In recent years, there has been a huge increase in consumers using mail order programs and internet prescription sites. The Food and Drug Administration (FDA) has issued numerous warnings about these programs and internet sites. According to the FDA Commissioner, the uncertain character and quality of the drugs ordered and sent constitute an unreasonable risk to public health.

Under the Federal Food Drug and Cosmetic Act, a drug is subject to refusal of admission into the United States if it appears that it:

• Has been manufactured, processed or packed under unsanitary conditions.
• Is forbidden or restricted for sale in the country in which it was produced or from which it was exported.
• Is adulterated, misbranded or in violation of Section 505 of the FDC Act, which relates to new drugs.

Many websites and advertisements claim consumers will save significant sums of money on the cost of prescription drugs. However, some of these drugs may pose a significant risk to a patient's health. False promises, coupled with a lack of consumer knowledge on the topic, have resulted in vast amounts of mail order prescriptions from other countries, the transactions of which are often conducted over the internet. Many of the drugs arrive from our neighbors Canada and Mexico.

While there may be savings involved by purchasing prescription drugs through Mexico, buyers need to be aware of the numerous risks, including counterfeit drugs. According to a registered pharmacist and a member of the World Health Organization's (WHO) Counterfeit-Drug Task Force, the estimate of the Mexican counterfeit drug market is approximately 15% and possibly higher.

In July 2004, the FDA issued warnings about purchasing prescription drugs from Mexico. The FDA cited a recent discovery that the cholesterol lowering drug Zocor, and a generic painkiller, being imported from Mexico were both counterfeit. Not only did the counterfeit Zocor not contain any of the cholesterol lowering qualities of the original drug, but also the painkiller had significantly lower doses of its active ingredient. The Agency warned that patients who use the "counterfeit Zocor" could face serious health risks. People taking the "fake painkiller" were warned they would get insufficient relief.

The FDA has also issued warnings about buying medicine online because many online sites are not U.S. licensed pharmacies. These pharmacies may not give the patient a correct diagnosis and therefore not prescribe the appropriate medication. Additionally, in some cases patients may order and receive drugs without proof of a valid prescription and therefore take medications they do not need. The FDA has issued warnings that medicines sold online may be fraudulent, expired, are of the wrong dosage, may contain dangerous ingredients, are not made using the appropriate safety standards and/or come with inadequate directions. Consumers should not assume that because a prescription drug is available to them, it is safe.

Even pharmaceuticals that enter the country and have been approved by the FDA may not be properly packaged or cared for en route. For example, according to a report made by the Boston Globe, the FDA conducted a sting operation and found that a portion of lower priced insulin brought into the country from Canada was shipped at room temperature. Insulin is supposed to be kept chilled. The danger to a patient is exacerbated because there is no way to tell by looking at the product if it has been heated beyond tolerable levels or tampered with en route.

The FDA has expressed similar concerns about the safety and validity of over the counter drugs purchased through the mail or internet.