The Truth About Prescription Drug Importation in the U.S.Is Personal Importation Legal?
February 8, 2022
Prescription drug prices in the US are significantly higher than in other countries. The free market in the US has created some of the highest drug prices in the world. Foreign governments set prescription drug prices far lower, making this is one of the main reasons why US residents turn to prescription drug importation.
Employers are also realizing that if their workforce becomes educated on prescription drug importation, they can save dramatically on prescription medication costs by purchasing from other countries.
According to the FDA, only 28% of the active pharmaceutical ingredients, or APIs, are manufactured in the United States (2019). Canada, China, India, and the EU (European Union) make up almost 60% of the APIs used in the US. In turn, these APIs are used to manufacture the actual medications that people use. Prescription drugs sold in the US are manufactured in facilities all over the globe.
Did you know that many prescription medications sold within the US, are not manufactured in the US? Tons of medications are made in Australia, Canada, China, India, France, Germany, Japan, Malta, Singapore, Sweden, the United Kingdom, and the United States. A lot of the medications you need may already be imported from a manufacturing facility outside of the United States. It’s the US open market that allows these same medications to be sold for much more money in the USA compared to other countries.
There is some debate over whether personal drug importation is legal in the US. However, the US has been allowing this practice to take place for the last 20 years. The process involves working with your chosen mail order pharmacy company, many of which are in Canada. Most of these mail order medication companies act as logistics partners, connecting licensed and regulated pharmacies outside of the US with the patient located within the US.
What is required to import prescription drugs for personal use? Patients must provide a valid prescription from their physician. The licensed pharmacy creating the order will have their pharmacists check the provided list of medical conditions and complete a thorough review to ensure drug related problems, such as drug interactions, have been addressed with the patient and/or physician.
Drug importation does not include controlled substances, narcotics, or those that could be used to manufacture illegal drugs in the US. Additionally, those medications that are temperature sensitive cannot be safely imported into the USA as these medications often end up outside of their required temperature ranges due to the time it takes to cross the US border.
Finally, patients are legally allowed to import a three-month supply of their medication. This three-month supply can be refilled when needed and often physicians will provide a prescription that is good for one full year. Patients are usually contacted quarterly by the drug importation company to determine if they need to have their medication refilled.
The FDA website states:
What is personal importation?
The U.S Food & Drug Administration (FDA) states the following: A personal importation is a product not for further sale or distribution into U.S. commerce. These products may be carried in baggage or shipped by courier or international mail.
Can I purchase or bring drug or device products from a foreign country to the U.S.?
In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S. For example, a drug approved for use in another country but not approved by the FDA would be considered an unapproved drug in the U.S. and, therefore, illegal to import.
The FDA cannot ensure the safety and effectiveness of medicine purchased over the Internet from foreign sources, storefront businesses that offer to buy foreign medicine for you, or during trips outside the U.S. For these reasons, the FDA recommends only obtaining medicines from legal sources in the U.S.
Is Personal Importation Legal?
The FDA does provide some information regarding personal importation. Although it does tend to be mostly discouraging of personal importation and focuses on medications that are not legal to import or that the practice is risky. The FDA’s job is to protect the health of Americans, so this is no surprise.
There is little enforcement by the FDA in preventing legitimate, personal, and mostly chronic use types of medications from being imported. Current law directs the FDA to exercise discretion in permitting personal importation of drugs when the product is clearly for personal use and does not appear to present and unreasonable risk to the user. So The FDA has not “turned a blind eye” to this practice but they are using their discretionary abilities to permit personal importation of medications. As a result, US Customs has allowed this practice to take place for the last twenty years.