Kan. Admin. Regs. § 28-21-204

Current through Register Vol. 43, No. 24, August 22, 2024

Section 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.

Kan. Admin. Regs. § 28-21-204

Authorized by K.S.A. 1965 Supp. 65-673; effective Jan. 1, 1966.