The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1969 - 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. |
Other editions - View all
Common terms and phrases
100 milliliters 85 percent addition to complying ampicillin antibiotic aqueous bacitracin batch complies batch mark batch was certified batch was completed benzathine penicillin blank being filled capsules chapter chloramphenicol chlortetracycline cillin cloxacillin conforms containing approximately contains not less crystalline penicillin dihydrostreptomycin dilute grams graph hydrochloride immediate container ingredient labeling latest assay less than 85 micrograms milliliter months mycin nafcillin neomycin novobiocin number of milligrams number of units nystatin ointment oleandomycin oxacillin packaged for dispensing person shall submit person who requests polymyxin potassium phosphate potency powder prescribed therefor previously submitted procaine penicillin Proceed as directed purity quantity rendered with respect represented to contain request for certification requests certification requirements prescribed sample submitted showing the batch sodium solution Standards of identity standards prescribed 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 30 - 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 6 - The scientific training and experience considered appropriate by the sponsor to qualify the investigators as suitable experts to investigate the safety of the drug, bearing in mind what is known about the pharmacological action of the drug and the phase of the investigational program that is to be undertaken.
Page 7 - The approximate number of subjects (a reasonable range of subjects is permissible and additions may be made) , and criteria proposed for subject selection by age, sex, and condition. iv. The estimated duration of the clinical trial and the intervals, not exceeding 1 year, at which progress reports showing the results of the investigations will be submitted to the Food and Drug Administration.
Page 12 - Notice of claimed investigational exemption for a new drug"; or (8) The drug is not intended solely for investigational use, since it is being or is to be sold or otherwise distributed for commercial purposes not justified by the requirements of the investigation; or (9) The labeling or other informational material submitted for the drug as required by section 7 of the "Notice of claimed investigational exemption for a new drug...
Page 79 - 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 597 - Warning — Serious and even fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia) are known to occur after the administration of chloramphenicol. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Bearing in mind the possibility that such reactions may occur, chloramphenicol should be used only for serious infections caused by organisms that are susceptible to its antibacterial effects.
Page 41 - Consent" means that the person involved has legal capacity to give consent, is so situated as to be able to exercise free power of choice, and is provided with a fair explanation of pertinent information concerning the investigational drug, and/or his possible use as a control, as to enable him to make a decision on his willingness to receive said investigational drug. This latter element means that before the acceptance of an affirmative decision by such person the investigator should carefully...
Page 77 - For each drug product, masterformula records shall be prepared, endorsed, and dated by a competent and responsible individual and shall be independently checked, reconciled, endorsed, and dated by a second competent and responsible individual. The record shall include : (1) The name of the product, a description of its dosage form, and a specimen or copy of the label and each other portion of the labeling contained in a retail package of the drug. (2) The weight or measure of each ingredient per...
Page 78 - ... distributed; to prevent mixups between drugs during the packaging and labeling operations; to assure that correct labeling is employed for the drug; and to identify finished products with lot or control numbers that permit determination of the history of the manufacture and control of the batch of drug. Packaging and labeling operations shall: (a) Be performed with adequate physical segregation of such operations from operations on any other drugs to avoid mixups. (b) Provide that each type of...