Last updated: January 2026
By: SOSCleanroom
Sterile compounding basics for pharmacies, hospitals, clinics, and new technicians
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.
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.
- 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).
- 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.
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.
- 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.
- 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.
- Use appropriate primary engineering controls (PECs) and room configurations that align with the 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.
- Select appropriate disinfectants and sporicidal agents; define contact times and application methods in SOPs.
- Standardize wiping 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.
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.
| 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 | Browse cleanroom IPA Browse cleanroom wipers |
| Precision cleaning of small surfaces/components | Cleanroom swabs for controlled application of solutions and targeted wipe-down | Browse cleanroom swabs |
| Barrier PPE and reduced handling | Cleanroom gloves and dispensing formats that support workflow discipline | Browse sterile nitrile gloves |
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.
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
SOSCleanroom supports critical environments with best-in-class cleanroom consumables and practical guidance that helps teams stay consistent, audit-ready, and in control.
Briefed and approved by the SOSCleanroom (SOS) staff.