Understanding the Gloved Fingertip Test for Compounded Sterile Preparations

How frequently is the gloved fingertip test required for low/medium risk CSPs?

• A. Monthly
• B. Annually
• C. Semi-annually
• D. Quarterly

Answer: (B)

The gloved fingertip test, also known as the fingertip sampling test, is a type of sterility testing that is performed to ensure the effectiveness of aseptic manipulations during the preparation of compounded sterile preparations (CSPs). This test is required to be performed for low/medium risk CSPs, which are those with a 12-hour or less BUD (beyond-use date). The frequency for this test is annually, as suggested by USP <797> guidelines, to ensure continuous validation of the aseptic technique. The other options, such as monthly, semi-annually, and quarterly, are not the recommended frequency for this test and may not provide adequate assurance of the aseptic technique used in the preparation of CSPs.

When it comes to ensuring patient safety in the world of pharmacy, every detail counts—especially those involving compounded sterile preparations (CSPs). One crucial piece of that puzzle is the gloved fingertip test. Now, if you’re feeling a bit bewildered by the various testing frequencies floating around, you’re not alone. So, let’s sort through this together, shall we?