(ii) Specified in a prescription, which was issued by a physician, dentist, or veterinarian in his professional practice, upon which such drug or device was dispensed; or (iii) Required by an official compendium. (6) In the case of a drug which is not designated solely by a name recognized in an official compendium and which is fabricated from two or more ingredients, its label also bears a statement of the quantity or proportion of each active ingredient. (c) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug which cannot be exempted under paragraph (b) of this section because of the provisions of subparagraph (1) thereof also shall be exempt from the requirements of section 502 (f) (1) of the act if it complies with all of the conditions set forth in paragraph (b) (4) and (5) of this section and with all of the following additional conditions: (1) Such drug is not a liquid solution, emulsion, or suspension and is not in tablet, capsule, or other unit form. (2) The name whereby such drug is designated in its label is recognized in an official compendium. (3) Such drug is ordinarily compounded with other substances before it is dispensed. (4) Such shipment or delivery is to be: (i) Compounded with other substances in filling prescriptions issued by physicians, dentists, or veterinarians in their professional practice; or (ii) Used in the manufacture of another drug. (d) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug which cannot be exempted under paragraph (b) of this section because of the provisions of subparagraph (1) thereof also shall be exempt from the requirements of section 502 (f) (1) of the act if it is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, of other drugs. (e) Except as otherwise provided by paragraphs (h) and (i) of this section, a shipment or other delivery of a drug or device also shall be exempt from the requirements of section 502 (f) (1) of the act if it complies with all the conditions set forth in paragraphs (b) (3) and (6) of this section and if such shipment or delivery is made to a physician, dentist, veterinarian, hospital, or clinic to be dispensed by or under the direction of physicians, dentists, or veterinarians in their professional prac tice. (f) A shipment or other delivery of a drug or device also shall be exempt from the requirements of section 502 (f) (1) of the act if it is made to a dealer or manufacturer to be used in the manufacture of another drug or device and its label bears the statement "For manufacturing use only." (g) A shipment or other delivery of a drug or device also shall be exempt from the requirements of section 502 (f) (1) of the act with respect to common uses, adequate directions for which are known by the ordinary individual. (h) No shipment or other delivery of any drug shall be exempt under any provision of this section from any requirement of section 502 (f) (1) of the act unless its labeling bears the information concerning its use which is contained in the labeling upon the basis of which an application under section 505 of the act is effective with respect to such drug. (i) No exemption under any provision of this section shall apply to any shipment or other delivery of: (1) A drug if its advertising disseminated or sponsored by or on behalf of its manufacturer, packer, or other person responsible for making such shipment or delivery, contains any representation not borne by its labeling and which, if so borne, would make it a new drug; (2) A drug intended for administration by iontophoresis or by injection into or through the skin or mucous membrane; or (3) A drug or device if such shipment or delivery is made in the course of the conduct of a business of dispensing drugs or devices pursuant to diagnosis by mail. (j) If a shipment or other delivery, or any part thereof, of a drug or device which is exempt under paragraph (b), (c), (e), or (f) of this section is disposed of for any purpose other than those specified in such paragraph, such exemption shall expire, with respect to such shipment or delivery or part thereof which is so disposed of, at the beginning of the act of such disposal. The causing of an exemption so to expire shall be considered to be an act which results in such drug or device being misbranded unless, prior to such disposal, it is relabeled to comply with the requirements of section 502 (f) (1) of the act, or it is disposed of for use otherwise than as a drug or device. (k) For the purposes of this section: (1) The term "manufacture" does not include the use of a drug as an ingredient in compounding any prescription issued by a physician, dentist, or veterinarian in his professional practice. (2) The terms "physician", "dentist", and "veterinarian", as used in relation to the exemption of any drug or device, include only those physicians, dentists, and veterinarians who are licensed by law to administer or apply such drug or device. CODIFICATION: Former paragraphs (b) and (c) were deleted, and paragraphs (b)-(k) as set forth above were substituted in lieu thereof, by Regulations, Federal Security Administrator, Oct. 