US Customs and Border Protection will require mailed prescription drugs to clear formal customs entry starting Oct. 22, with a licensed broker and a financial guarantee.
The agency issued the rule in June, ending a decades-old exemption that let low-value mail cross the border without a broker, a bond, or a filed entry.
FDA-regulated shipments, which include every approved drug, now face the same process used for large commercial cargo.
CBP says the change protects tariff revenue and blocks traffickers from moving fentanyl and counterfeit goods through low-value parcels.
More than 2 million people in the US who take prescription drugs bought them from abroad to save money, according to a 2020 study in JAMA Network Open.
The practice has run for decades in a legal gray area, technically barred under FDA rules but rarely enforced at the border.
"There will be just a full stop of anything coming into the States."
Tim Smith, Canadian International Pharmacy Association
The gatekeeping shifts to a private processor
Zonos, a Utah company that handles customs documentation for foreign mail services, will effectively decide which packages qualify under the FDA's actual criteria for personal imports.
Those criteria cover serious illness with no good US treatment, no unusual safety risk, and a doctor's note for a 90-day supply or less. A Department of Health and Human Services spokesperson said the FDA would keep evaluating personal imports case by case.
Pharmacies are already pulling back. British Columbia-based Northwest Pharmacy told customers it would accept orders only case by case for a short period after Oct. 9.
Eliquis, a blood thinner, ranks among the most commonly ordered drugs, with a 90-day supply from Canada costing less than $600.
The Campaign for Personal Prescription Importation added 20K members in under two weeks and coordinated more than 28K letters to Congress.
Drug pricing politics run in the opposite direction
The cutoff lands as the Trump administration pushes prices outside the US higher under most-favored-nation deals with more than a dozen large drugmakers.
Agreements signed by Pfizer and Eli Lilly name Canada as one of eight specified countries and suggest HHS could take a share of increased foreign revenue.
Canada's drug price review board reported the average US list price is more than three times the Canadian price.
Separately, Trump again accused Canada of failing to dismantle clandestine Canadian labs producing fentanyl, while leaving Canada off the annual list of major drug-producing countries.
The rule doesn't touch medication Americans carry home while traveling, leaving a narrow path for patients who can afford the trip.
