USP795

USP <795> Nonsterile Compounding Standards: Practical Compliance, Auditing Readiness, and Contamination Control

A field-ready guide for technicians and pharmacists: what USP <795> expects, how inspections unfold, and how to build defensible daily controls

USP <795>, Pharmaceutical Compounding—Nonsterile Preparations, establishes expectations for preparing nonsterile compounded medications in a way that promotes consistent quality and minimizes preventable risk. In real operations, compliance is rarely won or lost in the mixing step alone. It is won in hygiene discipline, cleaning execution, component control, and record completeness—day after day, across every shift.

A useful way to think about USP <795> is as a practical quality system: define what “clean and controlled” means for your space, train to it, document it, and periodically verify that the system works as written. The tools and supplies used in a USP <795> environment are not about being “more strict than necessary”; they are about reducing variability and making routines easier to execute consistently.

Where USP <795> Applies

USP <795> applies whenever nonsterile preparations are compounded outside manufacturer labeling to meet individual patient needs. This work most commonly occurs in:

Community and independent compounding pharmacies preparing oral liquids, capsules, topical creams and gels, suppositories, and specialty dosage forms.

Hospital and health-system pharmacies compounding nonsterile therapies in support of inpatient and outpatient care.

Veterinary pharmacies and veterinary hospitals compounding species-specific oral, topical, and transdermal preparations.

While USP itself is not an enforcement body, USP <795> is widely used by state boards of pharmacy and accreditation organizations as the benchmark for acceptable practice. In inspections, “compliance” is assessed through observation, documentation, and the facility’s ability to demonstrate consistent execution of written procedures.

How Inspections Usually Work: The Vertical Trace

A common inspection approach is a “vertical trace.” The inspector selects one recently dispensed preparation and traces it end-to-end: prescription/order → Master Formulation Record (MFR) → Compounding Record (CR) → component lots/expirations → equipment checks → cleaning logs → in-process checks/QC → labeling and Beyond-Use Date (BUD) → final disposition or release.

This matters because many findings are documentation or control failures rather than formulation failures. Typical breakdown points include missing lot numbers, incomplete weights/measures, undocumented changes, cleaning logs that do not match production dates, or labels that do not align with the record. If you design your workflow so that required fields cannot be skipped, you reduce inspection risk dramatically.

USP <795> as a Risk-Based Quality System

USP <795> does not prescribe a single facility type or “one right way,” but inspectors expect controls to be appropriate for the activity and consistently applied. A defensible program integrates contamination awareness, environmental control, equipment cleaning, component handling, and documentation into one system with clear responsibilities.

The goal is not perfection—it is repeatability. When procedures are clear and supplies are standardized, the work becomes predictable and easier to supervise, train, and audit.

Personnel Hygiene: Reducing Transfer, Shedding, and Cross-Contact

Personnel practices are a primary contamination pathway in nonsterile compounding. Inspectors often focus on whether hygiene behavior is defined, trained, and consistently executed during weighing, mixing, packaging, and labeling—especially when multiple preparations are handled in the same area.

Gloves are commonly standardized as a basic contamination barrier. Many facilities choose nitrile options to reduce transfer of residues and particulates between tasks. Examples include Ansell Microflex nitrile gloves such as XCEED XC-310, MidKnight MK-296, Cobalt N19, and Ultraform UF-524.

Some USP <795> environments also require hair containment in designated compounding areas. Bouffant-style head covers are commonly used to reduce the introduction of hair and associated particulate from personnel, particularly during handling and packaging steps. When implemented, head covers are most effective when incorporated into written hygiene procedures, training, and routine observation. Examples can be found in SOSCleanroom apparel and garments.

Dedicated lab coats or outer garments are also commonly used to minimize contamination from street clothing. When adopted, garments should be clean, dedicated to compounding areas, and managed through documented laundering or disposal procedures. One example is Ansell AlphaTec® 2000 lab coat (Model 209).

Training and Competency: What Staff Should Actually Be Able to Demonstrate

Training is most defensible when it is role-based and observable. In addition to formulation technique, nonsterile training programs commonly include hand hygiene, garbing expectations, cleaning and sanitation, component handling and storage, equipment use and cleaning between preparations, documentation discipline, and how to recognize and document deviations. A practical training structure helps technicians and pharmacists perform the same way on Monday morning and Friday night.

