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A U.S. Customs and Border Protection rule is set to suspend the under-$800 de minimis exemption on Oct. 22, adding data and bond requirements for international mail, including mailed medicines. The measure does not specifically target Canadian drugs, but advocates and lawmakers warn it could delay or impede access for Americans who rely on lower-cost prescriptions from abroad.
A U.S. Customs and Border Protection rule scheduled to take effect Oct. 22 will suspend an exemption for shipments valued under $800, adding data and bond requirements that could make it harder for Americans to receive medicines mailed from Canada. The rule applies to international mail broadly, not Canadian drugs alone, and officials have not said whether personal-use prescription shipments will be exempt or how the requirements will be enforced.
Under the rule, medications mailed from outside the United States will require additional shipment data and a bond guarantee. The previous de minimis exemption allowed shipments below the $800 threshold to pass through customs more easily. The change also affects other low-value goods, including textiles and toys, and is intended to collect tariffs and prevent illegal drugs from entering the country, according to the report.
The practical effect on Canadian medicines is not yet defined. Because the rule applies to international mail generally, advocates say added fees and registration requirements could lead to delays, refusals or greater difficulty getting prescriptions delivered. A 2020 study published in JAMA Network Open estimated that about 2.3 million Americans buy drugs abroad; the figure is an estimate of people who purchase medications outside the country, not a count of those who would be affected by this rule.
Ken Hunter, executive director of the Campaign for Personal Prescription Importation, cited the cost difference for apixaban, a blood thinner. He said his organization’s August comparison found a three-month supply of 180 five-milligram pills cost $565 from a Canadian mail-order pharmacy, compared with about $1,017 through Amazon’s pharmacy arm and $1,029 through GoodRx. Those figures come from the organization’s comparison and do not establish what every patient pays or what prices will be after the rule takes effect.
Access to Lower-Cost Prescriptions
The rule could affect patients who rely on imported medicines because they cannot afford, tolerate or readily obtain alternatives in the United States. Susan Hooper, a 75-year-old Toledo resident who uses oxygen and takes two daily medicines obtained through a Canadian pharmacy, said one of her drugs is not available in the United States. Her experience illustrates the stakes for some patients, but the report does not establish how many people depend on particular imported prescriptions.
The policy also intersects with President Donald Trump’s stated push to reduce drug costs. The administration has pointed to most-favored-nation agreements with pharmaceutical companies and its TrumpRx discount website. Federal data cited in the report showed prescription drug prices were 3.1% lower than a year earlier this summer, the steepest year-over-year decline since 1963. Experts said factors beyond the president’s policies likely contributed, and lower prices across the market do not necessarily address every drug or patient’s costs.
For consumers, the central concern is whether the new customs process will add expense or interrupt shipments before there is a workable alternative. The rule’s broad reach means the consequences may depend on implementation details, including how mail carriers and customs officials handle prescription packages.
The Rule and Its Critics
The de minimis exemption had allowed qualifying low-value shipments to enter with fewer customs requirements. The administration’s change is framed as a way to collect tariffs and help prevent illegal drugs from entering the country. The stated purposes apply beyond prescription medicines, while the concerns raised in the report focus on patients importing drugs for personal use.
Lawmakers from both parties have sought assurances. Three Florida Republican representatives—Aaron Bean, Gus M. Bilirakis and C. Scott Franklin—wrote to the administration last month about possible effects on constituents who cannot easily travel to Canada. Their letter said Customs and Border Protection and the Food and Drug Administration “must ensure that Floridians simply seeking relief from high drug prices will not be inadvertently impacted by the rule.” Florida has a federally authorized Canadian prescription importation program, but the report says that initiative has stalled.
More than 70 Democrats sent a separate letter to health and immigration enforcement officials last week, asking them to pause the rule unless they could guarantee that medicines intended for personal use would continue to enter. They wrote: “Americans should not lose access to affordable medicines simply because the government has better information about packages entering the country.” CBP representatives did not respond to the report’s requests for comment.
“The issue is a matter of life and death for me.”
— Susan Hooper, a 75-year-old Toledo, Ohio, resident
How Prescription Parcels Will Be Handled
It is not clear whether the administration will change, pause or decline to enforce the rule, or whether it will create a specific process for prescription medicines intended for personal use. The report says the rule is set to take effect Oct. 22, but does not provide detailed instructions for patients, pharmacies or mail carriers.
The final impact on delivery times and costs is also unknown. The rule adds requirements, but the available information does not quantify resulting fees for a particular prescription or establish that all Canadian drug shipments will be refused. Hooper said the price of her Canadian theophylline, including shipping, rose from $85 after additional tariffs on Canada were imposed in August; the report’s supplied account ends before giving the new price, so the amount of that increase cannot be stated.
Administration Decision Before October 22
The rule is scheduled to take effect Oct. 22. The administration could drop or alter it, or choose not to enforce it, according to the report. Lawmakers are seeking clarification from federal officials on whether patients who import medicines for personal use will retain access, while CBP and the FDA have yet to provide the assurances requested in the letters.
Patients and pharmacies will need clearer instructions on required shipment information, bond guarantees, possible charges and how customs will treat prescription packages. Until federal agencies explain those details or announce a change, the extent of disruption—and which medicines or patients may be affected—remains unsettled.
Key Questions
What changes on Oct. 22?
The under-$800 de minimis exemption is scheduled to be indefinitely suspended. Low-value international shipments, including mailed medicines, will face additional data and bond requirements.
Does the rule specifically ban drugs from Canada?
No. The rule applies to international mail generally, not Canadian medicines alone. Advocates warn that its requirements could still delay or complicate deliveries from Canadian pharmacies.
Will all imported prescription drugs be stopped?
The report does not say that all shipments will be refused. How officials will handle prescriptions for personal use, and whether there will be exceptions or special procedures, remains unclear.
How many Americans buy medicine abroad?
A 2020 JAMA Network Open study estimated that roughly 2.3 million Americans buy drugs abroad. That estimate does not show how many would be affected by the customs rule.
What happens next?
The rule is scheduled to start Oct. 22. Federal officials may change or pause it, or clarify how prescription shipments will be processed; the report says lawmakers are seeking answers and CBP had not responded to requests for comment.
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