9, 1944, effective one year from that date, 9 F.R. 12255. § 2.110 New drugs; applications. (b) An application shall not be accepted for filing if only one copy is submitted or if it is incomplete on its face in that (1) It does not contain all the matter required by clauses (1), (2), (3), (4), and (6) of section 505 (b) of the act; (2) It does not state the conditions under which the drug is to be used; or (3) The specimens of labeling proposed for use upon or within the retail package do not expressly or by reference to a brochure or other printed matter prescribe, recommend, or suggest the use of such drug under such conditions. The Food and Drug Administration shall notify the applicant of such nonacceptance and the reason therefor and, in case of incompleteness as to matter required by any clause of section 505 (b), shall specify such clause. Otherwise the date on which an application is received by the Agency shall be considered to be the date on which such application is filed, and the Food and Drug Administration shall notify the applicant of such date. If the applicant withdraws his application, such application shall be considered as not having been filed. [Paragraph (b) amended Oct. 9, 1944, effective Oct. 10, 1944, 9 F.R. 12256] (d) After an application has become effective with respect to a drug the applicant may file a supplemental application with respect thereto setting forth any proposed change in the conditions under which such drug is to be used, in the labeling thereof, in any circumstance relating to its production, or in any other information contained in the effective application. Such supplemental application may omit statements made in the effective application concerning which no change is proposed. [Paragraph (d) added Oct. 9, 1944, effective Oct. 10, 1944, 9 F.R. 12256] § 2.112 Insufficient information in application. The information contained in an application may be insufficient for the Administrator to determine whether a drug is safe for use if it fails to include (among other things) a statement showing whether the drug is to be exempt under any provision of § 2.106, as amended, promulgated pursuant to section 502 (f) of the act, from the requirement that its labeling bear adequate directions for use. If the drug is to be so exempt the information may also be insufficient if: (1) The specimen label of the drug fails to incorporate by reference a specifically identified brochure or other printed matter containing information adequate for the use of such drug by physicians, dentists, or veterinarians, as the case may be; (2) Such label fails to state that the drug is to be used as shown in such brochure or printed matter and that such brochure or printed matter will be sent to physicians, dentists, or veterinarians, as the case may be, on request; (3) The application fails to contain copies of such brochure or printed matter; or (4) The application fails to show that such brochure or printed matter is readily available to physicians, dentists, or veterinarians, as the case may be, or if not that it is to be made so when the application becomes effective. (52 Stat. 1055; 21 U.S.C. 371 (a)) [Reg., Oct. 9, 1944, effective Oct. 10, 1944, 9 F.R. 122561 § 2.113 Untrue statements in application. Among the reasons why an application may contain an untrue statement of a material fact are changes in: (1) Conditions of use prescribed, recommended, or suggested by the applicant for the drug from the conditions of such use stated in the application; (2) Articles used as components of the drug from those listed in the application; (3) Composition of the drug from that stated in the application; (4) Methods used in, or the facilities or controls used for, the manufacture, processing, or packing of the drug from such methods, facilities, and controls described in the application; and (5) Labeling from the specimens contained in the application. (52 Stat. 1055; 21 U.S.C. 371 (a)) [Reg., Oct. 9, 1944, effective Oct. 10, 1944, 9 F.R. 12257] Sec. 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 PART 14-CACAO PRODUCTS Cacao nibs, cocoa nibs, cracked cocoa, Cocoa, medium fat cocoa, identity; label statement of optional ingredients. Low-fat cocoa, identity; label statement of optional ingredients. Sweet chocolate, sweet chocolate coating, identity; label statement of optional ingredients. Milk chocolate, sweet milk chocolate, milk chocolate coating, sweet milk chocolate coating, identity; label statement of optional ingredients. Skim milk chocolate, sweet skim milk chocolate, skim milk chocolate coating, sweet skim milk chocolate coating, identity; label statement of optional ingredients. Buttermilk chocolate, buttermilk chocolate coating, identity; label statement of optional ingredients. 14.10 Mixed dairy product chocolates, mixed dairy product chocolate coatings, identity; label statement of optional ingredients. Sweet chocolate and vegetable fat (other than cacao fat) coating. identity; label statement of optional ingredients. 