The Personal Importation Policy, also known as the PIP, is a guidance that sets forth FDA’s
enforcement priorities related to the personal importation of drugs that are not FDA approved
and, therefore, are in violation of the Federal Food, Drug, and Cosmetic Act
(FDCA) and subject to enforcement action. FDA recognizes there are circumstances under
which a United States citizen may wish to seek treatment with an unapproved drug that is
not domestically available, or a foreign citizen traveling to the United States may wish to
continue treatment with a foreign drug that is not domestically available. The PIP was
developed to address such circumstances and gives FDA instructions on exercising its
enforcement discretion to permit importation of drugs otherwise considered illegal in the
United States. In determining whether exercise discretion is warranted, FDA considers the
following factors:
• The drug must be unapproved and intended for use in a serious medical condition for
which there is no effective treatment domestically available
• There must be no commercialization or promotion of the drug in the United States
• The drug cannot represent an unreasonable health risk to the patient
• The request must be accompanied by an affirmation that the drug is for the patient’s
use only and by the name and address of the United States–licensed physician
responsible for the patient’s treatment
• The request is generally for no more than a 3-month supply of the drug
The PIP does not give a license to individuals to import unapproved drugs for personal use
into the United States. It does not change the law or create or confer any legally
enforceable rights, privileges, or benefits on or for any individual, and it does not bind the
FDA or the public.
