What is sterile compounding?

• A. A preparation of medications that must be free from microorganisms, such as injectable medications and IV admixtures.
• B. Mixing finished dosage forms for dispensing.
• C. Nonsterile topical preparations.
• D. Quality testing of finished products.

Answer: (A)

Sterile compounding is the preparation of medications in a way that eliminates microorganisms, producing sterile products for routes that must be free of microbes, such as injections and IV admixtures. Achieving this requires a controlled environment (like a cleanroom or a laminar-flow hood with HEPA filtration), rigorous aseptic technique, proper garbing, surface disinfection, and the use of sterile equipment and ingredients. The goal is to prevent contamination and ensure the product can be safely administered parenterally or by other sterile routes.

This differs from simply mixing finished dosage forms for dispensing, which is repackaging or dispensing, and from creating nonsterile topical preparations, which do not require sterility. It also isn’t about quality testing of finished products, which is a separate quality-control activity.