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The Least You Need To Know
Last Updated : June 2017

Americans (in America) are allowed to import drugs from outside the United States only under very specific circumstances, and the FDA (Food and Drug Administration) web site specifically says that “cheap drugs from Canada” is not one of them—but sometimes state govenments will have programs to allow it anyway. Outside of the US, ordering cheaper drugs from legitimate pharmacies abroad is often not only legal, but also encouraged.

However, the FDA does not enforce this law strictly as written. The FDA has expressly clarified that their priority is safety and “interstate commerce”, and The FDA's own internal documents instruct employees to allow people to import up to a 90-day supply of personal prescriptions. The FDA can pursue criminal charges, should they choose to, but the people who end up getting charged are usually, if not exclusively, the ones who put people in danger by selling fake, adulterated, or illegally imported drugs. If you import your own, personal-use cheap drugs from Canada, Europe, or elsewhere, the problem you're most likely to face is that it will be hard for you to find a legitimate pharmacy willing to import into America, and any pharmacy that is eager to do so is probably a fake one you don't want to get drugs from. Legitimate drugs from a legitimate pharmacy in Canada, Europe, or any number of other countries abroad are just as safe, if not safer, than prescription drugs in the United States, but it's hard to tell the difference between real and fake pharmacies over the Internet. We provide you with resources to help you figure this out.

What follows is a thorough discussion of the laws in question, safety of buying prescription drugs online or abroad, and, most importantly, we explain how to tell a legitimate Canadian or European online pharmacy from an unsafe, illegitimate one.

I. How Pulp Fiction Can Help Explain Global Pharma

Quentin Tarantino's 1994 classic neo-crime-noir film, Pulp Fiction, opens with an iconic scene in which Vincent (John Travolta), a hitman just returned from a trip to Europe, tells his co-worker Jules (Samuel L. Jackson) about similarities and differences between Europe and America.

Caution: contains foul language

[VINCENT] But you know what the funniest thing about Europe is?

[JULES] What?

[VINCENT] It's the little differences. A lotta the same [expletive] we got here, they got there, but there they're a little different.

[JULES] Example?

[VNCENT] Alright, when you .... into a movie theatre in Amsterdam, you can buy beer. And I don't mean in a paper cup either. They give you a glass of beer. And in Paris, you can buy beer at MacDonald's. And you know what they call a Quarter Pounder with Cheese in Paris?

[JULES] They don't call it a Quarter Pounder with Cheese?

[VINCENT] No, they got the metric system there, they wouldn't know what the [expletive] a Quarter Pounder is.

[JULES] What'd they call it?

[VINCENT] They call it Royale with Cheese.

[JULES] Royale with Cheese. What'd they call a Big Mac?

[VINCENT] Big Mac's a Big Mac, but they call it Le Big Mac.

[JULES] Le big Mac! Ahhaha, what do they call a Whopper?

[VINCENT] I dunno, I didn't go into a Burger King.

Believe it or not, the global pharmaceutical industry can also be understood in the context of this conversation. Just like McDonald's can offer a large cheeseburger and call it a “Quarter Pounder with Cheese” in America, then offer what is essentially the exact same menu item as a “Royale with Cheese” in France, large pharmaceutical companies will often offer the same drug in different countries, with only slight cosmetic or external differences. In many cases these are the same drugs with the same ingredients made in the same place by the same company, but they are packaged differently, with slight differences related to the specific laws of each country.

For example, any American could walk into a McDonald's in Paris, order a Royale with Cheese, and say, “What a delicious Quarter Pounder with Cheese I just ate.” Maybe the manager is especially disagreeable—the French are, in fact, known for this—and he would correct the American, “No sir, you just ate a Royale with Cheese.” And in some ways they would both be right, because the receipt crumpled up in the American's jeans pocket says “Royale with Cheese”, but the Royale had the exact same taste, was made with the same recipe, same ingredients as the Quarter Pounder, and ultimately the profits and responsibility all point to the same place: McDonald's. If people got sick eating a Royale, the company that makes the Quarter Pounder would be in trouble, and vice versa. Profits from the Quarter Pounder make their way up the same chain and profits from the Royale, and so on. In other words, in some technical ways they Royale and Quarter Pounder are different, but essentially, they are the same.

So, for the rest of this article, we will use this simplified example to explain big pharma branded prescription drugs across the world. Imagine, if you will, a hypothetical American—we'll name him Vincent, in honor of the inspiration for this example—who has some kind of disease that can only be controlled by regularly eating large fast-food burgers. To treat this health condition, this American patient's American doctor has prescribed to him the Quarter Pounder with Cheese. But Vincent also takes frequent trips to France, and in this trips, his Cheeseburger Deficiency Syndrome (CDS)*(not a real disease) is controlled by eating the Royales that his French doctor has prescribed to him.

