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Off-Label Protocol Justification

Meaning

Off-Label Protocol Justification is the required, evidence-based documentation prepared by a prescribing clinician to support the therapeutic use of a medication for a condition, dosage, or patient population not explicitly approved or listed on the drug’s official regulatory label. This justification is a crucial ethical and administrative step, confirming that the clinician’s decision is based on sound medical reasoning, supported by scientific literature, and is in the best interest of the patient. It is frequently a necessary prerequisite for securing insurance coverage for non-standard, yet clinically warranted, treatments.