(4) Such person keeps the statement referred to in subparagraph (3) of this paragraph, and complete records showing the date, quantity, and batch or code mark (if any), of each such shipment and delivery.

(5) Such person makes all records and statements referred to in subparagraphs (3) and (4) of this paragraph available for inspection upon the request of any officer or employee of the Agency at any reasonable hour until 3 years after the introduction of such shipment or delivery into interstate commerce.

(b) A shipment or other delivery of a new drug which is being imported or offered for import into the United States shall be exempt from the operation of section 505 (a) of the act if all of the following conditions are complied with:

(1) The label of such drug bears the statement "Caution: New drug-Limited by United States law to investigational use."

(2) The importer of all such shipments or deliveries is an agent of the foreign exporter, residing in the United States, or the operator of an establishment in the United States which has facilities for regularly investigating the safety of such drugs, which facilities are manned by experts qualified by scientific training and experience to conduct such investigation.

(3) Such operator uses such drug solely for such investigation in such establishment, or such operator or agent otherwise disposes of such drug only to, and solely for investigational use by or under the direction of, such an expert other than one in such establishment.

(4) Such importer, prior to disposing of any of such drug to such an expert, obtains a statement signed by such expert showing that he has adequate facilities for the investigation to be conducted by him, and that such drug will be used solely by him or under his direction for the investigation, unless and until an application becomes effective with respect to such drug under section 505 of the act. This subparagraph shall not apply to any shipment or delivery or part thereof disposed of by such importer to an agency of the Government of the United States (including the National Research Council) or of any State or municipality whose official functions involve investigations of new drugs by such experts.

(5) Such importer keeps the statement referred to in subparagraph (4) of this paragraph and complete records showing the date, quantity, and batch or code marks (if any), of each such shipment and delivery and the disposition thereof.

(6) Such importer makes all statements and records referred to in subparagraphs (4) and (5) of this paragraph available for inspection upon the request of any officer or employee of the Agency at any reasonable hour until 3 years after disposition by such importer of the lot of such drug to which such statement and records relate.

(c) An exemption under paragraph (a) or (b) of this section shall become void ab initio if any record or statement required by such paragraph to be kept and made available for inspection is not kept or made available as so required.

(d) An exemption under paragraph (a) or (b) of this section shall expire with respect to any exempted shipment or delivery or part thereof which has been supplied to an expert who has signed the statement referred to in paragraph (a) (3) or (b) (4) of this section and which is used otherwise than in accordance with such signed statement.

(e) An exemption under paragraph (b) of this section shall become void ab initio if the exempted shipment or delivery or any part thereof is disposed of otherwise than as provided by subparagraph (3) of such paragraph.

(f) No exemption under paragraph (b) of this section shall apply to any shipment or delivery to such importer if such importer, within 3 years prior to the offering of such shipment or delivery for import, has caused an exemption to become void as provided by paragraph (c) or (e) of this section.

(Sec. 505 (1), 52 Stat. 1052; 21 U. S. C. 355 (i)) [13 F. R. 6555]

§ 1.115 Definition of term “insulin.” For the purposes of sections 502 (k) and 506 of the act, the term "insulin" as used therein means the active principle of pancreas which affects the metabolism of carbohydrate in the animal body and which is of value in the treatment of diabetes mellitus. [7 F. R. 776]

COSMETICS

AUTHORITY: §§ 1.200 to 1.204 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: §§ 1.200 to 1.204 appear at 3 F. R. 3168, redesignated at 13 F. R. 6969.

§ 1.200 Cosmetic; coal-tar hair dye defined. The term "coal-tar hair dye" includes all articles containing any coaltar color or intermediate which color or intermediate alters the color of the hair when such articles are applied to the hair under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.

(Sec. 601 (a), 52 Stat. 1054; 21 U. S. C. 361 (a))

§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 (a), 52 Stat. 1054; 21 U. S. C. 362 (a))

§ 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.

(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 cosmetic at a place 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 "12 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.

