Personal Importation

Personal importation describes an individual bringing a medicine into a country for their own use rather than for sale, usually by mail order or in accompanied baggage. The underlying United States law is unambiguous: an unapproved new drug, or an approved drug whose labelling and supply chain do not match the approved article, is subject to refusal of admission under the Federal Food, Drug, and Cosmetic Act. Nothing about a shipment being small, personal or medically motivated changes that classification.

What is usually meant by the phrase is the FDA personal importation policy set out in the agency's Regulatory Procedures Manual, which describes when field staff may exercise enforcement discretion. The conditions are narrow: a serious condition for which no effective treatment is available domestically, no promotion of the product to United States residents, no unreasonable risk, a quantity generally not exceeding roughly a three-month supply, and a written affirmation naming the licensed physician overseeing care. Other jurisdictions run their own schemes with different quantity caps and prescription requirements.

The distinction that matters is that discretion is not permission. A parcel released today creates no entitlement, and the same product from the same origin can be detained on the next attempt, particularly where an import alert authorises detention without physical examination. Nor does any of this reach quality: the policy governs entry, not what is in the vial.

The recurring error is reading the three-month figure as a legal allowance, then reading customs clearance as information about the product. Border screening examines a small fraction of parcels and analyses almost none. A vial that arrives has demonstrated only that it arrived; identity, content and sterility remain untested by delivery.