Essential Tips to Keep Your Sterile Compounding Program Inspection Ready
The Mechanics of Internal Mock Inspections
Part 3 of 3
Acquiring expertise on proper aseptic processes that significantly enhance the quality of your compounding practices and the safety of your CSPs.
Theoretical Case Scenario:
A 250-bed community hospital is preparing for an upcoming accreditation survey. The pharmacy leadership conducts a mock inspection and identifies several opportunities for improvement, including incomplete cleaning documentation, inconsistent competency records, and gaps in staff understanding of beyond-use dating. Use this scenario to determine how a proactive inspection uncovers risks before survey day.
Introduction:
The idea is that a continuous and non-reactive in-house survey program is most useful in maintaining a “state of control”. This strategy creates confidence among pharmacy staff when preparing for state and regulatory inspections. These inspections can seem daunting. However, by implementing regular in-house mock inspections, pharmacy leaders can create readiness among staff, keeping “surprises“ to a minimum.
Scope
Since USP<797> and <800> differ in compliance expectations, they evoke different “checklists”. Hazardous drug compounding will prove to be the toughest area to evaluate because the sterility requirement must be maintained while addressing “containment” and waste handling. The checklist below is not exhaustive but will serve as a framework to create your own. When creating a checklist, it is recommended to include findings from previous surveys. If a DP is new to compounding area, research into the facility’s certification history and past surveys will shed light on the scope of what needs to be addressed promptly, if not addressed already.
Things Out of Your Control
Considerations such as facilities design, configuration, or any pre-existing engineering issues can become the biggest findings, potentially resulting in a category downgrade if not resolved. If a facility’s room(s) do not meet ISO classification, or shows signs of visual deterioration, it will become necessary to voluntarily downgrade and right a plan of action. These actions must be documented, and the facility’s entrance should bear signage or a statement describing the temporary compounding category and the assigned BUD for all storage conditions. Projected renovations or repairs should also be included to justify current operations.
State of Compounding
It is possible not to have a clear understanding of how busy a cleanroom is and whether the allocated resources are sufficient to sustain daily workflows for every shift. It may be discovered that some tasks are not being performed due to time constraints or poor working conditions. IV workflow management systems may be able to calculate and analyze workflow data which can be useful for supply and personnel management. Knowledge of how much actual compounding (custom, chemo, TPN) versus commercially available pre-mixed dispensing is critical for compounding risk balancing. The point is, predicting what will happen with your workflow when your census fluctuates is of great value.
The Mock Inspection Checklist
Whether a monthly inspection approach to readiness or an all-out quarterly survey is used, it is recommended that the designated person (DP) and involved stakeholders look for sustainability and efficiency. A simple framework is provided below.
Note: a monthly cadence captures events more readily but may be difficult to sustain. However, monthly inspections are more in sync with inspections performed in various healthcare settings, i.e. monthly nursing unit inspections and expired crash cart switch outs.
1. Policies & Governance
- Policies and procedures
- Quality program
- Designated Person oversight
- Documentation
Notes: Policies updated annually
2. Personnel Training & Competency
- Training records (related to compounding)
- Media fills
- Gloved fingertip testing
- Garbing competency
- Hazardous drug competency
3. Environmental Controls
- Certification reports
- Pressure monitoring
- Temperature/humidity
- Cleaning/disinfection
- Environmental monitoring
4. Compounding Documentation
- Master Formulation Records
- Compounding records
- Beyond-use dating
- Labeling
- Verification process
Notes: If a facility makes regular compounding batches, it is recommended to have one of these for every single anticipatory compounding line item.
5. Medication Safety
- Storage
- Recall process
- Hazardous drug management
- Eyewash/spill response
Notes: Use both ISMP and TJC med standards here
6. Quality Improvement
- CAPA
- Trend analysis
- Internal audits
- Performance improvement
Notes:
Pre-determine what needs a CAPA and what doesn’t; but have a CAPA written for any deviation from your “state of control”
7. Staff Readiness
- Interview preparation
- Demonstrations
- Knowledge verification
Notes:
Ask the HR department if pre-qualifying a sterile compounding aspirant is against their policies. Not everyone can take the working conditions or can verbalize properly the work they do. Staff must be ready to “talk shop” with the surveyor.
Survey Questions
It is likely that surveyors will ask questions to personnel. Below is a list of sample questions that DPs can use to develop their own questions based on their facility’s unique characteristics.
Sample Survey Questions for Pharmacists
- How do you determine the beyond-use date for a compounded sterile preparation?
- Describe the responsibilities of the Designated Person.
- What actions would you take following an environmental monitoring excursion?
- How do you document and investigate a compounding deviation?
- How do you verify that compounded products are accurate before dispensing?
Sample Survey Questions for Pharmacy Technicians
- Please demonstrate your hand hygiene and garbing sequence.
- Describe how you clean and disinfect the PEC.
