10 Steps for USP 797 Competency Evaluation
Oct 15, 2025
Sterile compounding requires precision and adherence to strict guidelines to ensure patient safety. USP <797>, updated in November 2023, outlines the necessary steps for maintaining quality in sterile compounding practices.
Here’s a quick breakdown of the 10 steps for conducting competency evaluations:
Hand Hygiene Training: Master antiseptic handwashing and preparation.
Garbing Assessment: Verify proper use of gloves, gowns, and masks.
Gloved Fingertip Sampling: Test for contamination after garbing.
Aseptic Manipulation (Media-Fill Testing): Simulate sterile compounding to check for microbial growth.
Surface Sampling: Monitor contamination on work surfaces.
Environmental Monitoring: Track air quality, temperature, and pressure.
Documentation: Maintain detailed records of all procedures and results.
Remediation: Address failures with retraining and reassessment.
Oversight Personnel Evaluation: Ensure compliance from supervisors.
Audits: Regularly inspect and improve practices.
These steps ensure sterile compounding meets updated standards, reducing risks of contamination and errors. Compliance isn’t optional - it’s a critical part of patient safety and regulatory adherence.
Pharmacy Compounding 101: USP 797 Personnel Training and Evaluation | Esco TaPestle Rx
10 Steps for USP <797> Competency Evaluation
This section outlines the key steps required to meet the updated USP <797> standards. With the 2023 updates introducing new testing methods and stricter documentation requirements, a systematic approach is critical for implementing a competency evaluation program.
Step 1: Hand Hygiene Training
Hand hygiene is the cornerstone of sterile compounding. Training must cover antiseptic handwashing techniques and personnel preparation protocols. A Designated Person or Assigned Trainer needs to directly observe and verify compliance with these procedures.
"Personnel must also demonstrate competency within these core skills. This requires hands-on completion and observation by a Designated Person or Assigned Trainer." - Wolters Kluwer
Step 2: Garbing Competency Assessment
Garbing involves proper use of personal protective equipment (PPE) like gloves, gowns, and masks. Personnel must complete three initial garbing evaluations and undergo reassessment every six months for Categories 1-2, or every three months for Category 3. If Micrococcus bacteria are detected during sampling, this often signals issues with gowning or personnel practices. The gloved fingertip test confirms correct garbing by ensuring 0 CFU.
Step 3: Gloved Fingertip and Thumb Sampling
This step evaluates aseptic technique by testing for contamination. Personnel press their gloved fingertips and thumbs onto Tryptic Soy Agar (TSA) plates, which include agents to neutralize residues. Sampling is done after work in critical areas but before glove sanitization to reflect real conditions. A two-stage incubation process is required: 48 hours at 30–35°C, followed by at least five days at 20–25°C. Acceptable results are ≤3 CFU after media-fill testing and 0 CFU following proper garbing. In 503B outsourcing facilities, glove testing is conducted with every batch and monitored daily.
Step 4: Aseptic Manipulation Testing (Media-Fill Testing)
Media-fill testing simulates real compounding conditions using microbial growth media like Tryptic Soy Broth (TSB). The same two-stage incubation process as in Step 3 applies. Any microbial growth indicates failure, requiring immediate retraining. Testing frequency aligns with garbing assessments: every six months for Categories 1-2 and every three months for Category 3.
Step 5: Surface Sampling
Surface sampling checks for microbial contamination at the end of compounding activities. Contact plates with general growth media, such as TSA, and neutralizing agents like lecithin, are used to test a 24–30 cm² area. For uneven surfaces, swabs can be used. The incubation process mirrors the one described earlier, with plates inverted to prevent condensation issues. Sampling frequency varies: monthly for Categories 1-2 and weekly for Category 3. Exceeding action levels necessitates further investigation and microbial identification.
Step 6: Environmental Monitoring
Environmental monitoring tracks air quality (viable and non-viable particles), temperature, humidity, and differential pressure. Non-viable particle counts are measured near workstations, while viable air sampling collects at least 1,000 liters of air. Differential pressure, typically 10–15 Pascals, ensures proper airflow segregation. For 503B facilities, stricter protocols apply, including daily monitoring of non-viable and viable particles, as well as continuous tracking of environmental parameters. Accurate documentation is essential to maintain compliance.
