Compounding, Dispensing & Practice

USP General Chapter <795> — Pharmaceutical Compounding: Nonsterile Preparations. It sets standards for facilities, equipment, components, compounding processes, documentation, and beyond-use dating for nonsterile preparations.

USP General Chapter <797> — Pharmaceutical Compounding: Sterile Preparations. It defines categories, microbial contamination risk, air quality (ISO classes), garbing, aseptic technique, and beyond-use dating for compounded sterile preparations (CSPs).

USP General Chapter <800> — Hazardous Drugs: Handling in Healthcare Settings. It covers receipt, storage, compounding, dispensing, administration, and disposal of hazardous drugs to protect personnel and the environment.

The NIOSH List of Hazardous Drugs in Healthcare Settings. Facilities must maintain a list of hazardous drugs they handle, based on the current NIOSH list, and perform an assessment of risk for certain dosage forms.

The BUD is the date or time after which a compounded preparation must not be used, stored, or transported; it is calculated from the date/time compounding begins. BUD differs from a manufacturer expiration date and is generally much shorter because it accounts for compounding conditions rather than stability studies.

By dosage-form category: aqueous dosage forms (water activity ≥0.6, e.g., oral/topical liquids) get a BUD of up to 14 days refrigerated; nonaqueous dosage forms up to 90 days; solid dosage forms (oral) up to 180 days. A documented stability study can extend these.