6.1 Garbing, Hand Hygiene, and Personal Protective Equipment for Nonsterile Compounding

6.1 Garbing, Hand Hygiene, and PPE for Nonsterile Compounding

Quick Answer: Under current USP <795>, personnel must wash their hands and wear gloves for compounding. The facility's SOP determines other garb—such as a gown, hair or beard cover, mask, shoe covers, or eye protection—according to the preparation, process, contamination risk, and worker-safety assessment. There is no single universal nonhazardous garbing sequence beyond performing hand hygiene before donning gloves.

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Why Personnel Controls Matter

Hands, clothing, hair, jewelry, cosmetics, illness, and poor technique can introduce particles, microorganisms, allergens, or foreign material into a compounded nonsterile preparation (CNSP). PPE also protects the compounder from irritating, sensitizing, corrosive, or toxic ingredients. The designated person therefore converts the facility's process evaluation into written hygiene and garbing SOPs, trains personnel, and documents competency initially and at least every 12 months.

A technician should distinguish two questions:

1. Preparation protection: What controls prevent personnel from contaminating this CNSP?
2. Worker protection: What gloves, clothing, eye/face protection, respiratory protection, or containment does the ingredient hazard require?

Hazardous drugs add the specific controls of USP <800>; ordinary nonhazardous garb cannot substitute for a required C-PEC.

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Hand Hygiene

Personnel perform hand hygiene before starting compounding and before donning gloves. Wash whenever hands are visibly soiled and after contamination, restroom use, eating, or other activities identified by SOP.

A practical procedure is:

1. Remove hand and wrist jewelry when it interferes with cleaning, damages gloves, or creates contamination risk.
2. Wet hands and forearms with running water.
3. Apply soap and use friction over palms, backs of hands, fingers, thumbs, nail areas, wrists, and forearms for at least 30 seconds.
4. Rinse thoroughly without touching a contaminated surface.
5. Dry completely with a single-use towel or approved hand dryer.
6. Don clean gloves without touching an unclean surface.

An alcohol-based hand rub may supplement the facility procedure when hands are not visibly soiled, but it does not replace required washing. If a manual faucet must be touched, use a clean towel as the SOP directs.

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Gloves: The Universal <795> Garb Requirement

Gloves are required for all compounding under <795>. Select a glove material compatible with the chemicals and task. Inspect gloves before use and change them when torn, punctured, contaminated, or when moving between incompatible tasks or components. The SOP may define additional change points from its risk assessment; <795> does not impose a universal 30- or 60-minute change interval for ordinary nonhazardous compounding.

Powder-free gloves avoid adding glove powder to an open formulation. Gloves never replace handwashing. They also do not provide unlimited chemical protection: manufacturer permeation data and the safety data sheet help determine material and change frequency.

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Other Garb Is Process- and SOP-Specific

For nonhazardous nonsterile compounding, USP <795> does not universally require every compounder to wear a gown, hair cover, beard cover, mask, or shoe covers. The facility considers the dosage form and route, whether the process generates particles or splash, and the potential for hair, fibers, cosmetics, or street clothing to contaminate the work.

An example facility sequence might be: remove prohibited items, don any SOP-required covers, wash and dry hands, don any SOP-required gown, then don gloves. Another safe sequence may be appropriate for a different layout. Follow the posted SOP and avoid contaminating clean garb.

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Personal Health, Hygiene, and Behavior

Personnel report conditions that could affect CNSP quality or safe handling, such as an uncovered lesion, draining infection, severe dermatitis, respiratory symptoms, or a glove allergy. The designated person evaluates the task and decides whether covering, reassignment, or exclusion is needed. A diagnosis alone does not create an automatic universal exclusion; the decision protects both product and worker.

The SOP should address food, drink, tobacco, mobile devices, loose jewelry, cosmetics, artificial nails, and other contamination sources within the designated space. Natural nails should be clean and compatible with glove integrity. The important exam principle is to recognize and control the risk, not to invent sterile-cleanroom rules for every nonsterile operation.

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Technique While Wearing PPE

• Keep gloved hands away from the face, phone, door handles, and other unclean surfaces.
• Replace gloves immediately after a breach or contamination.
• Use a scoop or closed transfer method rather than touching ingredients.
• Remove PPE without transferring residue to skin or clothing.
• Dispose of contaminated garb according to the ingredient hazard and facility waste plan.
• Document exposure, spill, or PPE failure and follow the response SOP.

Exam Decision Pattern

When a question asks what <795> always requires for garb, choose gloves plus hand hygiene. When it asks about additional garb, look for the facility SOP and risk assessment. When an HD powder is manipulated, apply <800> containment and HD PPE; a mask or gloves alone are not an alternative.