California § 684 - For the purpose of this section: (1)

§ 684. For the purpose of this section: (1)

(a) For the purpose of this section: (1) “FDA” means the United States Food and Drug Administration. (2) “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). (3) “Stem cell therapy” means a therapy involving the use of HCT/Ps, but shall not include a therapy involving HCT/Ps that meets the criteria set out in Section 1271.10 of Title 21 of the Code of Federal Regulations, as amended May 25, 2004, as published in the Federal Register (69 Fed. Reg. 29829), or that qualifies for any of the exceptions described in Section 1271.15 of Title 21 of the Code of Federal Regulations, as amended May 25, 2004, as published in the Federal Register (69 Fed. Reg. 29829). (b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is subject to FDA regulation, but is not FDA-approved, shall communicate to a patient seeking stem cell therapy the following information in English: “THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This health care practitioner performs one or more stem cell therapies that have not been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a stem cell therapy.” (2) The information in paragraph (1) shall be communicated to the patient in all of the following ways: (A) In a prominent display in an area visible to patients in the health care practitioner’s office and posted conspicuously in the entrance of the health care practitioner’s office. These notices shall be at least eight and one-half inches by 11 inches and written in no less than 40-point type. (B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the patient with the notice described in paragraph (1) in writing. The notice shall be at least eight and one-half inches by 11 inches and written in no less than 40-point type. (c) This section does not apply to a health care practitioner licensed under this division who has obtained approval or clearance for an investigational new drug, or an investigational device exemption, from the FDA for the use of HCT/Ps. (d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner, not to exceed one thousand dollars ($1,000) per violation of this section. (2) No citation shall be issued and no fine shall be assessed upon the first complaint against a health care practitioner who violates this section. (3) Upon a second or subsequent violation of this section, a citation and administrative fine not to exceed one thousand dollars ($1,000) per violation may be assessed. (e) The Medical Board of California shall indicate in its annual report, commencing with the 2018–19 annual report, all of the following with regard to licensees who provide stem cell therapies: (1) The number of complaints received. (2) Any disciplinary actions taken. (3) Any administrative actions taken.