To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. Sets forth specified provisions respecting: (1) importer and foreign seller recordkeeping and information requirements; (2) qualified laboratory drug testing; (3) registration with the Secretary of Canadian sellers; and (4) approved labeling. Declares that the Secretary should: (1) focus enforcement on cases in which individual importation poses a significant public health threat; and (2) exercise discretion to permit individuals to make such importation for non-risk personal use. Authorizes the Secretary to grant individuals a waiver of the prohibition of importation of a prescription drug or device. Directs the Secretary to grant individuals a waiver of such prohibition for an approved prescription drug imported from Canada that is: (1) imported from a licensed pharmacy for not more than 90-day personal use; (2) accompanied by a valid prescription; (3) in a final finished dosage that was manufactured in a registered establishment; and (4) imported under such other conditions as the Secretary determines necessary to ensure public safety.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 20 January 2004

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 20 January 2004

   Introduced

   Introduced in House

   Source: IntroReferral

3. 20 January 2004

   Introduced

   Introduced in House

   Source: IntroReferral

4. 3 February 2004

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 20 January 2004 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 20 January 2004

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 20 January 2004

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 20 January 2004

  Open at official source

Sponsors

• Rep. Wexler, Robert [D-FL-19] · D · Sponsor
• · hsif00 · Standing

Related records

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