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Off-Label Testosterone Use

Meaning

Off-Label Testosterone Use refers to the clinical practice of prescribing testosterone therapy for an indication, patient population, or dosage regimen that has not been formally approved by a regulatory body, such as the FDA. While legal and common in medicine, this use is based on the prescribing clinician’s judgment and supporting medical literature rather than on a regulatory agency’s specific approval for that context. Patients should be fully informed that the use falls outside the strictly defined parameters of the drug’s approved label, particularly in the context of hormonal optimization and anti-aging medicine.