If

(i) The statement shall express the minimum quantity, or the average quantity, of the contents of the packages. 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 (b), 52 Stat. 1054; 21 U. S. C. 362 (b))

§ 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.

(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. 602 (c), 52 Stat. 1054; 21 U. S. C. 362 (c))

§ 1.204 Cosmetic; labeling requirements; exemptions. (a) Except as pro

vided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic 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 requirements of sections 601 (a) and 602 (b) of the act if:

(1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such cosmetic 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 cosmetic in such establishment as will insure, if such specifications are followed, that such cosmetic 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 all such shipment or delivery has been removed from such establishments, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the agency who requests them.

(b) An exemption of a shipment or other delivery of a cosmetic 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 cosmetic 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 cosmetic 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 clause.

(d) An exemption of a shipment or other delivery of a cosmetic under para

graph (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 cosmetic 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 cosmetic is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such clause.

(Sec. 603, 52 Stat. 1054; 21 U. S. C. 363)

IMPORTS AND EXPORTS

AUTHORITY: §§ 1.302 to 1.312 issued under sec. 701 (b), 52 Stat. 1055; 21 U. S. C. 371 (b). Interpret or apply sec. 801, 52 Stat. 1058; 21 U. S. C. 381.

SOURCE: §§ 1.302 to 1.312 appear at 4 F. R. 1549, redesignated at 13 F. R. 6969. Exceptions are noted following section affected.

§ 1.302 Bonds; delivery; sampling. (a) No food, drug, device, or cosmetic shall be delivered to the consignee prior to report of examination of such article, or prior to the stamping of the invoice as prescribed by paragraph (b) of this section showing that no sample is desired, except upon the execution on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of the merchandise, or any part thereof, upon demand of the collector of customs at any time, in such amount as is prescribed for such bonds in the customs regulations in force on the date of entry. The bond shall be filed with the collector of customs, who, in case of default, shall take appropriate action to effect the collection of liquidated damages provided for in the bond.

(b) As soon as the importer makes entry of an article, the invoice covering it and the package of it designated by the collector of customs for examination shall be made available with the least possible delay, for inspection by a representative of the district. When a sample is desired the representative shall request the collector of customs or the appropriate customs officer therefor, indicating the size of the sample. When no sample is desired the invoice shall be stamped by the representative "No sample desired. Food and Drug Administration, Federal Security Agency, per (initials of the representative).”

(c) (1) At ports of entry where there is no laboratory of the Food and Drug Administration the collector of customs or appropriate customs officer shall, on the day of receipt of the first notice, by invoice or entry, of an expected shipment of articles subject to the act, notify the chief of district, within whose territory the port is located, of the expected shipment.

(2) If no sample is desired, the chief of district, on the day he receives the notice, shall advise the collector of customs or appropriate customs officer by mail to that effect. Such advice shall be equivalent to stamping invoices at ports where districts are located with the statement prescribed in paragraph (b) of this section.

(3) If a sample is desired, the chief of district shall immediately request the collector of customs or appropriate customs officer to forward it and indicate the size of sample.

(4) Upon receipt of such request the collector of customs or appropriate customs officer shall forward the sample without delay, together with a description of the shipment.

(5) When samples will be desired from each shipment of a particular article or when samples will not be desired, the chief of district shall furnish, at least every 6 months, to collectors of customs or appropriate customs officers within the district territory, a list of such articles and on the list of articles of which samples will be desired, shall indicate the size of sample for each such article. Upon the arrival of shipments of articles appearing on the list of samples which will be desired, the collectors of customs or appropriate customs officers shall send such samples to the district without delay, together with a description of the shipments. The list of articles, samples of which will not be requested, shall be treated as the equivalent of paragraph (b) of this section and the invoices of such articles shall be handled accordingly.

(6) In all particulars the procedure shall be the same at non-laboratory ports as at laboratory ports except that the time consumed in delivery by mail of the notice of hearing shall be allowed for.

§ 1.303 Jurisdiction. (a) Whether or not an article is in compliance with or in violation of the provisions of sec