What is the Origin of USP Chapter 797?

The term is an official designation within the USP framework, developed to address the significant risks associated with compounded sterile products following several patient safety incidents in the late 20th century. The number '797' signifies its specific location within the USP compendium, which houses standards considered mandatory by regulatory bodies. It is a cornerstone of modern sterile compounding practice.

What is the Mechanism of USP Chapter 797?

The standard dictates rigorous environmental control, including air quality requirements for cleanrooms, specific garbing procedures for personnel, and stringent process controls for sterilization and testing. The mechanism ensures that the compounding process minimizes the introduction of microbial and particulate contamination from the environment, personnel, and equipment. Risk stratification based on the preparation's sterility risk level determines the specific quality control measures required for patient safety.

USP Chapter 797

Meaning

USP General Chapter is a set of official, enforceable standards published by the United States Pharmacopeia that specifies the minimum quality and safety requirements for the compounding of sterile preparations (CSPs) in all healthcare settings. This chapter’s primary goal is to prevent patient harm, including infection or death, resulting from microbial contamination, excessive bacterial endotoxins, or variability in the intended strength of the compounded product. Many injectable or specialized hormonal preparations fall under the strict quality control requirements of this standard.