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Sunday, April 5, 2009

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?

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.


The material contained here is "FOR INFORMATION ONLY" and should not replace the counsel and advice of your personal physician.
Promptly consulting your doctor is the best path to a quick and successful resolution of any medical problem.