USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, delineates the standards for compounding sterile preparations in all pharmacy settings.Established by the United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, USP <797> outlines the necessary procedures for compounding sterile drug preparations. The standards apply in various settings, including hospitals, retail establishments, ambulatory care centers, long-term care facilities, chemotherapy units, procedural areas, and operating rooms.
Originally implemented on January 1, 2004, and published in the United States Pharmacopeia and National Formulary (USP-NF), USP <797> aims to elevate the standard of practice, enhancing patient care and safety. Despite these standards, enforcement had been inconsistent until a nationwide meningitis outbreak in 2012 due to improper sterile compounding led many state-level pharmacy laws and regulations to be updated to require USP <797> compliance in all pharmacy settings. As evidence and experience progressed, a revision to USP <797> was introduced on November 1, 2022, and became effective on November 1, 2023, after nearly 20 years of review and stakeholder engagement.
USP <797> forms the foundation for regulatory agencies, particularly state-level boards of pharmacy, to address unsafe compounding practices in pharmacies. The Joint Commission and other accreditation agencies actively enforce compliance with USP <797>, as mandated by the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation.
What’s new with USP <797>?
The 2023 update to USP <797> included some signification changes which require a review of facility policies and procedures, facilities, and workflows. Major areas to assess include:
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- Compounding Definitions and Categories: The new chapter introduces three new categories for compounded sterile preparations (CSPs): Category 1, Category 2, and Category 3. These categories are based on a variety of factors, including the environment, starting ingredients, processing method, sterility testing, and personnel garbing.
- Beyond Use Dates (BUDs): The new chapter BUDs are primarily based on the category of compounding performed. A more controlled environment and processes allows for longer BUDs for CSPs, such as those that are subject to sterility testing or terminal sterilization. Compounding in an environment with less controls in air quality, i.e., Category 1, require shorter BUDs due to increased risk for microbial contamination. Keep in mind the chemical stability of some drugs may be shorter than the chapter default BUDs.
- Immediate Use Compounding: The new chapter provides additional guidance on immediate use compounding, in which BUDs have been expanded to a maximum of 4 hours to balance CSP quality and timely access to medication across healthcare settings. Clarified or new standards include preparation of CSPs cannot include more than 3 different sterile products, and personnel must be trained and demonstrate aseptic processes competency related to their assigned tasks and the facility’s SOPs.
- Cleaning and Disinfection: The updated chapter introduces new requirements for cleaning and disinfecting surfaces and equipment in pharmacy compounding areas. Only sterile cleaning solutions are allowed in the Primary Engineering Controls (PECs). Application of sporicidal cleaning and disinfecting agents is required at least monthly.
- Environmental Monitoring: The new chapter requires more frequent air and surface sampling in classified areas. Air sampling must be performed every 6 months for Category 1 and 2 CSPs and every month for Category 3 CSPs. Surface sampling must be performed monthly for Category 1 and 2 CSPs and on a weekly basis for Category 3 CSPs.
- Personnel Training: The new chapter requires that all personnel who compound CSPs or support compounding must be trained and demonstrate competency in defined core skills. More frequent competency assessment in garbing and aseptic manipulation is required for those actively compounding. Additional role-based training and competency is allowed and must be defined in the facility SOPs.
How to maintain USP <797> compliance
To safeguard both patients and pharmacy staff, USP <797> demands attention to compounding categories and BUDs, Standard Operating Procedures (SOPs), training and competency, environmental monitoring, and cleaning. The framework for compliance begins with defining the type of compounding performed in the facility. Policies and procedures provide further structure and definition of the requirements based on the facility and type of compounding. Staff training and competency ensure proper maintenance of the facility and the quality of the CSPs prepared. Cleaning, environmental monitoring, and documentation serve as evidence of a well-designed compounding program. A compliance management system is recommended to ensure each requirement is addressed in accordance with USP <797>.Maintain and prove USP <797> compliance with Simplifi 797. Speak with an expert today and be ready for your next inspection.
USP category determination
Determining what category of compounding is performed drives the compliance requirements at the facility.
Category 1 CSPs are prepared in an ISO 5 Primary Engineering Control (PEC) but in an otherwise uncontrolled or unclassified space e.g., a Segregated Compounding Area (SCA). BUDs are limited to 12 hours at room temperature and 24 hours refrigerated, or less per product stability.
BUDs for Category 2 CSPs are determined by the environment as well as the sterility of the starting ingredients and what type of sterilization techniques are used.
Examples when prepared in an ISO 5 PEC and a full cleanroom suite:
- Typical scenario: Sterile starting ingredients aseptically prepared with no additional sterility testing results in BUDs of 4 days (room temp), 10 days (refrigerated), 45 days (frozen)
- Maximum BUDs scenario: Terminally sterilized CSPs prepared with additional sterility testing performed and passed results in BUDs of 45 days (room temp), 60 days (refrigerated), and 90 days (frozen).
Multiple factors increase the risk of contamination when preparing Category 3 CSPs. These include the use of nonsterile starting ingredients or nonsterile devices which are inherently at risk of microbial contamination, as well as longer storage time which increases risk due to stability issues, compromise of the container closure system, and microbial proliferation. The greatest level of control is required to mitigate these risks.
Learn more about USP <797>: Translating low, medium, and high-risk compounding into categories
Policies and procedures for USP <797> compliance
Many pharmacies have established SOPs; however, these must be reviewed with the 2023 updates in mind. To comply with USP <797>, pharmacies need policies and procedures that describe overall compliance programs as well as cover specific situations that arise during compounding. Major topic areas include the types of CSPs prepared, cleaning and disinfection procedures, microbiological air and surface monitoring programs, staff training and evaluation programs, and quality assurance and quality control programs. Additional SOPs are required for more specific situations including immediate-use compounding; methods of monitoring and recording temperature, pressure, and humidity; verification and calibration of compounding equipment; final checks prior to release of CSPs; and storage and transport of finished CSPs.
The 2023 update also requires the identification of a Designated Person(s) who has oversight for compliance with the standards outlined in the Chapter. This may be a single person or several people with the responsibility and authority to implement and monitor compounding operations. This role includes specific duties named throughout the Chapter and is critical to the maintenance of compliance.
Regular staff training for USP <797>
USP <797> applies to everyone involved in sterile compounding including those actively compounding, providing direct oversight of compounding, and others who may be indirectly involved in cleaning or restocking the environment. Training should cover best practices and core competencies, ideally in a hands-on, situation-based learning format with both practical and written exams.
Core skills
Train staff in appropriate sterile compounding principles and practices to provide a strong foundation of knowledge and understanding. Annual training should be applicable to the job functions.
Topics to cover include:
- Antiseptic hand washing procedures and personnel preparation
- Use of appropriate protective garb, such as gloves, gowns, and masks
- How to clean, disinfect, and maintain the compounding environment
- Calculations and measurement of ingredients
- Proper aseptic handling of components and movement within the ISO 5 environment
- Use of equipment related to the compounding process
- Safe handling of materials and personnel movement to minimize contamination in the compounding areaDocumentation of the compounding process and related tasks to demonstrate compliance
Personnel must also demonstrate competency within these core skills. This requires hands-on completion and observation by a Designated Person or Assigned Trainer. Frequency of competency is based on role, category of compounding performed, and facility SOPs.
