503 (b) (1), the statement "Caution: Federal law prohibits dispensing without prescription." This exemption and the exemption under paragraph (k) of this section may be claimed for the same article. But the exemption shall not apply to a substance intended for a use in manufacture, processing, or repacking which causes the finished article to be a new drug, unless:

(1) An approved new-drug application held by the person preparing the dosage form or drug for dispensing covers the production and delivery to him of such substance; or

(2) If no application is approved with respect to such new drug, the label statement "Caution: For manufacturing, processing, or repacking" is immediately supplemented by the words "in the preparation of a new drug limited by Federal law to investigational use," and the delivery is made for use only in the manufacture of such new drug limited to investigational use as provided in § 130.3 of this chapter.

(m) Exemption for drugs and devices for use in teaching, law enforcement, research, and analysis. A drug or device subject to paragraph (b), (c), or (d) of this section shall be exempt from section 502 (f) (1) of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.

(n) Expiration of exemptions. (1) If a shipment or delivery, or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such drug or device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

(2) The exemptions conferred by paragraphs (i), (j), (k), (1), and (m) of this section shall continue until the drugs or devices are used for the purposes for which they are exempted, or until

they are relabeled to comply with section 502 (f) (1) of the act. If, however, the drug is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the dosage form is labeled as required by section 503 (b) and paragraph (b), (c), or (d) of this section.

(0) Intended uses. The words "intended uses" or words of similar import in paragraphs (a), (g), (i), (j), (k), and (1) of this section refer to the objective intent of the persons legally responsible for the labeling of drugs and devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug or device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.

(Sec. 502(f), 52 Stat. 1051; 21 U.S.C. 352(f)) [20 F.R. 9532, Dec. 20, 1955, as amended at 21 F.R. 2326, Apr. 11, 1956, 23 F.R. 7909, Oct. 14, 1958, 25 F.R. 12593, Dec. 9, 1960, 26 F.R. 295, Jan. 14, 1961, 26 F.R. 8389, Sept. 6, 1961, 27 F.R. 1317, Feb. 13, 1962, 28 F.R. 5719, June 12, 1963, 29 F.R. 18055, Dec. 19, 1964] § 1.107 Drugs and devices; exemptions.

(a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a drug or device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where

originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of sections 501 (b) and 502 (b), (d), (e), (f), and (g) of the act if:

(1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such drug or device is to be processed, labeled, or repacked; or

(2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post-office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such drug or device in such establishment as will insure, if such specifications are followed, that such drug or device will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such drug or device from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(b) An exemption of a shipment or other delivery of a drug or device under paragraph (a) (1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the drug or device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(c) An exemption of a shipment or other delivery of a drug or device under paragraph (a) (2) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such subparagraph.

(d) An exemption of a shipment or other delivery of a drug or device under paragraph (a) (2) of this section shall expire:

(1) At the beginning of the act of removing such shipment or delivery, or

any part thereof, from such establishment if the drug or device 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 drug or device is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such clause.

(e) Except as provided in paragraphs (g) and (h) of this section, a shipment or other delivery of a drug which is subject to section 507 of the act and which is, in accordance with the practice of the trade, to be processed or repacked in a substantial quantity at an establishment other than that where originally processed or packed shall be exempt from compliance with the labeling requirements of section 502 (f) of the act during the time such drug is also exempt from the requirements of section 502 (1) of the act under the provisions of § 144.5 or § 144.6 of this chapter.

(f) Except as provided by paragraphs (g) and (h) of this section, a shipment or other delivery of a drug which is subject to section 507 of the act and which is, in accordance with the practice of the trade, to be labeled in substantial quantity at an establishment other than that where originally processed or packed shall be exempt from compliance with the labeling requirements of section 502 (b), (e) and (f) of the act during the time such drug is also exempt from the requirements of section 502 (1) of the act under § 144.3 of this chapter, if the words, statements, and other information required by section 502 (b) and (e) of the act appear on each shipping container of such drug.

(g) In case the person who introduced such shipment or other delivery into interstate commerce is the operator of the establishment where such drug is to be processed, labeled, or repacked, an exemption of such shipment or delivery under paragraph (e) or (f) of this section shall become void at the beginning of the act of removing such shipment or delivery or any part thereof from such establishment if the drug comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(h) In case the person who introduced such shipment or delivery into interstate commerce is not the operator of the establishment where such drug is to be

processed, labeled, or repacked, an exemption of a shipment or other delivery of such drug under paragraph (e) or (f) of this section shall expire at the beginning of the act of removing such shipment or delivery or any part thereof from such establishment if the drug comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(Sec. 503, 52 Stat. 1051, as amended; 21 U.S.C. 353) [20 F.R. 9534, Dec. 20, 1955, as amended at 22 F.R. 891, Feb. 13, 1957] § 1.108 Drugs and devices; statement of policy re Spanish-language versions of required labeling statements.

An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language. Such labeling is authorized under § 1.103 (c). Two required warnings, the wording of which is fixed by law in the English language, are presently being translated in various ways, from literal translation to loose interpretation. The statutory nature of these two statements requires that the translation must convey the meaning properly, in order to avoid confusion and dilution of the purposes of the warnings. The Commissioner of Food and Drugs hereby adopts the following Spanishlanguage versions as the accepted equivalents of the English wording of the following:

(a) Section 503(b) (4) of the Federal Food, Drug, and Cosmetic Act requires the statement "Caution: Federal law prohibits dispensing without prescription." The Spanish version of this shall be: "Precaucion: La ley Federal prohibe su despacho sin prescripcion facultativa."