Step 7: Documentation and Recordkeeping
Thorough documentation underpins the entire competency program. Key records include Master Formulation Records, Compounding Records, and logs of equipment calibration and cleaning. Personnel files must track completed training and assessments, while quality program records document audits, adverse drug reactions, and complaints. Many facilities use compliance management systems to organize these records. Standard Operating Procedures (SOPs) should clearly outline processes and be reviewed regularly.
Step 8: Remediation and Reassessment Procedures
When test results exceed acceptable standards, immediate remediation and reassessment are critical. Root cause analysis identifies whether issues stem from personnel, environmental factors, or procedural gaps. Training should address specific problems, such as reviewing HVAC systems for Aspergillus detection or personnel practices for Micrococcus. All corrective actions and reassessments must be documented to prevent recurrence.
Step 9: Oversight Personnel Evaluation
The individuals overseeing compliance must also undergo regular competency evaluations to ensure the integrity of the program. In September 2023, UC San Diego Health introduced a proctor training program tailored to the updated USP <797> guidelines. This program included presentations, mock evaluations, written exams, and audits of evaluator performance.
"USP <797> 2023 requires a 2-stage incubation method for gloved fingertip and thumb sampling, media fills, and surface samples." - Jaclyn M. Jaskowiak, PharmD, BCPS, BCSCP, Inpatient Pharmacist Specialist and Health Sciences Clinical Instructor at University of California (UC) San Diego Health
Step 10: Audit and Quality Assurance Procedures
Routine audits ensure the competency evaluation program is effective and compliant. This involves reviewing documentation, observing personnel practices, and confirming that corrective actions address deficiencies. Quality assurance metrics, such as pass rates and environmental monitoring trends, help track program success. To maintain objectivity, audits should be conducted by personnel not involved in daily operations.
USP <797> Updates: Changes to Competency Requirements
Regular evaluations are essential for staying compliant and ensuring patient safety in sterile compounding. The 2023 updates to USP <797>, effective November 1, 2023, mark the most extensive changes since 2008. These updates introduce stricter testing protocols and broader personnel requirements.
New Testing Frequency and Procedures
Competency evaluations now follow category-specific schedules: every six months for Category 2 and quarterly for Category 3. These evaluations apply not only to compounding staff but also to supporting roles like restocking, cleaning, verification, and maintenance tasks.
Environmental monitoring requirements have also increased. Monthly surface sampling is now mandatory, paired with media-fill testing, while viable air sampling must occur more frequently in Category 3 areas.
Under the revised standards, compounding personnel must demonstrate proficiency in eleven core skills across four key areas: sterile compounding, hand hygiene and garbing, aseptic techniques, and maintaining the sterile environment. Annual training on these skills is now required.
Facilities must prepare for these changes by doubling supplies for gloved-fingertip tests and aseptic validation media. Additionally, sporicidal disinfectants must be applied at least once a month .
The table below highlights the key differences between the old standards and the updated 2023 requirements.
Old vs. New Requirements Comparison
Aspect | Previous Standards (Pre-Nov 2023) | 2023 USP <797> Revisions |
|---|---|---|
Categorization System | Low-, Medium-, and High-risk categories | Categories 1, 2, and 3 based on compounding conditions and microbial growth potential |
Competency Frequency (Compounding Personnel) | Annually for all risk levels | Category 2: Every six months |
Personnel Scope | Primarily compounding personnel | Expanded to include oversight personnel and supporting roles (e.g., restocking, cleaning, verification, maintenance) |
Core Competencies | General requirements without specific skill definitions | Eleven defined core skills across four specific areas |
Failure Criteria | Component-specific remediation | Failure of any portion requires repeating the entire competency evaluation |
Documentation Requirements | General documentation expectations | Detailed documentation including incubation criteria, passing thresholds, and skills validation |
Surface Sampling | Undefined or less frequent requirements | Monthly sampling required in conjunction with media-fill testing |
Facilities are now required to maintain detailed documentation, including incubation criteria, passing thresholds, and skills validation records, rather than relying on general competency logs.
The shift from the older risk-based categories (Low, Medium, High) to the new system (Categories 1, 2, 3) introduces a more refined approach to compounding conditions, environmental monitoring, and microbial growth potential. This change calls for a reassessment of current practices to ensure alignment with the updated categorization framework. Meeting these new standards is critical for maintaining a compliant and effective competency evaluation program.
