What are the key points of USP 797 (policies and procedures)?

October 17, 2025 •

4 min read

An estimated 150 million compounded sterile preparations (CSPs) are administered annually in the United States. The safety of these preparations is governed by the United States Pharmacopeia (USP) General Chapter <797>, which outlines the mandatory policies and procedures for sterile compounding. Adhering to these critical guidelines is essential for preventing patient harm from microbial contamination and other errors.

Quick Summary

This article details the policies and procedures mandated by USP 797 for safe sterile compounding, covering facility requirements, personnel training, environmental monitoring, cleaning, and beyond-use date determination based on compounding categories.

Key Points

Designated Person: A specific individual or team is responsible for implementing and monitoring USP 797 policies and procedures.
Personnel Competency: All compounding personnel must undergo initial and ongoing training, with regular hands-on evaluations and media-fill tests to prove competency.
Categorized Compounding: CSPs are divided into Category 1, 2, and 3, based on environmental controls and sterility testing, which in turn determines the Beyond-Use Date (BUD).
Stringent Garbing: Proper garbing, including sterile garb for Category 3, is critical to minimize human-introduced contamination.
Environmental Controls: Facilities must maintain ISO-classified cleanrooms with positive pressure differentials, supported by PECs and SECs.
Routine Monitoring: An environmental monitoring program requires regular viable air and surface sampling, with frequency dependent on the compounding category.
Controlled Cleaning: Specific cleaning and disinfection schedules, using sterile agents inside PECs and sporicidal agents monthly, are mandatory.
Immediate-Use Rules: A special category for CSPs prepared in emergencies mandates a maximum 4-hour BUD and limits the number of manipulations.

The Core Purpose of USP 797

USP General Chapter <797> establishes standards for compounding sterile preparations (CSPs) to ensure patient safety. The chapter provides a framework for quality assurance to prevent microbial contamination, excessive bacterial endotoxin, and variations in strength, all of which could cause harm. Compliance involves a comprehensive approach covering personnel, facilities, equipment, and processes.

The Role of the Designated Person(s)

Introduced in the 2023 update, the role of a Designated Person(s) is crucial for overseeing compliance with USP <797> standards. This individual or group must have the responsibility and authority to implement and monitor all compounding operations. Key duties include:

Managing and overseeing the facility's overall sterile compounding program.
Defining the types of CSPs prepared in the facility.
Developing, implementing, and enforcing standard operating procedures (SOPs).
Monitoring training, competency, and quality assurance programs.
Ensuring appropriate corrective actions are taken when noncompliance is identified.

Personnel Training, Competency, and Garbing

Personnel are the most significant source of contamination, making robust training and garbing protocols fundamental to USP 797 compliance.

Training and Evaluation

All personnel involved in or overseeing sterile compounding must undergo specific training:

Initial Training: Includes both classroom instruction and hands-on, observed training by an expert.
Ongoing and Remedial Training: Addresses new procedures, equipment, drugs, or incorrect techniques.
Annual Training: Required annually for all personnel involved.

Competency Assessment

Compounding personnel must demonstrate proficiency through regular evaluations, including:

Visual observation: Assessment of hand hygiene and garbing procedures.
Gloved fingertip sampling: Required every 6 months for Category 1 and 2 CSPs, and every 3 months for Category 3 CSPs.
Media-fill testing: Validates aseptic processing procedures.

Proper Garbing Procedures

USP 797 mandates strict garbing procedures to minimize particle shedding:

Outer garments, cosmetics, jewelry, and nail products must be removed.
Shoe covers, hair covers, face masks, and gowns are required.
Sterile gloves must be donned after proper hand hygiene.
For Category 3 CSPs, sterile garb must be used for additional protection.

Facility and Engineering Controls

Sterile compounding must occur in controlled environments to maintain air quality and minimize contamination.

ISO Class 5: The primary engineering control (PEC) area, such as a laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI), must maintain ISO Class 5 air quality.
ISO Class 7: The buffer room, where the PEC is located, must have at least ISO Class 7 air quality.
ISO Class 8: The ante-room, the transition area for garbing and staging, must meet ISO Class 8 standards.
Pressure Differentials: Classified areas must maintain specific pressure differentials to prevent contaminants from entering the cleaner areas. Continuous monitoring of pressure differentials is required.
Surfaces: All surfaces in compounding areas must be smooth, non-shedding, and resistant to cleaning agents.

Environmental Monitoring

An ongoing environmental monitoring program is required to verify the integrity of the compounding environment.

