According to USP 797, how often should a compounder performing low- to medium-risk preparations undergo validation testing?

According to USP 797, how often should a compounder performing low- to medium-risk preparations undergo validation testing?

• A. Every 6 months
• B. Once every year
• C. Every month
• D. Every two years

Answer: (B)

Validation testing under USP 797 is about confirming that personnel can perform sterile compounding aseptically and that the environment supports it. For someone doing low- to medium-risk sterile preparations, this involves revalidating aseptic technique at least once a year, often with methods like fingertip/thumb sampling and media-fill tests that simulate actual compounding to catch any contamination risk. The yearly interval reflects a reasonable cadence to ensure ongoing competency without overburdening practice. If there are changes in personnel, process, equipment, or any event that could affect aseptic technique, validation should be repeated sooner.

Validation testing under USP 797 is about confirming that personnel can perform sterile compounding aseptically and that the environment supports it. For someone doing low- to medium-risk sterile preparations, this involves revalidating aseptic technique at least once a year, often with methods like fingertip/thumb sampling and media-fill tests that simulate actual compounding to catch any contamination risk. The yearly interval reflects a reasonable cadence to ensure ongoing competency without overburdening practice. If there are changes in personnel, process, equipment, or any event that could affect aseptic technique, validation should be repeated sooner.