The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1970 - 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 amended at 29 ampicillin antibiotic aqueous bacitracin batch mark batch shall submit batch was certified batch was completed benzathine penicillin blank being filled capsules changes so caused chloramphenicol chlortetracycline cillin cloxacillin conforms contains not less crystalline penicillin dihydrostreptomycin diluent dilute distribution practice grams graph hydrochloride immediate container ingredient latest assay less than 85 mediate containers 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 powder previously submitted procaine penicillin Proceed as directed purity represented to contain request a statement request for certification requests certification requirements prescribed showing the batch sodium Standards of identity streptomycin submit in connection subpara suitable and harmless tablets tainer tests and assays tetracycline tetracycline hydrochloride tion toxicity units per milliliter
Popular passages
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 5 - ... (5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of admin-istration or application, or different condition, is not a new drug.
Page 17 - ... appear on the label of the finished article. State whether these numbers enable determination of the complete manufacturing history of the product. Describe any methods used to permit determination of the distribution of any batch if its recall is required. p. A complete description of, and data derived from, studies of the stability of the drug, including information showing the suitability of the analytical methods used. Describe any additional stability studies underway or contemplated. Stability...
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 79 - June 20, 1963] § 133.13 Stability. Adequate provision shall be made for testing the stability of components, drug preparations in the course of processing, when needed, and finished drugs. Such stability tests shall: (a) Make adequate provision for determining the reliability and specificity of stability test methods employed. (b) Make adequate provision to determine the stability of products in the containers in which they are marketed to assure, among other things, that the container is suitable,...
Page 78 - Jan. 29, 1965] § 133.9 Product containers. Suitable specifications, test methods, cleaning procedures, and, when indicated, sterilization procedures shall be used to assure that containers, closures, and other component parts of drug packages are suitable for their intended use, in that they are not reactive, additive, or absorptive to an extent that significantly affects the identity, strength, quality, or purity of the drug, and furnish adequate protection against its deterioration or contamination.