Viable Air Sampling: Measures airborne microbial contamination. Required every 6 months for Category 1 and 2 CSPs, and monthly for Category 3 CSPs.
Surface Sampling: Measures microbial contamination on surfaces. Required monthly for Category 1 and 2 CSPs, and weekly for Category 3 CSPs.
Certification: Compounding facilities must be certified by an independent party every 6 months, which includes testing airflow, HEPA filter integrity, and particle counts.

Cleaning and Disinfection

Effective cleaning and disinfection are critical for controlling microbial contamination.

Sterile Agents: Only sterile cleaning and disinfecting agents, including sterile 70% isopropyl alcohol, can be used inside PECs.
Sporicidal Agents: Sporicidal agents must be used in the PEC at least monthly.
Frequency: Specific frequencies are required for different surfaces:
- Daily: Floors, pass-through chambers, and easily cleanable work surfaces.
- Monthly: Ceilings, walls, and shelving.
- At shift start, before each batch, and after spills: PEC surfaces.

Compounding Categories and Beyond-Use Dates

The 2023 update introduced three compounding categories based on the compounding environment and quality assurance procedures. This replaced the old low-, medium-, and high-risk levels and directly influences the Beyond-Use Date (BUD).

Comparing Compounding Categories


Aspect	Category 1	Category 2	Category 3
Environment	Segregated Compounding Area (SCA), an unclassified room with an ISO Class 5 PEC.	Cleanroom suite with ISO Class 7 buffer room, ISO Class 8 ante-room, and ISO Class 5 PEC.	Requires a facility meeting additional quality assurance requirements, allowing for longer BUDs.
Personnel Garbing	Standard garbing (shoe covers, hair covers, masks, gown).	Standard garbing.	Standard garbing plus sterile low-lint outer garb and full skin coverage.
Environmental Monitoring	Viable air sampling every 6 months, surface sampling monthly.	Viable air sampling every 6 months, surface sampling monthly.	Viable air sampling monthly, surface sampling weekly.
Default BUD (Room Temp.)	12 hours or less.	Significantly longer than Category 1, but still limited based on stability.	Longer than Category 2, requires sterility testing.
Default BUD (Refrigerated)	24 hours or less.	Longer than Category 1, but still limited.	Longer than Category 2, requires sterility testing.
Default BUD (Frozen)	Not applicable.	Up to 45 days.	Longer than Category 2, requires sterility testing.

Immediate-Use Compounding

For emergency situations, USP 797 provides specific policies for immediate-use CSPs to ensure rapid access to medication without compromising safety.

The CSP must be prepared using strict aseptic technique.
Preparation must not involve more than three different sterile products.
The BUD for immediate-use CSPs is a maximum of 4 hours from the start of preparation.
Any unused portion must be discarded after 4 hours.

Conclusion

Understanding and adhering to the policies and procedures outlined in USP 797 is not just a regulatory obligation but a fundamental requirement for protecting patient and staff safety. The guidelines, especially in their latest revisions, emphasize a risk-based approach through compounding categories, strengthened personnel competency requirements, and increased environmental monitoring frequencies. Facilities must establish comprehensive programs that include robust training, strict adherence to garbing and cleaning protocols, meticulous documentation, and continuous monitoring to ensure compliance and maintain the highest standards of sterile compounding practice. For more detailed information on compliance and the latest revisions, refer to the official USP website.

Frequently Asked Questions

The main goal of USP 797 is to ensure the safety and quality of compounded sterile preparations (CSPs) by providing a framework of standards that minimize the risk of microbial contamination, excessive bacterial endotoxins, and other errors that could harm patients.

USP 797 standards apply to all healthcare settings that perform sterile compounding, including pharmacies in hospitals and retail settings, as well as all personnel involved in the compounding process or overseeing it.

All classified sterile compounding facilities must be certified by an independent party at least every six months. This certification includes testing airflow, HEPA filter integrity, and particle counts.

An expiration date is determined by the manufacturer for commercially available products. A Beyond-Use Date (BUD) is assigned by the compounder based on USP 797 guidelines and factors like stability, sterility, storage conditions, and compounding category.

For Category 3 compounding, additional garbing requirements include sterile, low-lint outer garb covering all exposed skin, including the face and neck. Reusable garb must be sterilized before reuse.

Immediate-use CSPs, intended for emergency situations, must be prepared using aseptic technique and cannot involve more than three sterile products. They must be administered within four hours of preparation, and any unused portion must be discarded promptly.

Environmental monitoring for sterile compounding areas includes viable air sampling and surface sampling. The frequency of this monitoring depends on the compounding category, with stricter requirements for higher-risk categories.