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, 1996 - Administrative law |
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Common terms and phrases
abbreviated new drug accurately weighed active ingredient addition to complying agar diffusion assay aliquot amdinocillin amended ampicillin approval aqueous azlocillin batch for potency Calculate cefadroxil cefixime cefprozil cefuroxime chapter chromatographic cilastatin clavulanic acid clinical concentration crystallinity cyclacillin described in paragraph dicloxacillin digoxin Dissolve distilled water dosage form drug application drug product Food and Drug grams hetacillin hydrochloride imipenem immediate containers injection investigation Iodometric assay labeled in ac listed drug loss on drying master standard means a specific Microbiological agar diffusion micrograms milligrams milliliter milliliter estimated mobile phase nafcillin obtain oxacillin patent peak penicillin percent phosphate buffer procedure Proceed as directed products containing pyrogens quirements of 431.1 reagent rected request shall contain Requests for certification Requirements for certification—(1 sample solution sodium monohydrate solu specific lot sponsor standard solution Standards of identity stock solution submitted Subpart tablets tency tests and assays Tests and methods ticarcillin volumetric flask
Popular passages
Page 104 - The refusal of the patient to participate in a study must never interfere with the physician-patient relationship. 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2). 6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research...
Page 302 - If offered for use in arthritis, or rheumatism, in juxtaposition therewith, the statement: Caution — If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician Immediately.
Page 353 - ... shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from...
Page 235 - For purposes of this section and of section 502(1), the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including the chemically synthesized equivalent of any such substance).
Page 175 - 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,...
Page 104 - In any medical study, every patient — including those of a control group, if any — should be assured of the best proven diagnostic and therapeutic method.
Page 103 - Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, The World Medical Association has prepared the following recommendations as a guide to each doctor in clinical research.
Page 103 - In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits, and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is...
Page 161 - ... application was approved, reveal that the drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...
Page 273 - If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor." (2) "If solution changes color or becomes cloudy, do not use.