The FDA approval process requires a rigorous clinical testing process to ensure a drug is safe and effective to treat a particular condition or indication. “Off-label” use is when a provider prescribes an FDA approved drug for an unapproved use (conditions that go beyond its approved indications). Such “off-label” prescribing is legal and commonly practiced. Healthcare providers have the discretion to prescribe drugs off-label if deemed appropriate for a patient based on their medical history, symptoms and preferences.