- What would you do if you touched a nonsterile surface while compounding?
- How do you document lot numbers and expiration dates?
- What steps would you take if a pressure alarm activated?
Conclusion
As we wrap up this three-part blog series, we’d like to leave you with highly recommended resources from our author, Luis Hernandez, rPh, BCSP, that help DPs and pharmacy staff to view their facilities through the eyes of a surveyor, creating further optimizations when developing in-house mock inspections.
Suggested Reading: Becoming an Excellent In-House Sterile Compounding Surveyor
Use these authoritative resources to deepen your knowledge of sterile compounding inspection readiness.
Note: Search by the exact title if a direct link changes.
USP
General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.
Publisher: United States Pharmacopeia.
Website: https://www.usp.org/compounding
Search: USP Chapter 797 Pharmaceutical Compounding—Sterile Preparations
USP
General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.
Publisher: United States Pharmacopeia.
Website: https://www.usp.org/compounding
Search: USP Chapter 800 Hazardous Drugs
ASHP
ASHP Guidelines on Compounding Sterile Preparations. American Journal of Health-System Pharmacy, 71(2), 145–166 (2014).
DOI: 10.2146/sp140001
Website: https://academic.oup.com/ajhp
Search: ASHP Guidelines on Compounding Sterile Preparations 2014
ISMP
ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations.
Website: https://www.ismp.org
Search: ISMP sterile compounding guidelines
The Joint Commission
Medication Compounding Certification resources.
Website: https://www.jointcommission.org
Search: Medication Compounding Certification
CriticalPoint
USP <797> educational resources, Designated Person training, mock inspections.
Website: https://criticalpoint.info
IJPC
International Journal of Pharmaceutical Compounding.
Website: https://ijpc.com
Controlled Environments
Cleanroom inspection and contamination control articles.
Website: https://www.cleanroomtechnology.com
CDC
Injection Safety and Environmental Infection Control.
Website: https://www.cdc.gov
Search: CDC injection safety healthcare
ASHP
Draft Guidelines on Compounding Sterile Preparations.
Website: https://www.ashp.org
Search: Draft Guidelines on Compounding Sterile Preparations
Finding Full Text
If an article is not freely available, search the title in PubMed or Google Scholar, or access it through your hospital or university library.
References
United States Pharmacopeia (USP)
- USP <797> Pharmaceutical Compounding—Sterile Preparations. Revised 2023. Official November 1, 2023.
- USP <800> Hazardous Drugs—Handling in Healthcare Settings.
- USP <795> Pharmaceutical Compounding—Nonsterile Preparations. Revised 2023.
These standards form the technical and operational foundation for:
- Designated Person accountability
- Personnel competency
- Environmental monitoring
- Documentation integrity
- Governance and oversight
Accreditation & Medication Management Standards
The Joint Commission
- Comprehensive Accreditation Manual for Hospitals (CAMH).
- Medication Management (MM) Standards
- MM.05.01.07 – Compounding sterile preparations.
- MM.05.01.09 – Labeling requirements
- MM.08.01.01 – Storage and security of medications
- Environment of Care (EC) Standards
These standards support the blog’s discussion regarding:
- Inspection focuses on differences.
- Medication safety emphasis
- Tracer methodology
- Continuous readiness posture
Federal Oversight of Accrediting Organizations
Centers for Medicare & Medicaid Services (CMS)
- State Operations Manual (SOM)
- Conditions of Participation for Hospitals (42 CFR §482)
- CMS Deeming Authority Requirements for Accrediting Organizations
These documents support discussion around:
- Validation surveys
- Oversight of accrediting bodies
- Regulatory alignment
Hazardous Drug & Safety Guidance
National Institute for Occupational Safety and Health (NIOSH)
- NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (2023).
- NIOSH Alert: Preventing Occupational Exposure to Hazardous Drugs (DHHS 2004-165).
Occupational Safety and Health Administration (OSHA)
- 29 CFR 1910.1450 – Occupational Exposure to Hazardous Chemicals in Laboratories
- OSHA Technical Manual, Section VI, Chapter 2 (Hazardous Drugs)
Professional Practice Guidance
American Society of Health-System Pharmacists (ASHP)
- ASHP Guidelines on Compounding Sterile Preparations (Am J Health-Syst Pharm. 2014;71:145–166).
- ASHP Guidance on Handling Hazardous Drugs (Am J Health-Syst Pharm. 2006;63:1172–1193).
These references support the blog’s emphasis on:
- System strengthening
- Governance structures
- Leadership responsibility in sterile compounding
Environmental & Infection Control References
Centers for Disease Control and Prevention (CDC)
- Guidelines for Environmental Infection Control in Health-Care Facilities (updated 2019).
- Guidelines for Hand Hygiene in Health-Care Settings (MMWR 2002;51[RR-16]).
ANSI/ISEA Z358.1-2014
Seven97 Training Insight
Released July 2026
About the Author
Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.