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Off-Label Peptide Use

Meaning

Off-Label Peptide Use refers to the practice of prescribing or utilizing synthetic peptides for a medical indication, dosage, or route of administration that has not been specifically approved by a regulatory body, such as the FDA, for that particular purpose. This practice is often seen in the wellness and longevity space where clinicians apply emerging scientific research on peptides, such as those targeting growth hormone secretagogues or immune modulation, outside of their officially sanctioned indications. While legally permissible for a prescribing physician, this use requires a careful risk-benefit analysis and extensive informed consent due to the limited long-term clinical trial data for these specific applications. The patient must understand the distinction between approved and non-approved therapeutic applications.