The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1964 - Administrative law The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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Page 21
... intended . Directions for use may be inadequate because ( among other reasons ) of omis- sion , in whole or in part , or incorrect specification of : ( 1 ) Statements of all conditions , pur- poses , or uses for which such drug or ...
... intended . Directions for use may be inadequate because ( among other reasons ) of omis- sion , in whole or in part , or incorrect specification of : ( 1 ) Statements of all conditions , pur- poses , or uses for which such drug or ...
Page 23
... intended for administration by parenteral injection , the quantity or proportion of all inactive ingredients , except that ingredients added to adjust the pH or to make the drug isotonic may be declared by name and a statement of their ...
... intended for administration by parenteral injection , the quantity or proportion of all inactive ingredients , except that ingredients added to adjust the pH or to make the drug isotonic may be declared by name and a statement of their ...
Page 24
... intended for both human and veterinary use shall comply with paragraph ( b ) of this sec- tion and subparagraphs ( 4 ) and ( 5 ) of this paragraph . ( d ) Exemption for prescription de- vices . A device which , because of any ...
... intended for both human and veterinary use shall comply with paragraph ( b ) of this sec- tion and subparagraphs ( 4 ) and ( 5 ) of this paragraph . ( d ) Exemption for prescription de- vices . A device which , because of any ...
Page 25
... intended for a use which re- sults in the preparation of a new drug , unless an effective new - drug application provides for such use . ( j ) Exemption for diagnostic reagents . A drug intended solely for use in the pro- fessional ...
... intended for a use which re- sults in the preparation of a new drug , unless an effective new - drug application provides for such use . ( j ) Exemption for diagnostic reagents . A drug intended solely for use in the pro- fessional ...
Page 26
... intended uses of an article may change after it has been introduced into interstate com- merce by its manufacturer . If , for ex- ample , a packer , distributor , or seller intends an article for different uses than those intended by ...
... intended uses of an article may change after it has been introduced into interstate com- merce by its manufacturer . If , for ex- ample , a packer , distributor , or seller intends an article for different uses than those intended by ...
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Common terms and phrases
0.2 percent 52 Stat acetate added alcohol Amprolium application bacitracin bear the statement blank being filled calcium cheese chickens chloride Chlortetracycline coating colby cheese color additive combination Component container copolymer corn sirup curd D&C Red definition and standard dosage dried exceed exemption extract Federal Food feed flavoring flour food additive Food and Drug food packaging fruit glucose sirup glycol grams gredients Hygromycin ingredients specified July June 30 label shall bear label statement less manufacturing ment method prescribed methyl milligrams milliliters million mixture Nystatin optional ingredients oxide Oxytetracycline oysters packing percent by weight phenol phosphate potassium prepared process cheese quantity regulation resin safely salt sample shrimp sieve sirup skim milk sodium solids specified in paragraph spice standard of identity statement of optional streptomycin subparagraph Subpart substances sugar sulfate tion titanium trichloride tolerances for residues units wheat
Popular passages
Page 573 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 9 - 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...
Page 316 - pesticide chemical," as denned in § 201 (q) of the act, means any substance which, alone, in chemical combination, or in formulation with one or more other substances, is an "economic poison...
Page 570 - The investigator certifies that the drug will be administered only to subjects under his personal supervision or under the supervision of the following investigators responsible to him, , and that the drug will not be supplied to any other investigator or to any clinic for administration to subjects. g. The investigator certifies that he will inform any subjects, including subjects used as controls, or their representatives, that drugs are being used for investigational purposes, and will obtain...
Page 61 - for the temporary relief of minor aches and pains" should appear with the same degree of prominence and conspicuousness as the phrase "arthritis and rheumatism". The label and labeling should bear in juxtaposition with such directions for use conspicuous warning statements to the effect: "Caution: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.
Page 565 - A statement of the methods, facilities, and controls used for the manufacturing. processing, and packing of the new drug to establish and maintain appropriate standards of Identity, strength, quality, and purity as needed for safety and to give significance to clinical Investigations made with the drug.
Page 6 - The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there Is a material weight of opinion contrary to such representation.
Page 28 - The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food 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.
Page 7 - If a person manufactures, packs, or distributes a food 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...
Page 574 - Each substance should be identified by its established name, if any, or complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified.