The Letter (and Spirit) of Drug Import Laws
It's illegal (nudge, nudge) to buy prescriptions drugs (wink, wink) from other countries.
Don't Ask, Don't Tell
When it comes to the importation of drugs from foreign countries, the FDA
acts a bit like Captain Renault in Casablanca who tells Rick that
"I am shocked, shocked to find that gambling is going on in
here!" as he gambles in Rick's club.
Here's how the FDA puts it in a consumer advisory on its web site:
"Don't purchase from foreign web sites at this time because generally it
will be illegal to import the drugs bought from these sites, the risks are
greater, and there is very little the U.S. government can do if you get ripped
And there's the rub: the words "generally" and "at this
time." Under current law, stated in an FDA "guidance" paper titled
"Coverage of Personal Importations," the importation or interstate
shipment of unapproved new drugs is prohibited. The definition of
"unapproved" includes "foreign-made versions of U.S. approved drugs
that have not received FDA approval to demonstrate they meet the federal
requirements for safety and effectiveness. It is the importer's obligation to
demonstrate to the FDA that any drugs offered for importation have been
approved by FDA."
Under those rules, it appears to be illegal to import into the U.S. the
cholesterol-lowering drug Lipitor purchased in Canada, even though the drug is
made in Ireland for shipment to both the U.S. and Canada. To make things even
more confusing, the FDA guidance cites "circumstances in which FDA may
consider exercising enforcement discretion and refrain from taking legal action
against illegally imported drugs."
These extenuating circumstances include importing an unapproved drug for a
serious condition for which there may be no effective treatment available in
the U.S. But the drug can't be marketed to U.S. citizens by distributors of the
drug in question, the product can't be considered to "represent an
unreasonable risk," and the patient doing the importing has to be ready to
affirm in writing that the drug is for his/her own use. The patient also has to
be willing to furnish contact details for a physician in the U.S., or provide
"evidence that the product is for the continuation of a treatment begun in
a foreign country."