Compounding and Drug Product Standards
Which standard applies
Compounding in Missouri must follow USP <795> (nonsterile), <797> (sterile), and <800> (hazardous drugs) as incorporated by Board rule, plus the federal 503A conditions: compounding only pursuant to a patient-specific prescription (with limited office-use exceptions under Missouri rule), bulk substances from the FDA 503A bulks list, no compounding of a drug that is "essentially a copy" of a commercially available product, and limits on interstate distribution.
Documentation and dates
Each compound requires a master formulation record and a compounding record identifying ingredients, sources, lot numbers, amounts, equipment, and the compounder. Assign a beyond-use date based on formulation and USP default limits (water-containing oral preparations are short-dated and refrigerated; nonaqueous dosage forms last longer). Sterile compounding adds ISO-classified areas, environmental monitoring, media-fill and glove-tip testing, and documented training and competency assessment.
Quality and safety
Weigh and measure accurately, use appropriate garb, verify calculations independently, and label with BUD and storage conditions. Hazardous drugs require containment and closed-system transfer devices.
Traps: using a non-listed bulk API because the supplier calls it "USP grade"; compounding a commercial product because the patient "can't swallow pills" without documented clinical need; assigning an arbitrary long BUD; forgetting that the prescriber must have authorized the compounded preparation.
Rule of thumb: if an identical commercial product exists and the prescriber has no documented clinical reason, it is a copy and it is prohibited.