USP 797 – Pharmaceutical compounding: Sterile preparations [USP797]

Published: January 30th, 2019

Revised: March 24th, 2023

What is USP 797?

USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, outlines the standards for compounding sterile drug preparations in all pharmacy settings including those in, hospitals, retail settings, and long-term care facilities as well as other environments such as chemotherapy units, hospital nursing stations, and operating rooms. This standard is specifically designed to prevent patient harm from microbial contamination (non-sterility) and excessive bacterial endotoxins originating from the compounding facility. Therefore, the greatest level of control over manufacturing must be proven.

To whom do USP 797 standards apply?

USP 797 applies to everyone involved in sterile compounding such as the pharmacists, nurses, physicians and pharmacy technicians. Individuals involved in compounding sterile preparations must demonstrate competency in:

• Antiseptic hand washing and disinfection of nonsterile compounding surfaces
• Use of appropriate protective garb, such as gloves, gowns and masks
• Proper aseptic handling of products, sterilization of high risk compounding sterile products

How to comply with USP 797 Standards and Requirements

To comply with USP 797, pharmacies need policies and procedures that cover specific situations that arise during compounding. Areas that should be addressed in policy include verification of accuracy and sterilization and environmental quality and control. These conditions can be met by undergoing routine media fill and glove tip testing.

Media Fill Challenge Testing

This method is used to evaluate the quality of the aseptic skill of the compounding personnel using sterile fluid bacterial culture media-fill verification. The media filled containers (either TSB filled glass vials or TSB filled IV bags to simulate the appropriate compounding procedures used in your facility) are incubated for a minimum of 14 days at specific incubation temperature ranges. Following incubation, samples are assessed for visible turbidity (bacterial growth). Failure is indicated by visible turbidity in the medium on or before 14 days.

Glove Tip Testing

The careful cleansing of hands and correct donning of PPE (personal protective equipment) by compounding personnel constitute the first major step in preventing microbial contamination in compounding sterile preparations. Cells are normally shed from the human body and those skin particles are laden with microorganisms thus posing an increased risk of microbial contamination. This method is used to assess the ability of the compounding personnel in proper hand hygiene and gowning techniques. After completing proper gowning procedures, fingertip and thumb samples (from both their left and right hand) are lightly pressed into TSA plates (separate plates for each hand). These plates are then incubated at 30-35 C for 2 days, and 20-25 C for 5 days. Following incubation, analysis includes enumeration of bacterial colony forming units (CFU). Failure is indicated by the presence of 1 CFU or greater.

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Laboratory code: USP797

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