How Audits Support Competency Evaluation
Regular audits play a key role in ensuring compliance with USP <797> standards and maintaining accreditation. They offer a reliable way to confirm that your facility consistently upholds the rigorous practices required for sterile compounding. Accrediting agencies rely on documented competency to verify adherence to these standards, making audits a cornerstone of any effective competency program.
Between 2001 and 2017, there were 1,416 negative incidents - including 115 fatalities - highlighting the critical need for audits that go beyond surface-level evaluations. These numbers emphasize why audits must focus on identifying real gaps in competency, not just checking boxes.
"Adherence to the USP 797 guidelines transcends mere regulatory compliance; it represents an ethical obligation to safeguard patient safety." - Brandon Russell, Solutions Marketing Leader for Life Science Solutions
Audits not only reinforce compliance with USP <797> but also promote ongoing improvements in compounding practices. They help uncover deficiencies in aseptic techniques and other vital processes before these issues can compromise patient safety or compliance.
How to Use Audit Checklists
Building on foundational training, audit checklists ensure that every critical step - from garbing to environmental monitoring - is consistently assessed. A well-designed checklist should cover key competencies, such as aseptic techniques, hand hygiene, garbing, equipment usage, and documentation. This applies to both theoretical knowledge and hands-on practices, including immediate-use compounding scenarios.
Start by focusing on essential skills every team member must master. These include antiseptic hand washing, proper use of protective garb, cleaning and disinfecting the compounding environment, accurate measurements, and aseptic handling within ISO 5 environments. Additionally, verify that staff correctly use compounding equipment, handle materials safely, and maintain thorough documentation of all processes.
During live compounding, use observational checklists to verify proper aseptic techniques and accurate record-keeping. Include checkpoints for sterile vial access, correct labeling of compounded sterile preparations, and appropriate responses to spills or contamination incidents.
To further enhance evaluations, consider integrating simulation scenarios. These controlled exercises replicate real-world conditions, allowing you to pinpoint gaps in technique without risking patient safety. Each simulation should be documented through hands-on demonstrations and observed by a Designated Person or Assigned Trainer.
Improving Through Regular Audits
Audits go beyond checklists - they foster the continuous improvement that USP <797> demands. The frequency of audits should align with your facility's compounding risk levels, but they should always be viewed as opportunities to learn and refine processes rather than as punitive measures. When audits identify areas needing improvement, they provide actionable data for targeted training and process updates.
By conducting regular audits, you can confirm staff competency and uncover process weaknesses that need attention. This not only ensures that personnel have the skills and knowledge required for safe sterile compounding but also cultivates a culture of constant progress.
Tracking audit results over time can reveal patterns or recurring issues. For example, if multiple staff members struggle with the same competency, it may signal the need for updated training materials or clearer standard operating procedures. Similarly, if certain environmental monitoring points consistently fail to meet standards, audit data can guide facility upgrades or process changes.
Audit documentation is also critical during accreditation surveys. Agencies like The Joint Commission actively monitor compliance with USP <797>. Detailed records demonstrate your facility’s commitment to maintaining high standards between inspections.
Finally, use audit results to highlight successes as well as areas for improvement. Celebrating consistent high performance or improved compliance rates reinforces the importance of the competency evaluation process and motivates continued adherence to proper procedures.
Audits should assess both individual performance and the overall effectiveness of your competency program. They help determine whether training materials are effective, standard operating procedures are clear, and testing methods accurately identify gaps. Regular audits ensure your program stays aligned with evolving regulations and best practices.
Resources and Support from 503Pharma
503Pharma is here to make navigating USP <797> competency evaluation requirements more manageable. Tailored specifically for 503A and 503B pharmacies, it offers resources designed to tackle the unique challenges compounding pharmacies face. By building on the practical steps discussed earlier, this section introduces tools and insights that can be put into action right away.
Educational Content and Best Practices
To help strengthen competency evaluation programs, 503Pharma provides free, step-by-step guides. These include everything from cleanroom design tips to equipment recommendations for achieving optimal ISO 5 setups, ensuring efficient airflow, and maintaining reliable environmental monitoring.
The platform also offers comprehensive training materials covering every aspect of competency evaluations. Topics include hand hygiene protocols, oversight personnel requirements, and more. These resources aim to equip trainers and evaluators with the knowledge they need to perform effective assessments.
Practical Guidance for Compliance
503Pharma simplifies regulatory requirements into actionable steps, making it easier for pharmacies to comply with USP <797>. The guidance focuses on addressing common hurdles, such as determining appropriate testing frequencies, creating effective remediation procedures, and keeping accurate documentation.
