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Buying Medicines
Outside the U.S. Poses Risks
By
Frances Allday
The rise in prescription drug prices has
forced many people to seek cheaper supplies outside the United States.
Some have traveled to foreign countries such as Mexico or Canada to buy
prescription drugs in greater quantities at a lower price. Others have
turned to online purchases from worldwide internet pharmacies. There are
legitimate foreign sources for prescription drugs, but there are also
risks associated with purchasing drugs outside the U.S.
The Food, Drug, and Cosmetic Act
prohibits importations into the U.S. of any prescription drugs that have
not been approved by the Food and Drug Administration (FDA). This includes
any drug that have been adulterated or misbranded within the meaning of
the Act. It is the obligation of the importer to show that drugs submitted
for importation have been approved by the FDA.
Some Americans suffering chronic and
serious illnesses seek to buy unapproved drugs from foreign countries when
they learn of the benefits the drugs have been found to have. So the FDA
has developed guidelines for personal importations of unapproved new drugs
by individuals for their personal use. The guidelines allow an individual
entering the U.S. to import a three month supply of an unapproved drug if
all of the following conditions are met:
1) the drug must be used for a serious
condition for which effective treatment is not available domestically; 2)
the drug cannot be sold commercially by the importer; 3) the drug is not
considered to represent an unreasonable risk; 4) the individual affirms in
writing that the drug is for the patient's own personal use and provides
the name and address of the physician in the U.S. responsible for
treatment with the drugs.
The FDA warns, however, that the
conditions are not a license for individuals to import unapproved drugs
for personal use into the U.S. Even if all the conditions are met, the
drugs remain illegal, and the FDA can still refuse entry at its
discretion.
The importation of approved drugs for
personal use is allowed, but also may be subject to risks. For instance,
according to the FDA "some medications which may appear to be U.S.
approved products may in fact be counterfeit versions of such
products." If complications from using the medication develops,
sufficient information about the dosage and strength may not be available.
Also, possession of certain medications without a prescription from a
licensed U.S. physician may violate Federal, State or local laws.
All imported medications must be
properly declared to Customs and Border Protection. Travelers and U.S.
residents entering the U.S. at land borders who carry a validly obtained
controlled substance are subject to additional requirements. If they do
not have a prescription issued by a licensed U.S. practitioner, they may
not import more than 50 dosage units of the medication. With a
prescription, more than 50 dosage units are allowed. Only medications that
are legally prescribed controlled substances in the U.S. may be imported
for personal use.
Medicines purchased over the internet
are often from overseas pharmacies who are operating illegitimately. The
FDA warns consumers about websites that sell prescription and
over-the-counter drugs that may not be safe to use. These sites often sell
unapproved drugs, or drugs that have dangerous ingredients. Some sites
sell counterfeit drugs that look like the real medicines, but their
quality and safety are unknown. This month the British police raided an
online pharmacy that was selling over half a million dollars in unlicensed
and fraudulent medicines. World wide counterfeiting of drugs and medicines
is epidemic. The World Health Organization says that up to 10% of
medicines available worldwide are counterfeits. The Center for Medicines
in the Public Interest estimates that counterfeit drug sales will reach
$75 billion globally in 2010.
For further information on
ordering medicines online, visit http://www.fda.gov/consumer/features/drugsonline0707.html.
Frances Allday was a specialist in commercial trade
with U.S. Customs and Border Protection for 25 years
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