Application Note

USP 797 Revision and Impact

Understand the latest USP <797> revisions and their impact on sterile compounding. This paper outlines key regulatory changes, including tighter controls on contamination risk, personnel qualification, and environmental monitoring, and what they mean for maintaining compliance and product quality. It also highlights how these updates are enforced and why they are critical to reducing risk to both product and patient.

Understand the most recent USP 797 revision and the impacts.

The United States Pharmacopeia (USP) is a scientific non-profit organization that sets standards used worldwide for the identity, quality, purity and strength of medicines, food ingredients and dietary supplements. The organization’s mission is to improve global health through public standards and related programs that help ensure that quality, safety, and benefit of medicines and foods. With the advancement of technologies and medicine, new standards are created to ensure the health and wellbeing of the public. The process is as follows:

USP Regulatory Standards Development Process

Public Health Need
Draft Standard
Public Comment Period
Review and Approval
Publication

Developing USP monographs and official Reference Standards is a collaborative process between USP, manufacturers and expert committees made up of volunteer experts from industry, health care practitioners, academia and government. USP takes a collaborative and rigorous approach to ensure USP Reference Standards reflect the highest quality in the industry, because helping companies comply with quality requirements is one of their chief goals.

This paper also covers:

Compound Sterile Preparations
- Beyond Use Dates Requirements
- Terminal Sterilization
Personnel Qualification
Calibrations, Certifications and Qualifications
- Facility Requirements
- Certification Requirements of Classified Cleanrooms
Environmental Quality and Control
Microbial Air and Surface Risk Assessment
Microbial Air and Surface Monitoring