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/Pbegin delete regulated by the FDA, as specified,end delete by a personbegin delete who is licensed to provide health care services, if specified circumstances apply,end deletebegin insert if that person is a hospital or outpatient setting and the HCT/P meets specified requirements,end insert includingbegin insert, among other things,end insert that the HCT/Pbegin delete areend deletebegin insert
wasend insert obtained from abegin delete licensedend delete
tissuebegin delete bank,end deletebegin insert bank licensed by the state, isend insert
storedbegin insert end insertbegin insertin the original unopened enclosure for one finished unit of transplantable tissue andend insert in strict accordance withbegin delete FDA regulationsend deletebegin insert the package insert and any other manufacturer instructions and guidelinesend insert, andbegin delete usedend deletebegin insert is intendedend insert 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.
P3 1(4) The collection, processing, storage, or distribution of
fetal
2tissue or tissue derived from a human embryo or fetus.
3(5) The collection, processing, storage, or distribution by an
4organ procurement organization (OPO), as defined in Section
5486.302 of Title 42 of the Code of Federal Regulations, if the OPO,
6at the time of collection, processing, storage, and distribution of
7the organ, has been designated by the Secretary of Health and
8Human Services as an OPO and meets the requirements of Sections
9486.304 and 486.306 of Title 42 of the Code of Federal
10Regulations, as applicable.
11(6) The storage of prepackaged, freeze-dried bone by a general
12acute care hospital.
13(7) The storage of freeze-dried bone and dermis by any licensed
14dentist practicing in a lawful practice
setting, providing that the
15freeze-dried bone and dermis have been obtained from a
licensed
16tissue bank and are stored in strict accordance with a kit’s package
17insert and any other manufacturer instructions and guidelines and
18are used for the express purpose of implantation into a patient.
19(8) The storage of a human cell, tissue, or cellular- or
20tissue-based product (HCT/P), as defined by the federal Food and
21Drug Administration (FDA), that is either a medical device
22approved pursuant to Section 510 or 515 of the Federal Food,
23Drug, and Cosmetic Act (21 U.S.C. Sec. 360 et seq.) or that is a
24biologic product approved under Section 351 of the federal Public
25Health Service Act (42 U.S.C. Sec. 262) by a licensed physician
26or podiatrist acting within the scope and authority of his or her
27license and practicing in a lawful practice setting. The medical
28device or biologic product must have been obtained from a
29California-licensed
tissue bank, been stored in strict accordance
30with the device’s or product’s package insert and any other
31manufacturer instructions, and used solely for the express purpose
32of direct implantation into or application on the practitioner’s own
33patient. In order to be eligible for the exemption in this paragraph,
34the entity or organization where the physician or podiatrist who is
35eligible for the exemption is practicing shall notify the department,
36in writing, that the practitioner is licensed and meets the
37requirements of this paragraph. The notification shall include all
38of the following:
39(A) A list of all practitioners to whom the notice applies.
P4 1(B) Acknowledgment that each listed practitioner uses the
2medical device or biologic product in the scope and authority of
3his or her
license and practice for the purposes of direct patient
4care as described in this paragraph.
5(C) A statement that each listed practitioner agrees to strictly
6abide by the directions for storage in the device’s or product’s
7package insert and any other manufacturer instructions and
8guidelines.
9(D) Acknowledgment by each practitioner that the medical
10device or biologic product shall not be resold or distributed.
11(9) The storage of an HCT/Pbegin delete regulated by the FDA pursuant to begin insert
by a person if bothend insert of the following apply:
12Parts 1270 and 1271 of Title 21 of the Code of Federal Regulations
13by a person who is licensed to provide health care services, acting
14within the scope of the license and practicing in a lawful practice
15setting, if allend delete
16(A) The person, as defined in Section 1635, is a hospital, or an
17outpatient setting regulated by the Medical Board of California
18pursuant to Chapter 1.3 (commencing with Section 1248), including
19an ambulatory surgical center.
20(B) The HCT/P meets all of the following:
end insert10 21(A)
end delete
22begin insert(i)end insert The HCT/Pbegin delete has beenend deletebegin insert
wasend insert obtained from abegin delete licensedend delete tissue
23begin delete bank.end deletebegin insert bank licensed by the state.end insert
11 24(B)
end delete
25begin insert(ii)end insert The HCT/Pbegin insert is stored in the original unopened enclosure
26for one finished unit of transplantable tissue andend insert is stored in strict
27accordance withbegin delete federal FDA regulationsend deletebegin insert
the package insert and
28any other manufacturer instructionsend insert and guidelines.
29(C)
end delete
30begin insert(iii)end insert The HCT/P isbegin delete usedend deletebegin insert intendedend insert for the express purpose of
31implantation into or application on abegin delete patient, andend deletebegin insert
patient.end insert
32begin insert (iv)end insertbegin insert end insertbegin insertThe HCT/P isend insert not intended for further distribution.
begin insert
33(v) The HCT/P is regulated by the FDA pursuant to Parts 1270
34and 1271 of Title 21 of the Code of Federal Regulations.
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