14.9 14.11 AUTHORITY: §§ 14.1 to 14.12, inclusive, issued under secs. 401, 701, 52 Stat. 1046, 1055, as amended; 21 U.S.C. 341, 371. SOURCE: §§ 14.1 to 14.12, inclusive, contained in FDC-26, Acting Administrator, Dec. 4, 1944, effective Apr. 1, 1945, 9 F.R. 14334. NOTE: For findings of fact with respect to Part 14, see 9 F.R. 14329. § 14.1 Cacao nibs, cocoa nibs, cracked cocoa, identify; label statement of optiona! ingredients. (a) Cacao nibs, cocoa nibs, cracked cocoa is the food prepared by heating and cracking dried or cured and cleaned cacao beans and removing shell therefrom. Cacao nibs or the cacao beans from which they are prepared may be processed by heating with one or more of the following optional alkali ingredients, added as such Bicarbonate, or in aqueous solution: carbonate, or hydroxide of sodium, ammonium, or potassium; or carbonate or oxide of magnesium; but for each 100 parts by weight of cacao nibs used, as such or before shelling from the cacao beans, the total quantity of such alkalis used is not greater in neutralizing value (calculated from the respective combining weights of such alkalis used) than the neutralizing value of 3 parts by weight of anhydrous potassium carbonate. The cacao shell content of cacao nibs is not more than 1.75 percent by weight (calculated to an alkali-free basis if they or the cacao beans from which they were prepared have been processed with alkali), as determined by the method prescribed under "Shell in Cacao Nibs-Tentative" beginning on page 208 of "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists", 5th Ed., 1940. (b) When cacao nibs or the cacao beans from which they are prepared are processed, in whole or in part, with any optional alkali ingredient specified in paragraph (a) of this section, the label shall bear the statement "Processed with Alkali"; but in lieu of the word "Alkali" in such statement the specific common name of the optional alkali ingredient may be used. Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, such statement shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter. § 14.2 Chocolate liquor, chocolate, baking chocolate, bitter chocolate, cooking chocolate, chocolate coating, bitter chocolate coating, identity; label statement of optional ingredients. (a) Chocolate liquor, chocolate, baking chocolate, bitter chocolate, cooking chocolate, chocolate coating, bitter chocolate coating is the solid or semiplastic food prepared by finely grinding cacao nibs. To such ground cacao nibs, cacao fat or a cocoa or both may be added in quantities needed to adjust the cacao fat content of the finished chocolate liquor. (For the purposes of this section the term "cocoa❞ means breakfast cocoa, cocoa, low-fat cocoa, or any mixture of two or more of these.) Chocolate liquor may be spiced, flavored, or otherwise seasoned with one or more of the following optional ingredients, other than any such ingredient or combination of ingredients specified in subparagraphs (1), (2), or (3) which imparts a flavor that imitates the flavor of chocolate, milk, or butter: (1) Ground spice. (2) Ground vanilla beans; any natural food flavoring oil, oleoresin, or extract. (3) Vanillin, ethyl vanillin, coumarin, or other artificial food flavoring. (4) Butter, milk fat, dried malted cereal extract, ground coffee, ground nut meats. (5) Salt. Any optional ingredient used with the cacao beans or cacao nibs from which such chocolate liquor is prepared, or used with any cocoa added in preparing such chocolate liquor, shall be considered to be an optional ingredient used with such chocolate liquor. The optional alkali ingredients specified for use with cacao nibs in § 14.1 (a) may be used as optional ingredients with chocolate liquor; but for each 100 parts by weight of cacao nibs used in preparing the chocolate liquor. the total quantity of such alkalis used is not greater in neutralizing value (calculated from the respective combining weights of such alkalis used) than 3 parts by weight of anhydrous potassium carbonate. The finished chocolate liquor contains not less than 50 percent and not more than 58 percent by weight of cacao fat. Unless the chocolate liquor is seasoned with butter, milk fat, or ground nut meats, the percentage of cacao fat is determined by the method prescribed under "Fat Method I-Official" beginning on page 202 of "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists", 5th Ed., 1940. (b) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements hereinafter prescribed showing the optional ingredients used shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter. (1) When the. food is seasoned with an optional ingredient specified in subparagraph (a) (1) of this section the label shall bear the statement "Spiced", "Spice Added", "With Added Spice", "Spiced With .. or "With Added the blank being filled in with the specific common name of the spice used. (2) When the food is flavored with an optional ingredient specified in paragraph (a) (2) of this section, the label shall bear the statement "Flavored", "Flavoring Added", "With Added Flavoring", "Flavored With Added", or "With Added ", the blank being filled in with