SOSCleanroom Education Center
USP <797> Compounding
Sterile compounding basics for pharmacies, hospitals, clinics, and new technicians
Sterile compounding basics for pharmacies, hospitals, clinics, and new technicians
A practical white paper on consumer safety benefits, operational compliance pillars, and execution tools that help teams stay consistent and audit-ready.
Last updated: January 2026
By: SOSCleanroom
Last updated: January 2026
By: SOSCleanroom
USP <797> overview Consumer safety Category 1 & 2 CSPs Cleaning & disinfection Monitoring & certification Customer checklist
USP <797> is a U.S. Pharmacopeia–National Formulary (USP–NF) General Chapter that establishes minimum standards for compounding sterile preparations (CSPs). The purpose is straightforward: reduce preventable patient harm by controlling microbial contamination, excessive endotoxins, ingredient and process variability, and other contamination risks that can arise when sterile preparations are compounded.
Important note on sources: USP standards are copyrighted. This SOSCleanroom white paper is an educational, operational interpretation written in plain language. It does not reproduce USP–NF text verbatim and is not a substitute for the official USP–NF chapter. Always consult the official USP–NF text and your jurisdiction’s adoption/enforcement requirements for definitive requirements.
In one sentence: USP <797> protects patients by requiring sterile compounding to be performed in controlled environments by trained personnel using validated processes, with measurable monitoring and defensible documentation.
1) Executive summary
USP <797> should be viewed as a system, not a single task. Strong programs align six elements: (1) governance and quality oversight, (2) trained and qualified personnel, (3) suitable engineering controls and facilities, (4) standardized cleaning/disinfection/sporicidal practices, (5) environmental monitoring and certification evidence, and (6) controlled handling/labeling/storage/transport including beyond-use date (BUD) discipline.
What “good” looks like
- Every shift compounds the same way (technique and staging are standardized).
- Cleaning is consistent (tools, chemistries, contact times, and logs).
- Monitoring detects drift early (trend review, escalation, corrective action).
- Records are complete and audit-ready (you can prove what happened).
What causes most compliance failures
- Variation: different wipe patterns, dwell times, or staging choices across staff.
- Incomplete documentation: missing logs, unclear ownership, weak review cadence.
- Supply mismatch: tools that shed, leave residue, or are inconsistent in format.
- Treating monitoring as “checkbox” instead of trend-based control.
2) Who is impacted by USP <797>
USP <797> applies when an organization performs sterile compounding—for example, preparing sterile doses by combining, admixing, diluting, reconstituting, pooling, or otherwise altering sterile ingredients or components to create a CSP. This includes many hospital pharmacies, health-system facilities, community pharmacies that compound sterile preparations, and certain clinic-based settings.
Operational takeaway: Your “scope decision” should be documented. If you decide an activity is in-scope (or out-of-scope), write the rationale, reference your SOPs, and keep it in your compliance binder so staff and auditors see the same logic.
3) How USP <797> benefits consumers
Patients rarely see the compounding environment, but they experience the outcomes. USP <797> improves consumer safety by requiring disciplined controls that reduce the likelihood of:
- Microbial contamination (nonsterility): a critical risk for injections and infusions.
- Excess bacterial endotoxins: can cause severe reactions even when a preparation appears “sterile.”
- Strength variability (dose errors): inconsistent compounding processes can yield unpredictable potency.
- Particulates and residues: fibers, lint, and cleaning residues can create clinical risks and product instability.
- Loss of traceability: inability to investigate and correct issues rapidly if something goes wrong.
Consumer-facing summary: USP <797> is designed so that sterile doses are prepared in controlled spaces by trained professionals, cleaned correctly, monitored over time, and documented well enough to demonstrate consistent performance and investigate issues quickly.
4) Core compliance pillars
Practical rule: If you reduce variation, you reduce risk. Most compliance work is “process engineering” for humans—making the right action the easiest action.
A) Governance and quality system
- Assign responsibility for sterile compounding oversight and record review (clear ownership prevents drift).
- Control SOPs: versioning, approvals, change control, and accessible training artifacts.
- Run deviations and CAPA: investigate excursions, document root cause, and record corrective actions.
- Maintain “audit readiness”: if it is not documented, it is difficult to defend.
B) Personnel training, garbing, and aseptic technique
- Train to a single best method (hand hygiene, garbing, disinfection steps, and aseptic behaviors).
- Qualify and re-qualify personnel on a defined cadence using observation and required competency assessments.
- Design workflow to reduce unnecessary touches and interruptions (human interventions are a contamination vector).
- Standardize supply staging so staff do not improvise.
C) Facilities and engineering controls
- Use appropriate primary engineering controls (PECs) and room configurations that align with CSP activities performed.
- Maintain certification and maintenance evidence; ensure repairs trigger impact assessments and any necessary requalification.
- Control clutter and storage behaviors; use cleanable surfaces and minimize dust-traps.
- Control material transfer so outer packaging and uncontrolled items do not compromise critical areas.
D) Cleaning, disinfection, sterile alcohol use, and sporicidal program
- Select appropriate disinfectants and sporicidal agents; define contact times and application methods in SOPs.
- Standardize wiping/mopping technique: direction, overlap, face control (folding/rotation), and change-out rules.
- Use controlled, low-lint tools and appropriate packaging formats to reduce shedding and recontamination.
- Log cleaning activities consistently and review logs routinely.
E) Environmental monitoring and trend-based control
- Implement viable air and surface sampling as required; evaluate results in context of operations.
- Trend data (not just single results) to detect drift; define action and alert pathways.
- Investigate excursions and adverse trends with documented corrective actions.
- Coordinate monitoring with cleaning practices and traffic patterns for meaningful signals.
