West Virginia Elder Alert

brought to you West Virginia Senior Legal Aid, Inc.

November 2002


Getting Prescription Drugs from Foreign Countries:

Is It Legal?


It depends. The law that covers most aspects of this question is the Federal Food, Drug, and Cosmetic Act (FFDCA), which is Title 21, Chapter 9 of the US Code. There may be other legal issues raised under rules of the Federal Trade Commission (FTC) or US Customs.

Under the FFDCA, a prescription drug purchased from another country, either in person, via internet, or mail order, can possibly be legal if it complies with all the Food and Drug Administration (FDA) requirements. These requirements include (but are not limited to) that the drug be produced by an FDA-approved manufacturer, handled and stored in compliance with FDA regulations, and labeled and dispensed in compliance with FDA regulations. In most situations, bringing home prescription medicines from Canada or other countries, is not legal.

How would a senior purchasing a prescription drug from a foreign country know if it is FDA compliant? It would be nearly impossible to determine for certain whether a particular international drug purchase is legal. If you make the purchase in person (perhaps on a trip to Canada or Mexico), you still may not be able to find out where the distributor actually got the drug. If you purchase through the mail, you're in the same position. If you purchase through the internet, you have even less assurance, because the website may give bogus information about source of the drug, and even about the country where the distributor is located. Most drugs available in other countries probably do not comply with all the FDA requirements.

Will a senior get in trouble with the American authorities for purchasing a prescription drug from a foreign country? As a practical matter, probably not. However, the drug may be detained by US Customs or the FDA if you can't prove it complies with applicable laws. According to ABCnews.com, a spokesman from the FDA said that most drug purchases through the internet from Canada and other countries are technically illegal, but the FDA generally looks the other way. "We don't want to punish seniors." Though it appears that FDA's current policy is non-enforcement for limited personal-use prescription drug importation, FDA could be change this policy and practice at any time, without a change in the law itself.

What about experimental drugs, or drugs not yet approved for use in the United States, but which are legally in use in Canada or other countries? An article in the FDA's Consumer Magazine, September/October 2002 issue, states that the FDA's current policy includes the discretion to allow importation of certain unapproved prescription medication for personal use in certain circumstances. That means that if you meet the FDA's criteria, the FDA may possibly permit you to bring in an experimental drug for your use. This might apply, for example, to an AIDS drug that is still in clinical trials in the US.

Links to learn more:

FDA: Imported Drugs Raise Safety Concerns http://www.fda.gov/fdac/features/2002/502_import.html

FDA: Buying Medicines and Medical Products Online http://www.fda.gov/oc/buyonline/default.htm

FDA: Buying Medicines and Medical Products Online :A Consumer Guide http://abcnews.go.com/sections/wnt/DailyNews/Canadian_RXdrugs020308.html

FDA: What You Should Know About Buying and Using Drug Products http://www.fda.gov/cder/consumerinfo/DPAdefault.htm

ABC News: Across-the-Border Bargains http://abcnews.go.com/sections/wnt/DailyNews/Canadian_RXdrugs020308.html

Is it legal to import prescription drugs? http://www.wecaremedicalmall.org/legal_information.htm (please note, this is a commercial website, not a government or non-profit source of information)

Wall Street Journal Online: US, Canada Discourage Trade Of Prescription Drugs http://sg.biz.yahoo.com/021113/72/34nta.html


This West Virginia Elder Alert is brought to you by West Virginia Senior Legal Aid, Inc., providing free legal services to needy senior West Virginians, age 60 and over. 1-800-229-5068 www.seniorlegalaid.org