Sterile compounding pharmacies face intense regulatory scrutiny. State boards of pharmacy and accreditation bodies conduct routine inspections, and the USP 797 violations can result in citations, fines, or facility closure. Understanding where pharmacies most frequently fall short helps you maintain compliance and protect patient safety.

This guide breaks down the most common USP 797 compliance issues identified during pharmacy inspections and provides actionable steps to correct them.

Why  Common USP 797 Violations Matters?

Pharmacy inspections have increased in frequency and rigor since USP 797 revisions took effect. State boards now issue citations for issues that previously received warnings. A single failed inspection can halt compounding operations, disrupt patient care, and damage your facility’s reputation.

Knowing the most cited violations gives you a compliance roadmap. You can prioritize corrections, allocate resources effectively, and train staff on high-risk areas before inspectors arrive. Facilities that address common USP 797 violations proactively spend less time on remediation and avoid the operational disruptions that follow a failed inspection.

Inadequate Personnel Training and Competency Assessment

Staff training deficiencies rank among the top Common USP 797 Violations USP 797 violations cited during inspections. The chapter requires initial training for all compounding personnel, followed by ongoing competency evaluations at defined intervals.

Many pharmacies fail to document training properly or skip required reassessments. Garbing and hand hygiene evaluations, aseptic technique demonstrations, and media fill testing must occur on schedule with written records maintained.

How to avoid this violation:

• Establish a training calendar with automated reminders
• Maintain individual competency files for each staff member
• Conduct gloved fingertip sampling and media fill tests per USP 797 timelines
• Document all training with dates, trainer signatures, and pass/fail results

Poor Environmental Monitoring Practices

one of Common USP 797 Violations is Environmental monitoring failures appear frequently in inspection reports. USP 797 mandates routine viable and nonviable particle sampling in all classified compounding areas. Pharmacies often miss required sampling frequencies or fail to act on out-of-specification results.

Total particle counts, viable air sampling, and surface sampling must occur at specified intervals. ISO 5, ISO 7, and ISO 8 environments each have distinct requirements.

How to avoid this violation:

• Create environmental monitoring SOPs with clear sampling locations and frequencies
• Use calibrated particle counters and air samplers
• Establish action levels and corrective action procedures for failed samples
• Review monitoring data monthly and document trend analysis

Deficient Cleaning and Disinfection Procedures

Cleaning protocol violations remain a persistent compliance issue. Inspectors frequently cite pharmacies for improper cleaning agents, incorrect contact times, or missing cleaning logs.

USP 797 specifies that cleaning must occur before compounding begins and after spills or contamination events. Sterile 70% isopropyl alcohol alone does not satisfy sporicidal requirements. A sporicidal agent must be applied at defined intervals.

How to avoid this violation:

• Develop written cleaning and disinfection SOPs
• Train staff on proper dilution, application, and contact times
• Rotate disinfecting agents to prevent microbial resistance
• Maintain daily and monthly cleaning logs with staff initials

Facility Design and Engineering Control Deficiencies

Physical plant issues trigger many USP 797 citations. Primary engineering controls like laminar airflow workbenches (LAFWs) and compounding aseptic isolators (CAIs) must meet ISO 5 air quality. Buffer rooms require ISO 7 classification, while ante-rooms need ISO 8 or better.

Common USP 797 Violations include incorrect pressure differentials, improper air changes per hour, and lack of HEPA filtration certification.

How to avoid this violation:

• Certify all primary engineering controls every six months
• Monitor and document differential pressure readings daily
• Ensure proper airflow direction from clean to less clean areas
• Address HVAC deficiencies before they become citations

Beyond-Use Dating Errors

Assigning incorrect beyond-use dates (BUDs) represents a significant patient safety risk. USP 797 establishes BUD limits based on compounding conditions, sterility testing, and storage temperature. Many pharmacies apply extended dating without meeting the required conditions.

Category 1 and Category 2 compounded sterile preparations have different BUD allowances. Extended dating requires specific environmental controls, ingredient testing, and in some cases sterility testing.

How to avoid this violation:

• Assign BUDs strictly according to USP 797 Category 1 or Category 2 criteria
• Document the rationale for each BUD assignment
• Never exceed default BUDs without supporting data
• Review labeling practices during internal audits

Gaps in Standard Operating Procedures

Missing or outdated SOPs contribute to many compliance failures. USP 797 requires written procedures covering all aspects of sterile compounding operations. Inspectors expect current, detailed documentation that staff can access and follow.

Pharmacies sometimes lack SOPs for critical processes or maintain documents that no longer reflect actual practice.

How to avoid this violation:

• Develop SOPs for every required element in USP 797
• Review and update all SOPs annually
• Train staff on SOP changes immediately
• Keep SOPs accessible in the compounding area

Insufficient Quality Assurance Programs

A weak quality assurance program underlies many individual violations. USP 797 requires pharmacies to establish ongoing QA activities including environmental monitoring review, competency tracking, and investigation of errors or deviations.

Pharmacies without formal QA oversight often accumulate multiple compliance gaps before detection.

How to avoid this violation:

• Designate a quality assurance lead or committee
• Schedule regular internal audits using a USP 797 compliance checklist
• Document all deviations and corrective actions
• Track quality metrics over time

Hazardous Drug Handling Crossover Issues

While USP 800 governs hazardous drug handling, crossover violations affect USP 797 compliance. Compounding hazardous sterile preparations requires negative pressure rooms, containment primary engineering controls, and specific cleaning protocols.

Many pharmacies compound hazardous drugs without proper segregation or containment.

How to avoid this violation:

• Use containment segregated compounding areas (C-SCAs) or negative pressure isolators for hazardous drugs
• Maintain separate negative pressure rooms from non-hazardous compounding areas
• Follow both USP 797 and USP 800 requirements for hazardous CSPs

Take Action Before Your Next Inspection

Proactive compliance prevents costly citations and protects patients. Conduct regular self-inspections, invest in staff training, and address facility deficiencies promptly.

Aseptic Enclosures provides USP 797 compliant cleanroom equipment, compounding aseptic isolators, and environmental monitoring systems built for pharmacy operations that overcome the most Common USP 797 Violations in todays compounding practice. Our team offers pharmacy planning, compliance consulting, and validated equipment to help you meet current standards. Contact Aseptic Enclosures at 1-800-418-9289 or visit asepticenclosures.com to discuss your compliance needs.