Key Requirements for Sterile Compounding According to USP 797 

Understanding USP 797 Standards

Sterile compounding in hospital pharmacies is a critical process to ensure patient safety and medication efficacy. The United States Pharmacopeia (USP) General Chapter 797 outlines essential standards for the preparation of sterile compounded medications. These regulations are designed to minimize the risk of contamination, ensure sterility, and protect patients from potentially harmful substances. Here are the key requirements for hospital pharmacies according to USP 797: 

1. Facility Design and Environmental Controls 

USP 797 mandates strict environmental controls for sterile compounding areas. These include cleanrooms with specified air quality levels, such as ISO Class 5 environments where compounding occurs, and ISO Class 7 or 8 environments for buffer and ante rooms. Hospital pharmacies must maintain positive pressure in cleanrooms to prevent contamination from surrounding areas. Proper HVAC systems with HEPA filters are required to ensure the air is continually cleaned and recirculated. 

2. Personnel Training and Competency 

Personnel involved in sterile compounding must undergo specialized training to ensure they understand aseptic techniques, environmental monitoring, and the potential risks of contamination. Pharmacists, pharmacy technicians, and other staff must demonstrate proficiency in sterile procedures through regular testing, including media-fill tests and gloved fingertip testing. Requalification is required periodically to maintain competency. 

3. Aseptic Technique and Hand Hygiene 

Aseptic technique is the cornerstone of sterile compounding. Staff must follow rigorous hand hygiene protocols, including thorough washing and the use of sterile gloves. Garbing procedures must be followed meticulously, requiring personnel to wear sterile gowns, masks, hair covers, and shoe covers to prevent contamination. 

4. Cleaning and Disinfection Procedures 

The sterile compounding environment must be regularly cleaned and disinfected to maintain sterile conditions. USP 797 requires pharmacies to establish cleaning schedules for work surfaces, equipment, and floors. Approved disinfectants, such as sterile isopropyl alcohol, must be used in cleaning protocols. Environmental monitoring, including surface sampling and air particle counts, must be conducted to ensure continued compliance. 

5. Beyond-Use Dating (BUD) and Stability 

USP 797 sets strict guidelines for beyond-use dating (BUD) of compounded sterile preparations (CSPs). The BUD is the date by which a preparation must be used or discarded, based on its stability and sterility. Pharmacies must assign appropriate BUDs based on factors such as preparation method (low, medium, or high risk), storage conditions, and stability testing data. 

6. Risk Levels of Compounding 

USP 797 categorizes sterile compounding into three risk levels: low, medium, and high. The classification is based on the complexity of the compounding process, the likelihood of microbial contamination, and the handling of sterile ingredients. Hospital pharmacies must ensure that compounded preparations fall into the correct risk category and that procedures appropriate for that risk level are followed. 

7. Quality Assurance and Monitoring 

A robust quality assurance (QA) program is essential under USP 797. This includes regular inspections of sterile compounding areas, routine verification of equipment functionality (e.g., laminar flow hoods, isolators), and ongoing staff competency assessments. Pharmacies must document all QA activities and promptly address any deviations from USP 797 standards. 

8. Documentation and Record-Keeping 

Accurate record-keeping is a fundamental requirement. Hospital pharmacies must maintain detailed records of all sterile compounding activities, including batch records, training logs, equipment maintenance, and environmental monitoring data. These records are essential for ensuring traceability and compliance with USP 797. 

Hospital pharmacies engaged in sterile compounding must adhere to the stringent requirements outlined by USP 797 to safeguard patient health and ensure the sterility of compounded medications. By focusing on proper facility design, personnel training, environmental monitoring, and aseptic techniques, pharmacies can maintain high standards of safety and compliance, reducing the risk of contamination and enhancing the quality of care delivered to patients. 

If you have any questions or would like to learn how MFR Library redefines Master Formula Record management, please reach out to us using the contact form at the bottom of this page. 

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