The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1971 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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100 milliliters 85 percent addition to complying agar amended at 29 ampicillin antibiotic aqueous bacitracin batch mark batch was certified batch was completed benzathine penicillin blank being filled capsules chapter chloramphenicol chlortetracycline cillin cloxacillin conforms containing approximately contains not less crystalline penicillin Demeclocycline dihydrostreptomycin dilute distilled water flask Food and Drug grams hydrochloride immediate container ingredient labeling latest assay less than 85 micrograms milliliter months mycin nafcillin neomycin new-drug number of milligrams number of units nystatin ointment oleandomycin oxacillin package shall bear packaged for dispensing paragraph penicillin G content person shall submit person who requests polymyxin potassium phosphate potency previously submitted procaine penicillin Proceed as directed purity represented to contain request for certification requests certification requirements prescribed showing the batch sodium Standards of identity sterility streptomycin submit in connection subpara suitable and harmless sulfate tablets tainer tests and assays tetracycline tetracycline hydrochloride tion toxicity units per milliliter
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xvi. lappuse - ... c. The investigator is required to prepare and maintain adequate and accurate case histories designed to record all observations and other data pertinent to the Investigation on each individual treated with the drug or employed as a control In the investigation. d. The investigator is required to furnish his reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained by various investigators. The sponsor is required to present progress reports to the...
28. lappuse - Administration with respect to the drug, evaluated together with the evidence available when the application was approved, that there is a lack of 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 labeling thereof...
xiii. lappuse - The approximate number of subjects (a reasonable range of subjects is permissible and additions may be made), and criteria proposed for subject selection by age, sex, and condition. Iv. The estimated duration of the clinical trial and the intervals, not exceeding 1 year, at which progress reports showing the results of the investigations will be submitted to the Food and Drug Administration.
77. lappuse - Jan. 29, 1965] § 133.12 Distribution records. Complete records shall be maintained of the distribution of each batch of drug in a manner that will facilitate its recall if necessary. Such records shall be retained for at least 2 years after distribution has been completed, and shall include the name and address of the consignee, the date and quantity shipped, and the lot or control numbers identifying the batch of drug.
573. lappuse - Serious and even fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia) are known to occur after the administration of chloramphenicol. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Bearing in mind the possibility that such reactions may occur, chloramphenicol should be used only for serious infections caused by organisms that are susceptible to its antibacterial effects.
xiii. lappuse - ... safety and effectiveness and optimum dosage schedules in the diagnosis, treatment, or prophylaxis of groups of subjects involving a given disease or condition. A reasonable protocol is developed on the basis of the facts accumulated in the earlier phases, including completed and submitted animal studies. This phase is conducted by separate groups following the same protocol (with reasonable variations and alternatives permitted by the plan) to produce well-controlled clinical data. For this phase,...
74. lappuse - medicated premix" means a substance that meets the definition in § 121.200 of this chapter for a "feed additive premix," except that it contains one or more drugs as defined in section 201 (g) of the act and is intended for manufacturing use in the production of a medicated feed. Medicated premixes are subject to §§ 133.200133.210, inclusive.
10. lappuse - ... 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...
76. lappuse - Jan. 29, 1965] § 133.9 Product containers. Suitable specifications, test methods, cleaning procedures, and, when indicated, sterilization procedures shall be used to assure that containers, closures, and other component parts of drug packages are suitable for their intended use, in that they are not reactive, additive, or absorptive to an extent that significantly affects the identity, strength, quality, or purity of the drug, and furnish adequate protection against its deterioration or contamination.