Vincent has observed that the Royale seems to look, work, and feel exactly like the Quarter Pounder at home, but it costs a lot less. Vincent wants to know if he can bring Royales home with him, have Royales mailed to him, or set up his own Royale importation business.

In many countries, importing cheap prescription drugs from legitimate pharmacies outside of the country is not only allowed, but also encouraged. If you are living or traveling outside of the US and unsure if this is the case where you are, please research local laws; we couldn't possibly list them all! What follows is a detailed explanation of laws pertinent laws in the United States of America.

Officially, the importation of prescription drugs from foreign countries into the United States by anyone other than the drug manufacturer is against federal law. The rule is the same for shipment via mail, or in your suitcase. The Food and Drug Administration (FDA) defines "personal importation" as:

A personal importation is a product not for further sale or distribution into United States commerce.  These products may be carried in baggage or shipped by courier or international mail. 1

But in practice, small, personal importations of legitimately-obtained prescription drugs are quietly tolerated by both the Customs and Border Protection (CBP) and FDA, and are occasionally even encouraged by official programs in states such as Maine, Illinois, Minnesota, New Hampshire, Vermont, and Wisconsin.


The Federal Food, Drug, and Cosmetic Act

Most of the federal laws concerning drug approval, importation, etc, come from a little (just kidding, it's almost 400 pages long) set of laws called the Federal Food, Drug, and Cosmetic Act (FFDCA). The FFDCA explicitly states that it deals with “interstate commerce”, i.e. it concerns itself with commercial drug sales, not personal use. However, it does specifically state that if a drug is manufactured in the US and exported outside, it can only be re-imported back into the US by the drug manufacturer. This stipulation effectively prevents people from being able to legally import drugs from abroad, even if it that drug was manufactured in the United States. Additionally, it also has a lot to say on the subject of "misbranded" and "counterfeit" drugs, which is what the FDA uses to forbid people from importing drugs from abroad.

The definition of "unapproved", "misbranded", or "counterfeit" drugs is a little bit of a logic puzzle. Here's how it works:

  1. Only FDA-approved drugs are allowed in the US.
  2. The FDA only approves drugs that are meant to be sold in the US
  3. Therefore, any drug that is not meant to be sold in the US is, by definition, non-FDA-approved.
  4. This applies to foreign-bought versions of drugs available in the US, even if they're made by the same manufacturer. What constitutes an "approved" drug is not just the chemical elements, but also the packaging and labeling, which is tailored to the specific country it is sold in.
  5. Catch 22: If you bring a drug into America and clearly document that is is foreign, it is "unapproved". If you label it like the American drug or otherwise claim it's the same, it becomes a "misbranded" or "counterfeit" version of the American drug.

It is technically possible for a drug manufacturer to package and label their drugs in such a way that the drug would be approved by the American FDA as well as the corresponding authority in another country, but there's no reason for them to do that, because this technicality is what allows them to charge twice as much or more for what is essentially the exact same product.

Translation:
Only McDonald's can bring a Royale to America; Vincent cannot.
If Vincent were to bring a Royale to America, he would be in possession of a "unapproved" foreign burger.
If Vincent were to put his Royale in a Quarter Pounder box or otherwise tell people it's the same thing, he would be guilty of having a "misbranded" or "counterfeit" Quarter Pounder.

Exceptions

For Foreign Nationals (defined as any person who is not a citizen or permanent resident of the US) who are traveling or even studying in the United States, the FDA says:

FDA understands that you will need to bring your personal medication while you are in the United States. FDA will allow foreign nationals to bring or ship a 90-day supply of drug products. If the foreign national is staying longer than 90 days, they may have additional medication sent to them. If you are having medication sent to you by mail or courier, it is suggested that you include documentation that provides evidence that the medication is being sent for your own use while visiting the United States. This may include.

  • A copy of the visa/passport
  • Letter from doctor
  • Copy of Prescription (in English)1

For Americans, the FDA spells out similar conditions for bringing personal medications into the United States, but has an added qualifying condition: "There is no known commercialization or promotion of the product to persons residing in the U.S."

The fact that foreigners are allowed to import prescription medications but Americans are not raises some questions. For example, if foreign drugs are banned from the US on the basis of safety, why don't we care about the safety of foreigners? A foreigner that gets sick in America would still go to an American hospital. Foreigners are still required to wear seatbelts, motorcycle helmets, follow alcohol restrictions, and generally follow all local laws, just like American citizens and residents. Why is there a nationality/residency-based exception for prescription medications?

