Amended in Senate June 13, 2016

Amended in Senate May 23, 2016

Amended in Assembly April 7, 2016

Amended in Assembly March 17, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 2750

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 allograft tissue by a person if that person is a hospital or outpatient setting, the person maintains a log including specified information pertaining to the allograft tissue, and the allograft tissue meets specified requirements, including, among other things, that the allograft tissue was obtained from a California-licensed tissue bank, is 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:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 1635.1 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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
begin delete 485.302 end delete begin insert end insert begin insert 486.302 end insert of Title 42 of the Code of Federal Regulations,
if the OPO, at the time of collection, processing, storage, and
distribution of the tissue, has been designated by the Secretary of
Health and Human Services as an begin delete OPO, pursuant to Section
485.305 of Title 42 of the Code of Federal Regulations, end delete begin insert OPO end insert and
meets the requirements of Sections begin delete 485.304 end delete begin insert 486.304 end insert and begin delete 485.306 end delete
begin insert 486.306 end insert 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 begin delete has end delete begin insert have end insert been obtained from a licensed tissue
bank, begin delete is end delete begin insert are end insert stored in strict accordance with a kit’s package insert
and any other manufacturer instructions and guidelines, and begin delete is end delete begin insert are end insert
used for the express purpose of implantation into a patient.

(8) The storage of a human cell, tissue, or cellular- or
tissue-based begin delete product, end delete begin insert end insert begin insert product (HCT/P), end insert as defined by the federal
Food and Drug begin delete Administration, end delete begin insert Administration (FDA), end insert 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. begin delete Secs. end delete
begin insert Sec. end insert 360 begin delete and 360e) end delete begin insert et seq.) end insert 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 begin delete California licensed end delete
begin insert California-licensed end insert 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 collection, processing, storage, or distribution of any
organ, as defined in paragraph (2) of subdivision (c) of Section
1635, within a single general acute care hospital, as defined in
subdivision (a) of Section 1250, operating a Medicare-approved
transplant program.

begin insert

(10) The storage of allograft tissue by a person if all of the
following apply:

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(C) The allograft tissue meets all of the following:

end insert begin insert

(i) The allograft tissue was obtained from a tissue bank licensed
by the state.

end insert begin insert

(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.

end insert begin insert

(iii) The allograft tissue is intended for the express purpose of
implantation into or application on a patient.

end insert begin insert

(iv) The allograft tissue is not intended for further distribution.

end insert begin insert

(v) The allograft tissue is registered with the FDA and
designated to be maintained at ambient room temperature
requiring no refrigeration.

end insert

begin delete

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 allograft tissue by a person if 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.

(C) The allograft tissue meets all of the following:

(i) The allograft tissue was obtained from a tissue bank licensed
by the state.

(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 allograft tissue is intended for the express purpose of
implantation into or application on a patient.

(iv) The allograft tissue is not intended for further distribution.

(v) The allograft tissue is registered with the FDA and
designated to be maintained at ambient room temperature requiring
no refrigeration.

end delete