Facilities, Cleaning Control, and Traffic Flow

USP <795> requires compounding areas to be clean, sanitary, orderly, and maintained to prevent contamination and cross-contamination. Inspectors often evaluate surface condition, organization, and how personnel and materials move through the space. If traffic flow is not managed, contamination controls are harder to sustain.

Cleaning programs are more defensible when they define frequencies, tools, and chemistries—and document completion. Disinfectant selection and program support can be found in SOSCleanroom disinfectants.

Low-lint polyester cleanroom wipers are widely used for benches, carts, shelving, and equipment exteriors to reduce fiber shedding during cleaning. Common examples include Texwipe AlphaWipe products such as TX1009, TX1004, and TX1013. Pre-wetted options are often used to improve consistency of wipe-down execution, such as TexVantage TX8949P (pre-wetted 70% IPA).

In facilities where foot traffic and tracked-in debris present an elevated risk, some nonsterile compounding programs implement shoe covers or controlled footwear policies as part of the sanitation strategy. These controls are typically applied at defined transitions and are most effective when paired with routine floor cleaning and documented housekeeping practices.

To further control tracked-in particulate and debris, many facilities place adhesive tacky (sticky) mats at transitions into compounding or support areas. These mats provide a simple, observable control to reduce contaminants carried on footwear and cart wheels, particularly in higher-traffic locations. An example is the Texwipe CleanStep® 24" x 36" adhesive sticky mats (240 sheets) .

Floors still require routine cleaning regardless of transition controls. Many programs standardize tools and schedules using cleanroom mops, which supports consistency and simplifies oversight. See SOSCleanroom cleanroom mops.

Cleaning as a Controlled Process (Not Just a Task)

Cleaning in a USP <795> environment is easiest to defend when it is treated as a controlled process: the right chemistry, used in the right way, on the right surfaces, at the right frequency, with the outcome documented. This also includes practical decisions such as surface compatibility, contact time expectations, and whether wiping, mopping, or targeted swabbing is most appropriate for the location.

This is one reason many teams standardize cleaning tools (low-lint wipers, pre-wetted wipes where appropriate, dedicated mops) and then document that the method is used consistently. Standardization reduces variation between staff members and shifts, and it makes retraining and supervision more effective.

Equipment Cleaning and Maintenance

Equipment used in nonsterile compounding must be suitable for its intended purpose and maintained in a clean condition. Inspectors often review balance calibration or verification records and assess how tools are cleaned between preparations.

Precision cleaning tools, such as cleanroom swabs, are often used for tight areas and equipment contact points. See SOSCleanroom swabs.

Documentation and Traceability (MFR/CR Discipline)

Master Formulation Records and Compounding Records are central to USP <795> compliance. During inspections, preparations are commonly traced from prescription through release, with reviewers verifying ingredient lots, cleaning records, in-process checks, and final disposition.

Documentation failures are a common source of findings. Standardized forms, controlled paper, and clear status labeling help reduce omissions and improve traceability. Examples include cleanroom stationery and cleanroom tapes.

Integrated Contamination-Control Programs

Many facilities manage these elements as part of an integrated contamination-control and sanitation program rather than as isolated tasks. Coordinating cleaning chemistries, wipes, floor-care tools, traffic controls, and documentation supports consistent execution and simplifies oversight during inspections.

A range of products used to support coordinated programs can be found within SOSCleanroom contamination control and cleaning solutions.

Conclusion

USP <795> compliance is built through consistency, visibility, and accountability. When hygiene controls are clear, cleaning is executed as a controlled process, and records are complete, the compounding operation becomes easier to manage and easier to defend. Standardizing tools and supplies does not replace technique—it reduces variability so technique is performed predictably and documented credibly.

Disclaimer: This content is provided for general educational use and operational planning only. It does not constitute legal, regulatory, clinical, or safety advice. Facilities are responsible for developing and maintaining procedures appropriate to their jurisdiction and scope of practice.