Posted by shasling on December 5, 2006, at 6:00:34
In reply to Re: Importing Amisulpride Legally?, posted by Karen44 on December 4, 2006, at 20:49:43
Drugs, Biologics, and Devices
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; or
2. 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.
From http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html
poster:shasling
thread:708376
URL: http://www.dr-bob.org/babble/20061129/msgs/710494.html