F) Handling, labeling, storage, transport, and BUD discipline
- Assign BUDs in alignment with the CSP category and the conditions under which the CSP is prepared and stored.
- Maintain traceability: ingredients/components, lots, personnel, timestamps, and storage conditions.
- Ensure storage/transport conditions match the assumptions used when establishing BUD.
- Use labeling and workflow steps that prevent mix-ups and support investigations.
5) Charts and program maps
How to use these charts: Share with stakeholders and new staff. They connect “patient risk” to “control systems” and to the documentation you need to defend performance.
Chart 1 — Patient risk mapped to control systems and audit evidence
| Primary risk to patients | Controls that reduce the risk (program systems) | Evidence you should be able to produce |
|---|---|---|
| Microbial contamination (nonsterility) | Personnel qualification • Controlled environments • Cleaning/disinfection discipline • Monitoring | Training & competency records • Cleaning logs • Monitoring trends • Certification reports |
| Excess bacterial endotoxins | Component control • Process controls • Handling and storage discipline | Receiving records • Supplier documentation • Deviations/CAPA tied to investigations |
| Strength variability (dose errors) | Standardized methods • Calculation checks • Batch records • Supervision/verification | Formulation/batch records • Independent checks • Training evidence |
| Particulates/residues | Low-lint tools • Residue-controlled chemistries • Material transfer control | Approved supply list • Compatibility/validation notes • Cleaning logs |
| Weak traceability and slow investigations | Labeling discipline • Record completeness • Ownership and review cadence | Logs and records that reconstruct “who/what/when/where/how” quickly |
6) SOSCleanroom products that support USP <797> execution
USP <797> compliance is won in day-to-day execution: consistent wiping, correct dwell times, appropriate tools that minimize shedding and residues, and standardized formats that reduce improvisation. SOSCleanroom helps customers build repeatable programs with cleanroom-grade consumables and practical guidance.
Non-endorsement clarity: USP does not endorse specific brands or products. The examples below are provided to help customers map “requirement → execution tools” inside their SOPs and validation expectations.
Execution mapping: common needs → product categories
| Program need | Typical execution tools | SOSCleanroom examples |
|---|---|---|
| Critical-area wipe downs and alcohol passes | Sterile 70% IPA wipes and/or sterile IPA solutions + low-lint sterile wipers | Texwipe TX3216 sterile pre-wetted 70% IPA wipers CiDehol ST 8316 sterile 70% IPA (WFI-based) Browse cleanroom wipers |
| Cleaning/disinfection and sporicidal support | Disinfectants/sporicides + compatible wipes/mops to standardize technique | Browse cleaning solutions Mops & refills for controlled environments |
| Large-area cleaning (floors/walls) | Cleanroom mop systems, low-shedding covers, controlled buckets/carts | Shop cleanroom mops Sterile AlphaMop covers (example) |
| Barrier PPE and reduced handling | Cleanroom gloves and dispensing formats that support workflow discipline | Sterile nitrile gloves (category) Ansell BioClean Emerald sterile nitrile (example) |
| Entryway particulate control (where appropriate) | Sticky mats and accessories as part of a broader contamination control plan | Sticky mats (18" x 36") Texwipe CleanStep sticky mats (example) |
| Precision cleaning of small surfaces/components | Cleanroom swabs for controlled application of solutions and targeted wipe-down | Browse cleanroom swabs Texwipe TX701 (example) |
Implementation tip: Build “standard kits” for shifts (same SKU set, same packaging, same location) to reduce improvisation. Standardization is one of the simplest ways to strengthen compliance and reduce drift.
7) USP <797> customer checklist
Use this checklist for a rapid internal self-assessment. Align each item to the currently applicable USP–NF official text and your jurisdiction’s enforcement posture. This checklist is designed to be operationally useful without quoting USP text.
How to use: Print this section and store it in your compliance binder. During audits, initial each line after verifying the supporting record exists and is complete.
A) Governance and quality system
B) Personnel, garbing, and aseptic technique
C) Facilities and engineering controls
D) Cleaning, disinfection, sterile alcohol use, sporicidal program
E) Environmental monitoring and trending
F) BUD, labeling, storage, transport, traceability
Audit stress test question: If an inspector asked you to prove compliance for last Tuesday, could you produce the complete record set in under 15 minutes?
8) Official USP references
Use the official USP resources below as your source of truth for requirements, official dates, and the current chapter text pathway.
- USP compounding resource portal (General Chapter <797>): https://www.usp.org/compounding/general-chapter-797
- USP–NF notice on publication/official date of revised <797>: https://www.uspnf.com/notices/797-pub-announcement-20221101
- USP–NF DOI record (chapter reference/preview pathway): https://doi.usp.org/USPNF/USPNF_M99925_07_01.html
- USP FAQ — Identifying “official text” in USP–NF: https://www.usp.org/frequently-asked-questions/identifying-official-text
- USP FAQ hub: https://www.usp.org/frequently-asked-questions
Need help selecting consumables that support your sterile compounding program?
SOSCleanroom supports critical environments with best-in-class cleanroom consumables and practical guidance that helps teams stay consistent, audit-ready, and in control.
SOSCleanroom Education Center
SOSCleanroom is the source for this educational entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
Briefed and approved by the SOSCleanroom (SOS) staff.
Questions? Contact our team.
Last reviewed: January 10, 2026 Customer-first, audit-ready guidance Cleanroom consumables + education
Need additional information? Please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.
If you have any questions please email us at Sales@SOSsupply.com or give us a call at (214) 340-8574.
© 2026 SOSCleanroom. All rights reserved.
If you need additional information please try our SOSCleanroom specific AI ChatBot which draws from our extensive cleanroom specific libraries.