Proposed Revisions to USP Chapters 795 and 797

Background

USP Chapter 795 provides standards for compounding nonsterile preparations, while Chapter 797 addresses pharmaceutical compounding of sterile preparations. These chapters established the national standards for pharmacy compounding practices and have been adopted into state laws and regulations for pharmacies nationwide.

The current revisions come in response to advancements in compounding science, evolution of pharmacy practice, and lessons learned from contamination incidents that highlighted gaps in existing standards. The proposed revisions attempt to balance patient safety with practical implementation considerations for pharmacies of all sizes and types.

Risk-Based Approach

One of the most significant changes in the proposed revisions is the implementation of a risk-based approach to compounding requirements. Rather than applying uniform requirements to all compounding activities, the new framework tailors requirements based on risk category:

Critical Revisions to Chapter 795 (Nonsterile Compounding)

Chapter 795 has been substantially reorganized and rewritten to focus more on risk-based requirements. Key revisions include:

• Revised beyond-use dating based on risk category and dosage form characteristics
• Updated personnel training and competency assessment requirements
• New provisions for compounding for specific populations (pediatric, geriatric)
• Enhanced requirements for outsourcing facilities when compounding exceeds in-house capabilities
• New provisions for veterinary compounding
• Updated environmental requirements based on risk category
• Revised quality assurance and testing requirements
• New provisions for stability testing of high-risk compounded preparations

Critical Revisions to Chapter 797 (Sterile Compounding)

Chapter 797 introduces significant changes to sterile compounding requirements:

• Revised requirements for ISO classification and environmental monitoring
• New provisions for compounding with automated compounding devices
• Revised definitions and requirements for Buffered Alcohol Hand Rub application frequency
• Updated garbing requirements and protocols
• New provisions for compounding of hazardous drugs
• Enhanced cleaning, disinfection, and storage requirements
• Revised beyond-use dating parameters for different dosage forms
• Updated requirements for compounding verification

Environmental Quality and Monitoring Revisions

The proposed revisions introduce significant changes to environmental quality monitoring requirements across both chapters:

Environmental Monitoring Aspect	Current Standard	Proposed Standard
ISO Classification for CSP Area	ISO 5	ISO 5 (with enhanced dynamic monitoring)
Cleanroom/Compounding Suite ISO Classification	ISO 7	ISO 7 for all sterile compounding activities
Environmental Sampling Frequency	Every 6 months	Risk-based (monthly to quarterly)
Particle Count Standards	Static measurement	Dynamic measurement in operational state
Differential Pressure Monitoring	Check at beginning of shift	Continuous monitoring required

Personnel Training and Qualification

The proposed revisions expand and clarify personnel requirements including:

• Enhanced training requirements with documented initial and ongoing competencies
• Specific qualifications for compounding supervisors with defined responsibilities
• New requirements for aseptic technique assessment and verification
• Requirements for media-fill testing frequency and documentation
• Expanded requirements for evaluation of compounding personnel at defined intervals
• New provisions for training on emergency procedures and equipment failures

Beyond-Use Dating Modifications

The proposed revisions introduce significant changes to beyond-use dating standards:

• Revised beyond-use dates based on risk category, storage conditions, and dosage form
• New provisions allowing extended beyond-use dates with appropriate stability testing
• Updated guidance for determining beyond-use dates for nonsterile compounded preparations
• Clarified requirements for water-containing nonsterile preparations
• New provisions for pediatric-specific beyond-use dating considerations
• Revised storage requirements for compounded preparations based on chemical stability

Facilities and Equipment Requirements

The proposed revisions introduce more detailed requirements for facilities and equipment:

• Revised requirements for primary engineering controls (C-PECs)
• Enhanced specifications for secondary engineering controls (C-SECs)
• New requirements for storage areas and conditions
• Updated standards for water purification and testing
• Revised design requirements for segregating compounding activities based on risk
• New provisions for equipment qualification and maintenance
• Enhanced requirements for cleaning and disinfection protocols

Documentation and Record-Keeping

Documentation requirements have been significantly expanded in the proposed revisions:

• Enhanced batch record requirements with standardized elements
• New requirements for master formulation records
• Updated environmental monitoring documentation standards
• Expanded requirements for documenting personnel training and competency assessments
• New provisions for documenting equipment maintenance and calibration
• Revised requirements for beyond-use dating documentation on labels

Implementation Timeline

Impact on Pharmacy Practice

These proposed revisions will have significant implications for pharmacy practice:

• Increased documentation requirements may necessitate workflow modifications
• Potential capital investments in equipment and facility upgrades
• Enhanced focus on continuous environmental monitoring systems
• Expanded role for quality assurance programs
• New requirements for stability testing of certain compounded preparations
• Reevaluated approach to beyond-use dating may alter prescribing practices
• More flexible requirements may enable certain compounding activities previously prohibited

Conclusion

The proposed revisions to USP Chapters 795 and 797 represent a significant transformation in compounding standards. By implementing a risk-based approach and incorporating contemporary scientific evidence, these revisions aim to improve patient safety while providing greater flexibility for pharmacies. The changes address lessons learned from compounding errors while balancing practical implementation considerations. Pharmacy professionals should carefully review the finalized requirements, conduct comprehensive gap analyses, and develop implementation plans to ensure compliance with these evolving standards. The ultimate goal of these revisions is to ensure compounded medications consistently meet appropriate quality, safety, and efficacy standards based on their risk profile and intended use.