The FDA elsewhere clarifies their Personal Importation Policy (PIP):2

Q. Can I use the PIP to get less expensive drugs from Canada?
A. No, the PIP is not intended to permit personal importation of cheaper versions of FDA approved drugs from Canada or other foreign countries. FDA cannot assure that foreign made versions of FDA-approved drugs have been properly manufactured, are safe and effective, and are exactly the same formulation as the FDA-approved versions. The PIP is intended to make available, through the exercise of enforcement discretion, unapproved drugs used to treat serious medical conditions for which no equivalent treatment exists in the United States, and unapproved drugs used to continue treatment begun in a foreign country.

Q. What kinds of drugs are eligible for importation under the PIP?
A. The PIP is intended to apply to unapproved drugs that are:

  • used to treat serious medical conditions
  • not a serious health risk to patients
  • not commercially available or marketed in the United States
  • part of a treatment regimen begun in a foreign country

Unapproved drugs that appear on Import Alert, that is, drugs that appear to be in violation of the FFDCA and are subject to detention without physical examination, are not eligible for importation under the PIP. Likewise, drugs with associated Risk Evaluation and Mitigation Strategies (REMS) requiring distribution of FDA-approved patient medication information necessary for safe and effective use of the drugs also are not eligible for importation under the PIP.

In essence, the PIP is meant to be used for people who have started or sought treatment outside the United States, or for drugs that are inaccessible in the USA. The PIP is not supposed to be a strategy to circumvent or compete with the pricey American drug market.

Translation:
Vincent's French friend, Fabienne, can bring her Royale with her when she travels or studies in the United States, as long as she has the proper documentation.
Because Quarter Pounders are available in America, and because Vincent is American, he cannot; he needs to buy a Quarter Pounder.

The FDA has gone to court both to defend its right to prevent Americans from importing foreign drugs—claiming there is no fundamental right “to purchase drugs from a preferred source at a preferred price,”3 —but the FDA has also gone to court to defend its right to allow importations—as was the case when they allowed correctional facilities to import misbranded, unapproved, foreign drugs used for the off-label (unapproved) purpose of lethal injections. 4 In essence, through these court cases, the FDA has said: “You can't stop me but also you can't make me.”

But before accuse the FDA of “arbitrary, capricious, and an abuse of discretion”5 or argue that the, "the FDA’s procedures protect the profits of drug manufacturers at the expense of consumer pocketbooks,"4 we should appreciate that, though they consistently insist that they would be well within their rights to lock Vincent for importing his Royale with him from France, the FDA appears to have no intention to do so, nor does it appear to have ever happened.

There was one suspiciously-timed sting in 2005:

Prior to November 17, 2005, CBP [U.S. Customs and Border Protection agency] officials tolerated prescription drug mail orders from Canada of up to 90 days worth of medication, “generally interpreting U.S. laws against the importation of drugs as applying to wholesalers and distributors.” However, the CBP began strictly enforcing importation laws on November 17, 2005, two days after the beginning of open enrollment for the Medicare prescription drug program. This policy change lead consumer groups and Canadian pharmacies to complain that CBP’s policy was intended to encourage seniors to enroll in the Medicare plan and decrease competition for often costly prescription drugs. CBP officials denied this charge, noting that the new enforcement policy was designed “to protect consumers from potentially dangerous drugs manufactured abroad.” For the next eleven months, CBP agents confiscated mail packages with foreign prescription drugs and often destroyed the drugs, then mailed letters about the violation to consumers attempting to import the drugs. An estimated 37,000 to 40,000 packages were detained by CBP during this period 4

Nonetheless, ever since 2006 the CBP has announced that agents now, “focus on intercepting only counterfeit medicines, narcotics, and illegal drugs.” As a result, the FDA assumed the primary responsibility for determining whether Canadian and other international drug imports may legally enter the United States. However, the FDA's Regulatory Procedures Manual states that:

FDA personnel are not to examine personal baggage. This responsibility rests with the CBP.
Chapter 9 Import Operations and Actions, section 9-2-3 PERSONAL BAGGAGE6

Which means that neither the CBP nor the FDA are especially interested in confiscating personal-use prescription medications. In order for Vincent to get in trouble for bringing his Royale in from France, first the CBP has to decide they have a problem with his suitcase or parcel, which they probably won't, as long as it's not a controlled substance or a quantity so large it's obviously for sale. In the unlikely even that the CBP refers Vincent to the FDA, the FDA would have to make the choice to prosecute him, which they probably won't, because:

Despite the range of penalties that FDA has available to punish those who import prescription drugs in violation of the act, the agency has clarified that its “highest enforcement priority would not be actions against consumers.”4

Criminal prosecutions under the FFDCA are rare:

“only a minuscule fraction of 1 per cent of the [FDA’s] inspections will result in criminal prosecution” and violations of the Act resulting from “extremely technical infractions” are very unlikely to result in criminal punishment. In fact, according to the FDA’s enforcement manuals, criminal prosecutions rarely occur if “a violative situation does not present a danger to health or does not constitute intentional, gross or flagrant violations.”7

According to the FDA's own records, they send less than 200 warning letters per year,8 and don't appear to ever prosecute individuals. At least, if they do, the stories don't make it to the Office of Criminal Investigations (OCI) news bulletin.

Plenty of more discrete signal that the FDA is not interested in pursuing cases against individuals are inconspicuously on display. On the Information for Consumers section of the FDA website, they have an article entitled, Imported Drugs Raise Safety Concerns. The article describes Selene Seguros Rios, who died shortly after receiving two injections of a pain and fever drug called Neo-Melubrina (dipyrone) in an illegal backroom clinic in Tustin, California. The article does not say where Selene's drugs came from, but they later describe Neena Quirion, director of the Maine Council of Senior Citizens in Augusta, who has organized bus trips to Canada where senior citizens receive a physical examination from a doctor who is licensed to practice medicine in both Maine and Canada, and then, if appropriate, writes then a (Canadian) prescription. Quirion estimated that 25 seniors collectively saved about $19,000 on an overnight trip.9

The article clearly states that, "a drug made in this country can only be re-imported back into this country by the original manufacturer," and, "Our members do not feel that Canadian pharmacists should be breaking laws of jurisdictions in which their patients reside." The FDA knows that Quirion and her busload of senior citizens were breaking the law, the FDA knows that Neena knows she was breaking the law, yet it does not appear that the FDA ever organized a sting operation to arrest Neena or her customers, on any of her organized Rx road trips.

Further, the very same article makes clear the limited FDA resources and interest:

The exact amount of imported drugs that come into the United States is hard to track, and the high volume makes it impossible to examine them all. In one pilot program, the Food and Drug Administration and the CBP examined 1,908 packages of drug products from 19 countries that came through a mail facility in Carson, Calif., during a five-week period. The FDA estimates that a total of 16,500 packages could have been set aside if there had been enough resources to handle them. Of the 1,908 packages, 721 were detained, and the addressees were notified that the products appeared to violate the Federal Food, Drug, and Cosmetic Act.
The FDA's enforcement efforts focus on drugs for commercial use, fraudulent drugs, and products that pose an unreasonable health risk. 7
(emphasis mine)

Looking at FDA enforcement of violations of the FFCDA show that their enforcement is inconsistent but predicable. The do not follow the FFDCA to the letter, in that they choose when they will prohibit and when they will allow foreign drug imports. But they also make it clear, in both their words and also their actions, that they are not interested in prosecuting average people who import legitimately-obtained prescription drugs for personal use.

Translation:
If Vincent brings his own Royale with him from France to America, it could by taken away from him, and he could be prosecuted. But unless he's trying to smuggle in a Quarter Pounder with Cocaine, or so many Royales that it's obvious he plans to sell them, that's almost certainly not going to happen. The CBP and the FDA have both said they don't care and don't have time to chase everyone who brings their own burgers across the border.

What do you think, the streets of Canada, Europe, Australia, etc, are just littered with corpses? Of course it's safe to buy prescription drugs abroad!

The problem, which we will get into later, is that fake pharmacies will disguise themselves as legitimate foreign pharmacies, and that's where the danger lies. Legitimately-prescribed and properly-stored medications from countries with robust regulations and testing are just as safe, if not safer, than drugs purchased in the United States—and how they can be safer is an issue worth getting into.


Heparin: Chinese manufacture problem causes more deaths in the US than abroad

In 2008, the multinational pharma company Baxter International Inc released a bad batch of the blood-thinner heparin, which caused 81 deaths and 785 adverse incidents in the United States.10 The same contaminant was suspected to have been supplied to 10 other countries: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand,10 but the only country, other than the US, to that reported any problems was Germany.11, 12 While all preventable complications are regrettable, to Germany's credit, only 2 people died,16 and another 80 experienced non-fatal allergic reactions;11, 14, 15, 16 which is quite minimal compared to nearly one hundred deaths and under one thousand adverse incidents in the US. Granted, Germany is a much smaller country with approximately 1/4th of the population of the United States, but even when taking population into account, that means the adulterated heparin caused 10 times as many deaths in the US than it did in Germany. The point remains, all of these countries were a put at risk from the drug's downward supply chain, but American patients were the ones who suffered the most.

