To amend the Public Health Service Act to authorize the Commissioner of Food and Drugs to conduct oversight of any entity engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue or human tissue-based products.
Brian Lykins Human Tissue Transplant Safety Act of 2004 - Amends the Public Health Service Act to provide for oversight by the Commissioner of Food and Drugs of entities engaged in activities relating to human tissue or human tissue-based products, requiring their registration and authorizing their inspection. Requires the reporting of any adverse incidents. Requires the Commissioner to develop a reporting mechanism and a database to store such information.
Allows the Commissioner, in an instance in which this Act is violated, to: (1) issue an order requiring any distributor of a human cell, tissue, or cellular or tissue-based product to recall or destroy such product; (2) condemn, seize, and destroy such product; (3) require a covered entity to cease the activity that resulted in the violation; or (4) suspend or revoke the registration and listing of the covered entity involved.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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