the specific common name of the flavoring used. 66 (4) When the food is seasoned with an optional ingredient specified in paragraph (a) (4) of this section, the label shall bear the statement "Seasoned With ..", the blank being filled in with the specific common name of the substance used as seasoning. (5) When any optional alkali ingredient specified in § 14.1 (a) is used, the label shall bear the statement "Processed with Alkali"; but in lieu of the word "Alkali" in such statement the specific common name of the optional alkali ingredient may be used. Label statements prescribed by subpara_raphs (1) to (4), inclusive, of this paragraph may be combined, as for example, "With Added Cinnamon, Vanilla, and Coumarin, An Artificial Flavoring." § 14.3 Breakfast cocoa, high fat cocoa, identity; label statement of optional ingredients. (a) Breakfast cocoa, high fat cocoa is the food prepared by pulverizing the residual material remaining after part of the cacao fat has been removed from ground cacao nibs. It may be spiced, flavored, or otherwise seasoned with one or more of the following optional ingredients, other than any such ingredient or combination of ingredients which imparts a flavor that imitates the flavor of chocolate, milk, or butter: (1) Ground spice. (2) Ground vanilla beans; any natural food flavoring oil, oleoresin, or extract. (3) Vanillin, ethyl vanillin, coumarin, or other artificial food flavoring. (4) Salt. Any optional ingredient used with the cacao beans, cacao nibs, or ground cacao nibs from which such breakfast cocoa is prepared shall be considered to be an optional ingredient used with such breakfast cocoa. The optional alkali ingredients specified for use with cacao nibs in § 14.1 (a) may be used as optional ingredients with breakfast cocoa; but for each 100 parts by weight of cacao nibs used in preparing the breakfast cocoa, the total quantity of such alkalis used is not greater in neutralizing value (calculated from the respective combining weights of such alkalis used) than 3 parts by weight of anhydrous potassium carbonate. The finished breakfast cocoa contains not less than 22 percent of cacao fat, as determined by the method prescribed under "Fat Method I-Official" beginning on page 202 of "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," 5th Ed., 1940. (b) Wherever the name of the food appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the statements hereinafter prescribed showing the optional ingredients used shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter: (1) When the food is seasoned with an optional ingredient specified in paragraph (a) (1) of this section, the label shall bear the statement "Spiced", "Spice Added", "With Added Spice", "Spiced With", or "With Added ----", the blank being filled in with the specific common name of the spice used. (2) When the food is flavored with an optional ingredient specified in subparagraph (a) (2) of this section, the label shall bear the statement. "Flavored", "Flavoring Added", "With Added Flavoring", "Flavored With Added", or "With Added ----", the blank being filled in with the specific common name of the flavoring used. (3) When the food is flavored with an optional ingredient specified in paragraph (a) (3) of this section, the label shall bear the statement "Artificially Flavored", "Artificial Flavoring Added", "With Artificial Flavoring", "Artificially Flavored With ", or "With An Artificial Flavoring", the blank being filled in with the specific common name of the artificial flavoring used. (4) When any optional alkali ingredient specified in § 14.1 (a) is used, the label shall bear the statement "Processed With Alkali"; but in lieu of the word "Alkali" in such statement the specific common name of the optional alkali ingredient may be used. Label statements prescribed by subparagraphs (1) to (4), inclusive, of this paragraph may be combined, as for example, "With Added Cinnamon, Vanilla, and Coumarin, An Artificial Flavoring." § 14.4 Cocoa, medium fat cocoa, identity; label statement of optional ingredients. Cocoa, medium fat cocoa conforms to the definition and standard of identity, and is subject to the requirements for label statement of optional ingredients, prescribed for breakfast cocoa by § 14.3, except that it contains less than 22 percent but not less than 10 percent of cacao fat, as determined by the method referred to in § 14.3 (a). § 14.5 Low-fat cocoa, identity; label statement of optional ingredients. Lowfat cocoa conforms to the definition and standard of identity, and is subject to the requirements for label statement of optional ingredients, prescribed for breakfast cocoa by § 14.3, except that it contains less than 10 percent of cacao fat, as determined by the method referred to in § 14.3 (a). § 14.6 Sweet chocolate, sweet chocolate coating, identity; label statement of optional ingredients. (a) Sweet chocolate, sweet chocolate coating is the solid or semiplastic food the ingredients of which are intimately mixed and ground, prepared from chocolate liquor (with or without the addition of cacao fat) |