The heparin incident is noteworthy precisely because it is unusual; most prescription drugs on the market are safe. But it nonetheless serves as a counter-argument to the claim that medications purchased outside the United States are somehow unsafe. The heparin incident shows that the pharmaceutical industry is way bigger than any one individual country (the problem came from a counterfeit raw ingredient in China). Moreover, the heparin incident demonstrates that medications outside the United States can actually be safer than those purchased within it.

A Pew Health Group white paper on the subject reported that:

USP officials believe that an up-to-date heparin monograph might have prevented the adulterated product from reaching the U.S. market, and that Europe’s more robust test specifications for heparin may have helped limit distribution of the adulterated drug there. 17
(emphasis mine)

Counterfeit, adulterated, or improperly-stored medications are unsafe, no matter where you buy them. The unique problem is that in the United States, the high price of medications in relation to other countries, creates extraordinary pressure for people to counterfeit medications, or sell real medications on the illegal "grey market." The same Pew whitepaper noted that:

“By one estimate, the return on counterfeit prescription drugs may be 10 times greater than that of the sale of illegal narcotics.”

“One industry insider estimates that to achieve this volume of distribution, from one to three tons of OSCS must have been produced and used to dilute real heparin, which would have generated $1 million to $3 million in profit for the individuals or companies that sold it”

"Several speakers made the point that it is currently more profitable and easier to counterfeit and adulterate medicines than to sell illicit drugs."

Translation:
Meat for both the Royales and Quarter Pounders comes from China. One time there was a meat shortage, so some bad guys supplied a cheap synthetic material instead of real meat, without telling anyone. The Royales were tested better than the Quarter Pounders, so a lot more people died in America than anywhere else.

The Illegal, and Highly-Profitable, Grey Market in American Pharmaceuticals

If you look at the FDA Office of Criminal Investigations (OCI) site, you see hundreds of press releases related to grey market drug sales. Highlights include:

  • An oncologist from California purchased cancer drugs from foreign countries including India, Honduras, Panama and the Philippines. He and his staff brought more than $1.3 million worth of unapproved drugs in at least 34 international trips. The foreign prescription drugs were given to his patients without their knowledge, and no adverse affects are noted in the article.

  • A Chinese national was sentenced to 78 months in prison for selling some 25 versions of counterfeit prescription drugs to American pharmacies. Analysis of the seized drugs determined the drugs did not have the appropriate active ingredient as reflected on the label, or less than the active ingredient unknown impurities.

  • Three people were charged with a "street diversion" scheme grossing $13 million dollars, in which they bought prescription drugs from people on the street and sold back to pharmacies throughout the United States.

  • A licensed medical doctor specializing in the treatment of cancer imported approximately 47 separate shipments containing 1,138 separate drug units, and gave them to his patients. It started when a nurse employed by the doctor received a fax transmission offering assorted prescription cancer treatment drugs at 14% – 60% off their average wholesale price in the United States. The article does not list any adverse affects by the patients, and notes that the imported drug had the same active ingredient as the FDA-approved version.

  • A woman was sentenced to two years' probation and required to pay $600,000 on her conviction of unlawfully importing prescription drugs from Portugal to the US. The imported medications were dispensed to persons in Pittsburgh, and no ill affects were noted.

  • An English national was found guilty of distributing adulterated prescription drugs used for cancer treatment to multiple physicians in the United States. Multiple doctors in the United States had received shipments of "cold chain" cancer prescription drugs that were warm upon arrival and damaged during shipment. An oncology nurse reported that two patients had "immediate bad reactions" during treatment with these pharmaceuticals. One of these patients "started to shake in the middle of being transfused and had to be disconnected from treatment." The FDA tested the drugs in question and determined that American customers had received counterfeit pharmaceuticals that did not contain any of the active drug ingredient.

  • Three more people were charged with the illegal diversion of prescription drugs. The defendants allegedly purchased pharmaceuticals from collectors who obtained the drugs on the streets of New York and Miami, then repackaged and distributed them to independent pharmacies throughou the US.

Clearly, the United States has its own problem with foreign, counterfeit, or diverted, drugs circulating through the supply chain. It's just not true to say that all drugs that make it to American hospitals or pharmacies are FDA-approved, or even safe, and it's definitely not true that prescription drugs in the United States are safer than anywhere else in the developed world; they might even be less so.

