part thereof, from such establishment if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(2) Upon refusal by the operator of the establishment where such food is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such paragraph.

(Sec. 405, 52 Stat. 1049; 21 U. S. C. 345)

§ 1.14 Conformity to definitions and standards of identity. In the following conditions, among others, a food does not conform to the definition and standard of identity therefor:

(a) If it contains an ingredient for which no provision is made in such definition and standard;

(b) If it fails to contain any one or more ingredients required by such definition and standard;

(c) If the quantity of any ingredient or component fails to conform to the limitation, if any, prescribed therefor by such definition and standard.

[8 F. R. 9936]

DRUGS AND DEVICES

AUTHORITY: §§ 1.100 to 1.115 issued under sec. 701 (a), 52 Stat. 1055; 21 U. S. C. 371 (a). Statutory provisions interpreted or applied are cited to text in parentheses.

SOURCE: §§ 1.100 to 1.115 appear at 3 F. R. 3165, redesignated at 13 F. R. 6969. Exceptions are noted following sections affected.

§ 1.100 Drugs; name. (a) The name by which a drug is designated shall be clearly distinguishing and differentiating from any name recognized in an official compendium unless such drug complies in identity with the identity prescribed in an official compendium under such recognized name.

(b) The term "drug defined in an official compendium" means a drug having the identity prescribed for a drug in an official compendium.

(c) A statement that a drug defined in an official compendium differs in strength, quality, or purity from the standard of strength, quality, or purity set forth for such drug in an official compendium shall show all the respects in which such drug so differs, and the extent of each such difference.

(Sec. 501 (b), 52 Stat. 1049; 21 U. S. C. 351. (b))

§ 1.101 Drugs and devices; labeling, misbranding. (a) Among representations in the labeling of a drug or device which render such drug or device misbranded is a false or misleading representation with respect to another drug or device or a food or cosmetic.

(b) The labeling of a drug which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such drug in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling. (Sec. 502 (a), 52 Stat. 1050; 21 U. S. C. 352 (a))

§ 1.102 Drugs and devices; labeling requirements. (a) If a drug or device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase which reveals the connection such person has with such drug or device, such as "Manufactured for and Packed by "Distributed by -," or other similar phrase which expresses the facts.

(b) The statement of the place of business shall include the street address, if any, of such place, unless such street address is shown in a current city directory or telephone directory.

(c) Where a person manufactures, packs, or distributes a drug or device at a place other than his principal place of business, the label may state the prinIcipal place of business in lieu of the actual place where each package of such drug or device was manufactured or packed or is to be distributed, if such statement is not misleading in any particular.

(d) The requirement that the label shall contain the name and place of business of the manufacturer, packer, or distributor shall not be considered to relieve any drug or device from the requirement that its label shall not be misleading in any particular.

(e) (1) The statement of the quantity of the contents of a package of a drug shall reveal the quantity of such drug in the package, exclusive of wrappers and other material packed with such drug.

(2) The statement shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure, which

are generally used by consumers and users of such drug to express quantity thereof and which give accurate information as to such quantity. But if no general usage in expressing accurate information as to the quantity of such drug exists among consumers and users thereof, the statement of the quantity of a drug which is not in tablet, capsule, ampule, or other unit form shall be in terms of weight if the drug is solid, semisolid, or viscous, or in terms of measure if the drug is liquid; the statement of the quantity of a drug which is in such unit form shall be in terms of the numerical count of such units, supplemented, when necessary to give accurate information as to the quantity of such drug in the package, by such statement (in such terms, manner, and form as are not misleading) of the weight or measure of such units, or of the quantity of each active ingredient in each such unit, as will give such information.

(3) The statement of the quantity of a device shall be expressed in terms of numerical count.

(f) A statement of weight shall be in terms of the avoirdupois pound, ounce, and grain, or of the kilogram, gram, and milligram. A statement of liquid measure shall be in terms of the United States gallon of 231 cubic inches and quart, pint, fluid ounce, and fluid dram subdivisions thereof, or of the liter, milliliter, or cubic centimeter, and shall express the volume at 68° Fahrenheit (20° Centigrade).

(g) Statements of the quantity of a drug shall contain only such fractions as are generally used in expressing the quantity of such drug. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than three places, except in the case of a statement of the quantity of an active ingredient in a unit of a drug.

(h) (1) Unless made in accordance with the provisions of subparagraph (2) of this paragraph, a statement of the quantity of a drug, in the terms of weight or measure applicable to such drug under the provisions of paragraph (e) (2) of this section, shall express the number of the largest unit specified in paragraph (f) of this section which is contained in the package (for example, the statement on the label of a package which contains one pint of a drug shall be "1 pint," and not "16 fluid ounces"). Where such

number is a whole number and a fraction, there may be substituted for the fraction its equivalent in smaller units, if any smaller is specified in such paragraph (f) (for example, 14 pounds may be expressed as "1 pound 4 ounces"). The stated number of any unit which is smaller than the largest unit (specified in such paragraph (f)) contained in the package shall not equal or exceed the number of such smaller units in the next larger unit so specified (for example, instead of "1 quart 16 fluid ounces" the statement shall be "12 quarts" or "1 quart 1 pint").

