Personal importation of prescription drugs not approved by the U.S. Food and Drug Administration (FDA) is an issue that has recently been brought to the forefront. This article will provide an overview of what personal importation is, and discuss the risks associated with this type of activity.
What is personal importation?
Personal importation is when a person brings in a drug or medical device that has not been approved by the FDA from a foreign country into the United States for their own use or for use on another person. It’s important to note that it must be done without any involvement of a commercial entity, like a pharmacy or drug wholesaler, for it to be considered personal importation.
Can I purchase or bring drug or device products from a foreign country to the U.S.?
The short answer is no. Patients do have access to certain medications from other countries but these medications must first meet FDA standards and be approved by the agency before they can be legally imported into the United States. If a patient attempts to purchase or bring an unapproved drug or device product from another country into the United States, even for personal use, they may face legal action. Additionally, because there are no guarantees about where these drugs come from and who manufactures them, there is no way of knowing if they are safe and effective.
If you need medication that cannot be obtained in the United States, you should talk with your doctor about getting access through clinical trials or expanded access programs overseen by the FDA. Your doctor can also contact drug companies directly if they believe importing medications may be necessary for your care.
US Citizens
Abady Law Firm, P.C. often assists clients in researching the regulations and laws related to the importation of drugs from foreign countries into the United States for US citizens. If a product is approved by the US Food and Drug Administration (FDA) and was manufactured in a facility with current good manufacturing practice standards, then it can be purchased or brought into this country. However, if the drug manufacturer does not comply with those regulations and standards, then it cannot be brought into the U.S., even if it is available outside of America. Abady Law Firm, P.C. will help its clients understand which foreign products are approved by domestic regulation and to make sure that their transactions complies with these requirements.
Foreign Nationals
As a foreign national, you may be wondering if you are allowed to bring in products such as biological products, or drug and device products, from a different country into the United States. The Food and Drugs Administration (FDA) highly restricts the importation of biological products into the United States. Therefore, it is essential for foreign nationals to check with the FDA’s regulatory requirements prior to importing any biological product into the United States. Depending on the biological product being brought in and how it will be used, additional restrictions may apply. It is important to familiarize yourself with these regulations before attempting to purchase or bring biological products from a foreign country to the US.
What if my prescription drug is a controlled substance?
If your prescription drug is a controlled substance, it may be more challenging to purchase. However, prescription drug importation policies across the world are constantly evolving and adapting to meet modern healthcare needs. In the United States, patients now have access to reputable prescription goods with confidence through reliable suppliers that follow FDA-approved protocols. To ensure you are obtaining prescription medication of the safest quality, purchasing health products from a licensed source and familiarizing yourself with the applicable rules and regulations is key.
Can I import prescription drugs not approved by the FDA
Generally speaking, no. The FDA requires that all drugs imported into the United States be approved by the FDA for safety and efficacy. There are very few exceptions to this rule. One exception is for so-called “unapproved” drugs that are already being marketed in the United States but have not yet been through the formal FDA approval process. These drugs may be imported if they meet certain conditions, including being manufactured in compliance with good manufacturing practices and being labeled in compliance with FDA labeling requirements. Another exception is for investigational drugs that are being used in clinical trials conducted in accordance with FDA regulations.
What if I want to bring in medical marijuana for personal use?
The importation of medical marijuana is strictly prohibited by federal law, even if you are importing it for personal use. Marijuana is classified as a Schedule I controlled substance by the DEA and as such, it cannot be imported into the United States without a DEA import license.
Are there any exemptions from the prior notice requirements for personal importation?
Yes. There are several exemptions from the prior notice requirements, including imports for personal use (generally limited to a 90-day supply of a drug), imports for emergency medical care, and imports of unapproved new drugs intended for investigational use.
When would the FDA refuse a personal importation?
There are several reasons why the FDA might refuse a personal importation, including if the drug is an unapproved new drug, if it is a controlled substance, if it appears to be counterfeit or otherwise unsafe, or if it is subject to recall. In addition, personal importations may be refused if they do not meet all of the other requirements noted above.
Conclusion:
Importing prescription drugs into the United States can be a complex and confusing process due to the many regulations that govern drug importation. It is important to understand these regulations before attempting to import any prescription drugs into the country. Generally speaking, only drugs that have been approved by the FDA can be imported legally, with very few exceptions. Additionally, some prescription drugs are classified as controlled substances by the DEA and require an import license in order to be brought into the country legally. Finally, personal importations may be refused by the FDA for several reasons, including if the drug is unapproved or counterfeit, if it is a controlled substance, or if it does not meet all other requirements for legal importation.
