The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1968 - 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
85 percent addition to complying ampicillin aqueous bacitracin batch complies batch mark batch shall submit batch was certified batch was completed benzathine penicillin blank being filled capsules chapter chloramphenicol chlortetracycline conforms contains not less crystalline penicillin dihydrostreptomycin dilute distribution practice grams graph hydrochloride immediate container ingredient labeling latest assay less than 85 milliliter months mycin nafcillin neomycin novobiocin number of milligrams number of units nystatin ointment oleandomycin oxacillin package shall bear packaged for dispensing person shall submit person who requests phosphate buffer polymyxin potassium potassium phosphate powder prepared previously submitted procaine penicillin Proceed as directed purity rendered with respect represented to contain request a statement request for certification requests certification requirements prescribed sample submitted showing the batch sodium solution Standards of identity sterility test streptomycin submit in connection submitted in accordance subpara sulfate tablets tainer tests and assays tetracycline tetracycline hydrochloride tion toxicity units per milliliter volumetric flask
Popular passages
Page 600 - SUBTITLE A — Office of the Secretary of the Interior SUBTITLE B — Regulations Relating to Public Lands I Bureau of Reclamation, Department of the Interior II Bureau of Land Management, Department of the Interior Title 44— Public Property and Works III Department of State IV Business and Defense Services Administration, Department of Commerce V Library of Congress VII Department of Housing and Urban Development (Community Facilities) VIII Economic Development Administration, Department of Commerce...
Page 27 - 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 10 - ... alarming, it shall be reported Immediately. An adequate report of the investigation should be furnished to the sponsor shortly after completion of the investigation. e. The investigator shall maintain the records of disposition of the drug and the case histories described above for a period of 2 years following the date a new-drug application is approved for the drug ; or if the application is not approved, until 2 years after the investigation is discontinued. Upon the request of a scientifically...
Page 75 - 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.
Page 6 - ... and clinical investigations and experience with its components, including all reports available to the sponsor 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...
Page 15 - It is understood that when this application is approved, the labeling and advertising for the drug will prescribe, recommend, or suggest its use only under the conditions stated in the labeling which is part of this application; and if the article is a prescription drug, it is understood that any labeling which furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for use of the drug will...
Page 72 - Control and production-laboratory operations. (b) Provide adequate lighting and ventilation, and when necessary for the Intended production or control purposes, adequate screening, filtering, dust, humidity, temperature, and bacteriological controls, as for example, to prevent contamination of products by extraneous adulterants (including the prevention of cross-contamination of one product by dust or particles of ingredients arising from the manufacture, storage, or handling of another drug) ; to...
Page 9 - ... the act (12) The sponsor shall obtain from each investigator involved in clinical pharmacology a signed statement in the following form: Form FD 1572 Department of Health, Education, and Welfare, Food and Drug Administration Statement of Investigator (Clinical Pharmacology) Name of investigator Date Name of drug To supplier of the drug: Name Address...
Page 294 - G, novobiocin, neomycln, and dihydrostreptomycin in refined peanut oil, with or without one or more suitable and harmless dispersing and suspending agents and with or without the addition of a hardening agent. It may contain a suitable and harmless preservative and cortisone or one or more suitable derivatives of cortisone. It contains 10,000 units of procaine penicillin G...
Page 30 - ... submissions received on or after July 1, 1968, adverse experiences shall be reported on form FD-1639. Adverse experiences with marketed drugs as a result of an investigational use other than a phase 1 study shall be reported on form FD-1639 under the conditions described in this paragraph. If desirable, such forms may be used on a per patient basis rather than on an adverse experience basis. (b) For the purpose of such report, the terms "drug experience...