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Unapproved Drugs

Meaning

Unapproved Drugs are pharmaceutical agents or compounds that have not received formal regulatory clearance from a national or international health authority, such as the FDA in the United States, for general marketing and therapeutic use. In the context of hormonal health, this term typically refers to substances that may be used off-label, compounded without standard oversight, or are still undergoing investigational trials, thus lacking the established safety and efficacy profile required for widespread clinical adoption. The use of such agents carries inherent risks and necessitates careful clinical consideration.