AB 1822, as introduced, 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
29begin delete 485.302end deletebegin insert 486.302end insert of Title 42 of the Code of Federal Regulations,
30if the OPO, at the time of collection, processing, storage, and
31distribution of the organ, has been designated by the Secretary of
32Health and Human Services as anbegin delete OPO, pursuant to Section begin insert OPOend insert and
33485.305 of Title 42 of the Code of Federal Regulations,end delete
P3 1meets the requirements of Sectionsbegin delete 485.304 and 485.306end deletebegin insert 486.304
2and 486.306end insert
of Title 42 of the Code of Federal Regulations, as
3applicable.
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 dermis has been obtained from a licensed
9tissue bank and is stored in strict accordance with a kit’s package
10insert and any other manufacturer instructions and guidelines and
11is used for the express purpose of implantation into a patient.
12(8) The storage of a human cell, tissue, or cellular- or
13tissue-basedbegin delete product,end deletebegin insert product (HCT/P),end insert
as defined by the federal
14Food and Drug begin deleteAdministration, end deletebegin insertAdministration (FDA), end insertthat is
15either a medical device approved pursuant to Section 510 or 515
16of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec.begin delete 360,, begin insert 360 et seq.)end insert or that is a biologic product approved under
17360e)end delete
18Section 351 of the federal Public Health Service Act (42 U.S.C.
19Sec. 262) by a licensed physician or podiatrist acting within the
20scope and authority of his or her license and practicing in a lawful
21practice setting. The medical device or biologic product must have
22been obtained from a California licensed tissue bank, been stored
23in strict accordance with
the device’s or product’s package insert
24and any other manufacturer instructions, and used solely for the
25express purpose of direct implantation into or application on the
26practitioner’s own patient. In order to be eligible for the exemption
27in this paragraph, the entity or organization where the physician
28or podiatrist who is eligible for the exemption is practicing shall
29notify the department, in writing, that the practitioner is licensed
30and meets the requirements of this paragraph. The notification
31shall include all of the following:
32(A) A list of all practitioners to whom the notice applies.
33(B) Acknowledgment that each listed practitioner uses the
34medical device or biologic product in the scope and authority of
35his or her license and practice for the purposes of direct patient
36care as described in this paragraph.
37(C) A statement that each listed practitioner agrees to strictly
38abide by the directions for storage in the device’s or product’s
39package insert and any other manufacturer instructions and
40guidelines.
P4 1(D) Acknowledgment by each practitioner that the medical
2device or biologic product shall not be resold or distributed.
3(9) The storage of an HCT/P regulated by the FDA pursuant to
4Parts 1270 and 1271 of Title 21 of the Code of Federal Regulations
5by a person who is licensed to provide health care services, acting
6within the scope of the license and practicing in a lawful practice
7setting, if all of the following apply:
8(A) The HCT/P has been obtained from a licensed tissue bank.
end insertbegin insert
9(B) The HCT/P is stored in strict accordance with federal FDA
10regulations and guidelines.
11(C) The HCT/P is used for the express purpose of implantation
12into or application on a patient, and not intended for further
13distribution.
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