Which factor disqualifies a drug from 340B eligibility?

A drug's eligibility for the 340B Program primarily hinges on its inclusion in the list of covered outpatient drugs, which must conform to specific criteria established by the program. One key factor is that the drug must be designated as a covered outpatient drug under the program guidelines.

The correct answer reflects that if a drug is not included in the latest Medicare cost report, it does not inherently disqualify the drug from 340B eligibility. In fact, the 340B Program does not rely solely on Medicare cost report inclusion as a criterion for determining a drug's eligibility. The essential criteria are instead based on the drug's listing within the 340B Program's covered outpatient drugs category.

The other options speak to factors that directly impact eligibility: drugs must be listed on the purchase agreement to ensure that they are accounted for under the program, prescribed by registered providers to align with legal and regulatory parameters, and not limited to those used in clinical studies since those may also fall under specific guidelines. Seeing as the eligibility criteria for the program emphasize direct program norms rather than Medicare reporting, the choice regarding inclusion in the cost report does not serve as a disqualifier for 340B eligibility.