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Customs changes threaten access to cheaper Canadian pharmaceuticals

If a drug is already sold in the U.S., it won’t likely make it past the border

Posted 10/1/26

REGIONAL- Millions of Americans who rely on Canadian and other international pharmacies for affordable prescription drugs will likely lose that access beginning Oct. 22 under new federal customs …

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Customs changes threaten access to cheaper Canadian pharmaceuticals

If a drug is already sold in the U.S., it won’t likely make it past the border

Posted

REGIONAL- Millions of Americans who rely on Canadian and other international pharmacies for affordable prescription drugs will likely lose that access beginning Oct. 22 under new federal customs requirements expected to block virtually all personal prescription shipments.
No new law specifically bans Americans from ordering their medications abroad. Instead, the cutoff comes from a new customs process that Canadian pharmacy representatives say they can’t realistically use for ordinary individual orders, coupled with longstanding Food and Drug Administration restrictions on importing medications already sold in the United States.
Put together, the two will function as a de facto ban.
The move also represents a striking reversal for President Donald Trump, who campaigned on allowing Americans to obtain cheaper prescription drugs from Canada and spent part of his first term trying to make that easier.
During his 2016 campaign, Trump promoted Canadian drug importation as a way to increase competition and bring down American prescription prices. His administration later developed rules allowing states to establish regulated Canadian drug-importation programs.
Trump went further in July 2020, signing an executive order directing the Department of Health and Human Services to facilitate waivers allowing individuals to import lower-cost prescription drugs when doing so posed no additional safety risk and saved patients money.
The new customs policy heads in the opposite direction by enforcing import rules that will make personal prescription shipments from Canada and other countries nearly impossible.
At the center of the change is the federal government’s suspension of the de minimis exemption. That exemption had allowed lower-value international packages of under $800 to enter the country without going through the formal customs process used for larger commercial shipments.
The key date is Oct. 22. After that, prescription shipments arriving through the international mail will generally need a formal customs entry or what is known as an Entry Type 13 filing.
The filing process calls for detailed information and customs paperwork ordinarily handled by commercial importers and customs brokers, not a pharmacy mailing a 90-day prescription to someone’s home.
The Canadian Pharmacy Store, one of several international prescription services warning customers about the change, said it had been advised how Customs and Border Protection and the FDA plan to apply the new requirements.
“We have just learned that, under the planned implementation by CBP and the Food and Drug Administration, virtually all prescription-medication parcels will be prohibited from entering the United States beginning on that date,” the company stated.
The Campaign for Personal Prescription Importation and the Canadian International Pharmacy Association have issued similar warnings.
They say shipments will be rejected when the medication is already sold in the United States. The FDA sometimes allows personal medication shipments through under limited circumstances, but not when the drug is being marketed to Americans. That would exclude the Canadian mail-order pharmacies whose business is filling prescriptions for U.S. customers.
That is the catch. The fact that a medication is sold here does not mean the patient can afford to buy it here.
Most people ordering prescriptions from Canada are not doing so because the drug is missing from American pharmacy shelves. They are doing it because the same medication can cost substantially more on this side of the border.
Eliquis offers a common example. The widely prescribed blood thinner is used to prevent strokes and blood clots and is readily available in the United States. It is also commonly covered by private insurance and Medicare prescription plans.
But coverage does not always mean affordability. Patients without adequate insurance, or those facing deductibles, formulary restrictions, and other coverage limits, can still wind up with sizable bills.
The manufacturer currently lists the price of a 30-day supply in the U.S. at $346, although insured patients often pay considerably less. Canadian and international pharmacies have offered Eliquis or its generic form, apixaban, at much lower cash prices.
Testimonials collected by the Campaign for Personal Prescription Importation offer a glimpse of what those differences can mean in a household budget.
An Owatonna woman with COPD and a history of blood clots reported saving about $110 a month through importation. She said the savings left her with more money for groceries, gasoline, and other medications.
In a 2024 submission, another patient reported paying $1,000 for six weeks of medication in the United States, compared with $165 for a 60- to 90-day imported supply. She said the domestic expense had once left her unable to make her house payment. The Timberjay was unable to independently verify the accounts.
The number of people who could be affected is harder to pin down. No federal agency keeps a reliable current count of Americans importing prescription medications.
A peer-reviewed analysis of federal survey data from 2015 through 2017 estimated that 2.3 million American adults purchased medications from foreign countries to save money in a single year. The Campaign for Personal Prescription Importation currently places the number above four million, although the organization has not explained how it arrived at that figure. The last detailed federal estimate of Canadian prescription purchases is more than two decades old.
Medicare has changed the equation for many older Americans, but not eliminated the problem.
Beneficiaries with Part D coverage may pay considerably less than the full domestic retail price. In 2026, their annual out-of-pocket costs for drugs covered by their plan are capped at $2,100. But that limit does not include plan premiums or medications the plan does not cover, and patients may still face significant costs because of deductibles, formularies, and other coverage restrictions.
Federal officials have long defended restrictions on personal prescription imports as a matter of safety. The FDA cannot guarantee that foreign versions meet American requirements for approval, labeling, packaging, storage, and distribution. Some websites presenting themselves as Canadian pharmacies have been identified as unregulated operations selling counterfeit, adulterated, or improperly handled drugs.
Certified Canadian pharmacies say they should not be lumped in with those operations. They require valid prescriptions and say they obtain medications through licensed pharmacies and regulated international fulfillment centers.
They argue that blocking established pharmacy services will do little to stop dangerous illicit drugs while cutting off affordable maintenance medications used by older and underinsured Americans.
The change does not necessarily end the separate state drug-importation programs authorized under rules adopted during Trump’s first administration. Those programs involve government-supervised commercial imports that must meet extensive FDA requirements. Florida became the first state to receive federal approval for such a program, although implementation has moved slowly.
Personal importation is much simpler. It typically involves someone sending a prescription to a foreign pharmacy and ordering a 30- or 90-day supply for home delivery. That is the pathway now in danger of disappearing.
Patient advocates are urging Congress and the Trump administration to preserve a workable personal-use option before Oct. 22. Without a change, the medications will remain readily available on American pharmacy shelves while becoming financially unreachable for some of the patients who need them.