Non-sterile preparations: solutions, suspensions, ointments, creams, capsules

What Is Non-Sterile Compounding?

Non-sterile compounding means preparing a customized medication that does not need to be free of all microorganisms. Common examples include oral suspensions, topical ointments and creams, and hand-filled capsules. A licensed pharmacist supervises every step; the pharmacy technician follows the master formulation record (MFR) exactly and documents each preparation on a compounding record. USP Chapter <795> sets the minimum standards for non-sterile preparations in the United States.

USP <795> Key Requirements

USP <795> covers personnel, facilities, equipment, ingredients, packaging, and quality checks. Key points you must know:

• Personnel training and competency must be documented before a technician compounds independently.
• Ingredients must come from a reliable source; use the highest-grade material required by the formula.
• Equipment (balances, graduates, mortars, capsule machines) must be clean, calibrated, and appropriate for the job.
• Compounding records must be completed in real time — never from memory after the fact.
• A pharmacist must verify the finished preparation before it is dispensed.

The Master Formulation Record

The MFR is the official recipe. It lists every ingredient with its quantity, the equipment needed, the step-by-step procedure, quality checks, packaging requirements, storage conditions, and the beyond-use date (BUD) calculation method. You must follow the MFR exactly. Any deviation must be reported to the pharmacist immediately.

Beyond-Use Dates Under USP <795>

A BUD is the date after which a compounded preparation should not be used. It is not the same as a manufacturer's expiration date. USP <795> provides default BUD limits based on the category of the preparation and the container and storage conditions. The pharmacist assigns the BUD; the technician must record it accurately on the label.

Default BUD categories under USP <795> (current guidance — always confirm against the active edition):

• Nonaqueous preparations (e.g., ointments, anhydrous creams): up to 180 days or the earliest expiration date of any ingredient, whichever is earlier.
• Aqueous oral preparations (e.g., oral suspensions): up to 35 days when refrigerated.
• Aqueous topical/mucosal preparations (e.g., water-containing topicals): up to 35 days when refrigerated.
• Nonaqueous oral solid preparations (e.g., capsules): up to 180 days or the earliest ingredient expiration, whichever is earlier.

These defaults apply unless stability data support a longer dating. The pharmacist makes the final determination.

Preparing an Oral Suspension

An oral suspension contains solid particles distributed throughout a liquid. Because particles settle, the label must say "Shake Well Before Use." General steps:

1. Verify the MFR and gather all ingredients and equipment.

2. Calculate and weigh or measure each ingredient accurately.

3. If using a powder, triturate (grind) it to a fine, uniform particle size in a mortar.

4. Add a small volume of the suspending vehicle and mix to form a smooth paste (levigation).

5. Gradually add the remaining vehicle with constant mixing until the target volume is reached.

6. Transfer to the dispensing container and label with BUD and storage instructions.

Preparing a Topical Ointment

An ointment is a semisolid preparation intended for skin application. It typically contains an oleaginous (oil-based) base such as white petrolatum. Steps:

1. Verify the MFR.

2. If the active drug is a powder, reduce particle size by triturating on an ointment slab or in a mortar.

3. Use geometric dilution: mix the smallest quantity first, then add equal amounts of base progressively.

4. Incorporate the remaining base until the product is smooth and uniform.

5. Transfer to the dispensing jar or tube and label with BUD and storage conditions.

6. Inspect for uniformity of color and texture before presenting to the pharmacist.

Filling Capsules by Hand

Hard-gelatin capsules are filled with a powder blend. A capsule machine speeds up the process and helps ensure uniform fill weight. Key steps:

1. Verify the MFR and check capsule size (000 is largest, 5 is smallest; size 0 and 1 are most common for adults).

2. Weigh all powders individually; do not estimate.

3. Mix powders using geometric dilution to ensure uniformity.

4. Load capsule bodies into the machine, fill with the powder blend, and tamp gently to consistent density.

5. Cap each capsule, remove from the machine, and wipe clean.

6. Weight check: weigh a sample of filled capsules; compare to the target weight from the MFR. Record results.

7. Present to pharmacist for verification.

Safety Points

• Personal protective equipment (PPE): wear gloves and a lab coat during all compounding. Goggles are required when working with powders or any material that could splash.
• No eating or drinking in the compounding area.
• Hand hygiene: wash hands and don gloves before starting; change gloves if contaminated.
• Avoid cross-contamination: clean and sanitize equipment between different preparations.
• Scope of practice: technicians prepare; pharmacists verify. Never release a preparation without pharmacist final check.
• Error reporting: if an ingredient quantity is wrong or a step is skipped, stop and notify the pharmacist immediately — do not guess or proceed.
• Waste disposal: dispose of excess materials and cleaning waste according to facility policy and local regulations.