United States Pharmaceutical

USP 797 Pharmaceutical Compounding - Sterile Preparations

USP General Chapter 797 establishes standards for compounding sterile preparations to help ensure patient safety. ATEK's environmental monitoring solutions help pharmacies maintain the controlled conditions required for sterile compounding.

Authority: United States Pharmacopeia (USP)

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Why Choose ATEK for USP 797 Compliance

Maintain Sterile Conditions

Continuous monitoring ensures your cleanroom environment meets USP 797 requirements.

Support BUD Assignments

Documented storage conditions provide evidence to support your beyond-use dating.

Pass Board Inspections

Comprehensive documentation and audit trails simplify state board pharmacy inspections.

Protect Patients

Proper environmental control ensures compounded preparations are safe and effective.

USP 797 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement	Description	ATEK Solution
797.4 Facilities and Engineering Controls	Facilities must maintain appropriate environmental conditions including temperature, humidity, and air quality.	Comprehensive Environmental Monitoring Monitor temperature, humidity, and differential pressure across cleanrooms and controlled areas.
797.6 Environmental Monitoring	A written environmental monitoring program must be established and followed.	Automated Monitoring Program Pre-configured monitoring schedules with automated alerts and reporting support your written program.
797.7 Cleaning and Disinfection	Procedures for cleaning and disinfection must be documented and followed.	Condition Verification Document environmental conditions before, during, and after cleaning procedures.
797.14 Beyond-Use Dating	BUDs are determined based on storage conditions and CSP category.	Storage Condition Documentation Continuous temperature logging provides evidence that storage conditions support assigned BUDs.
797.20 Documentation	All activities must be documented, including environmental monitoring results.	Automated Documentation All monitoring data is automatically logged with complete audit trails for regulatory review.
797.18 Quality Assurance	A QA program must ensure preparations are consistently produced to quality standards.	QA Reporting Generate quality assurance reports showing environmental compliance trends and excursion history.

Understanding USP 797

USP General Chapter 797 provides the minimum standards for compounding sterile preparations (CSPs) to help ensure they are safe for patient use. The chapter applies to all settings where CSPs are prepared, including hospitals, compounding pharmacies, and physician offices.

2023 Revisions

The revised USP 797, effective November 2023, includes significant updates:

Simplified facility categories (Category 1, Category 2, and Category 3)
Updated beyond-use dating requirements
Enhanced environmental monitoring requirements
New cleaning and disinfection procedures

Environmental Control Requirements

USP 797 establishes specific requirements for:

Temperature: 20°C or cooler in compounding areas, with specific storage ranges (CRT 20-25°C, refrigerated 2-8°C, frozen -25 to -10°C)
Humidity: Should be controlled below 60% relative humidity to minimize microbial growth
Air Quality: ISO Class 5 for primary engineering controls, ISO Class 7 for buffer areas
Pressure Differentials: Positive pressure in buffer areas, negative pressure for hazardous drug compounding

How ATEK Supports USP 797 Compliance

ATEK’s monitoring platform provides the environmental control documentation required by USP 797.

Comprehensive Parameter Monitoring

Monitor all critical parameters from a single platform:

Temperature in compounding and storage areas
Humidity in cleanroom environments
Differential pressure between classified areas
Alert on any parameter deviation

Documentation for Inspections

When state board inspectors arrive, be ready with:

Complete temperature logs for all storage areas
Environmental trending reports
Excursion documentation with corrective actions
Equipment calibration records

Support for BUD Assignments

Documented storage conditions are essential for beyond-use dating. ATEK provides:

Continuous temperature recording
Proof of proper storage throughout shelf life
Excursion alerts and documentation

USP 797 FAQs

What is USP 797?

USP 797 is a chapter in the United States Pharmacopeia that establishes requirements for compounding sterile preparations. It covers facility design, environmental monitoring, personnel training, beyond-use dating, and quality assurance to ensure patient safety.

What environmental conditions does USP 797 require?

USP 797 requires controlled temperature (typically 20C or cooler for compounding), controlled humidity below 60% relative humidity, appropriate air quality with HEPA filtration, and positive or negative pressure differentials depending on the type of preparation.

How does ATEK help with USP 797 compliance?

ATEK provides continuous monitoring of temperature, humidity, and differential pressure in cleanrooms and storage areas. Our automated documentation and alerting system helps pharmacies maintain compliance and quickly respond to any environmental excursions.

What storage temperatures are required for CSPs?

Controlled room temperature CSPs are stored at 20-25C. Refrigerated CSPs require 2-8C. Frozen CSPs must be stored at -25 to -10C. Each storage condition affects the beyond-use date assigned to the preparation.

Do I need to monitor differential pressure?

Yes, USP 797 requires maintaining pressure differentials between classified areas. Buffer areas must maintain positive pressure relative to ante-areas, and containment segregated compounding areas for hazardous drugs require negative pressure.

How often must environmental monitoring be documented?

Temperature should be monitored continuously or at minimum daily. Pressure differentials must be continuously monitored between all classified areas. ATEK's continuous monitoring meets these requirements and provides real-time visibility.

Need Help with USP 797 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet USP 797 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific USP 797 compliance requirements.

compliance@atek.io

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Related Regulations

United States

State Board Pharmacy

State Boards of Pharmacy across all U.S. states establish regulations for medication storage, temperature control, and documentation to ensure medication efficacy and patient safety. These regulations apply to retail pharmacies, hospital pharmacies, compounding pharmacies, and specialty pharmacies. Compliance requires maintaining specific temperature ranges for different medication types, documenting daily temperature checks, retaining records for 3 years, and managing temperature excursions appropriately. ATEK's monitoring platform helps pharmacies meet state board requirements across all 50 states through multi-zone temperature monitoring, automated documentation, NIST-traceable sensors, and comprehensive record retention.