Translation:
Quarter Pounders are really expensive, so sometimes people will import Royales and sell them in Quarter Pounder boxes, put together two half-eaten Quarter Pounders and sell them like a new one, or make a burger in their own kitchen then go out and sell it as a Quarter Pounder.

Official Comment on Safety of Drugs Abroad: No Comment

Relatedly, the FDA does not actually claim that drugs abroad are not safe; this would be a blatant lie. Official statements make frequent use of weasel words, i.e. words that are ambiguous or misleading. What the FDA actually says is that they cannot guarantee the safety of drugs purchased outside the United States. How could they, the FDA doesn't investigate drugs sold outside the United States. But, "I don't know if it's safe" is not the same as, "unsafe."

Take, for example, FAQs for the National Association of Boards of Pharmacy (NABP), the organization which accredits pharmacies in the US, 10 Canadian provinces, and New Zealand.

Can I get really cheap prices from pharmacies outside the US?
First, FDA generally prohibits the importation of foreign-made versions of prescription medications that are commercially available in the US. The safety and efficacy of these medications cannot be guaranteed. Many countries’ drug research and control programs are not as safety-oriented as those in the US. Though some of the drugs advertised by foreign sites may be manufactured by the same name brand international drug manufacturer as you are used to, they usually are not manufactured in FDA-inspected facilities that have met FDA standards. Further, sometimes the medications have been subjected to storage conditions that compromised their potency or safety.

Taking apart the sentences one-by-one shows that this paragraph hasn't told us much, and leaves a lot unsaid.

"First, FDA generally prohibits the importation of foreign-made versions of prescription medications that are commercially available in the US."
Our Note: Yes, it's possible, no it's not allowed.

"The safety and efficacy of these medications cannot be guaranteed."
Our Note: The FDA cannot guarantee something it doesn't investigate.

"Many countries’ drug research and control programs are not as safety-oriented as those in the US."
Our Note: Of course that's true, but many are as good or better. We're asking about Europe, not Uganda.

"Though some of the drugs advertised by foreign sites may be manufactured by the same name brand international drug manufacturer as you are used to, they usually are not manufactured in FDA-inspected facilities that have met FDA standards."
Our Note: This is also true about American drugs. As of 2010, the FDA had estimated that up to 40% of finished drugs used by US patients are manufactured abroad, and 80% of active ingredients and bulk chemicals used in US drugs come from foreign countries. The FDA inspects foreign facilities once every 9 years on average, and the FDA has reported that at least 242 foreign manufacturers of active pharmaceutical ingredients (API) had shipped product into the United States in 1999 without being inspected by the FDA. According to the U.S. Government Accountability Office (GAO), 2,394 overseas plants on the FDA’s inspection planning list have never been inspected by the agency.17

"Further, sometimes the medications have been subjected to storage conditions that compromised their potency or safety."
True. A look at the Office of Criminal Investigations (OCI) news bulletin shows that this "sometimes" happens in America, as well.

Translation:
The FDA implies that Royales are unsafe, but actually what they say is, "We don't know anything about Royales, we only look at Quarter Pounders."

By now, it should be clear that, contrary to alarmist threats or vague FDA statements, there is no reason to believe that prescription drugs in America are inherently safer than legitimately-obtained prescription drugs in many other countries. Criticism aside, the FDA should be commended for staying so busy keeping the promise described in the previous section: prosecute the sale of unsafe drugs. Nonetheless, it must be observed the shady business opportunities being exploited by these criminals exist precisely because of the price difference between prescription drugs in the US versus other countries, or the high price of prescription medications in general. This highly-profitable grey market would evaporate if people were allowed to easily, legally, and legitimately, import cheap drugs from outside the United States. It can thusly be argued that, not only is there no reason to say that drugs outside the United States are inherently less safe than drugs in America, but actually, circumstances unique to America make prescription drugs less safe in America than many other equally-developed countries.

The main problem with online pharmacies is that it's hard to tell which is real and which is fake. For example, when people talk about "unsafe Canadian pharmacies", they're not talking about a legitimate Canadian pharmacy that sells to Canadian citizens. They're talking about unsafe "Canadian" pharmacies (notice the change in quotation marks around "Canadian")— i.e. pharmacies that are pretending to be Canadian but are actually shipping medications from the Bahamas or somewhere similar.

Pharmacies that sell to Canadian citizens are regulated by HealthCanada's Health Products and Food Branch, which is essentially the Canadian FDA, and just as safe. But if a pharmacy calls itself "Canadian" but does not actually sell to Canadian citizens, it would not be regulated by HealthCanada, just like any business in the world could call itself, "Yankee Cowboy American Apple Pie Incorporated" and not be any of those things (except for maybe incorporated). Scammers exploiting this loophole have fooled plenty of Americans, and given legitimate Canadian, or otherwise foreign, pharmacies a bad name.


