What is the Origin of Compounded Sterile Preparations?

The practice of compounding is an ancient art, but the requirement for "sterile preparations" became paramount with the advent of parenteral drug administration, recognizing the catastrophic risks of non-sterile injectables. Regulatory standards, such as those promulgated by the United States Pharmacopeia (USP), define the necessary cleanroom environments and quality assurance processes. The term emphasizes the critical requirement for asepsis throughout the entire preparation process.

What is the Mechanism of Compounded Sterile Preparations?

The compounding process must occur within a certified clean environment, typically an ISO Class 5 area provided by a Laminar Airflow Workbench, to minimize the introduction of contaminants. Pharmacists utilize aseptic techniques to combine sterile components into the final dosage form. Final product safety is confirmed through mandated quality control testing, including sterility and bacterial endotoxin testing, ensuring the CSP is safe for direct introduction into the patient's tissues or circulation.

Compounded Sterile Preparations

Meaning

Compounded Sterile Preparations (CSPs) are customized medications prepared under strictly controlled, aseptic conditions by a licensed pharmacist to meet the unique, patient-specific needs not available through commercially manufactured products. These preparations, which include injectable solutions, ophthalmic drops, and intrathecal medications, require rigorous adherence to sterility and quality standards to prevent microbial and particulate contamination. CSPs are indispensable for personalized medicine, especially in endocrinology, where tailored hormone dosages are often necessary.