Compounding and Sterile/Non-Sterile Product Preparation
The standards
Compounding in a pharmacy is prescription-based and follows USP <795> (non-sterile), USP <797> (sterile), USP <800> (hazardous drugs), and USP <825> where applicable, plus Minnesota Board rules. Federal law distinguishes 503A traditional compounding pharmacies from 503B outsourcing facilities. 503A compounding must be for an identified patient pursuant to a prescription, with limits on bulk substances; 503B facilities operate under cGMP and can produce larger quantities. Compounding requires a master formulation record, a compounding record, specified equipment, training, and assigned beyond-use dates (BUDs).
Sterile basics
Sterile compounding requires an ISO-classified environment, proper garb, hand hygiene, disinfection, air and surface monitoring, and validated processes. High-risk preparations and hazardous drugs add engineering controls and closed-system transfer devices. Personnel must be trained and competency-assessed. Non-sterile compounding requires clean space, ingredient verification, and stability-based BUDs.
Traps
Questions confuse <795> and <797>; assume a BUD can be extended arbitrarily; or ignore hazardous drug handling. Another trap is treating a 503A pharmacy as a manufacturer, or compounding from a bulk substance not permitted.
Worked example
A non-sterile ointment is prepared from a manufactured cream and an API. Use the master formula, verify identity and purity, assign a BUD supported by stability data or USP defaults, and record lot numbers. Rule of thumb: if the preparation is sterile, <797> controls; if hazardous, <800> also applies.