United States Food and Drug Administration guidance on personal imports of drugs that FDA has not approved

"FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:

  • The drug is for use for a serious condition for which effective treatment is not available in the United States;

  • There is no commercialization or promotion of the drug to U.S. residents;

  • The drug is considered not to represent an unreasonable risk;

  • The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and

  • Generally, not more than a 3-month supply of the drug is imported."

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