A bill to provide for the regulation of human tissue for transplantation to ensure that such tissue is handled in a manner to preserve its safety and purity, and for other purposes.

Summary

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a specific definition for "human tissue" which expressly excludes vascularized human organs, gene therapy, blood, soluble blood components, milk, or products made by combining human tissue with biomaterials. Declares that human tissue is not a drug, biological product, or device unless reclassified under this Act. Amends the Public Health Service Act (PHSA) to subject human tissue to regulation under such Act only if voluntary regulation is inadequate, or if it is reclassified as a drug, biological product, or device pursuant to specified guidelines established by this Act. Requires any person subject to such regulation who recovers, processes, stores, or distributes human tissue for transplantation or implantation in the United States to register in accordance with FFDCA drug registration procedures. Deems registrants to be authorized to conduct human tissue recovery, processing, storage, and distribution activities identified as applicable on the registration, unless, among other things, the Secretary of Health and Human Services suspends or revokes such authority after determining that the registrant fails to meet operating standards established by the Secretary. Prescribes certain human tissue labeling and advertising requirements. Authorizes the Secretary to reclassify human tissue as a drug, biological product, or device in specified circumstances. Outlines the mechanism for enforcement of this Act in the event that any violations of it constitute a significant risk to the public health. Subjects registrants to inspections under the Act. Applies the PHSA to umbilical cord blood to the same extent as it applies to human tissue. Prohibits the Secretary from regulating eyes until voluntary regulation is inadequate to protect the public health.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 3 October 1996

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 3 October 1996

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• Introduced in Senate

  summary · EN · 3 October 1996

  Open at official source

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