The Code of Federal Regulations of the United States of America
U.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 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.