BILL NUMBER: AB 1822 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Bonta
FEBRUARY 18, 2014
An act to amend Section 1635.1 of the Health and Safety Code,
relating to tissue banks.
LEGISLATIVE COUNSEL'S DIGEST
AB 1822, as introduced, Bonta. 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 regulated by the
FDA, as specified, by a person who is licensed to provide health care
services, if specified circumstances apply, including that the HCT/P
are obtained from a licensed tissue bank, stored in strict
accordance with FDA regulations, and used for the express purpose of
implantation into or application on a patient.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1635.1 of the Health and Safety Code is amended
to read:
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
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
485.302 486.302 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, OPO and meets the
requirements of Sections 485.304 and 485.306
486.304 and 486.306 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.
(7) The storage of freeze-dried bone and dermis by any licensed
dentist practicing in a lawful practice setting, providing that the
freeze-dried bone and dermis has been obtained from a licensed tissue
bank and 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, product (HCT/P),
as defined by the federal Food and Drug Administration,
Administration (FDA), 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. Sec. 360,, 360e)
360 et seq.) 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
guidelines.
(D) Acknowledgment by each practitioner that the medical device or
biologic product shall not be resold or distributed.
(9) The storage of an HCT/P regulated by the FDA pursuant to Parts
1270 and 1271 of Title 21 of the Code of Federal Regulations by a
person who is licensed to provide health care services, acting within
the scope of the license and practicing in a lawful practice
setting, if all of the following apply:
(A) The HCT/P has been obtained from a licensed tissue bank.
(B) The HCT/P is stored in strict accordance with federal FDA
regulations and guidelines.
(C) The HCT/P is used for the express purpose of implantation into
or application on a patient, and not intended for further
distribution.