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AB-1060 Tissue banks: licensure.(2007-2008)

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Assembly Bill No. 1060
CHAPTER 427

An act to amend Section 1635.1 of the Health and Safety Code, relating to tissue banks, and declaring the urgency thereof, to take effect immediately.

[ Approved by Governor  September 27, 2008. Filed with Secretary of State  September 27, 2008. ]

LEGISLATIVE COUNSEL'S DIGEST


AB 1060, Laird. Tissue banks: licensure.
Existing law, with certain exceptions, requires every tissue bank operating in California to have a current valid license issued by the State Department of Public Health. Existing law defines a tissue bank as a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings.
This bill would, additionally, exempt the storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, providing that the freeze-dried bone and dermis has been obtained from a licensed tissue bank and is stored in strict accordance with a kit’s package insert and any other manufacturer instructions and guidelines and is used for the express purpose of implantation into a patient.
This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   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 shall 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, where 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 485.302 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, pursuant to Section 485.305 of Title 42 of the Code of Federal Regulations, and meets the requirements of Sections 485.304 and 485.306 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, providing that the freeze-dried bone and dermis has been obtained from a licensed tissue bank and is stored in strict accordance with a kit’s package insert and any other manufacturer instructions and guidelines and is used for the express purpose of implantation into a patient.

SEC. 2.

 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the Constitution and shall go into immediate effect. The facts constituting the necessity are:
In order to ensure that licensed dentists continue practicing without violating the provisions governing licensure of tissue banks, it is necessary that this act take effect immediately.