AB 1822, as amended, 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 1635.1 of the Health and Safety Code is
2amended to read:
(a) Except as provided in subdivision (b), every tissue
4bank operating in California on or after July 1, 1992, shall have a
5current and valid tissue bank license issued or renewed by the
6department pursuant to Section 1639.2 or 1639.3.
7(b) This chapter shall not apply to any of the following:
8(1) The collection, processing, storage, or distribution of human
9whole blood or its derivatives by blood banks licensed pursuant
10to Chapter 4 (commencing with Section 1600) or any person
11exempt from licensure under that chapter.
12(2) The collection, processing, storage, or distribution of tissue
13for autopsy, biopsy, training, education, or for other
medical or
14scientific research or investigation, where transplantation of the
15tissue is not intended or reasonably foreseeable.
16(3) The collection of tissue by an individual physician and
17surgeon from his or her patient or the implantation of tissue by an
18individual physician and surgeon into his or her patient. This
19exemption shall not be interpreted to apply to any processing or
20storage of the tissue, except for the processing and storage of semen
21by an individual physician and surgeon when the semen was
22collected by that physician and surgeon from a semen donor or
23obtained by that physician and surgeon from a tissue bank licensed
24under this chapter.
25(4) The collection, processing, storage, or distribution of fetal
26tissue or tissue derived from a human embryo or fetus.
27(5) The collection, processing, storage, or
distribution by an
28organ procurement organization (OPO), as defined in Section
29486.302 of Title 42 of the Code of Federal Regulations, if the OPO,
30at the time of collection, processing, storage, and distribution of
31the organ, has been designated by the Secretary of Health and
P3 1Human Services as an OPO and meets the requirements of Sections
2486.304 and 486.306 of Title 42 of the Code of Federal
3Regulations, as applicable.
4(6) The storage of prepackaged, freeze-dried bone by a general
5acute care hospital.
6(7) The storage of freeze-dried bone and dermis by any licensed
7dentist practicing in a lawful practice setting, providing that the
8freeze-dried bone and dermisbegin delete hasend deletebegin insert haveend insert been obtained from a
9
licensed tissue bank andbegin delete isend deletebegin insert areend insert stored in strict accordance with a
10kit’s package insert and any other manufacturer instructions and
11guidelines andbegin delete isend deletebegin insert areend insert used for the express purpose of implantation
12into a patient.
13(8) The storage of a human cell, tissue, or cellular- or
14tissue-based product (HCT/P), as defined by the federal Food and
15Drug Administration (FDA), that is either a medical device
16approved pursuant to Section 510 or 515 of the Federal Food,
17Drug, and Cosmetic Act (21 U.S.C. Sec. 360 et seq.) or that is a
18biologic product approved under Section 351 of the
federal Public
19Health Service Act (42 U.S.C. Sec. 262) by a licensed physician
20or podiatrist acting within the scope and authority of his or her
21license and practicing in a lawful practice setting. The medical
22device or biologic product must have been obtained from a
23California-licensed tissue bank, been stored in strict accordance
24with the device’s or product’s package insert and any other
25manufacturer instructions, and used solely for the express purpose
26of direct implantation into or application on the practitioner’s own
27patient. In order to be eligible for the exemption in this paragraph,
28the entity or organization where the physician or podiatrist who is
29eligible for the exemption is practicing shall notify the department,
30in writing, that the practitioner is licensed and meets the
31requirements of this paragraph. The notification shall include all
32of the following:
33(A) A list of all practitioners to whom the notice applies.
34(B) Acknowledgment that each listed practitioner uses the
35medical device or biologic product in the scope and authority of
36his or her license and practice for the purposes of direct patient
37care as described in this paragraph.
38(C) A statement that each listed practitioner agrees to strictly
39abide by the directions for storage in the device’s or product’s
P4 1package insert and any other manufacturer instructions and
2guidelines.
3(D) Acknowledgment by each practitioner that the medical
4device or biologic product shall not be resold or distributed.
5(9) The storage of an HCT/P regulated by the FDA pursuant to
6Parts 1270 and 1271 of Title 21 of the Code of Federal Regulations
7by a person who is licensed to provide health care services, acting
8within the scope of
the license and practicing in a lawful practice
9setting, if all of the following apply:
10(A) The HCT/P has been obtained from a licensed tissue bank.
11(B) The HCT/P is stored in strict accordance with federal FDA
12regulations and guidelines.
13(C) The HCT/P is used for the express purpose of implantation
14into or application on a patient, and not intended for further
15distribution.
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