The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1971 - Administrative law 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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Common terms and phrases
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 changes so caused chapter chloramphenicol chlortetracycline cillin cloxacillin conforms containing approximately contains not less crystalline penicillin Demeclocycline dihydrostreptomycin dilute flask Food and Drug grams graph hydrochloride immediate container ingredient labeling latest assay less than 85 micrograms milliliter months mycin nafcillin neomycin 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 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
Popular passages
Page 20 - 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 5 - 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 drug use of a combination of two or more substances, none of which is a new drug. (3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other...
Page 30 - 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 6 - A copy (one in each of the three copies of the notice) of all informational material, including label and labeling, which is to be supplied to each investigator: This shall include an accurate description of the prior investigations and experience and their results pertinent to the safety and possible usefulness of the drug under the conditions of the investigation. It shall not represent that the safety or usefulness of the drug has been established for the purposes to be investigated. It shall...
Page 7 - ... is being developed. ) Ordinarily, a plan for clinical trial will not be regarded as reasonable unless, among other things, it provides for more than one independent competent investigator to maintain adequate case histories of an adequate number of subjects, designed to record observations and permit evaluation of any and all discernible effects attributable to the drug in each individual treated, and comparable records on any individuals employed as controls. These records shall be individual...
Page 30 - 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 6 - 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. 6. A statement covering all Information available to the sponsor derived from precllnlcal investigations and any clinical studies and experience with the drug as follows : a.
Page 16 - The application must be signed by the applicant or by an authorized attorney, agent, or official. If the applicant or such authorized representative does not reside or have a place of business within the United States, the application must also furnish the name and post office address of, and must be countersigned by, an authorized attorney, agent, or official residing or maintaining a place of business within the United States.
Page 8 - Administration so notified. Upon request of a scientifically trained and properly authorized employee of the Department, at reasonable times, these reports shall be made available for inspection, and on written request copies of these reports shall be submitted to the Food and Drug Administration. (6) The sponsor shall promptly investigate and report to the Food and Drug Administration and to all investigators any findings associated with use of the drug that may suggest significant hazards, contraindications,...
Page 7 - ... metabolism, absorption, elimination, and other pharmacological action, preferred route of administration, and safe dosage range ; phase 2 covers the initial trials on a limited number of patients for specific disease control or prophylaxis purposes. A general outline of these phases shall...