Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 2000 |
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Page 3
... Medicated feed mill license 83 520 Oral dosage form new animal drugs ....... 87 522 Implantation or injectable dosage form new ani- mal drugs 210 ..... 524 Ophthalmic and topical dosage form new animal drugs 289 ...... 526 Intramammary ...
... Medicated feed mill license 83 520 Oral dosage form new animal drugs ....... 87 522 Implantation or injectable dosage form new ani- mal drugs 210 ..... 524 Ophthalmic and topical dosage form new animal drugs 289 ...... 526 Intramammary ...
Page 37
... medicated feed mill license application is in effect . 510.302 Reporting forms . 510.305 Maintenance of copies of approved medicated feed mill licenses to manufac- ture animal feed bearing or containing new animal drugs . Subpart E ...
... medicated feed mill license application is in effect . 510.302 Reporting forms . 510.305 Maintenance of copies of approved medicated feed mill licenses to manufac- ture animal feed bearing or containing new animal drugs . Subpart E ...
Page 44
... medicated feed mill license application is in effect . Records and reports of clinical and other experience with the new animal drug will be maintained and reported , appropriately identified with the new animal drug application ( s ) ...
... medicated feed mill license application is in effect . Records and reports of clinical and other experience with the new animal drug will be maintained and reported , appropriately identified with the new animal drug application ( s ) ...
Page 45
... medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs . Each applicant shall maintain in a single accessible location : ( a ) A copy of the approved medicated feed mill license ( Form FDA 3448 ) ...
... medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs . Each applicant shall maintain in a single accessible location : ( a ) A copy of the approved medicated feed mill license ( Form FDA 3448 ) ...
Page 46
... medicated free - choice feeds is subject to the current good manufacturing practice regulations for medicated feeds . ( b ) The Food and Drug Administra- tion has concluded that there are ques- tions about the safety and effectiveness ...
... medicated free - choice feeds is subject to the current good manufacturing practice regulations for medicated feeds . ( b ) The Food and Drug Administra- tion has concluded that there are ques- tions about the safety and effectiveness ...
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Common terms and phrases
50 milligrams acervulina acid amended Amount amoxicillin Amprolium animal drug animal feed application approved bacitracin bacterial Bambermycins body weight cattle caused by Eimeria chapter chlortetracycline coccidiosis coccidiosis caused coli Conditions of use-(1 contains daily days before slaughter dose erinarian Federal law restricts Feed continuously feeding practice Fenbendazole food additive Food and Drug gentamicin grams grams per pound hydrochloride Indications infections intramuscularly labeling lasalocid licensed veterinarian Limitations lincomycin manufac medicated feed melengestrol acetate ment milk milligrams milligrams per pound milliliter monensin necatrix neomycin Oesophagostomum oral dosage forms oxytetracycline P.O. Box paragraph percent pound of body prevention of coccidiosis rate of weight recognized as safe Related tolerances residues restricts this drug roundworms roxarsone sodium sole ration sole source Specifications spectinomycin Sponsor strongyles Subpart substance Sulfadimethoxine sulfamethazine sulfate swine tablets tains tenella tion tissue treatment turing or feeding tylosin veterinarian weight gain weight per day worms
Popular passages
Page 53 - ... 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 thereof.
Page 11 - 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 23 - ... 158 sq inches (1 sq ft 14 sq in)." (o) Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s) describing in nondeceptive terms the net quantity of contents, provided that such supplemental state-ments of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the drug contained in the package; for example, "giant pint
Page 30 - 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 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 drug...
Page 458 - Overseas Private Investment Corporation (Part 4301) XXXV Office of Personnel Management (Part 4501) XL Interstate Commerce Commission (Part 5001) XLI Commodity Futures Trading Commission (Part 5101...
Page 30 - ... if at any time prior to the enactment of this Act it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use...
Page 401 - Adoption of regulation on initiative of Commissioner. (a) The Commissioner upon his own initiative may propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used. Notice of such proposal shall be published in the FEDERAL REGISTER and shall state the reasons for the proposal.
Page 21 - 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 62 - 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...
Page 16 - 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 containers at a retail establishment, is displayed to the purchaser with either (1) the labeling of the bulk container plainly in view or (2) a counter card, sign, or other appropriate device bearing prominently and conspicuously the Information required to be...