USP795

SOSCLEANROOM | NONSTERILE PHARMACEUTICAL COMPOUNDING

USP <795>: Build a Safer, More Consistent Nonsterile Compounding Program.

A practical reference for pharmacy leaders and technicians covering training, designated compounding space, cleaning schedules, equipment and ingredient controls, master formulation records, beyond-use dating, inspection readiness and better supply decisions.

Explore the Guide ↓ View the USP <795> Checklist →

The essential distinction

USP <795> is a nonsterile compounding standard—not a general cleanroom certification.

USP General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations describes minimum quality practices for compounded nonsterile preparations (CNSPs) used in humans and animals. A preparation can be nonsterile without being acceptable to produce carelessly: identity, strength, physical quality, contamination prevention and reliable records still matter.

Do not equate USP <795> with ISO Class 5, USP <797>, or FDA-approved drug manufacturing. A pharmacy may need designated compounding space and process-specific containment, but not every nonsterile activity requires an ISO-classified cleanroom. Federal and state law, USP–NF standards, and accreditation or contractual obligations must be assessed separately.

What the chapter controls

How the preparation is made

Personnel qualification, documented recipes and batches, appropriate components, equipment, sanitation, inspection, labeling, beyond-use dating and a functioning quality program.

What it does not establish

Sterility of the finished drug

USP <795> does not make an oral liquid, capsule, cream or ointment sterile. Sterile preparations require separate evaluation under USP <797> and any other applicable controls.

Who owns the process

Facility leadership and quality

The designated person(s) and licensed professionals establish the approved workflow, evaluate deviations, maintain records and determine product release and suitability.

What supplies can do

Reduce operational variability

Appropriate wipers, swabs, gloves, cleaning solutions and labels support controlled execution; no supplier SKU by itself certifies a pharmacy as compliant.

Determine applicability first

Which compounding activities fall under USP <795>?

USP <795> addresses preparation of compounded nonsterile preparations by combining, admixing, diluting, pooling, or otherwise altering drug products or bulk drug substances, including certain reconstitution beyond a manufacturer’s labeled directions. Work performed strictly according to the manufacturer’s approved labeling is generally distinguished from compounding under the chapter.

Community pharmacy

Individualized oral formulations

Oral suspensions, flavored preparations, capsules and dosage forms for patients needing a different strength or administration option.

Hospital or health system

Nonsterile pharmacy preparations

Oral and topical preparations made with approved ingredients, procedures and records appropriate to institutional workflow.

Veterinary compounding

Animal-specific dosage forms

Species-specific nonsterile preparations with ingredient handling, labeling and quality controls appropriate to the preparation.

Topical and specialty work

Creams, gels and suppositories

Products may present different water-activity, preservative, equipment-cleaning and container-closure concerns from powders or capsules.

Regulatory boundary: federal law governing human drug compounding (including applicable 503A/503B conditions), state board rules, and the pharmacy’s applicable standards must be independently reviewed. FDA explains that compounded medications are not FDA-approved and that outsourcing facilities are subject to different quality requirements than qualifying 503A compounders.

What changed in the revised chapter

2023 revisions strengthened training, governance, cleaning and written records.

The revised USP <795> became official November 1, 2023. The comparison below summarizes selected changes documented by the American Society of Health-System Pharmacists (ASHP); it is not a substitute for the official chapter.

Control	Practical expectation in revised chapter	What to check in the facility
Designated responsibility	One or more responsible individuals oversee facility and personnel performance.	Named owners, role descriptions, training review and escalation paths.
Personnel competency	Initial training and demonstration of knowledge/competency; periodic re-evaluation at least every 12 months.	Role-specific assessments, dates, assessors and retraining actions.
Gloving and garbing	Gloves during compounding; additional garb based on task and contamination/exposure risk.	Hand-hygiene checks, glove change rules and PPE compatibility.
Compounding space	A designated nonsterile area with appropriate sanitation, storage and workflow control.	Segregated tasks, cleanable surfaces, controlled storage and documented cleaning.
Records	An MFR for each unique CNSP formulation and a CR for each preparation.	Approved master recipe, complete batch history and second-person review where required.
Release	Visual inspection before release/dispensing.	Defined acceptance and documented disposition including deviations.
Beyond-use dates	Water activity and product-specific stability guide date assignment.	Correct formulation category, shorter-date triggers and documented rationale.

