Which of these is a requirement of USP 797 (2022) for media-fill testing? The media-fill units are incubated for 14 days at room temperature and an incubator is not necessary. An authorized person must observe the employee performing media-fill testing, and the name of the observer must be documented. Tenured compounding staff perform media-fill testing once per year, where new staff perform it twice annually. Gloved fingertip and thumb sampling is performed immediately after completing the media-fill procedure on the initial MFT only.

The correct requirement of USP 797 (2022) for media-fill testing among the options provided is: **B. An authorized person must observe the employee performing media-fill testing, and the name of the observer must be documented.** ### Explanation: **USP 797** outlines stringent standards for **media-fill testing** to ensure aseptic practices in sterile compounding. Here's a breakdown of why option B is correct and the others are not: 1. **Observation by an Authorized Person:** - **Requirement:** USP 797 mandates that an authorized observer must oversee the media-fill procedure to ensure it is performed correctly. - **Documentation:** The name of the observer must be recorded as part of the testing documentation. - **Purpose:** This ensures accountability and provides a check against potential breaches in aseptic technique. 2. **Analysis of Other Options:** - **Option A:** While media-fill units are typically incubated for 14 days, USP 797 requires that the incubation environment maintains specific conditions, often necessitating a controlled incubator rather than just room temperature, depending on the facility's environment. - **Option C:** The frequency and differentiation between tenured and new staff performing media-fill tests can vary based on institutional policies, but USP 797 generally requires regular media-fill testing (at least twice a year) without necessarily distinguishing between tenured and new staff in this specific manner. - **Option D:** Gloved fingertip and thumb sampling is a part of certain aseptic techniques, but it is not a standalone requirement specific to media-fill testing as outlined by USP 797. ### Key Takeaway: Ensuring that an **authorized observer** oversees and documents the media-fill testing process is a fundamental requirement of USP 797 (2022), making option B the correct choice. **Answer:** An authorized person must observe the employee performing media-fill testing, and the name of the observer must be documented.