средняя общеобразовательная школа 17 новочебоксарск
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средняя общеобразовательная школа 17 новочебоксарск, Compounded Preparations Monographs (CPMs) | USP, <797> Pharmaceutical Compounding—Sterile Preparations - USP–NF, General Chapters: <795> PHARMACEUTICAL COMPOUNDING-NONSTERILE PREPARATIONS, USP Chapters <797> and <800> New and Revised Compounding Standards, General Chapters: <1231> WATER FOR PHARMACEUTICAL PURPOSES, General Chapters: <1151> PHARMACEUTICAL DOSAGE FORMS, 〈797〉 Pharmaceutical Compounding—Sterile Preparations - USP.
SŌJ7Oc |V{]Kҝda$a}^J_6V17ypM/\u0z%۾蒁o,AeY{f`l 9g@ njRШd8/m ]3Fs& ΰ]xYr}-g o$ [ KСQ)}l F qpv[wD1%(zv_(MBo@k'Lbv b"-&m--zO'((H$ޠ΅5 hqt.|f n ǫ}./ ,߶gܼ ^:,d1% 3f/B:is 1MPH+:0&OxV_EOL߭] sq؇\gd&V1vᐇ!]#RmV GElFP/>e[A`UQQT1m@w z4bАNE"T41 IQȮG^) Mc,]+_~tp둥aQv^h-oYütT(4d\;44| $ !L3s@ 389?9螤 xQ Amt9a 2 - tkKBG3]o[WW/_j7r{!2, USP compounded preparation monographs provide quality standards for specific preparations to assist practitioners in compounding formulations for which there is no suitable commercially available product., In accordance with the Rules and Procedures of the 2015–2020 Council of Experts, USP is postponing the official date of Pharmaceutical Compounding—Sterile Preparations <797>..
Sterility Assurance of sterility in a compounded sterile preparation is mandatory. Compounding and packaging of sterile drugs, such as ophthalmic solutions, will require strict adherence to guidelines presented in the general test chapter Pharmaceutical Compounding—Sterile Preparations 797 and in the manufacturers’ labeling instructions., At Issue The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards. Specifically, USP published the final revised version of general chapter <797> (Pharmaceutical Compounding of Sterile Preparations) to accompany the previous released general chapter <800> (Hazardous Drugs Handling in Healthcare Settings). Due to pending appeals, the , There are many different grades of water used for pharmaceutical purposes. Several are described in USP monographs that specify uses, acceptable methods of preparation, and quality attributes., Dosage forms are provided for most of the Pharmacopeial drug substances, but the processes for the preparation of many of them are, in general, beyond the scope of the Pharmacopeia. In addition to defining the dosage forms, this section presents the general principles involved in the manufacture of some of them, particularly on a small scale. Other information that is given bears on the use of , This chapter describes the minimum standards to be followed for the preparation of compounded sterile preparations (CSPs) for human and animal drugs. Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation., USP General Chapter 797> describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations..