Although current law prohibits importing foreign drugs that have not been approved by the FDA, the agency has a long-standing policy which permits "enforcement discretion" to allow entry of unapproved prescription drugs under these circumstances:

• The product is for personal use only (maximum 90-day supply), not for resale,
• It is for a serious condition for which effective treatment may not be available in the U.S.,
• Those distributing the product have not promoted it to U.S. residents,
• The product does not represent an unreasonable risk, and
• The person importing it affirms in writing that it is for his/her own use and provides the name and address of the U.S.-licensed doctor responsible for treatment with the drug.

Acknowledging that enforcement of this policy is difficult due to the high volume of drugs coming into the country, the FDA and the U.S. Department of Health and Human Services are currently examining ways to develop a more effective personal importation policy.

Related information Medications

Source:  FDA. Hubbard WK. Statement before the Subcommittee on Consumer Affairs, Foreign Commerce and Tourism, Senate Committee on Commerce, Science and Transportation, Sept. 5, 2001.