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 18
... reasonably related to the size and prominence of the front - panel display . ( i ) A drug packaged in a container too small or otherwise unable to accommo- date a label with sufficient space to bear the information required for ...
... reasonably related to the size and prominence of the front - panel display . ( i ) A drug packaged in a container too small or otherwise unable to accommo- date a label with sufficient space to bear the information required for ...
Page 20
... reasonably close association with the information concerning effec- tiveness and shall have the same relative degree of prominence as the information concerning effectiveness , taking into ac- count all pertinent factors , including ...
... reasonably close association with the information concerning effec- tiveness and shall have the same relative degree of prominence as the information concerning effectiveness , taking into ac- count all pertinent factors , including ...
Page 29
... reasonably large . ( k ) Where the statement does not ex- press the minimum quantity : ( 1 ) Variations from the stated weight or measure shall be permitted when caused by ordinary and customary ex- posure , after the cosmetic is ...
... reasonably large . ( k ) Where the statement does not ex- press the minimum quantity : ( 1 ) Variations from the stated weight or measure shall be permitted when caused by ordinary and customary ex- posure , after the cosmetic is ...
Page 33
... reasonably accessible for sam- pling is less than twice the quantity so estimated ; ( 2 ) The cost of twice the quantity so estimated exceeds $ 10 ; ( 3 ) The article is perishable ; ( 4 ) The sample is collected from a shipment or ...
... reasonably accessible for sam- pling is less than twice the quantity so estimated ; ( 2 ) The cost of twice the quantity so estimated exceeds $ 10 ; ( 3 ) The article is perishable ; ( 4 ) The sample is collected from a shipment or ...
Page 46
... reasonably be selected by the grocer for display purposes at the point of sale . ( f ) The amendment covering colored oleomargarine or colored margarine states that , " for the purposes of section 407 of the Federal Food , Drug , and ...
... reasonably be selected by the grocer for display purposes at the point of sale . ( f ) The amendment covering colored oleomargarine or colored margarine states that , " for the purposes of section 407 of the Federal Food , Drug , and ...
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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.