BILL NUMBER: AB 995 AMENDED
BILL TEXT
AMENDED IN SENATE JULY 23, 2009
AMENDED IN SENATE JUNE 30, 2009
AMENDED IN ASSEMBLY MAY 11, 2009
AMENDED IN ASSEMBLY MAY 5, 2009
AMENDED IN ASSEMBLY APRIL 13, 2009
INTRODUCED BY Assembly Member Block
FEBRUARY 27, 2009
An act to amend Section 1635.1 of the Health and Safety Code,
relating to tissue banks.
LEGISLATIVE COUNSEL'S DIGEST
AB 995, as amended, Block. Tissue bank licensing.
Existing law requires all tissue banks, with certain specified
exceptions, to be licensed by the State Department of Public
health Health .
This bill would add to the list of licensure exceptions the
storage of federal Food and Drug Administration
(FDA)-regulated tissue-engineered products a human
cell, tissue, or cellular- or tissue- based
product that is either a medical device or a biologic
product, as defined, by a person licensed
physician or podiatrist to provide health care
services, acting within the scope of their
his or her license and practicing in a lawful
practice setting, provided that the federal FDA-regulated
tissue-engineered product has been obtained from a licensed tissue
bank and is stored in strict accordance with federal FDA regulations
and guidelines and is used for the express purpose of implantation
into or application on a patient and is not intended for further
distribution as specified. The bill would also
require, to be eligible for this exemption, that the entity where the
physician or podiatrist practices notify the department of specified
information .
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
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.
(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, 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. Sec. 360,, 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
guidelines.
(D) Acknowledgment by each practitioner that the medical device or
biologic product shall not be resold or distributed.
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 a 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.
(7) The storage of freeze-dried bone and dermis by a 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 federal Food and Drug Administration
(FDA)-regulated tissue-engineered products by a person licensed to
provide health care services, acting within the scope of their
license and practicing in a lawful practice setting, provided that
the federal FDA-regulated tissue-engineered product has been obtained
from a licensed tissue bank and is stored in strict accordance with
federal FDA regulations and guidelines and is used for the express
purpose of implantation into or application on a patient and is not
intended for further distribution.