or repacking establishment.
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