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Off-Label Prescribing

Meaning

Off-Label Prescribing is the legitimate clinical practice where a licensed practitioner prescribes an FDA-approved medication for a condition, dosage, or patient group that has not received explicit approval from the Food and Drug Administration for that specific indication. In hormonal health, this often involves using established compounds to treat conditions supported by emerging clinical evidence but lacking formal labeling. This practice requires clinical judgment and acceptance of responsibility by the prescriber.