Marking Compliance on Prescription Medication for Retail Sale

Trade Update • Sept. 26, 2024

he U.S. law mandates that all foreign-origin products imported into the United States, including prescription medications, must be clearly marked with their country of origin. This requirement serves to inform U.S. consumers of the origin of the goods they are purchasing, including prescription drugs, enabling more informed purchasing decisions.

General Marking Requirements

Prescription medications, like other imported goods, must have visible and legible markings indicating their country of origin. These markings must be permanent and placed in a conspicuous location on the product or its packaging. The ultimate purchaser in the United States, which may be retail pharmacies or individual customers, should clearly understand where the product was manufactured.

Exceptions for Certain Medications

Some products are exempt from individual country of origin markings, particularly those listed in the “J-List” of the U.S. Customs and Border Protection (CBP). Notably, drugs and medications, when imported in forms such as capsules, tablets, or lozenges, fall under this exception. In such cases, although the individual items do not require marking, the outer packaging that reaches the ultimate purchaser must still display the country of origin.

Compliance Responsibilities for Importers and Retailers

When medication is repackaged by retail pharmacies, the importer must provide certification ensuring that the repackaged product will continue to display the appropriate country of origin information. If the medication is transferred to a third party for repacking, the importer is required to notify the re-packer in writing that the markings must comply with U.S. regulations.

Advance Ruling and Compliance Resources

Importers seeking clarity on the marking requirements or classification of goods can request binding advance rulings from CBP. These rulings provide official guidance on how CBP will treat specific import transactions, helping businesses ensure compliance.

More Information

For more information including examples of certification and notice statements, please review the full CBP Fact Sheet here.

For questions or concerns about how to ensure compliance with your prescription medication imports for retail sale please contact us.