Article 1. Definitions, Licensure, And Exceptions of California Health And Safety Code >> Division 2. >> Chapter 4.1. >> Article 1.
(a) "Donor" means an individual, living or deceased, from
whom tissue is removed.
(b) "Person" means 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" means a human cell, group of cells, 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" means a place, establishment, or institution
that collects, processes, stores, or distributes tissue for
transplantation into human beings.
(e) "Transplantation" means the act or process of transferring
tissue, including by ingestion, from a donor to the body of the donor
or another human being.
(f) "Department" means the State Department of Public Health.
(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
department pursuant to Section 1639.2 or 1639.3.
(b) This chapter does 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, when 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,
(6) The storage of prepackaged, freeze-dried bone by a general
acute care hospital.
(7) The storage of freeze-dried bone and dermis by any licensed
dentist practicing in a lawful practice setting, if the freeze-dried
bone and dermis has been obtained from a licensed tissue bank, is
stored in strict accordance with a kit's package insert and any other
manufacturer instructions and guidelines, and is used for the
express purpose of implantation into a patient.
(8) The storage of a human cell, tissue, or cellular- or
tissue-based product, as defined by the federal Food and Drug
Administration, that is either a medical device approved pursuant to
Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. Secs. 360 and 360e) or that is a biologic product approved
under Section 351 of the federal Public Health Service Act (42 U.S.C.
Sec. 262) by a licensed physician or podiatrist acting within the
scope and authority of his or her license and practicing in a lawful
practice setting. The medical device or biologic product must have
been obtained from a California licensed tissue bank, been stored in
strict accordance with the device's or product's package insert and
any other manufacturer instructions, and used solely for the express
purpose of direct implantation into or application on the
practitioner's own patient. In order to be eligible for the exemption
in this paragraph, the entity or organization where the physician or
podiatrist who is eligible for the exemption is practicing shall
notify the department, in writing, that the practitioner is licensed
and meets the requirements of this paragraph. The notification shall
include all of the following:
(A) A list of all practitioners to whom the notice applies.
(B) Acknowledgment that each listed practitioner uses the medical
device or biologic product in the scope and authority of his or her
license and practice for the purposes of direct patient care as
described in this paragraph.
(C) A statement that each listed practitioner agrees to strictly
abide by the directions for storage in the device's or product's
package insert and any other manufacturer instructions and
(D) Acknowledgment by each practitioner that the medical device or
biologic product shall not be resold or distributed.
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.