Kansas Administrative Regulations
Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT
Article 21 - FOOD, DRUGS AND COSMETICS
Section 28-21-205 - Drugs; statement of ingredients and proportion
Universal Citation: KS Admin Regs 28-21-205
Current through Register Vol. 43, No. 12, March 20, 2024
(a)
(1) The name of an ingredient, substance,
derivative, or preparation required by
K.S.A.
65-669(e) (1) (ii) to be
borne on the label of a drug shall be the name thereof, which is listed in
K.S.A.
65-669(e) (1) (ii), or, if
not so listed, shall be a specific name and not a collective name. But if an
ingredient is an article the name of which is recognized in an official
compendium and such article complies with the specifications set forth therefor
in such compendium, such ingredient may be designated on the label of such drug
by the common or usual name under which such specifications are so set forth.
(2) Where an ingredient contains a
substance the quantity or proportion of which is required by
K.S.A.
65-669(e) (1) (ii) to appear
on the label, and such ingredient is not a derivative or preparation of such
substance as defined in paragraph (b) (1) of this section, the label shall
bear, in conjunction with the name of the ingredient, a statement of the
quantity or proportion of such substance in such drug.
(3) An abbreviation or chemical formula shall
not be considered to be a common or usual name. The name "acetophenetidin"
shall be considered to be the same as the name "acetphenetidin," "aminopyrine"
the same as "amidopyrine." The name "alcohol" without qualification, means
ethyl alcohol.
(b)
(1) A derivative or preparation of a
substance named in
K.S.A.
65-669(e) (1) (ii) is an
article which is derived or prepared from such substance by any method,
including actual or theoretical chemical action.
(2) A statement on the label of a drug of the
name of an ingredient thereof, which ingredient is a derivative or preparation
of a substance named in
K.S.A.
65-669(e) (1) (ii), shall
show the substance from which such ingredient is derived or prepared and that
such ingredient is a derivative or preparation thereof.
(c)
(1) If
the drug is in tablet, capsule, ampul, or other unit form, the statement of the
quantity or proportion of a substance, derivative, or preparation contained
therein shall express the weight or measure of such substance, derivative, or
preparation in each such unit. If the drug is not in such unit form the
statement shall express the weight or measure of such substance, derivative, or
preparation in a specified unit of weight or measure of the drug, or the
percentage of such substance, derivative, or preparation in such drug. Such
statement shall be in terms which are informative to the ordinary consumer and
user of the drug.
(2) A statement
of the percentage of alcohol shall express the percentage of absolute alcohol
at 60° Fahrenheit (15.56° Centigrade). A statement of the percentage of a
substance, derivative, or preparation other than alcohol shall express the
percentage by weight; except that if both the substance, derivative, or
preparation and the drug containing it are liquid, the statement may express
the percentage by volume at 68° Fahrenheit (20° Centigrade), but in such case
the statement shall be so qualified as to show definitely that the percentage
is expressed by volume.
(d) In case a statement of the quantity or proportion of a derivative or preparation in a drug is not as informative, to consumers or users of such drug, of the activity or consequences of use thereof as a statement of the quantity or proportion of the substance from which such derivative or preparation is derived or prepared, the quantity or proportion of such substance shall also be stated on the label of such drug.
(e) A label of a drug may be misleading by reason (among other reasons) of:
(1) The
order in which the names of ingredients, substances, derivatives, or
preparations appear thereon, or the relative prominence otherwise given such
names; or
(2) Its failure to
reveal the proportion of, or other fact with respect to, an ingredient,
substance, derivative, or preparation, when such proportion or other fact is
material in the light of the representation that such ingredient, substance,
derivative, or preparation is a constituent of such drug.
(f)
(1) A
drug shall be exempt from the requirements of clause (1) (ii) of
K.S.A.
65-669(e) if all words,
statements, and other information required by or under authority of the act to
appear on the label of such drug, cannot, because of insufficient label space,
be so placed on the label as to comply with the requirements of
K.S.A.
65-669(c) and regulations
promulgated thereunder. But such exemption shall be on the condition that, if
the omission from the label of the statement of the quantity of the contents
affords sufficient space to state legibly thereon all the information required
by such clause (1) (ii), such statement of the quantity of the contents shall
be omitted as authorized by paragraph (m) of regulation 28-21-202 and the
information required by such clause (1) (ii) shall be so stated as prominently
as practicable even though the statement is not of such conspicuousness as to
render it likely to be read by the ordinary individual under customary
conditions of purchase.
(2) A drug
shall be exempt from the requirements of clause (1) (ii) of
K.S.A.
65-669(e) with respect to
the alkaloids atropine, hyoscine or hyoscyamine contained in such drug, if such
alkaloid is contained therein as a constituent of belladonna, hyoscyamus,
scopola, stramonium, or other plant material, or any preparation thereof, which
was used as an ingredient of such drug, and no practical and accurate method of
analysis exists for the quantitative determination of each such alkaloid in
such ingredient. But such exemptions shall be on the condition that the label
of such drug shall state the quantity or proportion of total alkaloids
contained therein as constituents of such ingredient.
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