Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index, Issue 21, Parts 500-599Division of the Federal Register, the National Archives, 1993 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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Common terms and phrases
50 milligrams acid administered amended Amount Ampicillin Amprolium animal drug animal feed application approved bacitracin bacterial Bambermycins body weight Broiler chickens brunetti cattle chapter chlortetracycline coccidiosis coccidiosis caused coli Conditions of use-(1 contains daily days before slaughter dose edible tissues erythromycin facturing or feeding Federal law restricts Feed continuously feeding practice Fenbendazole food additive Food and Drug grams grams per pound hydrochloride Indications infections labeling lasalocid licensed veterinarian Limitations lincomycin manu medicated feed melengestrol acetate ment milligrams milligrams per pound milliliter monensin NAS/NRC necatrix neomycin oxytetracycline P.O. Box paragraph penicillin percent pound of body prevention of coccidiosis rate of weight recognized as safe Related tolerances residues restricts this drug retort roundworms roxarsone sodium sole ration sole source solution Specifications Sponsor sterile strongyles Subpart substance sulfamethazine sulfate swine swine dysentery tablets tains tenella tion treat treatment tylosin veterinarian weight gain weight per day worms
Popular passages
Page 114 - ... substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. . . . [T]he term "substantial evidence...
Page 111 - ... 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, or suggested in the labeling or proposed labeling...
Page 68 - new drug" means — (1) 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 is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of...
Page 111 - ... (2) 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...
Page 69 - The composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions...
Page 111 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions...
Page 12 - If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.
Page 19 - An exemption of a shipment or other delivery of a food under paragraph (d)(l) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment become void ab initio if the...
Page 9 - If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.
Page 115 - ... of new information before him, evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...