The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1987 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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82 Stat acid administered amended Amount amoxicillin Amprolium animal drug animal feed antibiotic application aqueous bacitracin bacterial body weight cattle chapter chloramphenicol chlortetracycline cloxacillin coccidiosis coccidiosis caused Conditions days before slaughter dihydrostreptomycin dosage forms dose erythromycin facturing or feeding Federal law restricts Feed continuously feed efficiency feeding practice follows Food and Drug g/ton grams grams per pound hydrochloride Indications infections labeling lasalocid licensed veterinarian Limitations manu ment milligrams milligrams per pound milliliter monensin mycin NAS/NRC neomycin novobiocin oral oxytetracycline P.O. Box package paragraph percent phosphate polymyxin potassium pound of body prevention of coccidiosis Proceed as directed recognized as safe Related tolerances Requirements for certification residues restricts this drug retort roxarsone sample sodium sole ration sole source Specifications Sponsor Standards of identity sterile streptomycin strongyles Subpart substance sulfamethazine sulfate swine tablets tains Tests and methods tetracycline tion treat treatment tylosin veterinarian
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129. lappuse - 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,...
133. lappuse - ... 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...
133. lappuse - ... were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug...
25. lappuse - The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, they may be employed. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places. A statement...
133. lappuse - 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...
16. lappuse - Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as "Manufactured for ", "Distributed by ", or any other wording that expresses the facts.
75. lappuse - 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.
14. lappuse - 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.
74. lappuse - ... drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a "new animal drug...
19. lappuse - ... artificial flavoring, artificial coloring, or chemical preservative, as the case may be, cannot be placed on such units with such conspicuousness as to render it likely to be read by the ordinary individual under customary conditions of purchase and use. (e) A food shall be exempt while held for sale from the requirements of section 403(k) of the act (requiring label statement of any artificial flavoring, artificial coloring, or chemical preservatives) if said food, having been received in bulk...