What does Preamble of HR 3162 do?

This bill proposes to amend the Federal Food, Drug, and Cosmetic Act. The proposed amendment would permit the importation of affordable and safe drugs. The importation would be allowed for wholesale distributors, pharmacies, and individuals.

What does SHORT TITLE. of HR 3162 do?

This bill is formally titled the Affordable and Safe Prescription Drug Importation Act of 2025.

What does FINDINGS; SENSE OF CONGRESS. of HR 3162 do?

This section establishes findings regarding prescription drug prices in the United States, noting they are significantly higher than in comparable OECD countries. The text indicates that millions of Americans forgo filling prescriptions due to cost. It highlights the FDA's Mutual Recognition Agreements with several countries for drug manufacturing inspections and acknowledges that foreign manufacturers sometimes have fewer negative inspection outcomes. A significant portion of essential medicines used by Americans are manufactured overseas and imported. Current regulations permit personal drug importation through enforcement discretion but create uncertainty for patients due to formulation differences and potential seizures. Congress expresses the sense that high prescription drug costs represent a crisis impacting Americans' health and financial stability. The section asserts that import prohibitions have contributed to artificially inflated drug prices. It recognizes advancements in drug safety and approval processes in foreign nations. The text suggests that, with appropriate oversight, Americans can safely participate in a global pharmaceutical marketplace to obtain drugs at fairer prices.

What does IMPORTING AFFORDABLE AND SAFE DRUGS. of HR 3162 do?

This section amends Section 804 of the Federal Food, Drug, and Cosmetic Act to permit the importation of qualifying prescription drugs into the United States. The Secretary is required to promulgate regulations permitting this importation within one year of the Act's enactment. The legislation defines terms such as 'certified foreign seller,' 'foreign wholesale distributor,' 'importer,' 'licensed foreign pharmacy,' and 'qualifying prescription drug.' Certified foreign sellers must be listed on a dedicated internet website maintained by the Secretary, including contact information. The Act establishes criteria for certification of foreign sellers, including compliance with pharmacy laws and regulations and implementation of quality assurance programs. Qualifying prescription drugs must be approved for use in certain countries (Canada, UK, EU member states, Switzerland) and have the same active ingredient or be biosimilar to approved drugs. The legislation outlines penalties for online sales of adulterated or counterfeit drugs. The Act clarifies that it does not preempt state or federal laws providing civil remedies. The Secretary of Health and Human Services must submit a report to Congress annually on drug importation, and the Comptroller General must submit a report analyzing implementation within 18 months.

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Affordable and Safe Prescription Drug Importation Act of 2025 — HR. 3162

Last updated: 5/1/2025 · Introduced: 5/1/2025

Author: Janice Schakowsky (D-IL)

TL;DR (AI)

This bill amends federal law to permit the importation of prescription drugs from certified foreign sellers, including wholesale distributors, pharmacies, and individuals.
To qualify, imported drugs must be approved in countries like Canada, the UK, and EU member states, and the Secretary of Health and Human Services must establish regulations and a certification process for foreign sellers within one year.
The bill establishes penalties for counterfeit drugs and requires annual reports to Congress on drug importation activities.

119th Congressin committeeOfficial page

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Other Sections

Includes provisions on preamble, short title., and 2 more.

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