For Kathryn Branham, the cost of a blood thinner she and her terminally ill husband both take could jump by hundreds of dollars a month if they can no longer order the medication from a Canadian pharmacy.

Branham estimates the Royal Oak, Michigan, couple pays about $300 a month for Eliquis through a pharmacy in British Columbia, compared with about $720 combined if they purchase the drug in the United States.

“That’s a big difference in money for most people, I think,” Branham said. “That’s quite a bit.”

Branham, 69, and her husband, Bill, 72, are among millions of U.S. patients who face uncertainty over access to prescription drugs from Canadian and other international pharmacies as new U.S. Customs and Border Protection requirements are set to take effect Oct. 22.

Importing prescription drugs from foreign pharmacies is generally restricted under federal law. The Food and Drug Administration has historically exercised enforcement discretion in some cases involving medications for personal use, allowing some shipments to proceed despite those restrictions. That practice does not mean all orders from Canadian pharmacies are legally permitted.

The new customs requirements are raising questions about whether those shipments can continue. The rules do not explicitly ban personal prescription shipments, but they add documentation and processing requirements that could make them more difficult to send.

The change follows the end of duty-free treatment in August 2025 for most shipments valued at $800 or less. The new process requires more detailed shipment information and a customs bond for certain international mail shipments, according to a regulation published in the Federal Register.

The changes are part of broader efforts to collect customs duties, enforce import laws and prevent prohibited goods, including illicit drugs, from entering the country. But advocates and industry representatives worry that the added requirements could disrupt prescription orders that Americans have received by mail from international pharmacies for years.

Ken Hunter, executive director of the Campaign for Personal Prescription Importation, a nonprofit advocacy organization, said he has heard from patients worried about losing their ability to get their medications. He said some have emailed asking questions like, “Am I just going to drop dead because I can't get my medicine?”

'Million-dollar question'

An estimated 2.3 million U.S. adults purchased prescription medications from outside the U.S. during a 12-month period, according to a 2020 study published in JAMA Network Open.

Hunter said he's concerned the new customs requirements could disrupt the longstanding practice of allowing some personal-use shipments to enter the country. The outcome will depend on whether the Trump administration and U.S. Customs and Border Protection decide to halt personal prescription imports or exempt them from the new requirements, he said.

Bill Hepscher, a board member of the Ohio-based Trusted Healthcare Alliance, said the rule does not specifically address legitimate prescription medications shipped for personal use. Its language focuses on illicit drugs and counterfeit products, he said, but it remains unclear whether the new requirements could affect patients who rely on licensed international pharmacies.

“That is the million-dollar question,” Hepscher said. “Reading the rule, the language specifically addresses illicit drugs … but will the rule inadvertently impact legitimate personal use orders?”

He said the impact will depend on how federal agencies interpret and implement the requirements. Even if legitimate prescription shipments continue, he said he expects delays because the new reporting requirements will apply to packages passing through international mail facilities.

Hepscher encouraged patients to place orders early to avoid possible delays.

The issue has also drawn lawmakers' attention. Democratic U.S. Reps. Jan Schakowsky of Illinois and Mark Pocan of Wisconsin led a letter signed by 71 members of Congress urging federal health and homeland security officials to delay the new customs procedures for prescription medicines until they can assure that drugs intended for personal use will not be blocked. Reps. Rashida Tlaib and Kristen McDonald Rivet, both Michigan Democrats, also signed the letter.

"We support CBP's goal of using better data to identify and intercept high-risk shipments," the lawmakers wrote. "However, we are concerned that the new process could be implemented in a manner that prevents personal-use prescription medicines from being shipped to the United States or results in their routine refusal, including medicines Americans have long obtained from licensed pharmacies abroad."

Representatives from CBP’s Office of Public Affairs and the Office of Trade did not respond to requests for comment.

Hunter said the new customs rules could also affect Zonos, a Utah-based company that helps process international shipments through customs. He said Zonos has told shippers it will stop handling some personal prescription drug shipments to the U.S.

