CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 1387Introduced by Assembly Member ArambulaFebruary 17, 2017 An act to amend Section 111656.1 of the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 1387, as introduced, Arambula. Home medical device retail facility business: licensing: inspections. The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.This bill would modify the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.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 111656.1 of the Health and Safety Code is amended to read:111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 1387Introduced by Assembly Member ArambulaFebruary 17, 2017 An act to amend Section 111656.1 of the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 1387, as introduced, Arambula. Home medical device retail facility business: licensing: inspections. The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.This bill would modify the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Assembly Bill No. 1387
Introduced by Assembly Member ArambulaFebruary 17, 2017
Introduced by Assembly Member Arambula
February 17, 2017
An act to amend Section 111656.1 of the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 1387, as introduced, Arambula. Home medical device retail facility business: licensing: inspections.
The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.This bill would modify the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.
The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.
This bill would modify the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 111656.1 of the Health and Safety Code is amended to read:111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
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 111656.1 of the Health and Safety Code is amended to read:111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
SECTION 1. Section 111656.1 of the Health and Safety Code is amended to read:
### SECTION 1.
111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
111656.1. (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.
(2) The department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.
(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).
(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.