Inside World Trade

Buying Medicines Outside the U.S. Poses Risks

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