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 continued...
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."
To hedge its bets, the FDA cautions that "even if all of the factors
noted in the guidance are present, the drugs remain illegal and the FDA may
decide that such drugs should be refused entry or seized. The guidance
represents the FDA's current thinking regarding the issues of personal
importation and is intended only to provide operating guidance for FDA
personnel. The guidance does not create any legally enforceable rights for the
public; nor does it operate to bind the FDA or the public."
As for the consequences, FDA associate commissioner for planning and policy
William Hubbard told the Wall Street Journal in March 2003 that
"any party participating in" an import plan in which a health insurer
or claims processor helps arrange a purchase in Canada "does so at its own
legal risk." The article also quotes Hubbard as saying that "our
highest enforcement priority would not be actions against consumers."