FDA Guidance: Importation for Personal Use Permitted Only in Specific Circumstances

October 14, 2010 9:29 AM

A recent FDA guidance makes clear the limited instances in which personal importation of an unapproved drug product may be allowed. The guidance, aimed to assist FDA field personnel, explains that release of an unapproved drug for personal use may be appropriate if it is for the treatment of a “serious condition for which effective treatment may not be available domestically either through commercial or clinical means, and it is not considered to represent an unreasonable risk.” Further, the document notes that the guidance applies to patients who began treatment in a foreign country and are continuing that treatment, or patients who have made their own arrangements to obtain an unapproved drug that has not been promoted in the United States. The guidance notes that media reports have not accurately reported FDA’s guidance on the issue and have instead suggested that any drug may be imported into the US for personal use.