Sterile Compounding
Preparation of compounded medications that must be free of microbial contamination, such as injectables, IV admixtures, and ophthalmics.
Sterile compounding is the preparation of medications that must be free of microbial contamination before being administered. This includes injectables, intravenous admixtures, irrigations, and ophthalmic preparations. Sterile compounding requires a controlled environment and adherence to USP standards.
Sterile compounding is governed by USP standards (notably USP <797> and, where applicable, USP <800> for hazardous drugs). Pharmacies that perform sterile compounding maintain controlled environments, validated processes, and trained personnel.
Sterile compounding scope varies by pharmacy. Not every compounding pharmacy performs sterile compounding, and within sterile scope there are further distinctions (low-risk, medium-risk, high-risk, hazardous). Confirm directly with any pharmacy that their sterile compounding scope matches the prescription.
Sterile compounded medications are prescription-only and are typically used when a sterile commercial product is unavailable in the required strength or combination.
Related Specialties
Related Terms
Non-Sterile Compounding
Preparation of compounded medications that do not need to be sterile, such as oral suspensions, capsules, and topical creams.
503B Outsourcing Facility
A federally registered outsourcing facility that can prepare batches of compounded sterile medications without a patient-specific prescription.
Compounding Pharmacy
A pharmacy that prepares customized medications for an individual patient based on a prescriber's order.