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, 1981 - Administrative law Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
Other editions - View all
Common terms and phrases
acid addition to complying agar diffusion assay amended ampicillin antibiotic antibiotic drug batch for potency carbenicillin cefaclor cefadroxil cephaloglycin cephradine chapter clindamycin clinical Commissioner crystallinity cyclacillin dicloxacillin digoxin distilled water dosage forms dose Drug Administration drug application drug product exemption Food and Drug Further dilute give a stock grams hetacillin hydrochloride immediate containers injection insulin insulin zinc Iodometric assay loss on drying lution master standard means a specific methods of assay-(1 Microbiological agar diffusion micrograms milligrams milliliter milliliter estimated moisture nafcillin Neomycin oleandomycin oral oxacillin packaged penicillin plate potassium phosphate potassium phosphate buffer preparing the sample Proceed as directed purity reagent reference concentration request shall contain Requests for certification Requirements for certification Results of tests safety sample solution Samples required solu specific lot Standards of identity Stat sterility stock solution streptomycin submitted Subpart sulfate tablets tests and assays Tests and methods tetracycline tion U.S.P. Units volumetric flask
Popular passages
Page 78 - 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 61 - The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods. 3. 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. 4. The refusal of the patient to participate in a study must never interfere with the doctor-patient relationship.
Page 54 - A statement of the methods, facilities, and controls used for the manufacturing. processing, and packing of the new drug to establish and maintain appropriate standards of Identity, strength, quality, and purity as needed for safety and to give significance to clinical Investigations made with the drug.
Page 128 - 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 61 - 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 65 - As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled 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...
Page 63 - 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 xii - The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more substances, none of which is a new drug.
Page 74 - The specimen labeling proposed fails to bear adequate information for use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to administer the drug can use the drug...
Page 65 - The complete composition and/or method of manufacture of the new drug used in each submitted report of investigation should be shown to the extent necessary to establish its identity, strength, quality, and purity if it differs from the description in Item 6, 7, or 8 of the application.