BILL NUMBER: AB 2750 AMENDED
BILL TEXT
AMENDED IN SENATE MAY 23, 2016
AMENDED IN ASSEMBLY APRIL 7, 2016
AMENDED IN ASSEMBLY MARCH 17, 2016
INTRODUCED BY Assembly Member Gomez
FEBRUARY 19, 2016
An act to amend Section 1635.1 of the Health and Safety Code,
relating to tissue banks.
LEGISLATIVE COUNSEL'S DIGEST
AB 2750, as amended, Gomez. 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
allograft tissue by a person if that person is a
hospital or outpatient setting setting, the
person maintains a log including specified information pertaining to
the allograft tissue, and the HCT/P
allograft tissue meets specified requirements, including, among
other things, that the HCT/P
allograft tissue was obtained from a California-licensed
tissue bank licensed by the state,
bank, 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, individually boxed and labeled with a
unique identification number and expiration date, and is
intended 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 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 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 and meets the requirements of Sections 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, if the freeze-dried
bone and dermis have been obtained from a licensed tissue bank, are
stored in strict accordance with a kit's package insert and any other
manufacturer instructions and guidelines, and are used for the
express purpose of implantation into a patient.
(8) The storage of a human cell, tissue, or cellular- or
tissue-based product (HCT/P), as defined by the federal Food and Drug
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 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 allograft
tissue by a person if both all of
the following apply:
(A) The person, as defined in Section 1635, is a hospital, or an
outpatient setting regulated by the Medical Board of California
pursuant to Chapter 1.3 (commencing with Section 1248), including an
ambulatory surgical center.
(B) The person maintains a log that includes the date on which the
allograft tissue was received, the expiration date of the allograft
tissue, the date on which each allograft tissue is used for clinical
purposes, and the disposition of any allograft tissue samples that
remain unused at the time the allograft tissue expires.
(B)
( C) The HCT/P
allograft tissue meets all of the following:
(i) The HCT/P allograft tissue was
obtained from a tissue bank licensed by the state.
(ii) The HCT/P is stored in the original unopened enclosure for
one finished unit of transplantable tissue and is stored in strict
accordance with the package insert and any other manufacturer
instructions and guidelines.
(ii) Each allograft tissue is individually boxed and labeled with
a unique identification number and expiration date so that opening
the shipping container will not disturb or otherwise alter any of the
allograft tissue that is not being utilized.
(iii) The HCT/P allograft tissue is
intended for the express purpose of implantation into or application
on a patient.
(iv) The HCT/P allograft tissue is
not intended for further distribution.
(v) The HCT/P allograft tissue is
regulated by registered with the FDA
pursuant to Part 1270 and Part 1271 of Title 21 of the Code
of Federal Regulations. and designated to be
maintained at ambient room temperature requiring no refrigeration.