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Affordable and Safe Prescription Drug Importation Act of 2025
5/20/2025, 2:36 PM
Summary of Bill HR 3162
Congressional Summary of HR 3162
Affordable and Safe Prescription Drug Importation Act of 2025
This bill expands the categories of prescription drugs that may be imported into the United States and the countries from which such drugs may be imported.
Current law allows the Department of Health and Human Services (HHS) to authorize the importation of certain eligible prescription drugs from Canada. The bill requires HHS to issue regulations that permit the importation of qualifying prescription drugs from the United Kingdom, Switzerland, and member states of the European Union, in addition to Canada. After one year, if HHS determines that the importation of drugs from these countries has been conducted safely, HHS may authorize importation from other countries that meet certain requirements.
The bill also expands the types of prescription drugs eligible for importation to include, for example, biologics such as insulin.
Further, the bill allows individuals to use an eligible licensed foreign pharmacy to fill a U.S.-issued prescription for a qualifying drug for personal use. Currently, an individual seeking to import a prescription drug generally must acquire a waiver from HHS.
The bill also imposes various requirements related to certification of foreign sellers, labeling of imported drugs, and supply chain security.
Finally, the bill (1) prohibits certain acts that discriminate against foreign sellers, such as drug manufacturers charging higher prices to foreign sellers than to other sellers in the same country; and (2) imposes criminal penalties for websites that sell counterfeit drugs or dispense drugs without a required prescription.