Source: ASHP USP <795> Key Changes. Always consult the current official USP–NF text for binding chapter wording.

Physical environment and workflow

A designated, well-controlled workspace matters more than an unnecessary ISO label.

A practical nonsterile compounding space supports accurate measurement, safe movement, easy cleanup and separation of simultaneous activities. Select surfaces that resist cleaning damage; control exposure of powders and other materials; keep components, containers and finished CNSPs identifiable and properly stored.

Define

Designated work boundaries

Specify which area is used for nonsterile compounding, how it is separated from unrelated activities and how workstations are released between different formulations.

Organize

Unidirectional material movement

Separate receiving, staging, weighing, mixing, filling, labeling, and dirty-equipment handling as appropriate. Prevent mix-ups between materials and lots.

Verify

Environmental and storage conditions

Monitor storage temperature as required; verify conditions for ingredients and completed preparations, including any refrigerated storage.

Contain

Powder and exposure control

Assess aerosol-generating operations. Where containment devices are required, maintain engineering controls, user training, inspection and certification.

Maintain

Cleanable surfaces and plumbing

Keep work surfaces, floors and shelving intact. Provide a suitable handwashing/equipment-cleaning arrangement and maintain equipment-cleaning procedures.

Document

Area status and corrective action

Use practical logs to show cleaning completion, storage excursions, maintenance, unusual events and approval to resume affected operations.

An adhesive entrance mat, shoe cover, bouffant or cleanroom garment may support a facility-specific contamination plan, but none should be portrayed as universally mandated by USP <795>. Select only controls that solve a defined problem and do not introduce new hazards.

A practical schedule

Clean first when necessary, then sanitize using qualified chemistry and documented frequencies.

Cleaning removes soil and drug residues; sanitizing reduces microbial burden on appropriate surfaces. These are related but distinct operations. Where performed as separate steps, cleaning precedes sanitizing. Apply the product at its specified concentration and wet-contact time and verify compatibility with equipment, finishes and residue-control procedures.

Area	USP <795> routine-frequency framework	Important trigger or control
Work surfaces	Beginning and end of each shift on compounding days.	Also between CNSPs containing different components; after spills and suspected contamination.
Floors	Daily on days when compounding occurs.	Also after spills or suspected contamination.
Walls	When visibly soiled or contaminated.	Clean after spills or splashes; do not treat a more frequent facility SOP as a USP-wide mandate.
Ceilings	When visibly soiled or contamination is suspected.	Assess safety, access and protection of exposed materials before overhead cleaning.
Storage shelving	At least every three months.	Also after spills or suspected contamination.
Equipment or containment work surfaces	By equipment-specific instructions and between different formulations.	Follow applicable chapter tables, engineering-control procedures and any hazardous-drug requirements.

Source control: these are summarized from implementation/inspection references for the 2023 revised chapter, including Illinois pharmacy self-inspection guide and Kentucky USP <795> inspection template. Confirm the full official tables and local rules before changing an SOP.

Create a cleaning record that answers six questions.

1. What

Surface or equipment ID

Worktop, balance pan, mixing tool, floor zone, shelving bay or enclosure.

2. When

Date, shift and trigger

Routine schedule, between-formulation, visible soil, spill, repair or deviation.

3. With what

Agent and tool

Approved cleaner/sanitizer, concentration, solution lot if required, wiper or mop SKU.

4. How

Technique and contact time

Apply the approved sequence, coverage, dwell and residue-removal step.

5. Who

Operator and verification

Document performance and the additional checks specified in local policy.

6. What next

Status or exception

Record completion, re-cleaning, damage, incompatibility, or a QA hold if needed.

Safety: alcohol-based products are flammable and not suitable for every surface or soil. Do not mix disinfectants or assume 70% IPA controls drug residues, hazardous drugs or bacterial spores. Follow the current label/SDS and the facility’s approved sanitation method.

Human factors

Hygiene, correct glove use and competency are active process controls.

