Nov 1, 2023 · USP General Chapter describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring and storage and testing of finished preparations.

Greater care is required for aqueous injections that are compounded sterile preparations (CSPs) the most common CSPs used in therapy. Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.

The following represents key changes from the currently enforceable version of USP Chapter <797> (last major revision in 2008) to the revised USP Chapter <797> (official as of November 1, 2023). The following are the major changes and are not

Revision Bulletin 〈797〉 Pharmaceutical Compounding—Sterile Preparations 1 Change to read: 〈797〉 PHARMACEUTICAL COMPOUNDING—STE RILE PREPARATIONS INTRODUCTION The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1)

Jun 1, 2019 · Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a sterile medication. use of ingredients of inappropriate quality. Aseptic technique must be followed for preparing any sterile medication.

Apr 8, 2020 · Established by the United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, USP <797> outlines the necessary procedures for compounding sterile drug preparations.

Jul 19, 2023 · USP Chapter <797> categorizes risk levels based on the likelihood of contamination of a compounded sterile preparation (CSP). Contamination can come from a variety of sources.

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.

Nov 1, 2022 · The United States Pharmacopoeia published the revised General Chapter <797> Pharmaceutical Compounding – Sterile Preparations in USP-NF 2023 Issue 1 on November 1, 2022. To allow for a one-year implementation period, the …

Analyze the USP <797> requirements for documentation pertaining to all aspects of sterile compounding including Standard Operating Procedures (SOPs), Master Formulation Records and Compounding Records.