The Code of Federal Regulations of the United States of America

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U.S. Government Printing Office, 1973 - 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 342 - ... Commodities), Department of Agriculture XII Statistical Reporting Service (Agricultural Statistics), Department of Agriculture XIV Commodity Credit Corporation, Department of Agriculture XV Foreign Agricultural Service, Department of Agriculture XVI Consumer and Marketing Service (Food Stamp Program), Department of Agriculture XVII...
Page 32 - ... the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity...
Page 32 - Administration with respect to such drug, there is lack of substantial 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...
Page 101 - If offered for use in arthritis, or rheumatism, in juxtaposition therewith, the statement : 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 32 - 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 160 - Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved...
Page 138 - Shall provide for current monitoring of the Investigation by a person qualified by scientific training and experience to evaluate information obtained from the Investigation, and shall promptly investigate and report to the Food and Drug Administration and to all Investigators any findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the new animal drug.
Page 297 - ... no residue of such drug will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (c), (d), and (h)), in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animals; he shall issue an order refusing to approve the application.
Page 27 - ... a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug...
Page 104 - Warning— Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 130° Fahrenheit may cause bursting.

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