The FDA or U.S. Customs may intercept your shipment and question it. Please remain calm and go to the required procedures to have the shipment continue to you.
If you are entering the United States (U.S.) with FDA-regulated products in personal baggage or sending products by mail or courier from abroad, the FDA has guidance that governs personal importations. Below you will find useful information regarding importing personal goods that are regulated by the FDA.
What is personal importation?
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.
Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?
The FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:
- Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); or
- Product is for the treatment of a serious condition ( Prescription Drug Products):
- The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
- There is no known commercialization or promotion of the product to persons residing in the U.S.
- The product does not represent an unreasonable risk.
- The consumer affirms in writing that the product is for personal use.
- The quantity is generally not more than a three month supply and either:
- Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
- Provide evidence that the product is for the continuation of a treatment begun in a foreign country.