How to Verify Online Pharmacies

For European pharmacy sites, it's very easy to tell real sites from imposters. As of 2015, all European Union (EU) pharmacies are required to have a mandatory EU common logo at the bottom of site, which users can click on to verify the site's credentials.

Similarly, in The United Kingdom, you have 1 of 2 logos to look for. All legitimate British internet pharmacies must be regulated by either the General Pharmaceutical Council (GPhC) or the Royal Pharmaceutical Society (RPS). If they are affiliated with the GPhC, they will have a little logo of a green cross that says, "Registered Pharmacy", and their registration number.

If a pharmacy web site claims to operate in the EU or UK, but does not have these things, it's not a real pharmacy. End of story. You should navigate away from that site and never return, and maybe even report it to the authorities.

Online Pharmacy Verification

What it is Where it Applies Reccommended
EU-mandated logo European Union
General Pharmaceutical Council (GPhC) UK
Royal Pharmaceutical Society (RPS) UK
Verified Internet Pharmacy Practice Sites (VIPPS) United States
The Center for Safe Internet Pharmacies (CSIP) International
Canadian International Pharmacy Association (CIPA) "Canada"
PharmacyChecker.com International

In the United States it's a little less clear. There is no mandatory signal, like in the EU or UK, but there is an optional accreditation program: the Verified Internet Pharmacy Practice Sites.

There does not appear to be a reliable way to tell fake "Canadian" online pharmacies from real Canadian pharmacies. The Canadian International Pharmacy Association (CIPA) presents itself as a legitimate accreditor, but it has been accused of associating with criminally illegitimate pharmacies. PharmacyChecker.com is equally unreliable, having also "verified" multiple pharmacies that were later prosecuted for criminal operations, as well as having a former exective facing indightment. Google, Bing, and Yahoo have all cut off their relationships with PharmacyChecker.

There is an additional pharmacy verification program about which we are cautiously optimistic. The Center for Safe Internet Pharmacies (CSIP) has an online form to verify any pharmacy you're uncertain about. We are "cautiously" optimistic about CSIP because it is a nonprofit organization that is not officially affiliated with any country's FDA-like authorities, so any trust placed in it can't be derived from any official source, just the site itself. Additionally, it had mixed results in our unofficial test: it correctly identified fake "Canadian" pharmacy sites as frauds, but it lacked information on any European sites we tested; presumably because CSIP focuses on rogue "Canadian" illegal pharmacies. Nonetheless, we find the way they clearly and transparently explain and present data to be very trustworthy, and they have an impressive list of partners, that include American Express, Discover, Facebook, Go Daddy, Google, MasterCard, Microsoft, PayPal, Yahoo!, and UPS.


Example Pharmacy: HealthExpress from the UK

HealthExpress is the internet-facing side of a UK-based pharmacy called Hexpress Healthcare Ltd, which, as indicated by the clickable logos on the bottom of the page, is registered with the UK General Pharmaceutical Council (GPhC), as well as the Medicines and Healthcare products Regulatory Agency (MHRA). They ship prescription drugs outside of the UK and Europe, but not to the United States. Their shipping destinations are: Brazil, Denmark, Estonia, Finland, Germany, Greece, Greenland, Poland, Portugal, Sweden, Switzerland, and of course, the United Kingdom. If you peruse their site and find that you exact same prescription drug is available through them for much less than what you are currently paying, and you don't already live in one of their shipping destination countries, you will need to travel to one of those countries in order to receive them. If you're willing to invest the time to search thoroughly, round-trip flights from the USA to many of these locations can often be found for $500 or less via Skyscanner, Kiwi.com, or Expedia.
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Another Important Safety Concern

Any time you're getting a drug, but especially if you're in a foreign country, make sure that the drug you're ordering is exactly the same pharmacologically as what you should be getting (i.e. what you get at home), and not just the same name! From time to time the same drug will have a different name in a different country, or there will be something with a similar or identical name, that's a completely different drug. To avoid this kind of confusion, the FDA, the European Medicines Agency and HealthCanada all work together when a new drug is getting named, but mistakes can still happen. Additionally, it's important to note that drugs with similar names also cause confusion and incidents in the same country, such as the incident which prompted the FDA to issue a warning after a pharmacists gave the wart remover Durasal to someone who has a prescription for eye medicine Durezol. Ouch!