Training should verify that operators can demonstrate—not merely recite—safe nonsterile compounding. The 2023 chapter strengthened initial qualification and re-evaluation expectations. Inspectors may compare the written SOP with actual hand hygiene, component handling, equipment cleaning, measuring and batch documentation.

Before entry

Check personnel suitability

Address illness, skin conditions and other potential contamination concerns under the designated person’s assessment and policy.

Before gloving

Perform proper hand hygiene

Remove interfering jewelry, wash and dry hands per the approved procedure, and don intact gloves without compromising the clean glove surfaces.

During work

Protect between formulations

Avoid touching phones and non-controlled materials; change gloves when torn, soiled, contaminated or otherwise required by the task.

For each role

Demonstrate proficiency

Evaluate calculations, measuring, mixing, equipment use, cleaning, documentation, labeling, and deviation response.

At intervals

Requalify and retrain

Document competency at least every 12 months and following significant changes, recurring errors or identified weaknesses.

For hazardous materials

Add exposure controls

Chemical-protective glove choice and other PPE must reflect hazardous-drug and occupational controls rather than appearance or ISO marketing claims.

A cleanroom glove can be appropriate for certain handling tasks, but glove sizing and material compatibility matter more than treating an ISO-class marketing description as a USP certification. See SOScleanroom Glove Sizing and Fit Guide.

Balances, mixers, spatulas and enclosures

The equipment must be suitable, maintained, cleaned and reproducible.

Equipment selection depends on accuracy, capacity, drug compatibility and the likelihood of cross-contamination. Separate the concepts of routine performance verification, manufacturer calibration and formal suitability evaluation. Record equipment identification in the batch history where the facility requires it.

Measurement

Balances and volumetric devices

Select appropriate readability and capacity. Verify performance according to your quality system; document out-of-tolerance events and evaluate potentially affected preparations.

Product contact

Mortars, pestles and spatulas

Assess compatibility, condition, cleanability and whether materials absorb drug, retain residue or shed particles into subsequent formulations.

Powders

Containment and transfer

Evaluate dust generation during weighing and blending; apply engineering controls for airborne chemical hazards and avoid moving powders into incompatible workstations.

After use

Disassembly and cleaning

Define cleaning points and difficult geometries, rinse requirements, drying, inspection and prevention of wet equipment storage.

Validated processes

Swabbing vs. cleaning

A precision cleaning swab may reach crevices; an analytical sampling swab is chosen for measured background and recovery. They are not interchangeable without method review.

Maintenance

Device service lifecycle

Record calibration/maintenance, defects, component replacement, change control and return-to-service approval.

A manufacturer technical data sheet identifies product characteristics; it does not prove that a particular swab, solvent or device has been validated for your preparation or residue limit.

Ingredient control

Know the identity, source, grade and status of every component.

Component qualification starts before material enters the compounding room. Receiving should confirm the ordered substance, supplier, label, lot, expiration or retest information, packaging integrity and appropriate storage. Active pharmaceutical ingredients used in qualifying human 503A compounding are subject to specific federal source and certificate-of-analysis conditions.

Control point	What to verify	Why it matters
Bulk drug substance	Qualified supplier, applicable USP–NF monograph/503A eligibility, valid COA and source requirements.	Prevents uncontrolled introduction of a component with uncertain identity, strength or legal status.
Other ingredients/excipients	Identity, grade, suitability, lot, expiry and expected formulation function.	Inactive ingredients can affect physical stability, preservation and patient tolerability.
Water and solvents	Specified grade and suitability for the formulation or equipment rinse; appropriate storage.	A cleaning-grade alcohol or water is not automatically acceptable as a formulation ingredient.
Container/closure	Material compatibility, closure integrity, intended dispensing method and labeling.	Can affect stability, dosing accuracy, leachables and assigned BUD.
Receiving exception	Damaged packaging, temperature excursion, missing COA or label discrepancy.	Place on hold pending documented disposition, not informal substitution.

For qualifying 503A compounding from bulk drugs, refer to FDA: Bulk Drug Substances Used Under Section 503A.

Make traceability work

Master Formulation Records and Compounding Records serve different purposes.

MFR = approved recipe and method. CR = the actual execution record for the preparation. The revised chapter requires a Master Formulation Record for each unique compounded nonsterile formulation and a Compounding Record for each preparation. Make the workflow easy for the user but difficult to complete with missing or contradictory critical data.

