Conn. Agencies Regs. § 21a-115-20 - Name and quantity statement requirements; derivatives or preparations of substances

(a)

(1) The name of an ingredient, substance, derivative or preparation required by said section 21a-106 of the general statutes to be borne on the label of a drug shall be the name thereof which is listed in said section, 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 said section 21a-106 to appear on the label, and such ingredient is not a derivative or preparation of such substance as defined in subsection (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 section 21a-106 of the general statutes 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 said section 21a-106 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 by volume at 60°F. (15.56°C.). 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 substances, derivative or preparation and the drug containing it 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.

(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 subparagraph (A) (ii) of subdivision (1) of subsection (E) of section 21a-106 of the general statutes 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 said section 21a-106 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 said subparagraph (A) (ii), such statement of the quantity of the contents shall be omitted as authorized by section 21a-115-17(m) (1), and the information required by said subparagraph (A) (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 said subparagraph (A) (ii) 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 exemption 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.

Notes

Conn. Agencies Regs. § 21a-115-20

Effective July 27, 1984