Kan. Admin. Regs. § 28-21-204 - Habit-forming drugs; label requirements
(a)
(1) The name of a substance or derivative
required to be borne on the label of a drug by
K.S.A. 65-669(d) shall be the
common or usual name of such substance or derivative, unless it is designated
solely by a name recognized in an official compendium and such designation
complies with the provisions of
K.S.A. 65-669(c).
(2) A statement on the label of a drug of the
name of a constituent, which constituent is a chemical derivative of a
substance named in
K.S.A. 65-669(d), shall show the
substance from which such constituent is derived and that such constituent is a
derivative thereof.
(b)
If the drug is in tablet, capsule, ampul, or other unit form, the statement of
the quantity or proportion of such substance or derivative contained therein
shall express the weight or measure of such substance or derivative in each
such unit. If the drug is not in such unit form the statement shall express the
weight or measure of such substance or derivative in a specified unit of weight
or measure of the drug. Such statement shall be in terms which are informative
to the ordinary consumer and user of the drug.
(c) The names and quantities or proportions
of all such substances and derivatives, and the statement "warning may be habit
forming," shall immediately follow (without intervening written, printed, or
graphic matter) the name by which such drug is titled in the part or panel of
the label thereof which is presented or displayed under customary conditions of
purchase.
(d) A drug shall not be
considered to be misbranded by reason of failure of its label to bear the
statement "warning may be habit forming":
(1)
If such drug is not suitable for internal use, and is distributed and sold
exclusively for such external use as involves no possibility of habit
formation; or
(2) If the only
substance or derivative subject to
K.S.A. 65-669(d) contained in such
drug is chlorobutanol, which is present solely as a preservative and in a
quantity not more than 0.5 percent by weight, and such drug is for parenteral
use only; or
(3) If the only
substance or derivative subject to
K.S.A. 65-669(d) contained in such
drug is chlorobutanol, which is present as an analgesic or as an analgesic and
a preservative in a quantity not more than 3.0 percent, and such drug contains
one or more other active ingredients and is for parenteral use only.
Notes
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