The World Health Organization (WHO) and Joint Commission International (JCI) have put together an example list of drugs whose names sound the same as each other, but don't assume that just because your drug isn't on there, you're in the clear. To help people find information about drugs and their active ingredients, the FDA has created a search tool for consumers, as well as one for healthcare professionals. You can use these, or similar international tools (like this one for Canada), to find out what the active ingredients are in a drug you take, or are thinking about taking.

When in doubt, always talk to a doctor or pharmacist, both locally and abroad.

Translation:
Imagine that Vincent's French friend, Fabienne, went to the United States and ordered a "Royale", not knowing that in the USA, it's called a, "Quarter Pounder". Who knows what a "Royale" is in America? Maybe an American "Royale" is something that will make her sick. If she had done her research, she would have known to order a Quarter Pounder, not a Royale.

Prescription drugs in many (but not all) non-US countries are pretty much the same as prescription drugs in America, and just as safe, if not safer, but they might go by a different name. If you're an American in America, you're not supposed to bring foreign prescription drugs into America. If you're a foreigner in America, this is okay, and if you're living somewhere else, this is probably okay as well (but you need to check local laws). The Food and Drug Administration (FDA) has said that saving money is not a good enough reason to buy abroad, but sometimes local state governments will challenge this and allow constituents to buy prescription drugs abroad anyway (to help them save money). If the FDA or the Customs and Border Protection (CBP) want to, they can confiscate foreign prescription drugs, even from your suitcase (not just in the mail). However, both the FDA and the CBP have said that they're not interested in people's personal prescriptions, just people who sell them—and those people keep them pretty busy! Lots of "Canadian pharmacies" online aren't actually Canadian, and are untrustworthy. It's hard to tell a legitimate Canadian pharmacy from an illegitimate one online. It's pretty easy to tell if an EU or UK pharmacy web site is legitimate, but they might not ship to USA; you might have to travel somewhere else if you want to receive prescription drugs from an EU or UK pharmacy. If you stand to save a lot of money on getting your prescription abroad, it may be worth it to you to travel every 3 months to get it yourself. If you don't stand to save significantly more than the cost of traveling, or don't want to risk the slim chance of it getting confiscated, you should probably just forget it.

References:


1. U.S. Food and Drug Administration. Personal Importation.Accessed June 7, 2017.

2. U.S. Food and Drug Administration. Personal Importation Policy (PIP) Frequently Asked Questions (FAQs). Accessed June 7, 2017.

3. 2005 U.S. Dist. LEXIS 5710 (D.D.C. 2005)

4. Congressional Research Service. Prescription Drug Importation: A Legal Overview.. December 1, 2008. Accessed June 7, 2017.

5. Beaty v. FDA (No. 11-289). Accessed June 7th, 2017 from hpm.com

6. FDA Regulatory Procedures Manual. Chapter 9 Import Operations and Actions. Accessed June 7th, 2017.

7. Congressional Research Service. Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues.June 19, 2014. Accessed June 7, 2017.

8. Thompson Information Serices. Trends in Issuing Warning Letters. Accessed June 7, 2017.

9. U.S. Food and Drug Administration. Imported Drugs Raise Safety Concerns. Page Last Updated: 05/04/2016. Accessed June 7, 2017.

10. Harris, Gardiner.U.S. Identifies Tainted Heparin in 11 Countries. The New York Times. April 22, 2008. Accessed June 7, 2017.

11. Peck,Peggy. FDA Confirms Heparin Contaminant as Cause of Deaths. MedPage Today. April 21, 2008. Accessed June 7, 2017.

12. Barnes, Kirsty.China-made heparin scare spreads beyond US. Outsourcing-Pharma.com. March 11, 2008. Accessed June 7, 2017.

13. Hoppensteadt, D.A., Wahi, R., Adiguzel, C., Iqbal, O., Ramacciotti, E., Bick, R.L., Messmore, H.L., Bansal, V. and Fareed, J., 2008. Contaminant in the recalled unfractionated heparin preparations: where is the problem?.Clinical and Applied Thrombosis/Hemostasis.

14. Akre, Jane. Heparin Recall Expands to Germany, 80 Sickened. Injury Board National News Desk. March 07, 2008. Accessed June 7, 2017.

15. Chow, Elaine. Germany Asks Cos. To Look For Tainted Heparin. Law360. March 13, 2008. Accessed June 7, 2017.

16. Bartens, Werner. The Worldwide Epidemic Of Counterfeit Drugs. WorldCrunch. May 23, 2017. Accessed June 7, 2017.

17. Cosel, G., 2011. After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs. Pew Health Group, Philadelphia, PA. Accessed June 7, 2017.