Master Formulation Record (approved instructions)	Compounding Record (actual batch evidence)
Preparation name, strength, dosage form and formulation reference.	Preparation identifier, preparation date/time as applicable, operator and reviewer.
Components and intended quantities, including relevant characteristics.	Actual component sources, lot numbers, quantities and any adjustments/deviations.
Equipment, materials and step-by-step method.	Equipment identification and evidence steps were completed per the workflow.
Container/closure specification and expected appearance.	Actual packaging, quantity yielded, in-process findings and final observations.
BUD rationale, storage and special labeling instructions.	Assigned BUD, labeling check, release disposition and traceability.
Expected QC steps and acceptance characteristics.	Actual checks, findings, investigations and disposition where applicable.

Example: follow one lot from receipt to dispensing.

Prescription/order → verified formulation → approved component lots → balance/equipment checks → documented cleaning status → execution/measurements → inspection → label and BUD → release. A vertical trace is a useful audit method, not a claim that every inspection follows the same sequence.

Use controlled digital fields or clean, legible paper records with revision control. If a mistake is corrected, preserve a traceable correction rather than overwriting or obscuring the original entry.

Critical patient-safety topic

Beyond-use dates are not manufacturer expiration dates or automatic shelf lives.

A beyond-use date (BUD) is assigned to the compounded preparation using the appropriate formulation category, water activity, chemical/physical stability, microbial risk, container/closure compatibility and supporting information. In the absence of a USP–NF compounded preparation monograph or suitable formulation-specific stability information, the following default limits from the revised chapter provide the framework.

Preparation type	Default BUD limit	Storage under default framework
Nonpreserved aqueous dosage form (a_w ≥ 0.60)	14 days	Refrigerator.
Preserved aqueous dosage form (a_w ≥ 0.60)	35 days	Controlled room temperature or refrigerator.
Nonaqueous oral liquid (a_w < 0.60)	90 days	Controlled room temperature or refrigerator.
Other nonaqueous dosage forms (a_w < 0.60)	180 days	Controlled room temperature or refrigerator.

These are limits, not guaranteed stability claims. Use a shorter BUD where component expiry, physical or chemical instability, microbial concerns, container compatibility or process deviations warrant it. Approved monographs or appropriate stability data may provide a different basis subject to the official chapter. Do not assume every cream is a “35-day product” merely because it is semisolid; determine its relevant water activity and preservation status.

Water activity (a_w) is not % water

A product containing water is not classified solely by its ingredient list. Water activity better characterizes water available for microbial growth.

Preservation

Preservative added does not equal proven protection

A preservative system must be appropriate to the formulation and the applicable evidence; adding a preservative does not automatically justify 35 days.

Chemistry

Stability can be the limiting factor

Drug degradation, phase separation, precipitation, odor/color changes and container interactions may require shorter dates.

Packaging

The container can change the decision

Assess light exposure, closure materials, sorption, leaching and intended use conditions.

Process

Deviations can shorten or invalidate a BUD

Review incorrect temperature, unexpected equipment conditions, ingredient substitution and process changes before releasing a batch.

Label

State both BUD and storage instructions

Staff and patients must not confuse manufacturer ingredient expiration with the final compounded preparation BUD.

Compare USP educational presentation on <795> BUD categories and UConn School of Pharmacy: Nonsterile Compounding BUD Overview. The official chapter and the approved formulation remain controlling.

Quality and release

A complete batch record is necessary but not sufficient.

Before dispensing, verify that the compounded preparation matches the intended formulation and its quality expectations. The revised chapter identifies visual inspection before release; any additional testing is dictated by the formulation, the SOP, risk assessment and the applicable standards.

Visual

Color, uniformity and appearance

Compare against the formulation specification; flag unexpected particles, discoloration, separation or container damage.

Measurement

Yield and dosage consistency

Review measurements, calculations and in-process checks appropriate to the dosage form and risk.

Label

Identity, directions and BUD

Check concentration, dosage form, patient requirements, storage and any auxiliary warnings against the record.

Quality event

Deviation, hold and decision

Investigate missing lot data, incorrect ingredients, temperature excursions or unexplained appearance before release.

