What is Off-Label Prescribing?

The FDA requires that prescription drugs go through a clinical testing process to establish that they’re safe and effective to treat a particular condition. Healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. This type of prescribing is called “off-label” prescribing. Off-label prescribing practices are sometimes validated by clinical experience and research and may be a widely recognized clinical practice. Roman-affiliated providers have the discretion to prescribe certain drugs off-label based a patient’s unique medical history, symptoms, and preferences.

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