The rules of personal importation from the FDA start with a statement that it’s not allowed, and then follow on with the exception cases:
https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/ucm432661.htm
In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because…
It then goes on to say:
Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?
FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:
- Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); and
- Product is for the treatment of a serious condition ( Prescription Drug Products):
- The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
- There is no known commercialization or promotion of the product to persons residing in the U.S.
- The product does not represent an unreasonable risk.
- The consumer affirms in writing that the product is for personal use.
- The quantity is generally not more than a three month supply and either:
- Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
- Provide evidence that the product is for the continuation of a treatment begun in a foreign country.
This is the grey area in which we operate. There has definitely been a recent tightening of these rules and the assumption that the status quo will prevail indefinitely has ALWAYS been wrong. The going is still good but like the financial people say “past performance is no guarantee of future performance”. We offer a money back delivery guarantee to help de-risk it for patients.
It has been said often but bears repeating.
There is currently a window of opportunity to access these medications.
That opportunity may well not exist indefinitely.
.
