Posted by Bruce on January 2, 2000, at 21:34:45
In reply to Re: Purchasing drugs overseas? , posted by Stephanie L. on January 1, 2000, at 17:22:37
> Bruce:
> I read your recent posting saying that US Docs
> can prescribe medicines that are not approved
> in the US. I know that my Doc does not know this, and I want to bring him this information. Do you know where I can get a written policy regarding this? I know my Doc will insist on seeing something in writing, from a recognized authority (person or group) source. Thanks for your help.
This is from the FDA, and is their policy on personal importation.
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html
In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may
consider a more permissive policy in the following situations:1. when the intended use is appropriately identified, such use is not for treatment of a serious condition,
and the product is not known to represent a significant health risk; or2. when a) the intended use is unapproved and for a serious condition for which effective treatment may
not be available domestically either through commercial or clinical means; b) 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; c) the product is considered not to represent an unreasonable risk; and d) 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.
Note especially the sentence about the 'physician responsible for his or her treatment with the product'.
The FDA *expects* medical guidance for unapproved drugs. I am sure each and every one of us on this board is following that advice. Ahem.In general a physician may prescribe any substance that he deems helpful to his patient's illness.
I will search further for a more concrete example. That could take awhile (most laws are of the form "Thou shalt not" instead of "Thou can do")I know in the past I have been prescribed vitamins and OTC substances for which a prescription is not necessary - a weak form of a doc writing a prescription for an unapproved drug.
Bruce
poster:Bruce
thread:16003
URL: http://www.dr-bob.org/babble/20000101/msgs/17869.html