Compounding, Drug Preparation, and Distribution Standards
Quality standards for preparations
Compounding is preparing, mixing, or altering a drug to meet an individual patient's need when an approved product is not appropriate. The framework rests on USP <795> (nonsterile), <797> (sterile), and <800> (hazardous drugs), adopted through state regulation and enforced at inspection. Key concepts: a prescription-based, patient-specific model rather than manufacturing; sourcing active ingredients from FDA-registered establishments with valid certificates of analysis; beyond-use dates assigned from the applicable standard and supported by a master formulation record; a compounding record that lets another professional reproduce the preparation; and documented training, competency assessment, and environmental monitoring for sterile operations. Sterile compounding requires an ISO-classified environment, an appropriate primary engineering control, validated processes, garbing and hand hygiene, and media-fill and surface sampling on a defined schedule. Hazardous drugs require containment, closed-system transfer devices, personal protective equipment, and designated storage. Advance "office use" distribution is limited and state-specific, and a pharmacist may not simply copy a commercially available product. Final verification - ingredients, calculations, labeling, and beyond-use dating - is a pharmacist function, and the preparation must be traceable from ingredient lot to patient.
Traps
Extending a beyond-use date past the standard without a stability basis; using a non-FDA-registered bulk ingredient; compounding a copy of a commercially available product; skipping environmental sampling because the hood "looks clean"; assuming unlimited anticipatory compounding or office-use distribution; overlooking hazardous drug handling in nonsterile areas.
Rule of thumb
Every compounded preparation should answer five questions on paper: what formula, from which lots, made by whom, checked by whom, and good until when.