FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
The drug is for use for a serious condition for which effective treatment is not available in the United States;
>> You are gonna die and they have something not in the USA that could save your ass
There is no commercialization or promotion of the drug to U.S. residents;
>> You are fine as long as you do not compete with US drug companies
The drug is considered not to represent an unreasonable risk;
>> This could literally mean anything. Who defines what unreasonable risk means? And you are comparing the risk of the unapproved drug with what exactly? You are certainly not comparing with the risk of death by not having access($$) to some drug you need
The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country;
>> Again you are forbidden to compete with US drug companies
and
Generally, not more than a 3-month supply of the drug is imported.
>> And even if the drug could save your life and it's not available in the US you still have to play this stupid traveling game every three months. I'm sure most people with chronic illnesses love to burn their money being forced to travel due to some arbitrary regulation