October 22 Customs Changes: What They Mean for Imported Drugs and Self-Funded Plans

By: Naga Vivekanandan, Esq.

On October 22, 2026, a new customs requirement will take effect for mailed packages containing FDA-regulated products, including prescription drugs. The change has drawn conflicting reactions. Some describe it as a ban on drugs from Canada and other countries, while others suggest it changes very little. The reality falls somewhere in between.

The requirement stems from an interim final rule that US Customs and Border Protection (CBP) published on June 24, 2026, which took effect on July 24, 2026. For years, packages valued at $800 or less could enter the country duty-free under what is known as the “de minimis” exemption, and any mailed packages in that range typically arrived with minimal paperwork. A 2025 executive order suspended the exemption for most imports, and Congress enacted legislation ending it permanently on July 1, 2027. The June rule formalizes that suspension for international mail and replaces the interim process CBP had relied on in the meantime.

In place of de minimis, CBP established a new “postal informal entry” process for mailed packages valued at $2,500 or less. While less demanding than formal entry, the new process requires far more than the old system did. For each package, the filer must report a description of the item, its country of origin, its tariff classification, its value, and the duty owed. This information is submitted to CBP monthly, and duties are paid electronically rather than collected from the recipient at delivery. CBP has also narrowed who may file. Only the owner or buyer of the goods, or a licensed customs broker acting on their behalf, is eligible, and third-party filers are no longer permitted. In addition, the filer must hold a customs bond, without which CBP will not release the package.

Not every product qualifies for this simplified process. Goods regulated by other federal agencies, including FDA-regulated drugs, must instead go through formal entry, as must certain goods subject to special duties, quotas, or trade agreement claims. CBP allowed a grace period for these products, which ends on October 22, 2026. To coincide with that deadline, CBP launched a voluntary test of a new electronic option, known as Entry Type 13, on September 22 for mailed packages valued at $2,500 or less. Beginning October 22, then, a mailed package of prescription drugs must clear customs through either formal entry or Entry Type 13. Under both routes, the package requires a qualified filer, a bond, and complete data, and it must satisfy FDA’s requirements before release. Many foreign mail-order pharmacies are not equipped to meet these conditions.

It is important to understand that this rule does not create a new prohibition on drug importation. According to the FDA, the practice was already prohibited under existing law. The Federal Food, Drug, and Cosmetic Act bars unapproved drugs from entering the country, and the FDA typically treats a foreign version of a US drug as unapproved, even when it appears identical. Consistent with that structure, the FDA states that, in most cases, individuals may not legally import drugs. The agency’s “personal importation policy” is sometimes cited as authorization, but the FDA describes the policy as guidance for its staff on when they may choose not to take enforcement action, such as for small, personal-use quantities of a drug to treat a serious condition. In other words, a decision not to enforce in a given case is not the same as permission, and the FDA retains full authority to refuse or seize any shipment. Historically, limited enforcement resources and minimal paperwork on mailed packages meant that many such shipments reached consumers. The new customs requirements will change this reality by routing these packages through formal review.

Some self-funded plans rely on international pharmacy programs to reduce drug costs. Under these arrangements, vendors typically ship brand-name drugs directly to members from Canada, the United Kingdom, or other countries. Certain vendors maintain that their programs are lawful under the personal importation policy. That view is difficult to reconcile with the FDA’s own description of the policy, and some may take the view that the October 22 change makes the associated risks considerably harder to overlook.

The most immediate risk falls on members whose packages may be delayed, detained, or refused at the border. As an example, for someone who depends on blood thinners or insulin, a gap of several weeks between refills is more than just a minor inconvenience. Fiduciary exposure is a second concern, as ERISA requires plan fiduciaries to act prudently, and directing members to a program that is both unlawful and increasingly unreliable would be difficult to defend. The plan’s own involvement may present further risk, since federal drug law extends to anyone who “causes” an unlawful shipment, not only the sender. A plan that designs, funds, or promotes an importation program could fall within that scope. There is also the possibility that plan documents and contracts will no longer reflect actual operations. Members may rely on an international program described in the Plan Document or Summary Plan Description (SPD), even as vendors find themselves unable to meet their contractual commitments. Finally, stop-loss carriers typically exclude claims involving unlawful sources or treat them as falling outside the Plan’s terms.

The October 22 change, in other words, is not a new ban. What it does is close a gap in customs processing that allowed many of these packages to enter. Given the FDA’s position and the new customs requirements, a conservative approach would be for self-funded plans not to design benefits around drug importation. Because the rule was issued on an interim basis, CBP may still revise it, and the FDA’s approach at the border may evolve as well.