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Unapproved Compounds

Meaning

Unapproved compounds are substances, typically pharmaceutical agents, active pharmaceutical ingredients, or research chemicals, that have not received authorization from a recognized regulatory body, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), for clinical use or marketing. These compounds often lack the rigorous safety, efficacy, and quality data required for clinical prescription. In the hormonal health space, this term frequently refers to substances sold illegally or marketed deceptively as dietary supplements, posing significant risks to patient safety and therapeutic outcomes.