Prescription Justice Warns New CBP Rule Could Severely Curtail Americans’ Access to Affordable Imported Prescription Drugs

Brooklyn, N.Y. - September 16, 2026 - Prescription Justice is urging the Food and Drug Administration and U.S. Customs and Border Protection to ensure that a new CBP rule does not stop shipments of affordable prescription medications personally imported by Americans that normally come through international mail facilities. Tens of millions of Americans have obtained lower-cost drugs from Canada and other countries, and for some it is their only option. See Prescription Drug Importation Myths and Facts. Ending or strictly curtailing this channel of drug affordability could have serious health consequences and is not consistent with Congress’ directive under federal law on permitting personal importation using enforcement discretion.

Prescription Justice founder Gabriel Levitt states: “Prescription Justice supports stronger enforcement against fentanyl, controlled substances, counterfeit medicines and fraudulent sellers. But FDA should exercise enforcement discretion so that Americans with valid prescriptions can continue to receive genuine, non-controlled medicines dispensed by licensed pharmacies in Canada and other countries with advanced regulatory systems.”

For decades, processing inbound international mail at international mail facilities has been primarily a manual process. CBP screened incoming packages and referred a small fraction of those believed to contain FDA-regulated products to FDA for admissibility review. FDA has estimated, for example, that its staff physically inspect less than 0.06% of packages presumed to contain drug products.

Beginning October 22, under a new CBP rule – Indefinite Suspension of the De Minimis Exemption for Mail Shipments and New Postal Informal Entry Process – personal drug imports must be electronically filed, either through the formal entry process required of drug manufacturers, or under a test protocol called Entry Type 13.

The new electronic filing requirement will give CBP substantially more detailed entry information about incoming international mail shipments. CBP’s stated goals are to “target and intercept high risk shipments with greater precision” and reduce the amount of dangerous and counterfeit product that “reach American families.” The federal rule states that CBP’s goal is to “detect and prevent the entry of illicit drugs, such as fentanyl.” Genuine prescription drugs from licensed Canadian pharmacies may violate FDA import requirements, but historically many of these shipments nonetheless reached the Americans who ordered them. Under the new system, personal prescription drug orders could be blocked before they are even mailed or, once electronically presented to CBP and FDA, routinely refused under FDA’s existing approach to personal importation.

Levitt stated further, “Better information at the international mail facilities should help the government distinguish dangerous drugs from lower-cost prescription medicines Americans are obtaining for their own use—not simply make it easier to stop both. We should strengthen drug safety while protecting patients who depend on affordable medications from abroad. FDA and CBP have an opportunity to get this right.”

Prescription Justice is calling on FDA and CBP to work together before the new requirements take effect to establish a patient-centered, risk-based approach, consistent with Congress’ declaration under Section 804(j)(1). That approach would protect patients by prioritizing the use of enforcement discretion for personal importation so that Americans can continue to import more affordable medications. Specifically, the agencies should:

• Ensure a workable electronic pathway for personal prescription imports, using the existing Intended Use Code 100.000 and Entry Type 13 so that the new customs procedures do not themselves impede personal importation.
• Use the new electronic information to identify lower-risk personal imports, including whether the shipment is supported by a valid prescription and declares the dispensing pharmacy and country of origin/source.
• Focus enforcement on affirmative indicators of unreasonable risk, such as counterfeit products, materially false information about a product or its source, known significant product-quality or manufacturing problems, controlled substances, or circumstances indicating commercial use (resale) rather than personal use.
• Not treat technical violations as sufficient to deny entry—including a drug’s unapproved or misbranded status, foreign labeling, or the availability of an FDA-approved version in the United States—as evidence that a personal-use shipment presents an unreasonable risk.
• Provide clear implementation guidance to FDA personnel, CBP, customs brokers and other filers so that increased electronic visibility facilitates risk-based enforcement rather than unnecessarily increasing detention and refusal of personal-use prescription shipments.

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.

Learn more about drug importation by reading Prescription Drug Importation: Myths and Facts.

Contact: Gabriel Levitt, president, Prescription Justice, gabriel@prescriptionjustice.org.