What is the expected outcome of applying USP 797 standards?

The application of USP 797 standards is fundamentally aimed at ensuring the safety and quality of compounded sterile preparations. One of the primary outcomes of adhering to these standards is the significant reduction in the rates of patient infections associated with these medications. By implementing stringent guidelines for the preparation, handling, and storage of sterile compounds, USP 797 establishes a framework that promotes aseptic techniques, proper environmental controls, and thorough training for compounding personnel.

This focus on minimizing contamination risks directly leads to improved patient safety and healthcare outcomes. The standards emphasize the importance of maintaining a sterile environment, practicing proper hand hygiene, using appropriate PPE (personal protective equipment), and following detailed protocols for compounding procedures. As a result, the incidence of infection associated with compounded sterile drugs can be expected to decline significantly, benefitting patient health and enhancing the overall reputation of compounding pharmacies.

In contrast, increasing commercialization of compounded sterile products, higher production rates, or decreasing regulatory oversight do not align with the primary intent of USP 797, which is to prioritize patient safety. Increased commercialization and higher production rates might actually introduce more risks if safety measures are compromised, while less regulatory oversight would undermine the very protections that USP 797 is designed to enforce.