CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 617Introduced by Assembly Member MullinFebruary 14, 2019 An act to amend Section 684 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 617, as introduced, Mullin. Stem cell therapies notice.Existing law provides for the licensure and regulation of various health care practitioners by various boards within the Department of Consumer Affairs. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA), but are not FDA-approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy.This bill would make nonsubstantive changes to that notice provision.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 684 of the Business and Professions Code is amended to read:684. (a) For the purpose of this section: this section, the following terms have the following meanings:(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.
CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 617Introduced by Assembly Member MullinFebruary 14, 2019 An act to amend Section 684 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 617, as introduced, Mullin. Stem cell therapies notice.Existing law provides for the licensure and regulation of various health care practitioners by various boards within the Department of Consumer Affairs. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA), but are not FDA-approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy.This bill would make nonsubstantive changes to that notice provision.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO
CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION
Assembly Bill No. 617
Introduced by Assembly Member MullinFebruary 14, 2019
Introduced by Assembly Member Mullin
February 14, 2019
An act to amend Section 684 of the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 617, as introduced, Mullin. Stem cell therapies notice.
Existing law provides for the licensure and regulation of various health care practitioners by various boards within the Department of Consumer Affairs. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA), but are not FDA-approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy.This bill would make nonsubstantive changes to that notice provision.
Existing law provides for the licensure and regulation of various health care practitioners by various boards within the Department of Consumer Affairs. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA), but are not FDA-approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy.
This bill would make nonsubstantive changes to that notice provision.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 684 of the Business and Professions Code is amended to read:684. (a) For the purpose of this section: this section, the following terms have the following meanings:(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 684 of the Business and Professions Code is amended to read:684. (a) For the purpose of this section: this section, the following terms have the following meanings:(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.
SECTION 1. Section 684 of the Business and Professions Code is amended to read:
### SECTION 1.
684. (a) For the purpose of this section: this section, the following terms have the following meanings:(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.
684. (a) For the purpose of this section: this section, the following terms have the following meanings:(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.
684. (a) For the purpose of this section: this section, the following terms have the following meanings:(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.
684. (a) For the purpose of this section: this section, the following terms have the following meanings:
(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 practitioners office and posted conspicuously in the entrance of the health care practitioners 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 201819 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.