Patients report stockpiling and rationing as deadline approaches
Diamantina Cavazos, a 38-year-old project manager in Dallas, has spent two years ordering Xifaxan, a drug she takes for a painful gut condition, from an online Canadian pharmacy for about $10 a week. Her insurer in the U.S. will not cover the medication, where it costs roughly $1,100 a week. After Oct. 22, the personal importation channel that has made her regimen affordable will effectively close.
“I’ll have to pay $1,100 a week for my prescription because I couldn’t get it covered by my insurer in the U.S.,” Cavazos said. “I’m extremely upset.”
The cutoff stems from a federal customs rule, scheduled to take effect late next month, that will require any FDA-regulated medication shipped into the country by mail to clear a formal customs entry process. After that date, anyone importing prescription drugs by mail will need a licensed customs broker and a financial guarantee — a bar that low-value personal parcels have not had to clear for decades, because of a longstanding exemption that allowed parcels under $800 in value to move through customs without broker involvement.
The government says the rule is meant to address illegal contraband that it says comes into the country through low-value foreign shipments that don’t pay tariffs or submit data for tracking. The change fully closes what had been a regulatory gap, after the U.S. government in August 2025 began requiring patients to pay customs fees on parcels that previously arrived free of charge. Once the rule is in force, prescription drugs will have to move through a formal entry process with an accountable company or person legally on the hook if a shipment does not qualify.
The practical enforcement of the new rule will fall largely to Zonos, a St. George, Utah-based company that processes customs documentation for foreign mail services and handles much of the mail moving through Canada and other countries. Zonos, not customs agents at the border, will effectively decide which packages get through, by checking each one against the FDA’s actual criteria for personal drug imports — criteria that have gone largely unenforced at scale for years. Zonos did not respond to requests for comment.
The practice has operated for decades in a legal gray area: technically barred under FDA rules, importers say it is rarely enforced. Customs agents have historically waved through low-value, personal-use packages rather than individually checking each one against the agency’s criteria.
The FDA’s published criteria generally permit a personal shipment if the drug treats a serious illness with no good U.S. alternative, is not marketed to American consumers, carries no unusual safety risk, and arrives with a doctor’s note covering a 90-day supply or less. Before the rule change, parcels under $800 in value were rarely checked against those criteria because of the long-standing exemption. A spokesperson for the Department of Health and Human Services said the FDA would continue to evaluate personal imports on a case-by-case basis.
Tim Smith, general manager of the Canadian International Pharmacy Association, a trade group of licensed Canadian pharmacies that built much of its business serving American patients, said his members have relied on the FDA’s leniency for 25 years and that the era is ending. “Rather than exercising discretion, they’re going to exercise enforcement,” he said. “There will be just a full stop of anything coming into the States,” he added, describing what he expects once the rule takes effect. The patients most affected, he said, are “cash-strapped, uninsured or underinsured people; many senior citizens on fixed incomes.”
The scale of the practice is substantial. More than two million people in the U.S. who take prescription drugs bought them from outside the country to save money, according to a 2020 study published in JAMA Network Open, some of the most recent research available on the topic.
That population has mobilized quickly in the past two weeks. Ken Hunter, executive director of the New Jersey-based Campaign for Personal Prescription Importation, said his organization’s membership surged by 20,000 people after logistics operators such as Zonos began notifying shippers of the October cutoff. The group has fielded more than 1,000 frantic emails and coordinated more than 28,000 letters sent to members of Congress, Hunter said. The situation “turned into a five-alarm issue,” he added.
Among the drugs Hunter’s members and other patients order most often from Canada, he said, is Eliquis, a blood thinner that costs less than $600 for a 90-day supply from a Canadian pharmacy — almost half the U.S. retail price on domestic discount platforms.
Many patients have told Hunter they will cut their doses, skip pills, or go without their medications entirely in anticipation of the change. “It is just such an avalanche of fear and concern out there,” he said.
Online pharmacies have begun responding. Northwest Pharmacy, a British Columbia-based international drugstore, posted on its blog that orders placed after Oct. 9 would not be guaranteed for delivery and that the company had stopped replenishing its inventory. A different online pharmacy urged people to stock up on as much medication as possible and warned that the change would put it out of business.
The rule applies to any FDA-regulated mail shipment from any country, including smaller medication pipelines from India, the United Kingdom, Australia and Turkey. It does not change regulations around Americans who buy medication in person while traveling.
For Cavazos and the millions of Americans in similar circumstances, what ends on Oct. 22 is the customs tolerance that in practice has let their prescription shipments through without individual screening. The practice has technically been barred under FDA rules for decades, but importers say it has rarely been enforced — and after Oct. 22, the de facto exemption that has allowed it to continue will close.