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- $Unique_ID{BRK00395}
- $Pretitle{}
- $Title{Importation of Unapproved Drug Products}
- $Subject{medications medication FDA Community Social Food Drug Administration
- importation unapproved drugs personal use sold commercially affirm medicine
- medicine treatment treatments}
- $Volume{Q-0, R-0}
- $Log{}
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- Copyright (c) 1991-92,1993 Tribune Media Services, Inc.
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- Importation of Unapproved Drug Products
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- 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.
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- 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.
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