What is the Origin of USP 797 Sterile Compounding?

The standard originates from pharmaceutical quality assurance and regulatory necessity, specifically in response to documented outbreaks of patient infections linked to improperly prepared sterile medications. The numerical designation 797 is the chapter number within the USP compendium.

What is the Mechanism of USP 797 Sterile Compounding?

The core mechanism of USP 797 is the establishment of strict environmental controls, personnel training, and quality assurance procedures within compounding facilities. This includes specifying requirements for cleanroom air quality, surface disinfection, appropriate garbing, and rigorous sterility testing of the final product. By controlling the compounding environment and process, the standard minimizes the introduction of contaminants, thereby safeguarding the integrity and sterility of injectable hormonal therapies.

USP 797 Sterile Compounding

Meaning

USP 797 Sterile Compounding refers to the official standard published by the United States Pharmacopeia (USP) that provides guidelines and enforceable requirements for the preparation of sterile compounded products, including injectable hormones and ophthalmic solutions. The standard aims to prevent patient harm from microbial contamination, excessive bacterial endotoxins, variability in strength, and chemical or physical contaminants. Adherence to USP 797 is mandatory for pharmacies engaged in sterile compounding to ensure product quality and patient safety.