Is It Safe to Purchase Medications Outside of the US?

The skyrocketing healthcare costs in the US, specifically the high cost of prescription medications, have led many Americans to compare drug prices and be tempted to order prescription drugs from online pharmacies. But is it safe to import prescription drugs from other countries? And is it legal? Please read on to find out.

Why do people buy prescription medications from online pharmacies or import them overseas?

Lower Drug Prices

One of the key reasons people think of buying medicines from foreign pharmacies is to save on cost. For example, certain diabetes medications can cost thousands of dollars a year in the US, even with insurance, causing people with diabetes to run up credit card debts. The same medications are available for less than 10% of the US cost south of the border in Mexico. A RAND Corporation survey found that, on average, prices of prescription drugs are roughly 2.5 times higher in the US compared to 32 other countries. For brand-name drugs, the price difference can be nearly 3.5 times.

Availability of Prescription Medications Over-The-Counter

Many drugs that require a prescription in the US, such as antibiotics and birth control pills, are not only cheaper but also available over the counter in Mexico and other countries. In some countries, even controlled substances such as Valium can be purchased without a prescription.

Undocumented Immigrants Seeking Healthcare

Importing medication is common among immigrant communities such as Latinos, Russians, and Asians because they can easily access imported medicines from their home countries, such as visiting relatives. Also, such individuals tend to seek healthcare in backroom establishments for fear of their immigration status being discovered.

What are the risks of the personal importation of drugs from online pharmacies?

Given the high cost of prescription drugs in the US, there are calls to make it easier for Americans to import drugs from foreign countries. But several public health safety risks are associated with importing prescription drugs from abroad. The U.S. Food and Drug Administration (FDA) warns of the following:

Prescription drugs not approved for sale in the US may not be manufactured using the same quality assurance standards as US drug manufacturers.
The origin and quality of imported drugs are unknown. They can be expired, contaminated, fake, or tampered with, making them ineffective or even dangerous.
Imported prescription drugs may contain untested and potentially dangerous substances as additives.
The medication’s label and instructions could be in another language that you do not understand, leading to overdoses or other complications.
Using prescription drugs without a physician's supervision means it might be hard to identify and treat the problem if you suffer any serious side effects or allergic reactions.

What are the advantages of buying US FDA-approved drugs?

FDA-approved drugs are manufactured at registered plants, either domestic or overseas, ensuring effective treatment. They have proper labeling, conform to FDA requirements, and are made using robust quality assurance practices. If a pharmaceutical manufacturer lists a foreign facility as the manufacturing site for a drug, FDA personnel usually travel to the facility to inspect it. In the US, drugs make it to pharmacy shelves through a closed distribution system, meaning there are several safeguards to protect against counterfeit or poor-quality drugs.

Is it legal to buy prescription drugs from another country?

In most circumstances, customs agents look the other way if you’re importing medicines from other countries. However, importing unapproved prescription medications from countries outside the US is illegal.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) states that importing non-FDA-approved prescription drugs or shipping them across state borders is illegal. The FD&C Act also states that prescription drugs manufactured in the US and exported to other countries can only be re-imported by the original manufacturer. Re-imported drugs must be properly handled and re-labeled for the US market if required.

Personal Use Guidance

Although it is illegal to import prescription drugs that are not FDA-approved, the FDA's personal use guidance recognizes that there can be certain circumstances in which a US citizen may need to import medications from another country. The FDA has the discretion not to take any action against such imports.

However, the FDA guidance is limited to individuals with serious conditions to enable them to obtain treatments that do not have FDA approval but are legally available in foreign countries.

Some of the conditions that must be fulfilled to import prescription drugs under the personal use guidance include:

The medication should be for a serious condition for which effective treatments are not available in the US.
The medication should not represent an unreasonable risk.
The person importing the drug must say in writing that it is for their own use.
The person importing the medications must provide the name and address of a doctor licensed in the US who can provide evidence that such drugs are required to continue treatment begun overseas.
The personal importation must be a three-month supply or less.
There must not be any known commercial interest for the consumer or distributor.

Simply put, it means that if you purchase pills for high blood pressure or diabetes from an online pharmacy in a foreign country because of the significantly lower drug prices, it’s technically illegal, even if the same medication is approved for sale in the US under the exact same name. Also, you should know that the Drug Enforcement Administration (DEA) has additional rules about importing prescription drugs that are controlled substances.

Are medications from other countries safe?

The internet has made it easy for patients to buy medicine from foreign sources. However, the U.S. Food and Drug Administration (FDA) warns against using imported and unapproved drugs. There are several safety concerns associated with drugs purchased from outside the US, as outlined above.

Many people think that while regulations in Mexico are lax and importing drugs from our southern neighbor could be dangerous, medications from Canada are entirely safe.

The truth is that drugs from Canada may not be made there, and could have been passed through Canada, manufactured elsewhere in the world, and could therefore be counterfeit drugs.

Also, Canada’s regulatory agency, Health Canada, does not regulate drugs made by Canadian companies purely for export. Therefore, medications obtained from Canada can pose health risks.

Moreover, the Canadian government does not encourage Canadian pharmacies to break the law and provide drugs to overseas citizens.

The Trump Administration released a Safe Importation Action Plan to allow the importation of certain drugs from Canada and other foreign markets. However, this does not relate to consumers individually and is only at a wholesale level.

Buying an unapproved drug from a foreign country or buying a prescription drug not meant for sale in the US is dangerous and illegal. Always purchase your medications from a state-licensed pharmacy to ensure the safety and effectiveness of your prescriptions.

References: