A moving target of as many as 40,000 active online pharmacies, a huge majority of them fly-by-night start-ups, may sell products at a cut-rate price but they may also deliver expired, contaminated and fake drugs that can harm consumers, the FDA said today.
"You have no guarantee of the safety, efficacy or quality of those products," Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, told ABC News. "You want to go to an online pharmacy that is licensed, located in the United States, [and] importantly, that will ask for a prescription from a doctor."
"This a real problem. In fact, it is a growing problem, it is a problem that we are doing everything we can ... to try and protect the safety and security of the drug supply chain," Hamburg said. "The consumers have a role to play, as well, and that's why we want them to be informed about how to recognize a safe and legal online pharmacy so they can get those drugs that they really do need."
In May, the FDA surveyed more than 6,000 adults and found that almost a quarter of Internet shoppers bought prescription drugs online, and three in 10 said they weren't confident they could do so safely.
What many consumers don't realize is they are more likely online to get fake drugs that are contaminated or past their expiration date, or contain no active ingredient, the wrong amount of active ingredient or even toxic substances such as arsenic and rat poison.
They could sicken or kill people, cause them to develop a resistance to their real medicine, cause new side effects or trigger harmful interactions with other medications being taken.
Just how easy is it to set up an online pharmacy?
Two University of California, San Diego medical researchers showed ABC News how they set up their own fake drug store using search engines, Facebook and Twitter to draw potential buyers, and no pharmaceutical degree or any medical license, is required to set up any of these websites.
Timothy Mackey, a doctoral student in the joint doctoral program between San Diego State University and the University of California, San Diego created a fake pharmacy in less than 15 minutes and for less than $80.
"We basically created a Web app which is very descriptive and has a medical professional, a picture of a person that we just purchased, and we were able to post it online without any verification or requirements at all," Mackey said.
A hit-and-run pharmacy is lightning fast to start and even faster to disappear -- all before authorities can catch up.
"The bad guys know when they're getting chased, so they just shut down with a minute, and then literally within another hour they've set themselves right back up again," said Brian Liang, head of the Center for Patient Safety at the University of California, San Diego School of Medicine. "What it's telling us is that there's clearly no enforcement, and Facebook and others in this space are making money off of illicit drug sales."
Liang and Mackey said their mock sites saw more than 1,000 unique users in the 10 months they were active. The outgoing links they included went to a "dead page," and they did not actually sell any pharmaceuticals.
While there are some legitimate online pharmacies, about 2 percent according to the Alliance for Safe Online Pharmacies, how can you tell which are legitimate and which are fake?
According to the FDA, watch out for sites that ...
1. ... allow you to buy drugs without a prescription;
2. ... offer deep discounts that seem too good to be true;
3. ... send unsolicited emails offering cheap drugs;
4. ... are located outside of the United States, beyond the reach of regulators.
"If you find out about the website because of spam or unsolicited email, be very, very careful," Hamburg said. "If the price is bedrock cheap and it seems too good to be true, it probably is too go to be true. And if it is not located in the United States and it's offering to ship drugs worldwide, another red flag; don't go there."
Liang added that when they were searching for online pharmacies, the first 10 pages of hits was comprised entirely of fake pharmacies, and they did not come to a legitimate site until page 10 in the Google search results.
The new "BeSafeRx" website allows consumers to check a pharmacy's license through state boards of pharmacy, as well as providing tips for shopping online and seeing the signs of a fake pharmacy.
"We want consumers to be able to get safe, effective, high-quality drugs," Hamburg said. "And if they want to order them online that is terrific, but use a safe and legal online pharmacy.
"The important messages," Hamburg added, "are have a prescription, know your online pharmacy, make sure it is safe and take your medication as directed."
The National Association of Boards of Pharmacy also recommends only using Internet pharmacies accredited through Verified Internet Pharmacy Practice Sites or Vet-VIPPS program. It also provides a listing of "Not Recommended Sites."
The Associated Press contributed to this report.