The platform also provides practical advice to improve the efficiency of competency evaluations. This includes tips on scheduling assessments to minimize disruptions, choosing testing methods suited to specific facilities, and establishing quality assurance practices that promote continuous improvement.
Connecting Pharmacy Professionals
503Pharma goes beyond resources and guidance by fostering connections among pharmacy professionals. Its network allows facilities to share knowledge, exchange best practices, and learn from the experiences of others in the compounding community. This collaborative approach ensures that every pharmacist, regardless of their operation’s size or resources, has access to expertise that supports patient safety and regulatory compliance.
Conclusion
Ensuring effective USP <797> competency evaluation hinges on structured training, precise testing, and thorough documentation. By following the ten critical steps outlined earlier, pharmacies can create an evaluation program that not only meets regulatory requirements but also prioritizes patient safety. These steps lay the groundwork for a compliance strategy that safeguards both patients and pharmacy operations.
The importance of these evaluations is backed by data. FDA inspections reveal that 90% of facilities preparing compounded sterile preparations (CSPs) faced issues, often tied to lapses like improper hand hygiene or contaminated gloves.
"Properly trained and competent employees are the key to CSP integrity and safety." - Annie Lambert, PharmD, BCSCP, Clinical Program Manager for Compliance Solutions, Wolters Kluwer
Consistency is a cornerstone of competency evaluation. Regular gloved fingertip tests, media-fill assessments, and environmental monitoring create a continuous cycle of checks to prevent safety lapses. Detailed documentation acts as a vital tool during inspections and ensures traceability, reinforcing quality assurance. These practices highlight the importance of unwavering dedication to compliance.
Success in this area requires viewing competency evaluation as an ongoing effort. Role-specific training, consistent testing schedules, and audit-ready documentation, combined with continuous oversight, work together to minimize risks and maintain compliance. Routine environmental monitoring helps identify potential issues before they escalate.
"Ultimately, mastering these regulations isn't just about passing inspections - it's about protecting patients." - Adam West, Course and Curriculum Manager, CriticalPoint
Focusing on the essentials - hand hygiene, proper garbing, aseptic techniques, and precise documentation - can drastically lower risks and ensure the highest standards of patient care. After all, personnel errors remain the leading cause of CSP-related problems.
A well-executed competency evaluation program not only mitigates contamination risks but also simplifies inspections and, most importantly, protects the patients who rely on your expertise.
FAQs
What are the key changes in the 2023 USP <797> updates for sterile compounding competency evaluations?
The 2023 updates to USP <797> bring more stringent rules for training, competency evaluations, and record-keeping, all aimed at boosting safety and minimizing contamination risks in sterile compounding. One notable change is the new requirement for personnel who fail their initial garbing competency evaluation. They must now pass three consecutive evaluations before being approved to proceed.
These changes, which take effect on November 1, 2023, place a greater focus on compliance and maintaining top-tier standards in sterile compounding practices. The revisions underscore the critical role of proper training and thorough evaluations in safeguarding patient safety and ensuring the reliability of compounding procedures.
How often should personnel undergo competency evaluations under the updated USP <797> guidelines?
Competency assessments for personnel involved in sterile compounding are crucial and follow specific timelines based on the category of compounded sterile preparations (CSPs) they handle:
Category 1 and Category 2 CSPs: Evaluations must be conducted every 6 months.
Category 3 CSPs: More frequent assessments are required, occurring every 3 months.
Before starting independent work, personnel must complete at least three initial assessments. Afterward, ongoing competency must be demonstrated annually or more often, depending on the CSP category.
These evaluations are essential for meeting USP <797> standards and ensuring the highest levels of safety and quality in sterile compounding practices.
What should be done if a compounding facility does not meet USP 797 standards during a competency evaluation?
If a compounding facility doesn't meet USP 797 standards during a competency evaluation, it's crucial to act quickly to address the issues. Staff members must participate in remediation, which usually involves extra training aimed at refining their sterile compounding skills.
For deficiencies in areas like media fill testing, gloved fingertip sampling, thumb sampling, or surface sampling, staff are required to undergo focused retraining. They must also successfully pass follow-up evaluations before returning to their roles. These steps are essential for maintaining compliance with USP 797 standards, ensuring both patient safety and high product quality.