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Hormonal Reclassification

Meaning

The formal process of changing the regulatory or clinical categorization of a substance within the endocrine domain, often involving a shift in how a compound is legally defined or therapeutically managed. This may involve a drug being reclassified from prescription-only to over-the-counter status, or, more clinically, a re-evaluation of its role from a simple replacement agent to a pleiotropic signaling molecule. In the context of compounding, it can refer to the debate over classifying bioidentical hormones as traditional drugs or as unique compounded preparations. This reclassification has significant implications for accessibility and oversight.