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Off-Label Prescribing Ethics

Meaning

Off-Label Prescribing Ethics refers to the complex moral and professional principles that guide a clinician’s decision to utilize a pharmaceutical agent for a medical condition, dosage, or patient demographic that has not received formal approval from national regulatory bodies like the FDA. While legally permissible, this practice imposes a heightened ethical duty on the prescriber, demanding reliance on robust scientific literature, sound clinical judgment, and absolute transparency with the patient. It is a necessary consideration in specialized fields, including highly individualized hormonal therapies.