Amended IN Assembly June 22, 2017 Amended IN Assembly June 12, 2017 Amended IN Senate April 17, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 512Introduced by Senator HernandezFebruary 16, 2017An act to add Section 684 to the Business and Professions Code, relating to healing arts.LEGISLATIVE COUNSEL'S DIGESTSB 512, as amended, Hernandez. Health care practitioners: stem cell therapy.Existing law provides for the licensure and regulation of various health care practitioners by boards and agencies within the Department of Consumer Affairs. Existing law requires a health care practitioner, as defined, to communicate to a patient his or her name, state-granted practitioner license type, and highest level of academic degree, in a specified manner.This bill would require a health care practitioner, as defined, practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA)-approved (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy. The bill would not apply to a health care practitioner who has obtained approval for an investigation of a investigational new drug or device from the FDA for the use of human cells, tissues, or cellular or tissue-based products. The bill would authorize the licensing board having jurisdiction of the health care practitioner to cite and fine the health care practitioner, not to exceed $1,000 per violation, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 684 is added to the Business and Professions Code, to read:684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).(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 but subsequently complies within the 30-day period described in paragraph (1). 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.
Amended IN Assembly June 22, 2017 Amended IN Assembly June 12, 2017 Amended IN Senate April 17, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 512Introduced by Senator HernandezFebruary 16, 2017An act to add Section 684 to the Business and Professions Code, relating to healing arts.LEGISLATIVE COUNSEL'S DIGESTSB 512, as amended, Hernandez. Health care practitioners: stem cell therapy.Existing law provides for the licensure and regulation of various health care practitioners by boards and agencies within the Department of Consumer Affairs. Existing law requires a health care practitioner, as defined, to communicate to a patient his or her name, state-granted practitioner license type, and highest level of academic degree, in a specified manner.This bill would require a health care practitioner, as defined, practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA)-approved (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy. The bill would not apply to a health care practitioner who has obtained approval for an investigation of a investigational new drug or device from the FDA for the use of human cells, tissues, or cellular or tissue-based products. The bill would authorize the licensing board having jurisdiction of the health care practitioner to cite and fine the health care practitioner, not to exceed $1,000 per violation, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
Amended IN Assembly June 22, 2017 Amended IN Assembly June 12, 2017 Amended IN Senate April 17, 2017
Amended IN Assembly June 22, 2017
Amended IN Assembly June 12, 2017
Amended IN Senate April 17, 2017
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Senate Bill No. 512
Introduced by Senator HernandezFebruary 16, 2017
Introduced by Senator Hernandez
February 16, 2017
An act to add Section 684 to the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 512, as amended, Hernandez. Health care practitioners: stem cell therapy.
Existing law provides for the licensure and regulation of various health care practitioners by boards and agencies within the Department of Consumer Affairs. Existing law requires a health care practitioner, as defined, to communicate to a patient his or her name, state-granted practitioner license type, and highest level of academic degree, in a specified manner.This bill would require a health care practitioner, as defined, practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA)-approved (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy. The bill would not apply to a health care practitioner who has obtained approval for an investigation of a investigational new drug or device from the FDA for the use of human cells, tissues, or cellular or tissue-based products. The bill would authorize the licensing board having jurisdiction of the health care practitioner to cite and fine the health care practitioner, not to exceed $1,000 per violation, as specified.
Existing law provides for the licensure and regulation of various health care practitioners by boards and agencies within the Department of Consumer Affairs. Existing law requires a health care practitioner, as defined, to communicate to a patient his or her name, state-granted practitioner license type, and highest level of academic degree, in a specified manner.
This bill would require a health care practitioner, as defined, practitioner who performs a stem cell therapy that is not approved by the United States Food and Drug Administration (FDA)-approved (FDA) to communicate to his or her patient seeking stem cell therapy specified information regarding the provision of stem cell therapies on a specified notice in a prominent display in an area visible to patients in his or her office, posted conspicuously in the entrance of his or her office, and provided in writing to the patient prior to providing the initial stem cell therapy. The bill would not apply to a health care practitioner who has obtained approval for an investigation of a investigational new drug or device from the FDA for the use of human cells, tissues, or cellular or tissue-based products. The bill would authorize the licensing board having jurisdiction of the health care practitioner to cite and fine the health care practitioner, not to exceed $1,000 per violation, as specified.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 684 is added to the Business and Professions Code, to read:684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).(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 but subsequently complies within the 30-day period described in paragraph (1). 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.
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 is added to the Business and Professions Code, to read:684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).(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 but subsequently complies within the 30-day period described in paragraph (1). 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.
SECTION 1. Section 684 is added to the Business and Professions Code, to read:
### SECTION 1.
684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).(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 but subsequently complies within the 30-day period described in paragraph (1). 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.
684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).(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 but subsequently complies within the 30-day period described in paragraph (1). 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.
684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).(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 but subsequently complies within the 30-day period described in paragraph (1). 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.
684. (a) For the purpose of this section, stem 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 human cells, tissues, or cellular or tissued-based products (HCT/Ps) 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). HCT/Ps.
(b) (1) A health care practitioner licensed under this division who performs a stem cell therapy that is not United States Food and Drug Administration (FDA)-approved 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 yet 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 on a notice at least eight and one-half inches by 11 inches and written in no less than 42-point type by both of the following methods: 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. The notice These notices shall be at least eight and one-half inches by 11 inches and written in no less than 48-point 40-point type.
(B) Prior to providing the initial stem cell therapy, a health care practitioner shall provide the written disclosure. 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 for an investigation of a investigational new drug or device from the FDA for the use of a HCT/Ps.
(d) (1) The licensing board having jurisdiction of the health care practitioner may cite and fine the health care practitioner for a first offense, practitioner, not to exceed one thousand dollars ($1,000) per violation of this section after doing both of the following: section.
(A)Providing the health care practitioner with reasonable notice of noncompliance, which informs the health care practitioner that he or she is subject to a citation and fine if he or she does not correct the violation within 30 days from the date the notice is sent to the health care practitioner.
(B)Verifying that the violation was not corrected within the 30-day period described in subparagraph (A).
(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 but subsequently complies within the 30-day period described in paragraph (1). 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.