Thousands of U.S. citizens have discovered that one way to beat the high cost of prescription drugs is to buy them from Canada, where the gov-ernment controls drug prices. First there were organized bus trips across the border to fill prescriptions. Now, some 50 licensed Internet pharmacies with names like CanadaMeds.com, RxNorth.com and PayLessMeds.com have sprung up across Canada to fill orders from American consumers.

The savings can be dramatic. A three-month supply of the cholesterol drug Zocor costs $327.86 from U.S.-based Drugstore.com, but only $189.55 if ordered from the Manitoba-based Hometownmeds.com. Ninety 20-mg tablets of the breast-cancer drug Tamoxifen sell for $287 in the U.S. and less than $50 in Canada.

But is it legal to buy medications from Canadian pharmacies? The answer is, technically no, but U.S. officials are allowing it to happen.

Under the Prescription Drug Market-ing Act of 1987, it is illegal for anyone other than the original manufacturer to bring prescription drugs into the country. However, federal officials have decided to exercise "enforcement discretion" in dealing with prescription drugs brought across the border, provided the drugs are not narcotics or other controlled substances. This means that as long as a person brings back no more than a three-month supply for personal use, border officials generally look the other way, Thomas McGinnis, director of pharmacy affairs for the U.S. Food and Drug Administration (FDA), told the Milwaukee Journal Sentinel http://www.elderlawanswers.com/buying-prescription-drugs-from-canada-legal-or-illegal-1204 in March 2001. Patients generally may order refills in amounts up to a three-month supply without interference.

What about ordering over the Internet? Prescription drugs cannot be legally mailed into the United States by foreign "e-pharmacies." But here again officials are employing "enforcement discretion," preferring to use limited resources to crack down on large commercial drug supplies and narcotics, not prescription-drug shipments for personal consumption. Thus, customs officials allow the companies to mail up to 90-day supplies of medications.

Congress thought it had cleared up some of this legal ambiguity in 2000 by passing the Medicine Equity and Drug Safety Act, which allows prescription drugs from certain foreign countries to be sold to American consumers. However, Secretary of Health and Human Services Tommy Thompson has refused to implement the act, saying it would increase public health risks.

In the meantime, the FDA is being realistic. "We urge people not to import foreign drugs," the Wall Street Journal quoted a "senior FDA official" as saying. "That said, if people are going to go ahead and order drugs outside the U.S., they're better off getting them from Canada than from a country like Thailand or Mexico. At least Canada has drug regulations and testing systems that are comparable to ours in the U.S., which makes it a little safer."

Paul Clark, chief executive of Hometownmeds.com and a Manitoba pharmacist, offers Americans some suggestions for making sure they're dealing with a legitimate Canadian pharmacy: only do business with a pharmacy that requires a prescription from a U.S. doctor; try to speak directly with the pharmacist filling the prescription; ask the pharmacy what country the drugs are coming from; request a copy of the pharmacy's license; and ask if the pharmacy will guarantee the timing of its delivery.

For more information on the importation of drugs for personal use visit the homepage of the FDA Import Program: http://www.fda.gov/ora/import/ora_import_program.html and the subchapter of the Regulatory Procedures Manual dealing with personal importation: http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf.

-Excerpted from: ElerLawAnswers.com, Date: 10/30/2002./P>

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