Congress 108 - HR 2427 - Pharmaceutical Market Access Act of 2003

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Administrative procedure Commerce Congress Congressional reporting requirements Consumer protection Counterfeiting Crime and Law Enforcement Department of Health and Human Services Drug industry Drugs Foreign Trade and International Finance Government Operations and Politics Government paperwork Governmental investigations Health Identification devices Import restrictions Imports Labeling Law Packaging Prescription pricing Product safety Science, Technology, Communications Sunset legislation

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Summary

(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Pharmaceutical Market Access Act of 2003 - (Sec. 4) Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations allowing qualifying individuals to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products).

Amends provision pertaining to record keeping regarding imported covered products. States that the Secretary shall not have to store records in cases in which qualifying individuals have imported a covered product.

Amends provisions regarding the importation of covered products, including to remove language directing the Secretary to require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received.

Amends provisions regarding the testing of imported covered products. Declares that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging. (Currently either the importer or the manufacturer may conduct such tests).

Eliminates the sunset date current law establishes for the provisions pertaining to the importation of covered products.

(Sec. 5) Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in packaging.

Actions

Jul 25, 2003

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jul 25, 2003

On passage Passed by recorded vote: 243 - 186 (Roll no. 445).
Jul 25, 2003

Motion to reconsider laid on the table Agreed to without objection.
Jul 25, 2003

Passed/agreed to in House: On passage Passed by recorded vote: 243 - 186 (Roll no. 445).
Jul 25, 2003

On motion to recommit Failed by voice vote.
Jul 25, 2003

The previous question on the motion to recommit was ordered without objection.
Jul 25, 2003

Mr. Dingell moved to recommit to Energy and Commerce. (consideration: CR H7610; text: CR H7595-7596)
Jul 25, 2003

The previous question was ordered pursuant to the rule.
Jul 25, 2003

DEBATE - The House proceeded with one hour of debate on H.R. 2427.
Jul 25, 2003

Rule provides for consideration of H.R. 2427.
Jul 25, 2003

Considered under the provisions of rule H. Res. 335. (consideration: CR H7595-7611)
Jul 24, 2003

Rule H. Res. 335 passed House.
Jul 24, 2003

Rules Committee Resolution H. Res. 335 Reported to House. Rule provides for consideration of H.R. 2427.
Jun 24, 2003

Referred to the Subcommittee on Health.
Jun 11, 2003

Referred to the House Committee on Energy and Commerce.
Jun 11, 2003

Introduced in House

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