“Ozempic® up to 50% off!” screams the impressively large ad. “Call toll-free or order online.” The ad lists a Canadian company as the sponsor, with a Winnipeg P.O. Box. Is it safe for an individual private consumer to order this pricey drug from this source, even with a doctor’s bona fide prescription? The best answer is “it depends.”

It’s true that many medications are cheaper in Canada, especially brand name drugs. There has been talk for years, even among U.S. politicians, about letting Americans legally buy prescription drugs from Canada. But there have also been reports that not all Canadian sources are equally reputable. In fact, not all Canadian sources are necessarily “Canadian.”

For example, in 2019, the U.S. Food and Drug Administration (FDA) sent a warning letter to a Canadian company selling prescription drugs online to Americans. The FDA charged that the company had sent “unapproved” and “misbranded” drugs to U.S. consumers, putting their health and safety at risk. The FDA has said in the past that where you buy medications outside of the United States can make the difference between taking a pill that improves your health and getting one that doesn’t help. One that may even harm you.

Although the company cited by the FDA denied any wrongdoing or posing any risk to Americans’ health, then FDA Commissioner Scott Gottlieb, MD, said in a press release that when an American consumer goes online to buy medicines purportedly from Canada, “they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded.” Separately, a pharmacy law professor weighed in, saying that drugs supposedly coming from Canada “in many cases are coming from Third World countries.”

Safety measures weakened or bypassed with on-line pharmacies

A key concern is that companies in other countries may bypass the protections that the FDA has in place to protect the health and safety of Americans buying prescription medications. The FDA ensures that the medication you buy is what you expect, at the right dose and free of contaminants. It issues recalls when problems with the drugs are detected. The FDA also inspects facilities where medications sold legally in the U.S. are manufactured, even for drugs made outside the country. And companies handling prescription drugs have to follow FDA guidelines on how they are stored and shipped.

These protections can disappear for medications acquired online from outside the country. Some pharmaceuticals may be fine, others not. Experts in the U.S. have said that Canada itself has a first-rate drug regulatory process, on par with the FDA’s. But securing that protection would require physically going to Canada to buy your prescription at a Canadian pharmacy, after getting your U.S. prescription “reissued” by a Canadian physician—steps the typical American would not choose to do, or in many cases be unable to do.

Ways to protect yourself when buying online

The FDA says you can protect yourself and your family by being cautious when buying medicine online. The agency points out that some pharmacy websites do operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines. But, again, they are not all the same, and there are many that are unsafe, some even offering drugs at deeply discounted prices without requiring a prescription.

“These internet-based pharmacies often sell unapproved, counterfeit or otherwise unsafe medicines outside the safeguards followed by licensed pharmacies,” states the FDA. Also “Many unsafe online pharmacies use fake ‘storefronts’ to mimic licensed pharmacies or to make you think their medicines come from countries with high safety standards. But the medicines they sell could have been made anywhere, with little care or concern for safety and effectiveness. These drugs could be fake, expired or otherwise unsafe for you and your family.”

How can you tell if an online pharmacy is operating legally? The FDA’s BeSafeRx page has resources and tools to help you make safer and more informed decisions when buying prescription medicines online. The agency also offers the following guidance:

Warning signs of an unsafe online pharmacy

Beware of online pharmacies that:

  • Do not require a doctor’s prescription.
  • Are not licensed in the U.S. and by your state board of pharmacy.
  • Do not have a licensed pharmacist on staff to answer your questions.
  • Send medicine that looks different from what you receive at your usual pharmacy, or arrives in packaging that is broken, damaged, in a foreign language, has no expiration date, or is expired.
  • Offer deep discounts or prices that seem too good to be true.
  • Charge you for products you never ordered or received.
  • Do not provide clear written protections of your personal and financial information.
  • Sell your information to other websites.

These pharmacies often sell medicines that can be dangerous because they may:

  • Have too much or too little of the active ingredient you need to treat your disease or condition.
  • Not contain the right active ingredient.
  • Contain the wrong ingredients or other harmful substances.
  • Also these drugs may not have been stored properly, such as in a warehouse without necessary temperature controls, which may cause the medicine to be ineffective in treating your condition.

Know the signs of a safe online pharmacy

There are ways you can identify a safe online pharmacy. These pharmacies:

  • Always require a doctor’s prescription.
  • Provide a physical address and telephone number in the U.S.
  • Have a licensed pharmacist on staff to answer your questions.
  • Are licensed with a state board of pharmacy.

Another way to help ensure you are using a safe and legal online pharmacy is to check the pharmacy’s license in the state’s board of pharmacy license database by using the location tool on the FDA’s BeSafeRx website. Or go directly to Colorado’s Board of Pharmacy at https://dpo.colorado.gov/Pharmacy. The FDA flatly states: “If your online pharmacy is not listed, don’t use that pharmacy.”

Key distinction: “Personal importation vs. Colorado’s official drug importation program

This article has discussed what is often called “personal importation” of drugs. Personal importation is when an individual purchases prescription drugs from a pharmacy in another country and has the drug sent to their residence. As explained here, such “unofficial” sourcing of drugs can harbor risks for the private buyer, due to the uncertainty of consistent safeguards. Do not confuse this with Colorado’s new legally established drug importation program, expected to be up and running sometime in 2023. This program will have a robust oversight framework for Colorado’s drug importation, which represents a crucial safety component that distinguishes it from personal importation. See separate AgeWise Colorado article on Coloradans’ Canadian Drug Savings [Coloradans to Gain Access to Canadian Drug Savings – AgeWise Colorado] for more details on this program.