Tissue banks.

Existing federal law governs the processing, storage, and use of human tissue and human cell, tissue, or cellular- or tissue-based products (HCT/P) , as specified, and imposes certain regulatory duties relating to HCT/P upon the federal Food and Drug Administration (FDA) . Existing state law requires the State Department of Public Health to license and regulate tissue banks, which process, store, or distribute human tissue for transplantation into human beings. Existing law generally requires every tissue bank operating in this state to have a current and valid tissue bank license issued or renewed by the department, but exempts certain activities from that requirement, including the storage of HCT/P by a licensed physician or podiatrist, as specified, if the products were obtained from a California-licensed tissue bank, stored in strict accordance with manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioner's own patient, among other criteria. This bill would create an additional exemption from the tissue bank licensing requirement for the storage of HCT/P by a person if that person is a hospital or outpatient setting and the HCT/P meets specified requirements, including, among other things, that the HCT/P was obtained from a tissue bank licensed by the state, is stored in the original unopened enclosure for one finished unit of transplantable tissue and in strict accordance with the package insert and any other manufacturer instructions and guidelines, and is intended for the express purpose of implantation into or application on a patient.