Traceability

Recall capability

Confirm that distribution records can connect dispensed preparations to batches and ingredient lots.

Change

Controlled improvement

Update instructions, training, testing and supplier approvals when recurring events show the process is weak.

Compounded drug products are not FDA-approved; see FDA compounding Q&A. The guide should help practitioners strengthen controls, not imply that an ingredient label or supplier certificate guarantees the final CNSP.

Do not conflate chapters

USP <795>, <797> and <800> have different scopes.

Standard / framework	Primary scope	Operational implication
USP <795>	Compounded nonsterile preparations.	Dedicated space, personnel and quality controls; no automatic ISO-class requirement.
USP <797>	Compounded sterile preparations.	Sterile compounding has different environmental, aseptic and monitoring requirements.
USP <800>	Hazardous-drug handling to protect personnel, patients and the environment.	Additional engineering containment, PPE, deactivation/decontamination and exposure controls as applicable.
FDA 503A / 503B and state rules	Different legal pathways and enforcement obligations.	Confirm facility status and applicable federal/state requirements separately from purchasing decisions.

Do not assume ordinary 70% IPA or generic nitrile gloves are sufficient for hazardous drugs. Use a risk-based hazardous-drug program with the appropriate containment equipment, tested chemotherapy gloves where indicated, drug-specific deactivation/decontamination and labeled waste disposal. Cleaning a visible spill is not equivalent to rendering an exposure hazard safe.

Approved catalog examples

Select consumables by task, chemical compatibility and your pharmacy SOP.

The links below are verified SOScleanroom product pages, not automatic endorsements for pharmaceutical compounding or a claim of USP certification. Confirm the current supplier data sheet, availability, package quantity, lot documentation, permitted chemical use and your approved procurement specification.

Routine worktop wipe

/product/wipers/texwipe-tx1009-alphawipe-9-x-9-polyester-cleanroom-wiper/

Nonsterile 9 × 9 in polyester knit. Candidate for approved routine wipe-downs where low fiber release and durable dry wiping matter.

General absorbent wipe

/product/wipers/texwipe-tx609-technicloth-9-x-9-cellulose-and-polyester-cleanroom-wiper/

Nonsterile cellulose/polyester blend. Consider for compatible aqueous soil pickup or facility cleaning; assess lint sensitivity.

Pre-wetted solvent wipe

/product/wipers/texwipe-tx8949p-texvantage-9-x-9-polyester-cleanroom-wiper-pre-wetted-70-ipa/

Nonsterile 70% IPA pre-wetted polyester wiper; flammable and not a universal cleaner or drug-residue remover.

Pre-wetted polyester format

/product/wipers/texwipe-tx1039-alphasat-9-x-9-polyester-cleanroom-wiper-pre-wetted-70-ipa-case-qty/

Nonsterile 70% IPA pre-wetted option; choose only for label-compatible facility surfaces and the approved method.

Detailed equipment cleaning

/product/swabs/texwipe-tx714a-large-alpha-polyester-cleanroom-swab/

Nonsterile polyester swab for small equipment details, grooves and controlled wiping. Not intrinsically a qualified analytical sampling device.

Validation sampling

/product/swabs/texwipe-tx714k-large-alpha-sampling-snap-swab-low-toc/

Low-background sampling swab for appropriately validated analytical programs; not a routine replacement for a cleaning applicator.

Controlled hand protection

/product/brands/ansell-93-311-nitrilite-cleanroom-nitrile-gloves-class-100-iso-5/

Nonsterile cleanroom nitrile glove. Assess fit, task, puncture and chemical compatibility; ISO labeling does not establish USP compliance.

Sterile solution when needed

/product/solutions/texwipe-tx3270-sterile-70-ipa-isopropanol-alcohol-solution-16-oz-bottle-12-case/

Sterile IPA product for programs that specifically require it. Routine <795> does not universally require sterile IPA; confirm flammability and label use.

A simple selection checklist for purchasing.