Zonos did not respond to a request for comment. In guidance posted Sept. 23 on its website about the new customs requirements, the company outlined existing FDA restrictions on importing prescription drugs for personal use. Zonos said most orders currently do not meet the FDA’s conditions for importation, including that the drugs be intended to treat a serious condition and that there is no effective treatment available in the U.S.

Tim Smith, general manager of the Canadian International Pharmacy Association, said pharmacies have relied on the FDA’s case-by-case discretion for about 25 years to allow some prescription drugs to be imported for personal use.

But he said pharmacies have been told that when the new customs process takes effect Oct. 22, that instead of operating under the FDA's more permissive approach to personal importation of medications, CBP will begin to block shipments of drugs already commercially available in the United States.

“The bad part of it is that our understanding and what we have been told is that CBP will no longer be honoring the FDA’s guidance on importation and using that more permissive approach,” Smith said.

Pharmacies prepare

Some pharmacies have already changed their shipping practices ahead of the deadline. Canada Pharmacy Online said as of Oct. 8, it temporarily suspended processing and shipping prescription orders from Canada to the United States because of the upcoming customs changes.

“We remain hopeful that circumstances may change and allow us to resume serving our U.S. customers,” the company wrote on its site.

NorthWestPharmacy.com also warned patients that the changes could disrupt shipments. In an email to patients, the pharmacy said that without a postponement, reversal or exemption, the Oct. 22 changes would “prevent virtually all routine prescription shipments from licensed Canadian and international pharmacies” from reaching U.S. patients.

In response to an email seeking comment, NorthWestPharmacy.com said it was busy filling orders and referred the inquiry to Tim Smith with the CIPA and Ken Hunter with CPPI.

Maple Leaf Meds, the Canadian pharmacy where Branham gets her medication, is urging customers to stock up on prescription refills before Oct. 22, warning that new U.S. customs requirements could prevent many shipments from reaching American patients.

In an email to customers, the pharmacy warned that packages could be blocked if the drugs are also sold in the United States or if the supplying company markets to American consumers.

After receiving the pharmacy’s warning, Branham has been trying to reach the company but said she has been unable to get through. The retiree is caring for her husband, who has a rare cancer called pulmonary arterial intimal sarcoma, and hopes to obtain at least a 90-day supply of Eliquis for both of them. She has not decided what to do after that.

“I'm in the process of seeing if I can get off the Eliquis because honestly between my husband and I, that's a lot of money,” Branham said.

She said warfarin is an alternative, but it requires regular blood testing.

Hunter said his organization’s August study comparing prices for 10 commonly prescribed medications found significant savings through Canadian mail-order pharmacies.

For Eliquis, a 90-day supply of 180 5-milligram pills cost $565 through a Canadian pharmacy, compared with $1,017 through Amazon Pharmacy and $1,029 through GoodRx, according to the study.

Paul Pruitt, co-founder of Missouri-based SHARx, which helps employers and health plans source lower-cost prescription drugs, said the new requirements could make it harder for patients to obtain medications from abroad.

Pruitt said the process could require consumers to register as importers of record, work with a logistics provider and obtain a customs bond. It's an administrative burden that could be especially difficult for patients unfamiliar with customs procedures. Pruitt said packages that fail to meet the requirements could be returned to the sender or destroyed.

“There's going to be a lot of Americans that are going kind of be forced to make some tough choices on their own,” he said. “Whether it's shifting money in their budget or doing without medication, and I'm sure, and I know that's probably against the ultimate goal of the current administration, right? Trying to make medications more affordable ... trying to prevent drug trafficking and fentanyl coming into the U.S … I think there's some good intentions behind it, but this unintended consequence is devastating to a lot of people.”

The changes could also significantly affect Canadian pharmacies that have built businesses around serving U.S. patients.

CIPA's Tim Smith said many of the association’s member pharmacies have specialized over the years in selling to Americans and will need to consider how to replace that business if shipments stop.

“They are probably thinking about that a lot and wondering how to shift their clientele,” Smith said.

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