New customs requirements taking effect October 22 could disrupt Americans’ access to lower-cost medicines unless FDA maintains its longstanding, risk-based approach to personal imports
WHITE PLAINS, NEW YORK – September 17, 2026 – PharmacyChecker, an independent organization that verifies international online pharmacies and publishes prescription drug price comparisons, is calling on the United States Food and Drug Administration (FDA) to continue exercising reasonable, risk-based enforcement discretion for prescription medicines imported by Americans for their own use as new U.S. Customs and Border Protection (CBP) procedures for international mail take effect October 22, 2026.
While the CBP rule itself does not establish an explicit prohibition on personal prescription drug importation, PharmacyChecker is concerned that the new process could undermine a channel through which Americans have for decades obtained lower-cost prescription medicines from licensed pharmacies abroad.
“Increased information at the border should aid FDA in distinguishing between your daughter’s inhalers or your neighbor’s insulin – medicines clearly intended for an individual patient’s use – and nefarious shipments that pose a genuine threat to public health,” said Lucia Mueller, President of PharmacyChecker. “It is imperative that CBP and FDA not sever this American lifeline to affordable prescription drugs.”
Personal prescription drug importation in the United States has existed for decades within a complicated legal and regulatory framework. FDA states that personal importation of prescription drugs is prohibited in most circumstances under federal law, while also maintaining a Personal Importation Policy under which personnel have long exercised enforcement discretion. Congress has addressed how that discretion should be exercised in Section 804(j)(1) of the Federal Food, Drug, and Cosmetic Act, declaring that enforcement against individuals should focus on cases in which an import poses a “significant threat to public health” and that the Secretary should exercise discretion where an import is clearly for personal use and does not appear to present an unreasonable risk to the individual.
Taking into account Congress’s declaration and FDA's Personal Importation Policy, PharmacyChecker calls on FDA to:
- Maintain reasonable, risk-based enforcement discretion for prescription drug shipments clearly intended for an individual patient’s personal use;
- Give meaningful consideration to Congress’s declaration in Section 804(j)(1) that enforcement against individuals should focus on imports presenting a significant threat to public health; and
- Provide clear guidance to patients, pharmacies, carriers, customs brokers, and other filers about the information necessary to identify legitimate personal-use prescription drug shipments so patients with valid prescriptions continue to receive the medicines they need.
Protecting Patients Who Depend on Lower-Cost Medicines
Ending or severely curtailing personal prescription drug importation could have serious consequences for Americans who cannot afford the domestic price of a prescribed medication. An estimated 2.3 million U.S. adults purchased prescription drugs from outside the United States each year to save money.
“The stakes are high. Many patients obtaining prescribed medicines via international mail order are doing so to adhere to their prescribed drug therapies,” Mueller said. “Without international mail order, many may decide to ration or completely forgo needed medicine due to high domestic costs.”
PharmacyChecker has advised accredited international pharmacies and their dispensing partners of the October 22 changes and emphasized the importance of complying with all applicable U.S. laws, regulations, and CBP and FDA requirements.
“Robust standards and policies are the foundation of our verification program,” said Ross Phan, PharmD, Director of PharmacyChecker’s International Pharmacy Verification Program. “Accredited participants undergo continuous monitoring and auditing to ensure adherence to high standards for drug quality, pharmacy practice, and patient safety.”
PharmacyChecker cautions international pharmacies and patients against interpreting the October 22 deadline as a ban on personal prescription drug importation. Prioritizing patient safety, PharmacyChecker is advising accredited participants to not push patients into stocking up on prescription medications based on speculation about rule updates, but instead to encourage them to communicate with their healthcare team to prevent gaps in therapy.
PharmacyChecker encourages patients, clinicians, policymakers, and media to review Prescription Drug Importation: Myths and Facts, published by Prescription Justice, a nonprofit organization dedicated to lowering U.S. drug prices through safe prescription drug importation.
PharmacyChecker also urges U.S. patients, caregivers, and healthcare professionals to contact Congress to express their views about the role of personal prescription drug importation in access to affordable medicines through the Campaign for Personal Prescription Importation.
About PharmacyChecker
PharmacyChecker is an independent U.S. company with a global impact. Through its International Pharmacy Verification Program and drug price comparisons, PharmacyChecker helps patients identify safe and affordable prescription medication options.
International online pharmacies serve as a lifeline of savings, helping patients adhere to their prescribed drug therapies.
JAMA, a peer-reviewed medical journal published by the American Medical Association, recommends that patients and clinicians use PharmacyChecker to compare drug prices among trusted online pharmacies.
To learn more about how PharmacyChecker can help patients and caregivers save on prescription medications, visit www.pharmacychecker.com.
