CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 351Introduced by Senator RothFebruary 14, 2017 An act to amend Section 4029 of, and to add Section 4127.15 to, the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTSB 351, as introduced, Roth. Hospital satellite compounding pharmacy: license: requirements.Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacies by the California State Board of Pharmacy. A knowing violation of the Pharmacy Law is a crime. Existing law prohibits the operation of a pharmacy without a license and a separate license is required for each pharmacy location.Under existing law, a hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets specified requirements. A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license as a general acute care hospital that includes more than one physical plant maintained and operated on separate premises or that has multiple licenses for a single health facility on the same premises. As a condition of licensure by the board, the pharmacy in another physical plant is required to provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as specified. Existing law requires a pharmacy compounding sterile drug products to possess a sterile compounding pharmacy license.With respect to a hospital pharmacy located outside of the hospital in another physical plant, this bill would redefine a hospital pharmacy as regulated as a general acute care hospital, as defined.This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements and would make the license subject to annual renewal. The bill would define a hospital satellite compounding pharmacy as an area licensed by the board to perform sterile compounding that is separately licensed by the board to perform that compounding and located outside of the hospital in another physical plant that is regulated as a general acute care hospital. The bill would require a hospital satellite compounding pharmacy to compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. The bill would also require the services to be directly related to the services or treatment plan administered in the physical plant. The bill would require a hospital satellite compounding pharmacy to comply with specified requirements relating to, among other things, purchasing, supervision, and required recall and adverse effect notices.By imposing new requirements on these pharmacies, the knowing violation of which would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4029 of the Business and Professions Code is amended to read:4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.SEC. 2. Section 4127.15 is added to the Business and Professions Code, to read:4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration. SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 351Introduced by Senator RothFebruary 14, 2017 An act to amend Section 4029 of, and to add Section 4127.15 to, the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTSB 351, as introduced, Roth. Hospital satellite compounding pharmacy: license: requirements.Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacies by the California State Board of Pharmacy. A knowing violation of the Pharmacy Law is a crime. Existing law prohibits the operation of a pharmacy without a license and a separate license is required for each pharmacy location.Under existing law, a hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets specified requirements. A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license as a general acute care hospital that includes more than one physical plant maintained and operated on separate premises or that has multiple licenses for a single health facility on the same premises. As a condition of licensure by the board, the pharmacy in another physical plant is required to provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as specified. Existing law requires a pharmacy compounding sterile drug products to possess a sterile compounding pharmacy license.With respect to a hospital pharmacy located outside of the hospital in another physical plant, this bill would redefine a hospital pharmacy as regulated as a general acute care hospital, as defined.This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements and would make the license subject to annual renewal. The bill would define a hospital satellite compounding pharmacy as an area licensed by the board to perform sterile compounding that is separately licensed by the board to perform that compounding and located outside of the hospital in another physical plant that is regulated as a general acute care hospital. The bill would require a hospital satellite compounding pharmacy to compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. The bill would also require the services to be directly related to the services or treatment plan administered in the physical plant. The bill would require a hospital satellite compounding pharmacy to comply with specified requirements relating to, among other things, purchasing, supervision, and required recall and adverse effect notices.By imposing new requirements on these pharmacies, the knowing violation of which would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Senate Bill No. 351
Introduced by Senator RothFebruary 14, 2017
Introduced by Senator Roth
February 14, 2017
An act to amend Section 4029 of, and to add Section 4127.15 to, the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 351, as introduced, Roth. Hospital satellite compounding pharmacy: license: requirements.
Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacies by the California State Board of Pharmacy. A knowing violation of the Pharmacy Law is a crime. Existing law prohibits the operation of a pharmacy without a license and a separate license is required for each pharmacy location.Under existing law, a hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets specified requirements. A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license as a general acute care hospital that includes more than one physical plant maintained and operated on separate premises or that has multiple licenses for a single health facility on the same premises. As a condition of licensure by the board, the pharmacy in another physical plant is required to provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as specified. Existing law requires a pharmacy compounding sterile drug products to possess a sterile compounding pharmacy license.With respect to a hospital pharmacy located outside of the hospital in another physical plant, this bill would redefine a hospital pharmacy as regulated as a general acute care hospital, as defined.This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements and would make the license subject to annual renewal. The bill would define a hospital satellite compounding pharmacy as an area licensed by the board to perform sterile compounding that is separately licensed by the board to perform that compounding and located outside of the hospital in another physical plant that is regulated as a general acute care hospital. The bill would require a hospital satellite compounding pharmacy to compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. The bill would also require the services to be directly related to the services or treatment plan administered in the physical plant. The bill would require a hospital satellite compounding pharmacy to comply with specified requirements relating to, among other things, purchasing, supervision, and required recall and adverse effect notices.By imposing new requirements on these pharmacies, the knowing violation of which would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists and pharmacies by the California State Board of Pharmacy. A knowing violation of the Pharmacy Law is a crime. Existing law prohibits the operation of a pharmacy without a license and a separate license is required for each pharmacy location.
Under existing law, a hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets specified requirements. A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license as a general acute care hospital that includes more than one physical plant maintained and operated on separate premises or that has multiple licenses for a single health facility on the same premises. As a condition of licensure by the board, the pharmacy in another physical plant is required to provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as specified. Existing law requires a pharmacy compounding sterile drug products to possess a sterile compounding pharmacy license.
With respect to a hospital pharmacy located outside of the hospital in another physical plant, this bill would redefine a hospital pharmacy as regulated as a general acute care hospital, as defined.
This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements and would make the license subject to annual renewal. The bill would define a hospital satellite compounding pharmacy as an area licensed by the board to perform sterile compounding that is separately licensed by the board to perform that compounding and located outside of the hospital in another physical plant that is regulated as a general acute care hospital. The bill would require a hospital satellite compounding pharmacy to compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located. The bill would also require the services to be directly related to the services or treatment plan administered in the physical plant. The bill would require a hospital satellite compounding pharmacy to comply with specified requirements relating to, among other things, purchasing, supervision, and required recall and adverse effect notices.
By imposing new requirements on these pharmacies, the knowing violation of which would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 4029 of the Business and Professions Code is amended to read:4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.SEC. 2. Section 4127.15 is added to the Business and Professions Code, to read:4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration. SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
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 4029 of the Business and Professions Code is amended to read:4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
SECTION 1. Section 4029 of the Business and Professions Code is amended to read:
### SECTION 1.
4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
4029. (a) Hospital pharmacy means and includes a pharmacy, licensed by the board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay and that meets all of the requirements of this chapter and the rules and regulations of the board.
(b) A hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant that is regulated under a hospitals consolidated license issued pursuant to Section 1250.8 of the Health and Safety Code. as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code. As a condition of licensure by the board, the pharmacy in another physical plant shall provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, except as provided in Article 7.6 (commencing with Section 4128). The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. Nothing in this subdivision shall be construed to restrict or expand the services that a hospital pharmacy may provide.
(c) Hospital satellite compounding pharmacy means an area licensed by the board to perform sterile compounding that is separately licensed by the board pursuant to Section 4127.15 to perform that compounding and is located outside of the hospital in another physical plant that is regulated as a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
SEC. 2. Section 4127.15 is added to the Business and Professions Code, to read:4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
SEC. 2. Section 4127.15 is added to the Business and Professions Code, to read:
### SEC. 2.
4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
4127.15. Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license shall be renewed annually and is not transferable.
(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.
(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.
(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.
(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:
(1) Reviews a current copy of the hospital satellite compounding pharmacys policies and procedures for sterile compounding.
(2) Reviews the hospital satellite compounding pharmacys completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.
(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.
(c) A hospital satellite compounding pharmacy shall do all of the following:
(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.
(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.
(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.
(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.
(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration.
SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
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