CBP Delays Trade Regulations That Threaten Americans' Access to Lower-Cost Prescription Drugs
Prescription Justice welcomes 90-day extension, urges federal agencies to protect personal prescription drug importation when new requirements take effect
Brooklyn, NY, October 15, 2026 — U.S. Customs and Border Protection (CBP) announced yesterday that it is delaying implementation of new electronic customs filing requirements for low-value international mail shipments from October 22, 2026, to January 20, 2027. Prescription Justice welcomed the decision, having warned that the new requirements could create serious barriers for millions of Americans who import lower-cost prescription drugs for personal use.
For decades, Americans have obtained more affordable prescription medicines from licensed pharmacies in Canada and other countries through international mail. [See Prescription Drug Importation: Myths and Facts.].
The new trade regulations would substantially complicate that process, potentially making it too costly or burdensome for patients and pharmacies to continue. Under the new requirements of CBP’s Entry Type 13, shipments of FDA-regulated products valued at $2,500 or less, including prescription drugs, will be subject to electronic customs entry through CBP's Automated Commercial Environment (ACE). This process may require an importer of record, a customs bond, additional filing services, and payment of applicable duties and fees. These requirements could impose substantial new costs and administrative burdens on patients seeking affordable medications.
The regulations also raise a separate concern about how the Food and Drug Administration (FDA) will handle personal prescription drug imports. Electronic filing will provide FDA with greater visibility into shipments that previously moved through a relatively simple international mail process. Because personally imported prescription drugs often do not meet all federal requirements for admission, according to the FDA, patients could face increased refusals unless FDA exercises its enforcement discretion to permit appropriate imports.
Section 804(j)(1) of the Federal Food, Drug, and Cosmetic Act recognizes the importance of enforcement discretion for personal drug imports that do not appear to present an unreasonable risk to the individual.
"We are very pleased that CBP has delayed implementation of these regulations, giving Americans who rely on personal prescription drug importation more time before facing potentially serious disruptions to their medication access," said Gabriel Levitt, president of Prescription Justice. "We appreciate the many members of Congress, Democrats and Republicans, Patients for Affordable Drugs, and other non-profit organizations, who have urged federal agencies to protect access to affordable medicines from Canada and other countries."
CBP stated that the delay is intended to avoid disruptions to certain international postal shipments. Prescription Justice believes that the significant congressional, patient advocacy, and media attention surrounding the potential consequences for prescription drug importation helped demonstrate the need for additional time.
"This is an important short-term success, but the underlying threat to personal prescription drug importation remains," Levitt continued. "We hope to work constructively with CBP, FDA, and other stakeholders over the next three months to establish a patient-centered approach that preserves access to genuine, lower-cost prescription medicines while protecting public health and preventing the importation of counterfeit drugs, illicit opioids, and other dangerous products. Federal law accommodates such a policy favoring access to personal drug importation."
Prescription Justice is urging CBP and FDA to clarify how the new requirements will affect personal prescription drug imports and to develop procedures that allow patients to continue receiving prescribed medicines from licensed pharmacies abroad when those imports do not appear to present an unreasonable risk.
About Prescription Justice
Prescription Justice brings together medical professionals, lawyers, public health experts, consumer advocates, businesses, and policy leaders focused on lowering U.S. drug prices through safe prescription drug importation. The organization advocates for policies that make lower-cost medicines accessible to Americans by protecting and expanding personal importation and advancing legislative reforms to expand wholesale drug importation beyond Canada.
Media Contact: Gabriel Levitt, Gabriel@prescriptionjustice.org.