Final answer:
A formulary list includes prescription drugs covered by an insurance plan, focusing on efficacy, safety, and cost-effectiveness, while a non-formulary list contains drugs that are not typically covered, possibly incurring higher out-of-pocket costs.
Step-by-step explanation:
The terms non-formulary list and formulary list pertain to the list of prescription drugs that a particular health insurance plan or hospital system will cover. A formulary list, also known as a drug formulary, is a list of generic and brand name prescription medications that are approved by the Food and Drug Administration (FDA) and are selected for their efficacy, safety, and cost-effectiveness.
These drugs are generally covered by an insurance plan, and patients will pay a predetermined co-pay. On the other hand, a non-formulary list includes drugs that are not typically covered by an insurance plan. Patients may need to pay a higher cost out-of-pocket or provide medical necessity documentation to get these drugs covered.
The FDA's Center for Drug Evaluation and Research sets different requirements for new drugs, generic drugs, and over-the-counter drugs. Under an NDA, new drugs are rigorously tested for safety and effectiveness. A drug may undergo a change from prescription-only to over-the-counter if it’s found to be safe and effective when used as directed without a doctor's supervision.