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Pharmaceutical Market Access and Drug Safety Act of 2004

Introduced: April 21, 2004 See on congress.gov
This bill died when the 108th Congress ended
It never became law before the 108th Congress (2003–2004) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 14, 2004
Committee on the Judiciary. Hearings held.
May 20, 2004
Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 108-470.
Apr 21, 2004
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 21, 2004
Sponsor introductory remarks on measure. (CR S4227-4228)
Apr 21, 2004
Introduced in Senate
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 Plain-English summary Congressional Research Service

Pharmaceutical Market Access and Drug Safety Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions governing the importation of prescription drugs. Requires the Secretary of Health and Human Services to promulgate regulations allowing the importation of prescription drugs by registered exporters or registered importers from Canada within 90 days of passage of this Act and from Australia, European Union countries, Japan, New Zealand, or Switzerland within one year.

Provides for inspection, tracking of drugs, and registration and inspection fees for registered importers and exporters.

Requires manufacturers to: (1) submit a statement to the Secretary explaining each difference between a drug approved and distributed in the United States and a related drug distributed in a foreign country; and (2) submit an application to the Food and Drug Administration (FDA) for approval of a related drug that is distributed in a foreign country if there is no comparable drug already approved in at least half of the permitted countries that can be imported to the United States.

Allows for the immediate importation of prescription drugs for personal use from licensed Canadian pharmacies.

Amends the Clayton Act to prohibit drug manufacturers from preventing importation by engaging in behavior such as charging higher prices or limiting supplies to registered exporters and importers or changing the form of the drug for such purpose.

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

Requires the Secretary of Homeland Security to refuse admission of drugs that violate importation provisions. Allows the destruction of certain violative shipments.

Amends the Controlled Substances Act to repeal the exemption that permitted individuals to import controlled substances for personal medical use.

What's happening now July 14, 2004

Committee on the Judiciary. Hearings held.

 Bill text 1 version

Source documents hosted by congress.gov.

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APA
U.S. Congress. (2026). S. 2328: Pharmaceutical Market Access and Drug Safety Act of 2004. 108th Congress. Open America. https://openamerica.io/bill/108-S-2328/
MLA
"S. 2328: Pharmaceutical Market Access and Drug Safety Act of 2004." 108th Congress, 2026, Open America, https://openamerica.io/bill/108-S-2328/.
Bluebook (legal)
S. 2328, 108th Cong. (2026), https://openamerica.io/bill/108-S-2328/.
Markdown link
[S. 2328: Pharmaceutical Market Access and Drug Safety Act of 2004](https://openamerica.io/bill/108-S-2328/)
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