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Creates a federal regulatory framework for businesses and organizations that buy, sell, or transfer whole human bodies or body parts when used for education, research, or advancement of medical, dental, or mortuary science and not for transplantation. It requires those entities to register with the Secretary, keep specified records, meet labeling and packaging standards, allow inspections, limit and protect donor information, follow rules for final disposition, and face penalties for violations, with the rules taking effect two years after enactment. The law defines key terms, sets duties for covered entities, and authorizes oversight and enforcement actions to improve traceability, donor privacy, and safe handling of non‑transplant human remains and parts used by academic, research, and mortuary programs.
Creates a new statutory section (373A) inserted after section 373 in Title III of the Public Health Service Act addressing human bodies/body parts donated or transferred for education, research, or advancement of medical, dental, or mortuary science (not for transplantation).
A person who acquires human bodies and sells for profit a whole human body or human body part in or affecting interstate commerce must register with the Secretary at the time and in the manner the Secretary requires.
Paragraph (1) (the registration requirement) does not apply to: the Organ Procurement and Transplantation Network under section 372 and its members under 42 C.F.R. §121.3 (or successors); funeral service professionals for preparation, transportation, and final disposition; and schools of medicine, dentistry, mortuary science, research and training organizations, and other entities that do not sell whole bodies or body parts for profit.
Applications for registration or renewal must include information the Secretary prescribes; unless the Secretary specifies otherwise, the application must include: applicant name (including trade names), start date of activities, all business addresses, description of premises and equipment, types of services, identification of an authorized adult representative (age 18+), assurances permitting inspections, assurances about recordkeeping, assurances about labeling/packaging, and assurances about limiting use/disclosure of information.
The Secretary shall establish a registration and renewal fee; the Secretary determines the amount annually based on projected implementation and enforcement costs (including inspections).
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced April 3, 2025 by Thomas Roland Tillis · Last progress April 3, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate