Pharmaceuticals are a $700+ billion global industry.
The U.S. pharmaceutical industry is a dominant force in the marketplace with tentacles reaching to industrialized and non-industrialized nations throughout the world. Much of the success of U.S. pharmaceuticals can be traced to the Food & Drug Administration (FDA) and its efforts to enforce a strict approval process for new medications and prescription drugs.
However, FDA approval guidelines can be a source of frustration for entrepreneurs interested in importing foreign pharmaceuticals to the U.S. Lax import requirements could dilute FDA standards and result in a flood of inferior drugs on the U.S. market. As a countermeasure, the FDA applies the same, strict standards to imported drugs as it does to pharmaceuticals that are produced domestically. This has important ramifications for medications imported for commercial and personal use.
The U.S. government has gone out of its way to make the importation of prescription drugs virtually impossible. Under the Food, Drug, and Cosmetic Act, it is illegal to import drugs that have not been approved by the FDA, or have been "misbranded or adulterated". Here's the problem: All drugs that could be imported by individuals fall into one of these categories (including foreign versions of FDA-approved drugs and drugs that have been obtained without a prescription), making it impossible for individual citizens to import prescription drugs into the U.S. When a U.S. pharmaceutical manufacturer produces an FDA-approved drug and sends it abroad, only the original manufacturer is permitted to import the drug back to the U.S. So if your business model is built around importing foreign drugs for U.S. markets, you're out of luck.
Importing for Personal Use
The federal government allows individuals to import a limited amount of foreign pharmaceuticals for personal use. Although they can exercise this allowance at their discretion, FDA generally allows individuals to import a three-month supply of an unapproved drug into the U.S., if it meets the following criteria:
- The drug must be used to treat a serious medical condition for which there is no similar drug available in the U.S.
- The importer has no plans to engage in commercial distribution of the drug.
- The drug does not pose an "unreasonable risk".
- Importers submit written verification that the drug is for their own personal use, and provide the name of a doctor in the U.S. that is responsible for their treatment or provide evidence that the medication is intended to maintain a treatment plan that began abroad.