FAQs

Answers to your frequently asked questions!

Question: What does “off-label use” mean?

Answer: Off-label prescribing is when a physician prescribes a medication for a different age patient, different condition, or different dosage than the U.S. Food and Drug Administration (FDA) has approved as shown on the medication label. This practice is legal and common. Sometimes off-label prescribing is appropriate, especially if there are studies demonstrating its effectiveness and safety. In some situations, clarification is needed about why a medication is being used off-label instead of the FDA-approved options (if they exist). “Off-label” does not mean prescribing a generic medication instead of the brand-name version.