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, 1978 - Administrative law 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
52 Stat 90 percent accurately weighed addition to complying agar diffusion assay ampicillin assay as follows azlocillin bacitracin batch for potency chapter convenient concentration crystallinity cyclacillin demeclocycline described in paragraph dicloxacillin dilute an aliquot distilled water dosage forms doxycycline drug product Food and Drug Further dilute gentamicin give a stock grams griseofulvin hydrochloric acid immediate containers labeled in accordance less than 90 loss on drying lution methods of assay-(1 micrograms milligrams milliliter milliliter estimated nafcillin neomycin neomycin sulfate number of milligrams nystatin oral oxytetracycline penicillin ples polymyxin potassium phosphate potassium phosphate buffer preparing the sample Proceed as directed purity pyrogens reference concentration represented to contain request shall contain Requests for certification Requirements for certification Results of tests sample for assay sample solution Samples required sodium solu solution of convenient Standards of identity stock solution Subpart tablets tests and assays Tests and methods tests except sterility tetracycline tion volumetric flask
Popular passages
Page 106 - 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 81 - In the purely scientific application of medical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out.
Page 81 - In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.
Page 86 - English name and complete chemical name, using structural formulas when necessary for specific Identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified. If the...
Page 241 - ... of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use; or in law enforcement; or in research not involving clinical use; or in chemical analysis or physical testing, provided they are to be used only for such instruction, law enforcement, research, analysis, or testing, and provided further that their labels bear the statement "Not for drug use.
Page 106 - 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 75 - The investigator certifies that the drug will be administered only to subjects under his personal supervision or under the supervision of the following investigators responsible to him, , and that the drug will not be supplied to any other investigator or to any clinic for administration to subjects. g. The investigator certifies that he will Inform any subjects, including subjects used as controls, or their representatives, that drugs are being used for investigational purposes, and will obtain...
Page 69 - ... suggesting side-effects, contraindications, and ineffectiveness in use of such components: Such summary should include an adequate bibliography of publications about the components and may incorporate by reference any information concerning such components previously submitted by the sponsor to the Food and Drug Administration. Include a statement of the expected pharmacological effects of the combination.
Page 73 - States) law to investigational use. 1. A statement of the education and training that qualifies me for clinical pharmacology. 2. The name and address of the medical school, hospital, or other research facility where the clinical pharmacology will be conducted. 3. The expert committees or panels responsible for approving the experimental project.
Page 165 - 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.