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Tissue Resources Program

The Tissue Resources Program oversees all tissue banking activities and services provided in New York State, from donor solicitation to clinical use.  Regulations also include requirements for facilities (Non-Transplant Anatomic Banks) that recover, process, store and/or distribute nontransplant anatomic parts for medical research or health professional education.

Tissue Bank License Application Instructions

As applicable, complete the appropriate forms below and provide additional documentation as requested:

Tissue Services

Public Health Law Article 43-B, enacted in 1990, established the Commissioner's authority over tissue banks.  Part 52, Tissue Banks and Nontransplant Anatomic Banks, covers such tissues as skin, eye, semen, embryos, and stem cells. Subpart 58-5, Hematopoietic Progenitor Cell Banks, regulates activities involving hematopoeitic progenitor cells (precursors of blood cells found in umbilical cord blood, peripheral blood, and bone marrow). Licensure is required for all tissue banking activities in New York, including collection, processing, storage, and distribution.

Regulations also include requirements for licensure of facilities that recover, process, store and/or distribute nontransplant anatomic parts for medical research or health professional education.

Statutes - Public Health Law

  • Article 5, Title V: Clinical Laboratory and Blood Banking Services: Navigate to the NYS Legislature resource and enter CLINICAL LABORATORY AND BLOOD BANKING SERVICES in the search box, then click PUBLIC HEALTH LAW ARTICLE 5T5
  • Article 43-B: Organ Tissue and Body Parts: Navigate to the NYS Legislature resource and enter ORGAN TISSUE AND BODY PARTS in the search box, then click PUBLIC HEALTH LAW ARTICLE 43-B

Regulations Title 10, NYCRR