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 begin delete HCT/P end delete begin insert allograft tissue end insert by a person if that person is a hospital or outpatient begin delete setting end delete begin insert setting, the person maintains a log including specified information pertaining to the allograft tissue, end insert and the begin delete HCT/P end delete begin insert allograft tissue end insert meets specified requirements, including, among other things, that the begin delete HCT/P end delete begin insert end insert begin insert allograft tissue end insert was obtained from a begin insert California-licensed end insert tissue begin delete bank licensed by the state, end delete begin insert bank, end insert is begin delete 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, end delete begin insert individually boxed and labeled with a unique identification number and expiration date, end insert 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 begin delete an HCT/P end delete begin insert allograft tissue end insert by a person if begin delete both end delete
begin insert all end insert 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.

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 delete

(B)

end delete

begin insert ( end insert begin insert C) end insert  The begin delete HCT/P end delete begin insert allograft tissue end insert meets all of the following:

(i) The begin delete HCT/P end delete begin insert allograft tissue end insert was obtained from a tissue bank
licensed by the state.

begin delete

(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.

end delete 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

(iii) The begin delete HCT/P end delete begin insert allograft tissue end insert is intended for the express
purpose of implantation into or application on a patient.

(iv) The begin delete HCT/P end delete begin insert allograft tissue end insert is not intended for further
distribution.

(v) The begin delete HCT/P end delete begin insert allograft tissue end insert is begin delete regulated by end delete begin insert registered with end insert
the FDA begin delete pursuant to Part 1270 and Part 1271 of Title 21 of the
Code of Federal Regulations. end delete begin insert and designated to be maintained at
ambient room temperature requiring no refrigeration. end insert