Last updated: January 2026
By: SOSCleanroom
Non-sterile compounding basics for pharmacies, hospitals, clinics, and new technicians
USP <795> is a U.S. Pharmacopeia–National Formulary (USP–NF) General Chapter that establishes minimum standards for compounding non-sterile preparations (often called compounded non-sterile preparations, or CNSPs). The purpose is straightforward: reduce preventable patient harm by controlling contamination, ingredient variability, dosing errors, mix-ups, and process drift that can occur when non-sterile preparations are compounded.
USP <795> 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 facilities and equipment, (4) controlled component selection and handling, (5) standardized compounding and cleaning practices, and (6) controlled packaging/labeling/storage and beyond-use date (BUD) discipline.
- Every batch is compounded the same way (weights, measures, order of addition, mixing method, and time are standardized).
- Components are controlled (identity, grade, storage, and expiration are verified and documented).
- BUDs and labels are consistent (rationale is documented and tied to risk and stability basis).
- Records are complete and audit-ready (you can prove what happened and why).
- Variation: different mixing techniques, weighing habits, or shortcuts across staff.
- Weak component control: missing CoAs where needed, unclear lot traceability, poor storage discipline.
- Inconsistent BUD assignment: unclear rationale, missing documentation, or mismatched labels.
- Incomplete documentation: missing batch records, cleaning logs, or review cadence.
Patients rarely see the compounding environment, but they experience the outcomes. USP <795> improves consumer safety by requiring disciplined controls that reduce the likelihood of:
- Contamination: microbial, cross-contamination between products, allergens, and foreign material.
- Strength variability: inconsistent weighing/measuring and mixing can yield unpredictable potency.
- Mix-ups and labeling errors: incorrect instructions, concentration, or patient-specific labeling details.
- Instability and degradation: inappropriate BUDs or storage conditions can reduce effectiveness or change product performance.
- Loss of traceability: inability to investigate and correct issues rapidly if something goes wrong.
- Assign responsibility for non-sterile compounding oversight and record review (clear ownership prevents drift).
- Control SOPs: versioning, approvals, change control, and accessible training artifacts.
- Manage 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 for weighing/measuring, mixing, and documentation steps.
- Define hygiene and attire expectations appropriate to the activity and risk level.
- Design workflow to prevent mix-ups: clear staging, labeled intermediates, and one-batch-at-a-time habits where practical.
- Standardize supply staging so staff do not improvise.
- Use suitable designated areas that support cleanliness, organization, and controlled access during compounding.
- Maintain equipment suitability: calibration/verification where needed and documented maintenance.
- Control components: identity, grade, labeling, storage, and expiration; keep lot traceability in records.
- Control material flow to prevent cross-contamination and allergen transfer.
- Define cleaning frequencies, chemistries, and methods; document completion and review logs routinely.
- Standardize wipe technique: direction, overlap, face control (folding/rotation), and change-out rules.
- Ensure labeling and packaging are controlled and consistent with the batch record and counseling needs.
- Document BUD rationale and storage expectations consistently; align labels, records, and internal references.
USP <795> compliance is won in day-to-day execution: accurate measuring, consistent mixing technique, controlled components, clean work surfaces, and documentation that matches what actually happened. SOSCleanroom supports customers by providing cleanroom-grade consumables and practical guidance to help teams build repeatable programs.
| Program need | Typical execution tools | SOSCleanroom examples |
|---|---|---|
| Worksurface wipe-downs and routine sanitation | 70% IPA solutions or pre-wetted wipes + low-lint wipers appropriate to the surface and residue sensitivity | Texwipe TX167 non-sterile 70% IPA solution (USP-grade) Texwipe TX8727 pre-wetted 70% IPA wipers Browse cleanroom wipers |
| Precision cleaning of small surfaces and hard-to-reach areas | Cleanroom swabs for controlled application of solutions and targeted wipe-down | Browse cleanroom swabs Texwipe TX701 (example) |
| Barrier PPE and reduced handling | Cleanroom gloves and dispensing formats that support workflow discipline | Cleanroom gloves (category) |
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 <795>): https://www.usp.org/compounding/general-chapter-795
- USP–NF notice on publication/official date of revised <795>: https://www.uspnf.com/notices/795-pub-announcement-20221101
- 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 controlled environments with cleanroom consumables and practical guidance that helps teams stay consistent, audit-ready, and in control.
Briefed and approved by the SOSCleanroom (SOS) staff.