If a sterile compounded drug product is prepared by someone who has not passed the media fill test, what is the condition for it to be dispensed?

The correct answer focuses on the requirement for adequate supervision when a sterile compounded drug product is prepared by someone who has not successfully passed the media fill test. The media fill test is a crucial component in verifying that compounding personnel are capable of maintaining sterility during the compounding process. If someone has not passed this test, it indicates a potential risk for contamination.

In this context, having the process witnessed by a qualified individual serves as an additional layer of oversight to ensure that the compounding is performed correctly and safely. This qualified individual would likely have the necessary expertise and training to identify any risks or errors during the compounding process, thereby helping to ensure patient safety.

The other choices imply conditions that do not provide sufficient protection or oversight in the absence of a successful media fill test. For instance, a patient requesting the compounded product or a prescriber authorizing it in writing does not intrinsically address the underlying risk associated with the compounding process, particularly when the operator's competence has not been validated. Therefore, having a qualified individual oversee the compounding is a necessary safeguard in such a situation.