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Replaces existing section 804 (21 U.S.C. 384) with a new, comprehensive importation framework permitting importation from specified foreign countries, establishing certified foreign seller criteria, importer and individual importation rules, testing, labeling, supply-chain and enforcement provisions, reporting, and other requirements.
Adds a new subsection (h) to section 303 (21 U.S.C. 333) creating penalties related to internet-based sales violating section 301(aa), including sales of adulterated or counterfeit drugs or dispensing without a valid prescription to U.S. individuals.
Creates a new FDA/HHS-approved drug importation program that lets Americans access certain prescription drugs from approved foreign sellers and specified countries under safety, labeling, certification, reporting, and enforcement rules. The law directs the Secretary to write regulations on program operation and reporting timelines, defines who may import drugs (including limits for personal import), and bars certain discriminatory manufacturer practices that raise prices or block access.
Prescription drug prices are, on average, 2.78 times more expensive in the United States compared to comparable countries in the Organisation for Economic Co-operation and Development (OECD). Drugs that are still under a patent are 4.22 times more expensive in the United States than those in comparable nations in the OECD.
Multiple studies have demonstrated that tens of millions of Americans have opted not to fill a prescription due to the prohibitive cost of the prescription.
The Food and Drug Administration has entered into Mutual Recognition Agreements with the United Kingdom, the European Union, and Switzerland to recognize drug manufacturing inspections conducted by each entity as valid and equivalent to an inspection conducted by their own inspectors.
The Food and Drug Administration, in testimony provided to Congress, acknowledged that fewer negative inspection outcomes were assessed to drug manufacturers in the European Union than in the United States, representing a drug manufacturing industry that is comparably safe and effective to that of the United States.
In 2022, the Food and Drug Administration found that 57 percent of all finished dosage form manufacturing sites for drugs categorized as essential medicines were located in foreign nations and relied on importation to reach American patients.
Major effects on multiple groups:
Risks and tradeoffs:
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Referred to the House Committee on Energy and Commerce.
Introduced May 1, 2025 by Janice D. Schakowsky · Last progress May 1, 2025
Referred to the House Committee on Energy and Commerce.
Introduced in House