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...
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."
"The agency doesn't go after individuals, per se," says Tom
McGinnis, PharmD, director of pharmacy affairs for the FDA. "The agency has
tended to focus its priorities on people making money from this illegal
McGinnis tells WebMD that the personal importation policy "has been in
existence for a long time, probably since the '50s, and that if you read it
carefully, only deals with things that are not available in the U.S."
McGinnis says that the policy was intended to allow patients with serious,
life-threatening conditions who have exhausted all available alternatives in
the U.S. to try, under the guidance of their physicians, alternative therapies
approved for the condition in other countries.
Anything to Declare?
U.S. Customs, for its part, warns travelers not to assume that medications
approved abroad are also legal in the U.S., or that the labeled uses for which
a drug is approved elsewhere hold true in the United States. The Customs
service also cautions that:
- Some medications available only by prescription in the U.S. may be sold
over the counter in foreign countries. They could be dangerous to use without
- Some drugs that appear to be made in the U.S. may be counterfeits.
- It may be a violation of federal or state law to be in possession of some
drugs without a prescription from a U.S. physician.
- All imported medications must be properly declared to U.S. Customs.