Posted by Looper on February 20, 2001, at 9:10:28
In reply to Re: Purchasing drugs overseas? , posted by Stephanie L. on January 1, 2000, at 17:22:37
< http://www.fda.gov/ora/import/pipinfo.htm >
That said, FDA's guidance for coverage of personal importations of unapproved drugs identifies several factors that should be considered by FDA personnel when determining whether to exercise enforcement discretion and refrain from taking action against the importation of unapproved drugs. The General Guidance Section states that FDA should consider not taking enforcement actions against such importation:
"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country." (Emphasis added)
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----found this..might help..Looper
poster:Looper
thread:16003
URL: http://www.dr-bob.org/babble/20010212/msgs/54456.html