Importation of Unapproved Drug Products

QUESTION: We are going to be traveling abroad this summer, and have heard of
a drug that can help my wife's condition that is not available as yet in the
United States. I am sure that our government would understand and allow us
to bring this medicine back into our country, but my wife fears that not only
will the drug be taken away, but that we might also face imprisonment if we
are caught. Can you provide us with any information that might help us?
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ANSWER: The regulations which govern the use of medications in the United
States and which are enforced by the Food and Drug Administration (FDA) have
been formulated to provide drugs that have the greatest degree of safety, as
well as proven ability to combat disease effectively. The process of approval
is a long, difficult and expensive one, so that frequently medications are
available in other countries before they are approved for use in the United
States. However, the regulations of the FDA do allow importation of
unapproved drug products, providing four basic criteria are met. The product
must be purchased for personal use. The drug will not be sold commercially,
and the quantity must not be excessive. Usually a three month supply is
considered allowable. The use of the drug must be appropriately identified.
Last but not least, and perhaps the most difficult criteria to achieve, the
patient importing the medication must affirm in writing that the drug is for
their own use, and provide the name and address of a physician licensed in the
United States who will be responsible for the patient's treatment with the
drug product. The FDA considers this a humane method of implementing rules
that have been established to protect our society against the cruelties of
medical quackery and health fraud. Complying with these guidelines will
assure that you may openly and without fear import these medications for your
personal use.