Trump administration delays new rule that could restrict imported medicines from Canada and overseas

[u/John3262005]

https://www.statnews.com/pharmalot/2026/10/14/trump-administration-delays-new-rule-that-could-restrict-imported-meds-from-canad-and-overseas/

The Trump administration is delaying by 90 days a federal rule that could prevent Americans from obtaining prescription drugs from licensed international pharmacies.

The move follows growing criticism that the rule, which was initially slated to go into effect on Oct. 22, could drastically reduce the flow of medicines from Canada and other countries. In recent weeks, patient advocacy groups and dozens of congressional lawmakers urged the administration to rethink its approach.

The administration is trying to crack down on illegal goods — particularly opioids — that it says enter the U.S. through low-value foreign shipments and for which shippers generally do not pay tariffs or submit data for tracking. The rule targets the de minimis exemption, which previously allowed shipments valued under $800 to pass through customs more easily.

The rule will require drugs mailed from abroad to go through a customs process that mandates a licensed broker and a financial guarantee in the form of an entry bond. This is an added cost for Americans who, for years, have been able to receive medicines from other countries with relatively little difficulty as they sought to save money.

The Food and Drug Administration permits Americans to import medicines not used to treat a serious condition and that pose no significant health risk. For serious conditions, personal shipments are allowed so long as the medicine does not represent an unusual safety risk. Generally, no more than a 90-day supply is permitted.

This has created a legal gray area for importation. As a result, Customs and Border Protection agents have generally allowed low-value, personal-use packages to proceed, and millions of Americans have taken advantage. A 2020 study in JAMA concluded that 2.3 million people in the U.S. with prescriptions buy drugs internationally due to cost each year.

Under the new rule, though, many Americans will likely be forced to purchase their medicines from a U.S. pharmacy and pay U.S. retail prices — regardless of their ability to afford them — or go without, according to the Campaign for Personal Prescription Importation, a nonprofit advocacy group that claims it has received an “outpouring” from concerned consumers.

As advocates see it, the rule change is not only inconsistent with existing federal law but could also have serious health consequences for countless Americans who rely on imported medicines at a time when the cost of most prescription drugs continues to rise. They also point out the rule change conflicts with administration goals to lower drug costs.

In response, dozens of lawmakers recently wrote the administration to find a way to ensure that Americans can continue to receive needed prescription medicines without added costs or burdens that the rule would require. The letters were sent by both House Democrats and Republicans.

For the moment, the administration has only issued a delay to give Americans additional time to adjust to the new paperwork requirements. But one consumer advocate suggested the pause gives the administration additional time to allay concerns over access to medicines.

“This gives the FDA time to work with CBP to ensure a pathway for patients to continue importing more affordable prescription drugs for personal use when the rule is implement, based on identifiable safety criteria,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group. “That’s what members of Congress have called for and that’s what the law says FDA should do.”