2005 California Health and Safety Code Sections 1635-1635.2 Article 1. Definitions, Licensure, and Exceptions

1635.  (a) "Donor" is an individual, living or deceased, from whom
tissue is removed.
   (b) "Person" is an individual, corporation, business trust, estate
trust, partnership, association, state or local government, or
subdivision or agency thereof, or any other legal entity.
   (c) "Tissue" is any human cell, group of cells, tissue or organ
including the cornea, sclera, or vitreous humor and other segments
of, or the whole eye, bones, skin, arteries, sperm, blood, other
fluids, and any other portion of a human body.
   (d) "Tissue bank" is any place, establishment, or institution that
collects, processes, stores, or distributes tissue for
transplantation into human beings.
   (e) "Transplantation" is the act or process of transferring
tissue, including by ingestion, from a donor to the body of the donor
or another human being.
   (f) "State department" is the State Department of Health Services.
1635.1.  (a) Except as provided in subdivision (b), every tissue
bank operating in California on or after July 1, 1992, shall have a
current and valid tissue bank license issued or renewed by the state
department pursuant to Section 1639.2 or 1639.3.
   (b) This chapter shall not apply to any of the following:
   (1) The collection, processing, storage, or distribution of human
whole blood or its derivatives by blood banks licensed pursuant to
Chapter 4 (commencing with Section 1600) or any person exempt from
licensure under that chapter.
   (2) The collection, processing, storage, or distribution of tissue
for autopsy, biopsy, training, education, or for other medical or
scientific research or investigation, where transplantation of the
tissue is not intended or reasonably foreseeable.
   (3) The collection of tissue by an individual physician and
surgeon from his or her patient or the implantation of tissue by an
individual physician and surgeon into his or her patient.  This
exemption shall not be interpreted to apply to any processing or
storage of the tissue, except for the processing and storage of semen
by an individual physician and surgeon when the semen was collected
by that physician and surgeon from a semen donor or obtained by that
physician and surgeon from a tissue bank licensed under this chapter.
   (4) The collection, processing, storage, or distribution of fetal
tissue or tissue derived from a human embryo or fetus.
   (5) The collection, processing, storage, or distribution by an
organ procurement organization (OPO), as defined in Section 485.302
of Title 42 of the Code of Federal Regulations, if the OPO, at the
time of collection, processing, storage, and distribution of the
organ, has been designated by the Secretary of Health and Human
Services as an OPO, pursuant to Section 485.305 of Title 42 of the
Code of Federal Regulations, and meets the requirements of Sections
485.304 and 485.306 of Title 42 of the Code of Federal Regulations,
as applicable.
   (6) The storage of prepackaged, freeze-dried bone by a general
acute care hospital.
1635.2.  The Legislature hereby declares its intent that the
collection, processing, storage, or distribution of tissue for the
purpose of transplantation, as regulated by this chapter, shall be
deemed a service by those persons engaged in these activities.
Therefore, the collection, processing, storage, or distribution of
tissue for the purpose of transplantation, as regulated by this
chapter, shall not be subject to the requirements of Division 2
(commencing with Section 2101) of the Commercial Code.