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Pharmaceutical Market Access and Drug Safety Act of 2005

Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 109-143.

Official summary

Version 00 · Introduced in Senate · Feb 9, 2005

Pharmaceutical Market Access and Drug Safety Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States.

Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use.

Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions.

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Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.

Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug.

States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.

Requires the Secretary to educate consumers regarding prescription drug importation.

Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA.

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Who introduced it

Sen. Dorgan, Byron L. [D-ND] · D–ND

Committees

  • Health, Education, Labor, and Pensions Committee
33 cosponsorship records, including any withdrawals

Actions

A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.

  1. Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 109-143.

  2. Sponsor introductory remarks on measure. (CR S1253-1254)

  3. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  4. Sponsor introductory remarks on measure. (CR S1206)

  5. Introduced in Senate

  6. Sponsor introductory remarks on measure. (CR S540-541)

Bill text & related measures

Text links open the official source. We currently store references to these documents.

Related bills identified by Congress.gov

Source last updated: Aug 15, 2025. Consult Congress.gov for the current record.

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