No, the guidance does not specify that a prescription for the unapproved drug is required
for consideration of importation using the PIP. However, to help facilitate a timely
decision, the unapproved drug offered for importation under the PIP should be
accompanied by a letter explaining the intended use of the drug, including the name and
address of the United States–licensed physician responsible for the patient’s treatment
with the drug, and affirming the drug will be used only for the individual patient and not
distributed to others.
