USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations.

2 〈795〉 Pharmaceutical Compounding—Nonsterile Preparations Official January 1, 2014 (OSHA) hazard communication labels (see OSHA. Description of Categories gov), and Material Safety Data Sheets (MSDSs) are available to compounding personnel for all drugs and chemicals used in compounding. Simple—Making a preparation that has a United ...

The following represents key changes from the currently enforceable version of USP Chapter: 795> (last major revision in 2014) to the revised USP Chapter ; 795> (official as of November 1, 2023). The following are the major changes and are not meant to be an exhaustive list of the entirety of all changes made.

795 pharmaceutical compounding—nonsterile preparations For the purposes of this chapter, the pharmacist or other licensed health care professional responsible for preparing the compounded preparations is referred to as “compounder”.

d nonsterile preparations (CNSPs) for humans and animals. For purposes of this chapter, nonsterile compounding is defined as combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug. ntaminan.

Identify USP <795> requirements for personnel qualification including training, evaluation, and requalification. Describe USP <795> standards that apply to compounding spaces, equipment, and components used in nonsterile compounding. Explain how to handle complaints and report adverse events.

May 9, 2024 · Explain the scope of USP <795> including who it applies to, the basic aspects of nonsterile compounding, and the roles and responsibilities of designated persons. Identify USP <795> requirements for personnel qualification including training, evaluation, and requalification.

An Overview of USP 795 Pharmaceutical Compounding—Nonsterile Preparations The following are general principles of compounding nonsterile preparation as described in USP 795 to ensure that preparations compounded are of appropriate strength, quality, and purity. 1. Personnel are trained and competent in performing extemporaneous compounding

Nov 22, 2019 · In accordance with the Rules and Procedures of the 2015–2020 Council of Experts, USP is postponing the official date of Pharmaceutical Compounding—Nonsterile Preparations <795>. After publication of the revised <795> on June 1, 2019, USP received appeals on certain provisions in <795>.

Compounding is an integral part of pharmacy practice and is essential to the provision of healthcare. This chapter and applicable monographs on formulation help define good compounding practices.