Conn. Agencies Regs. § 21a-115-19 - Labeling of drugs; names; quantity; warning

(a)

(1) The name of a substance or derivative required by or under authority of section 21a-106 of the general statutes to be borne on the label of a drug 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 said section 21a-106.

(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 said section 21a-106 shall show the substance from which such constituent is derived and that such constituent is a derivative thereof.

(b)

(1) If the drug is in tablet, capsul, 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.

(2) The statement of the percentage of such substance or derivative contained in a drug shall express the percentage by weight; except that, if both the substance or derivative and the drug are liquid, the statement may express the percentage by volume at 68°F. (20°C.), but in such case the statement shall be so qualified as to show definitely that the percentage is expressed by volume.

(c) The names and quantities or proportions of all such substances and derivatives, and the statement "Warning-May be habit forming," shall immediately precede or 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 section 21a-106(d) of the general statutes contained in such drug is chlorobutanol, which is present solely as a preservative and in a quantity not more than 0.5 per cent by weight, and such drug is for parenteral use only; or (3) if the only substance or derivative subject to said section 21a-106(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 per cent and such drug contains one or more active ingredients and is for parenteral use only.

Notes

Conn. Agencies Regs. § 21a-115-19

Effective July 27, 1984