(b) Section 502(d) of the Federal Food, Drug, and Cosmetic Act requires the statement "Warning-May be habit forming" on habit-forming drugs. The Spanish version of this shall be: "AvisoPuede formar habito o vicio."

(Secs. 502, 503; 53 Stat. 854, 65 Stat. 648; 21 U.S.C. 352, 353) [28 F.R. 5719, June 12, 1963]

is of value in the treatment of diabetes mellitus.

(b) The following substances, when they are intended for use in the manufacture of insulin-containing drugs that will subsequently be submitted for certification, shall not be considered to be subject to certification as "drugs composed wholly or partly of insulin":

(1) Pancreas glands; and

(2) Materials prepared from pancreas glands, such as "salt cake" and "isoelectric precipitate," which materials must be subjected to further purification in order to meet the standards of purity established by Part 164 of this chapter. (Sec. 506, 55 Stat. 851; 21 U.S.C. 356) [24 F.R. 5367, July 2, 1959]

COSMETICS

AUTHORITY: §§ 1.201 to 1.204 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted. §1.201 Cosmetic; labeling; misbranding.

(a) Among representations in labeling of a cosmetic which render such cosmetic misbranded is a false or misleading representation with respect to another cosmetic or a food, drug, or device.

(b) The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic 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. 602, 52 Stat. 1054, as amended; 21 U. S. C. 362)

§ 1.202 Cosmetic; labeling; required statements; exemptions.

(a) If a cosmetic 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 cosmetic such as "Manufactured for and Packed by "Distributed by or other similar phrase which expresses the facts.

other than his principal place of business, the label may state the principal place of business in lieu of the actual place where each package of such cosmetic 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 cosmetic from the requirement that its label shall not be misleading in any particular.

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

(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 to express quantity of such cosmetic and which give accurate information as to the quantity thereof. But if no general consumer usage in expressing accurate information as to the quantity of such cosmetic exists, the statement shall be in terms of liquid measure if the cosmetic is liquid, or in terms of weight if the cosmetic is solid, semisolid, or viscous, or in such terms of numerical count, or numerical count and weight or measure, as will give accurate information as to the quantity of the cosmetic in the package.

(f) (1) A statement of weight shall be in terms of the avoirdupois pound and ounce. A statement of liquid measure shall be in terms of the United States gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions thereof, and shall express the volume at 68° Fahrenheit (20° Centigrade). However, in the case of an export shipment, the statement may be in terms of a system of weight or measure in common use in the country to which such shipment is exported.

(2) A statement of weight or measure in the terms specified in subparagraph (1) of this paragraph may be supplemented by a statement in terms of the metric system of weight or measure.

(3) Unless an unqualified statement of numerical count gives accurate information as to the quantity of cosmetic in the package, it shall be supplemented by such statement of weight, measure, or

size of the individual units of the cosmetic as will give such information.

(g) Statements shall contain only such fractions as are generally used in expressing the quantity of the cosmetic. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places.

(h) (1) If the quantity of cosmetic in the package equals or exceeds the smallest unit of weight or measure which is specified in paragraph (f) of this section, and which is applicable to such cosmetic under the provisions of paragraph (e) (2) of this section, the statement shall express the number of the largest of such units contained in the package (for example, the statement on the label of a package which contains one pint of cosmetic shall be "1 pint" and not "16 fluid ounces"), unless the statement is made in accordance with the provisions of subparagraph (2) of this paragraph. 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 examples, 134 quarts may be expressed as "1 quart 11⁄2 pints" or "1 quart 1 pint 8 fluid ounces"; 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 examples, instead of "1 quart 16 fluid ounces" the statement shall be "12 quarts" or "1 quart 1 pint"; instead of "24 ounces" the statement shall be "11⁄2 pounds" or "1 pound 8 ounces").

(2) In the case of a cosmetic 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 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 shall be considered to express the average 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 caused by ordinary and customary exposure, after the cosmetic 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.

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

(1) Variations from the stated weight or measure shall be permitted when caused by ordinary and customary exposure, after the cosmetic 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 shall be permitted when caused by unavoidable deviations in weighing, measuring, or counting individual packages which occur in good packing practice. But under this subparagraph 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 cosmetic 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 cosmetic shall be exempt from compliance with the requirements of clause (2) of section 602 (b) of the act if the quantity of the contents of the package, as expressed in terms applicable to such cosmetic under the provisions of paragraph (e) (2) of this section, is less than one-fourth ounce avoirdupois, or less than one-eighth fluid ounce, or (in case the units of the cosmetic can be easily counted without opening the package) less than six units.

(Sec. 602, 52 Stat. 1054, as amended; 21 U. S. C. 362)

§ 1.203 Cosmetic; labeling requirements, form of stating.

(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 required by section 602 (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;

(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) (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: Provided, however, That in the case of articles distributed solely in a Territory where the predominant language is one other than English the predominant language may be substituted for English.

(2) If the label contains any representation in a foreign language, all

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