Skip to main content

FDA Personal Importation

Meaning

FDA Personal Importation refers to the specific policy guidance issued by the U.S. Food and Drug Administration that, under limited circumstances, permits an individual to bring small quantities of unapproved drugs, including certain hormonal or peptide therapies, into the United States for personal use. This regulatory exception is highly restrictive and generally applies only when the product is for a serious condition for which no satisfactory treatment is available domestically and the product does not represent an unreasonable risk. Understanding the precise parameters of this policy is crucial for patients considering foreign-sourced treatments for complex hormonal conditions.