§ Regulatory & Safety
FDA-Approved
A medication reviewed by the U.S. Food and Drug Administration for safety, efficacy, and manufacturing quality.
Fact-checked 12 May 2026Plain-English Reference
An FDA-approved drug has cleared randomized clinical trials and ongoing manufacturing inspections. The label is enforceable and changes through regulated processes. Compounded medications, OTC supplements, and gray-market products are not FDA-approved, even if their active ingredient is.