USP 795 Non-Sterile Compounding: Technician Essentials
Master USP 795 requirements for non-sterile compounding including beyond-use dating, equipment, quality controls, and documentation. Key PTCE study material.
What Is USP 795?
USP chapter 795 sets the standards for compounding non-sterile preparations such as capsules, solutions, suspensions, ointments, and creams. These preparations are made when a commercially available product does not meet a patient's needs, such as when a specific strength, dosage form, or flavor is required.
When Is Non-Sterile Compounding Appropriate?
Non-sterile compounding is indicated when:
- A commercially manufactured product is not available in the needed strength or dosage form
- A patient has an allergy to an inactive ingredient in the commercial product
- A pediatric or veterinary formulation is needed
- A prescriber orders a specific customized formulation
Key Equipment
Common equipment used in non-sterile compounding includes electronic balances (Class III or better), graduated cylinders, mortars and pestles, ointment slabs, spatulas, and capsule-filling machines. All equipment must be properly calibrated and cleaned between uses to prevent cross-contamination.
Beyond-Use Dating (BUD)
Under USP 795, if no stability data is available, default BUDs apply:
- Non-aqueous formulations - 180 days or the earliest expiration date of any ingredient, whichever is shorter
- Aqueous formulations - 14 days refrigerated (unless stability data supports longer)
- All others - Based on available stability information and professional judgment
Documentation Requirements
Every compounded preparation requires a master formulation record (the recipe) and a compounding record (the batch-specific log). The compounding record must include the date prepared, ingredients and quantities, lot numbers, equipment used, BUD assigned, compounder identification, and quality control checks performed.
Quality Control
Each preparation must undergo visual inspection for appearance, color, and consistency. Weight variation testing for capsules, pH testing for solutions, and other tests as appropriate ensure the finished product meets standards.
Non-sterile compounding appears in the order entry and processing domain of the PTCE. Study these standards thoroughly.
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