Purpose: Is the item for routine wipe-down, cleaning, sanitizing, direct product contact, sampling, or PPE?
Sterility: Is a sterile article actually required? Do not spend for or claim sterility without a process reason.
Compatibility: Check cleaner chemistry, substrate, equipment surface and applicable instructions.
Performance: Review fibers, extractables, absorbency, dimensions, glove fit and relevant published test data.
Package and traceability: Choose workable pack sizes, controlled opening, lot identity and approved alternatives.
Safety and costs: Account for hazardous shipping, flammability, storage, PPE and total cost per completed task.
Approval: Require review before substituting a different wiper material, cleaner concentration, glove or packaging format.

Browse Cleanroom Wipers, Precision and Sampling Swabs, Cleaning Solutions, Mops and Glove Fit Guidance.

A useful internal audit method

Trace an actual preparation from the approved formula to release.

A vertical trace is effective for training and inspection readiness because it reveals gaps across departments. A clean record should let a reviewer find each item below without searching through unrelated files.

Formulation approved

Unique MFR with ingredients, method, equipment, packaging and BUD rationale.

Components received

Trace ingredient lots, valid supplier documents, expiry and controlled storage.

Operator authorized

Current competency evidence and role-specific authorization.

Area and equipment ready

Cleaning status, environmental conditions, device verification and required controls.

Batch faithfully documented

Actual ingredient quantities, process steps, anomalies and any approved changes.

Release supported

Visual checks, labeling, assigned BUD, review and final disposition.

Recall traceability works

Locate recipients/dispensed units and connected ingredient lots quickly.

Corrective action closes

Investigations assign ownership, verify effectiveness and update training when needed.

The facility’s official SOPs determine what records are required and who approves them. This audit method is a suggested operational framework, not a claim that the chapter requires this exact eight-step checklist.

From theory to practice

Four common compounding situations and the control questions they raise.

Scenario 01

A second formula needs the same bench

A cream follows an oral suspension. Are the worktop, tools and surrounding surfaces cleaned and sanitized between different components? Has the new batch started with the right MFR and cleared staging area?

Scenario 02

A preservative is added to an aqueous formula

Does the actual preparation support the proposed preservation strategy? Has water activity, chemical stability and container suitability been considered? Adding a preservative alone does not guarantee a longer BUD.

Scenario 03

The balance fails a verification check

Which previous preparations might be affected? What do the records show? Hold any affected product, investigate the discrepancy, arrange service and document return-to-use criteria.

Scenario 04

A preferred 70% IPA wipe is unavailable

Do not approve a substitution based only on the words “70% IPA.” Compare the solution composition, wipe material, chemistry, package, flammability, surface suitability and required approval.

These are illustrative training scenarios. Specific dispositions, BUD decisions and cleaning protocols belong to qualified pharmacy personnel and the applicable controlled procedures.

Connect the knowledge base

Related SOScleanroom guides for deeper practical education.

Audit checklist

USP <795> Nonsterile Compliance Checklist

A companion self-assessment tool designed to support internal gap reviews.

Sterile comparison

USP <797> Cleaning Solutions

Understand how sterile compounding cleaning requirements differ.

Hazardous drugs

USP <800> Handling Guide

Review containment and exposure-control considerations.

Chemical/application fit

Match Solutions to Wipers and Swabs

Evaluate chemistry and applicator interactions before standardizing.

Supplier selection

Cleanroom Product Match

Compare consumables by environment, material and application.

Operator education

Training and How-to Guides

Use broader handling and contamination-control education.

Technical library

Technical Vault — All Resources

Explore approved educational resources across cleanroom disciplines.

Procurement continuity

Sterile Procurement Planning

Where sterile supplies are separately required, review sourcing and inventory principles.

Frequently asked questions

Direct answers for pharmacists, technicians and technical buyers.

Does USP <795> require an ISO Class 5 cleanroom?

No universal ISO Class 5 requirement applies to all nonsterile compounding. The chapter requires appropriate designated space and controls; certain risks and additional standards may require more specialized facilities.

Is USP <795> the same as USP <797>?

No. <795> governs compounded nonsterile preparations; <797> addresses compounded sterile preparations and different aseptic/environmental requirements.

Does every nonsterile formulation require a Master Formulation Record?

The revised chapter requires an MFR for each unique CNSP formulation and a Compounding Record for each compounded preparation.

How often must personnel competency be re-evaluated?