(2) In the case of a drug with respect to which there exists an established custom of stating the quantity of the contents as a fraction of a unit, which unit is larger than the quantity contained in the package, or as units smaller than the largest unit contained therein, the statement may be made in accordance with such custom if it is informative to consumers.

(i) The statement of the quantity of a drug or device shall express the minimum quantity, or the average quantity, of the contents of the packages. If the statement is not so qualified as to show definitely that the quantity expressed is the minimum quantity, the statement, except in the case of ampules, shall be considered to express the average quantity. The statement of the quantity of a drug in ampules shall be considered to express the minimum quantity.

(j) Where the statement expresses the minimum quantity, no variation below the stated minimum shall be permitted except variations below the stated weight or measure of a drug caused by ordinary and customary exposure, after such drug is introduced into interstate commerce, to conditions which normally occur in good distribution practice and which unavoidably result in decreased weight or measure. Variations above the stated minimum shall not be unreasonably large. In the case of a liquid drug in ampules the variation above the stated measure shall comply with the excess volume prescribed by the National Formulary for filling of ampules.

(k) Where the statement does not express the minimum quantity:

(1) Variations from the stated weight or measure of a drug shall be permitted when caused by ordinary and customary exposure, after such drug is introduced into interstate commerce, to conditions

which normally occur in good distribution practice and which unavoidably result in change of weight or measure;

(2) Variations from the stated weight, measure, or numerical count of a drug or device shall be permitted when caused by unavoidable deviations in weighing, measuring, or counting the contents of individual packages which occur in good packing practice.

But under subparagraph (2) of this paragraph variations shall not be permitted to such extent that the average of the quantities in the packages comprising a shipment or other delivery of the drug or device is below the quantity stated and no unreasonable shortage in any package shall be permitted, even though overages in other packages in the same shipment or delivery compensate for such shortage.

(1) The extent of variations from the stated quantity of the contents permissible under paragraphs (j) and (k) of this section in the case of each shipment or other delivery shall be determined by the facts in such case.

(m) A drug or device shall be exempt from compliance with the requirements of clause (2) of section 502 (b) of the act if:

(1) The statement of the quantity of the contents, as expressed in terms applicable to such drug or device under the provisions of paragraph (e) (2) of this section, together with all other words, statements, and information required by or under authority of the act to appear on the label of such drug or device, cannot, because of insufficient label space, be so placed on the label as to comply with the requirements of section 502 (c) of the act and regulations promulgated thereunder, or

(2) The quantity of the contents of the package, as expressed in terms of numerical count in compliance with paragraph (e) (2) or (3) of this section, is less than six units, and such units can be easily counted without opening the package.

(Sec. 502 (b), 52 Stat. 1050; 21 U. S. C. 352 (b))

§ 1.103 Drugs and devices; forms of making required statements. (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness re

quired by section 502 (c) of the act by reason (among other reasons) of:

(1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

(2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;

(3) The failure of the label to extend over the area of the container or package. available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;

(4) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(5) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or

(6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.

(b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502 (b) or (e) of the act, shall apply if such insufficiency is caused by:

(1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;

(2) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by section 502 (c) of the act; or (3) The use of label space for any representation in a foreign language.

(c) (1) All words, statements, and other information required by or under authority of the act to appear on the

label or labeling shall appear thereon in the English language.

(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.

(3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.

(Sec. 502 (c), 52 Stat. 1050; 21 U. S. C. 352 (c))

§ 1.104 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 section 502 (d) of the act 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 section 502 (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 section 502 (d) of the act, 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, ampule, 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 "WarningMay 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 section 502 (d) of the act 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 section 502 (d) of the act 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. [3 F. R. 3165, as amended at 4 F. R. 2711 and 6 F. R. 5801]

§ 1.105 Drugs; statement of ingredients and proportion. (a) (1) The name of an ingredient, substance, derivative, or preparation required by section 502 (e) (2) of the act to be borne on the label of a drug shall be the name thereof which is listed in such section 502 (e) (2) of the act, 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 section 502 (e) (2) of the act 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 section 502 (e) (2) of the act 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 section 502 (e) (2) of the act, 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, ampule, 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 pro

portion 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 (2) of section 502 (e) of the act 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 section 502 (c) of the act 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 (2), such statement of the quantity of the contents shall be omitted as authorized by § 1.102 (m) (1), and the information required by such clause (2) 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 (2) of section 502 (e) of the act 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