Connie Perry, PharmD, Chief Pharmacy Officer, Partner, Ethica Pharmacy Advisors
On October 22, 2026, the U.S. Customs and Border Protection (CBP) will implement a change to how low-value international mail shipments are processed by suspending duty-free de minimis treatment. Drug shipments that once moved through simplified channels may now require additional shipment-level data, an informal or formal customs entry, and payment of applicable duties, taxes, or fees. These requirements can increase processing time and create additional points at which a shipment may be held or refused.
How FDA Requirements Apply
Customs processing and drug importation are separate issues. CBP administers entry procedures, while the U.S. Food and Drug Administration (FDA) determines whether a prescription drug complies with federal requirements. In most circumstances, individuals may not import prescription drugs that are unapproved in the United States. FDA personnel may exercise enforcement discretion in limited personal-importation situations, including certain cases involving a serious condition for which effective treatment is not available domestically, provided additional criteria are met. This discretion is not a general authorization, and each shipment remains subject to review.
Potential Impact on Prescription Programs
Programs that source low-cost maintenance medications through international pharmacies may experience longer delivery times, added administrative requirements, and higher costs because of the CBP change. Some shipments may be detained or denied entry if customs or FDA requirements are not satisfied. Even shipments that are ultimately admitted may arrive later than expected.
For plan members, these disruptions may lead to refill delays, interrupted maintenance therapy, confusion about coverage, and increased service needs. For plan sponsors, the change may require domestic dispensing alternatives, revised member communications, vendor-transition planning, and review of related contractual and compliance obligations.
Recommended Next Steps
- Contact your M3 Team to determine whether your prescription drug program relies on international prescription shipments.
- If so, ask the program vendor to document the applicable implementation date, affected medications, anticipated processing changes, and transition plan.
- Identify members who may be affected, prioritizing those who use maintenance medications or therapies for serious conditions.
- Review contractual, legal and fiduciary obligations with a reliable advisor and consult with vendors to evaluate domestic dispensing, coverage, and clinical alternatives before current supplies are exhausted.
- Prepare clear communications for members, benefits teams, pharmacies, and service representatives.
- Monitor CBP and FDA guidance for further updates.
Prescription medications shipped to plan members from international pharmacies, including pharmacies in Canada, may face additional customs processing, duties, delays, or denial of entry. Plan sponsors that rely on international prescription sourcing should confirm whether the October 22, 2026, transition date applies to their program and plan accordingly.
The information provided is a summary of laws and regulations relating to employee benefit plan compliance. This information should not be construed as legal advice. In all cases, employers should consult with their own legal counsel.
