FDA CPG Sec. 635.100 Large Volume Parenterals (LVPs) for Animal Use
标准简介
CPG Sec. 635.100 Large Volume Parenterals (LVPs) for Animal Use[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
![CPG Sec. 635.100 Large Volume Parenterals (LVPs) for Animal Use[附网盘链接]](/img/202109141036543uls2.jpg)
标准文档说明
标准文档类型为CPG Sec. 635.100 Large Volume Parenterals (LVPs) for Animal Use[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Sec. 635.100 Large Volume Parenterals (LVPs) for Animal Use Compliance Policy Guide Guidance for FDA Staff This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. Introduction The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on large volume parenterals (LVPs or large volume injections). In general, FDA’s guidance documents, including this CPG, do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency’s guidances means that something is suggested or recommended, but not required. II. Background For purposes of this document, large volume parenterals (LVPs or large volume injections) are aqueous solutions usually supplied in volumes of 100 ml to 5,000 ml. LVPs are typically used to provide fluid replacement therapy to animals. Routes of administration may include intravenous, intraperitoneal, or subcutaneous. Some examples of LVPs include solutions containing: • Sodium bicarbonate • Electrolytes • Dextrose (glucose) and other sugars • Amino acids, peptides and other protein-fractions • Vitamins, minerals • Dextrans, and other plasma expanders III. Policy LVPs may be considered new animal drugs and considered unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(a)(1)) and adulterated
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