3.0.0 2307 2023-01-15T04:48:32Z 2023-01-15T04:48:32Z Senate S S 2004-04-08 108 ssfi00 Finance Committee Senate Standing Referred to 2004-04-08T19:17:43Z 2004-04-08 ssfi00 Finance Committee Senate Read twice and referred to the Committee on Finance. IntroReferral 2004-04-08 Sponsor introductory remarks on measure. (CR S4042-4046) IntroReferral B00100 9 Library of Congress 2004-04-08 Introduced in Senate IntroReferral 10000 9 Library of Congress G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. N Health Administrative fees Administrative procedure Administrative remedies Australia Business records Canada Civil actions and liability Commerce Congress Congressional reporting requirements Crime and Law Enforcement Department of Health and Human Services Directories Drug advertising Drug approvals Drug industry Drug therapy Drugs EEC countries East Asia Economics and Public Finance Electronic government information Europe Evidence (Law) Export controls Exports Fines (Penalties) Food and Drug Administration (FDA) Foreign Trade and International Finance Forfeiture Gifts Government Operations and Politics Government paperwork Government publicity Governmental investigations Health care fraud Import restrictions Imports Income tax Injunctions Internet Japan Labeling Law Legislation Licenses New Zealand Oceania Packaging Pharmaceutical research Pharmacies Pharmacists Prescription pricing Product counterfeiting Product safety Quality control Research and development tax credit Restrictive trade practices Science, Technology, Communications Tax deductions Taxation Web sites Wholesale trade Health 00 2004-04-08 Introduced in Senate 2004-07-28T15:40:22Z Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards 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 qualifying prescription drugs from permitted countries (defined as Canada, other countries that may be designated by the Secretary as meeting qualifying requirements, and, after a specified report due within 18 months is published, Australia, European Union countries, Japan and New Zealand). Allows such importation only from registered exporters by importers or by individuals for personal use.

Sets conditions on registered exporters, including that they must: (1) submit to the jurisdiction of U.S. courts; (2) export only qualifiying drugs manufactured in and obtained from registered establishments; (3) permit facility and record inspections and place of business monitoring; (4) pay user fees to cover the costs of administering this Act; and (5) be authorized under foreign law to dispense drugs that are only safe for use under supervision of a licensed practitioner.

Requires the Secretary to regulate such importation, including by verifying the chain of custody of drugs from the manufacturer to the exporter, conducting random sampling of exports for personal use to determine whether all conditions are being met, and listing registered exporters on the Food and Drug Administration (FDA) web site.

Allows non-FDA approved drugs to be imported if the drugs have the same manufacturer and the same active ingredients, route of administration, dosage form, and strength as FDA approved drugs, with specific limitations.

Bars importation of qualifying drugs supplied for free or for a nominal cost by a manufacturer to a charitable or humanitarian organization or a foreign government.

Allows for the immediate importation for personal use under certain conditions.

Provides for penalties for violations of this Act, including the destruction without notice of drug shipments.

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

Amends the Internal Revenue Code to: (1) disallow any deduction for advertising expenditures of a drug manufacturer that does not certify that it has not taken any action to prevent authorized importation; and (2) provide a 20 percent increase in the tax credit for research activities for a drug manufacturer that makes such certification.

]]> Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004 Display Title Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs by importers, and by individuals for personal use, and for other purposes. Introduced in Senate IS Short Titles as Introduced Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004 Introduced in Senate 2004-04-08T04:00:00Z 2004-04-08 Read twice and referred to the Committee on Finance. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.