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AB-617 Stem Cell and Regenerative Therapy Regulation Advisory Group.(2019-2020)



SECTION 1.

 Article 24.5 (commencing with Section 2524) is added to Chapter 5 of Division 2 of the Business and Professions Code, to read:

Article  24.5. Stem Cell and Regenerative Therapy Regulation Advisory Group
2524.
 For purposes of this article, the following definitions apply:
(a) “Board” means the Medical Board of California.
(b) “Clinic” has the meaning set forth in Section 1200 of the Health and Safety Code.
(c) “Department” means the State Department of Public Health.
(d) “FDA” means the United States Food and Drug Administration.
(e) “HCT/Ps” means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).
(f) “Licensee” means a licensee of the Board of Registered Nursing, the Medical Board of California, or the Osteopathic Medical Board of California.
(g) “Stem cell therapy” means a therapy involving the use of HCT/Ps.
2524.1.
 (a) No later than February 1, 2020, the board shall establish the Stem Cell and Regenerative Therapy Regulation Advisory Group comprised of the following members who shall serve in an advisory capacity:
(1) Three members appointed by the board that are members of the board, including two physician and surgeon members and one public member.
(2) Three members appointed by the California Institute for Regenerative Medicine no later than January 15, 2020. On or after July 1, 2020, the board may make those appointments that the California Institute for Regenerative Medicine fails to make pursuant to this paragraph.
(3) Two members of the Osteopathic Medical Board of California appointed by the Osteopathic Medical Board of California.
(4) One member of the Board of Registered Nursing appointed by the Board of Registered Nursing.
(b) The Stem Cell and Regenerative Therapy Regulation Advisory Group shall convene a series of stakeholder meetings for the following purposes:
(1) Review the Medical Practice Act, the Osteopathic Act, and the department’s current licensing and certification laws and procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics and other practice settings.
(2) Make recommendations to the Legislature, on or before July 1, 2020, regarding how to improve state oversight of licensees offering or providing stem cell therapies to patients. A report submitted to the Legislature authorized by this paragraph shall be in compliance with Section 9795 of the Government Code.
(3) Make recommendations to the board, if appropriate, for the adoption of emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the FDA.
(c) The board may adopt emergency regulations recommended pursuant to paragraph (3) of subdivision (b). The board shall consult relevant stakeholders prior to adopting those regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is deemed to address an emergency, for purposes of Sections 11346.1 and 11349.6 of the Government Code, and is hereby exempted for this purpose from the requirements of subdivision (b) of Section 11346.1 of the Government Code.
2524.2.
 This article shall remain in effect only until January 1, 2024, and as of that date is repealed.