The PIP is intended to apply to unapproved drugs that are:
• used to treat serious medical conditions
• not a serious health risk to patients
• not commercially available or marketed in the United States
• part of a treatment regimen begun in a foreign country
Unapproved drugs that appear on Import Alert, that is, drugs that appear to be in violation
of the FDCA and are subject to detention without physical examination, are not eligible for
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importation under the PIP. Likewise, drugs with associated Risk Evaluation and Mitigation
Strategies (REMS) requiring distribution of FDA-approved patient medication information
necessary for safe and effective use of the drugs also are not eligible for importation under
the PIP.
