Animal Drug Amendments of 1965: Hearing, Eighty-ninth Congress, Second Session. June 13, 1966

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Page 4 - As used in this subsection and subsection (e) of this section, 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,...
Page 2 - ... a full list of the articles used as components of such drug; (c) a full statement of the composition of such drug; (d) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of such drug...
Page 1 - Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That...
Page 9 - Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug...
Page 3 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 48 - Act snail not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.
Page 6 - ... (6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that clauses (1) through (6) do not apply, he shall issue an order approving the application. As used in this subsection and subsection (e) the term 'substantial evidence...
Page 5 - Secretary's order. (i) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Page 18 - ... worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, are hereby prohibited. The Secretary of Agriculture...
Page 18 - ... no residue of such drug will be found (by methods of examination prescribed or approved by the Secretary...

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