ASHP’s 2023 chapter comparison identifies initial qualification and re-evaluation at least every 12 months; verify applicable chapter wording and additional local requirements.

When should worktops be cleaned and sanitized?

At the beginning and end of compounding shifts, between preparations with different components, after spills and when contamination is known or suspected. Follow the official chapter and facility procedure.

Are sterile wipers mandatory for routine USP <795> cleaning?

No general requirement makes every routine nonsterile compounding wipe sterile. Select cleaning tools and chemistry for the actual task and the facility’s defined controls.

Can 70% IPA remove all compounded-drug residues?

No. Alcohol is not a universal cleaner, deactivation agent or sporicide. Drug residue and surface compatibility may require different approved cleaning methods.

What is the difference between cleaning and sanitizing?

Cleaning removes soil and residue; sanitizing reduces microbial burden using an appropriate agent and method. Separate cleaning should occur before sanitizing.

What is water activity and why does it matter?

Water activity (a_w) measures water availability in a product, distinct from total water content. It helps categorize CNSPs for default BUD assignment and microbial-growth considerations.

Is every preserved aqueous CNSP stable for 35 days?

No. Thirty-five days is a default upper limit only in the specified absence-of-evidence framework, not a stability guarantee. Shorter dates may be required.

Can I put a 180-day BUD on any capsule or ointment?

No. The preparation must meet the relevant nonaqueous category and remain chemically, physically and microbiologically suitable; shorter dates and other chapter restrictions may apply.

Does a manufacturer expiration date equal a compounded preparation BUD?

No. The manufacturer’s dating applies to its specified item/conditions; the final preparation requires its own BUD rationale based on the final formulation and storage.

Do hazardous-drug compounds need additional precautions?

Yes, if hazardous-drug handling requirements apply. Evaluate USP <800>, occupational safety and exposure-control needs rather than relying solely on <795> sanitation.

Is a cleaner labeled “cleanroom safe” automatically suitable for compounding?

No. Review chemistry, contact time, residue, surface compatibility, safety information and your approved SOP before use.

Do all compounded drugs undergo FDA approval?

No. FDA states that compounded drugs are not FDA-approved; qualifying compounding activities are governed by distinct federal and state requirements.

Can SOSCleanroom certify my facility’s USP compliance?

No. SOSCleanroom supplies candidate consumables and manufacturer product information; facility leadership, quality personnel and regulators determine requirements and compliance.

Primary sources and official context

Authoritative references for chapter scope, implementation and federal requirements.

The following references are included to support editorial transparency. Licensed USP–NF text, applicable state law and current facility-specific requirements take precedence over summaries and educational guides.

Source	How to use it
USP General Chapter <795> official record	Scope, title and official USP–NF chapter pathway. Access to full text may require a subscription.
USP Compounding <795> resource portal	Publisher updates and reference pathway.
ASHP: Key Changes to USP <795> (2023)	Summary of designated-person, training, hygiene, cleaning, record and BUD revisions.
Kentucky Board of Pharmacy <795> Inspection Template	Practical examples of inspection controls and cleaning frequency interpretations.
Illinois Nonsterile Compounding Self-Inspection	Current operational checklist and cleaning/sanitizing references for that jurisdiction.
FDA: Compounding Questions and Answers	Federal jurisdiction, safety, quality and differences between 503A and 503B.
FDA: 503A Bulk Drug Substances	Supplier, monograph, registered establishment and COA requirements for bulk substances.
UConn School of Pharmacy: Nonsterile Compounding	Educational synthesis of BUD categories, records and formulation-quality issues.

Publisher/source review: October 27, 2026. Editions, rules, external URLs, product specifications and local requirements may change.

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Educational scope: This guide summarizes selected USP <795> concepts for professional education and product-selection discussion; it is not a licensed copy of USP–NF, a compounding instruction, a medication stability determination, a facility compliance certificate or legal/clinical advice. Obtain the currently official USP chapter and all applicable federal/state requirements. Only the authorized pharmacy professional and quality organization may determine the appropriate SOP, ingredient selection, preparation BUD, cleaning program, handling controls, suitability of purchased products and release of compounded preparations. SOScleanroom does not compound medications or approve facilities.