SB 351: Hospital satellite compounding pharmacy: license: requirements.
- Session Year: 2017-2018
- House: Senate
- Latest Version Date: 2017-10-09
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 to include a pharmacy that is located in any physical plant that is regulated as a general acute care hospital.
This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements. The bill would make a license subject to a fee and an annual renewal fee, as specified. 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 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.
This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 752, that would become operative only if SB 752 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
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 to include a pharmacy that is located in any physical plant that is regulated as a general acute care hospital.
This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements. The bill would make a license subject to a fee and an annual renewal fee, as specified. 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 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.
This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 752, that would become operative only if SB 752 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
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 to include a pharmacy that is located in any physical plant that is regulated as a general acute care hospital.
This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements. The bill would make a license subject to a fee and an annual renewal fee, as specified. 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 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.
This bill would incorporate additional changes to Section 4400 of the Business and Professions Code proposed by SB 752, that would become operative only if SB 752 and this bill are both chaptered and become effective on or before January 1, 2018, and this bill is chaptered last.
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 to include a pharmacy that is located in any physical plant that is regulated as a general acute care hospital, as defined. hospital.
This bill would authorize the board to issue a license to a hospital satellite compounding pharmacy meeting specified requirements. The bill would make a license subject to a fee and an annual renewal fee, as specified. 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 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 requirements. The bill would make the license a license subject to a fee and an annual renewal. renewal fee, as specified. 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 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.
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.
(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 may include a pharmacy that is located in any physical plant that is regulated under the license of 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 fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be 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.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative or designated representative-3PL shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 3.5.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 4.Section 3.5 of this bill incorporates amendments to Section 4400 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4400 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 3 of this bill shall not become operative.
SEC. 5.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.
(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 may include a pharmacy that is located in any physical plant that is regulated under the license of 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 fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be 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.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative or designated representative-3PL shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 3.5.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative, designated representative-3PL, or designated representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 4.Section 3.5 of this bill incorporates amendments to Section 4400 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4400 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 3 of this bill shall not become operative.
SEC. 5.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.
(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 may include a pharmacy that is located in any physical plant that is regulated under the license of 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 fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be 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.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative or designated representative-3PL shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 3.5.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, or as a designated representative-reverse distributor pursuant to Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative representative, designated representative-3PL, or designated representative-3PL representative-reverse distributor shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 4.Section 3.5 of this bill incorporates amendments to Section 4400 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4400 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 3 of this bill shall not become operative.
SEC. 4.SEC. 5.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.
(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 may include a pharmacy that may be is located outside of the hospital in another in any physical plant that is regulated as under the license of 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 fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be 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.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative or designated representative-3PL shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 4.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.
(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 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 fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall be renewed annually and shall not be 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.Section 4400 of the Business and Professions Code, as added by Section 26 of Chapter 799 of the Statutes of 2016, is amended to read:4400.The amount of fees and penalties prescribed by this chapter, except as otherwise provided, is that fixed by the board according to the following schedule:
(a)The fee for a nongovernmental pharmacy license shall be five hundred twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The fee for the issuance of a temporary nongovernmental pharmacy permit shall be two hundred fifty dollars ($250) and may be increased to three hundred twenty-five dollars ($325).
(b)The fee for a nongovernmental pharmacy license annual renewal shall be six hundred sixty-five dollars ($665) and may be increased to nine hundred thirty dollars ($930).
(c)The fee for the pharmacist application and examination shall be two hundred sixty dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d)The fee for regrading an examination shall be ninety dollars ($90) and may be increased to one hundred fifteen dollars ($115). If an error in grading is found and the applicant passes the examination, the regrading fee shall be refunded.
(e)The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist biennial renewal shall be three hundred sixty dollars ($360) and may be increased to five hundred five dollars ($505).
(f)The fee for a nongovernmental wholesaler or third-party logistics provider license and annual renewal shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(g)The fee for a hypodermic license shall be one hundred seventy dollars ($170) and may be increased to two hundred forty dollars ($240). The fee for a hypodermic license renewal shall be two hundred dollars ($200) and may be increased to two hundred eighty dollars ($280).
(h)(1)The fee for application, investigation, and issuance of a license as a designated representative pursuant to Section 4053, or as a designated representative-3PL pursuant to Section 4053.1, shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative or designated representative-3PL shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(i)(1)The fee for the application, investigation, and issuance of a license as a designated representative for a veterinary food-animal drug retailer pursuant to Section 4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten dollars ($210).
(2)The fee for the annual renewal of a license as a designated representative for a veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may be increased to three hundred dollars ($300).
(j)(1)The application fee for a nonresident wholesaler or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(2)For nonresident wholesalers or third-party logistics providers that have 21 or more facilities operating nationwide the application fees for the first 20 locations shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820). The application fee for any additional location after licensure of the first 20 locations shall be three hundred dollars ($300) and may be decreased to no less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty dollars ($550).
(3)The annual renewal fee for a nonresident wholesaler license or third-party logistics provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780) and may be increased to eight hundred twenty dollars ($820).
(k)The fee for evaluation of continuing education courses for accreditation shall be set by the board at an amount not to exceed forty dollars ($40) per course hour.
(l)The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165) and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern hours or verification of licensure to another state shall be twenty-five dollars ($25) and may be increased to thirty dollars ($30).
(m)The board may waive or refund the additional fee for the issuance of a license where the license is issued less than 45 days before the next regular renewal date.
(n)The fee for the reissuance of any license, or renewal thereof, that has been lost or destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(o)The fee for the reissuance of any license, or renewal thereof, that must be reissued because of a change in the information, shall be one hundred dollars ($100) and may be increased to one hundred thirty dollars ($130).
(p)It is the intent of the Legislature that, in setting fees pursuant to this section, the board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to approximately one years operating expenditures.
(q)The fee for any applicant for a nongovernmental clinic license shall be five hundred twenty dollars ($520) for each license and may be increased to five hundred seventy dollars ($570). The annual fee for renewal of the license shall be three hundred twenty-five dollars ($325) for each license and may be increased to three hundred sixty dollars ($360).
(r)The fee for the issuance of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee for renewal of a pharmacy technician license shall be one hundred forty dollars ($140) and may be increased to one hundred ninety-five dollars ($195).
(s)The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual renewal fee for a veterinary food-animal drug retailer license shall be three hundred thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t)The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-five dollars ($35) and may be increased to forty-five dollars ($45).
(u)The fee for issuance of a nongovernmental sterile compounding pharmacy license or a hospital satellite compounding pharmacy shall be one thousand six hundred forty-five dollars ($1,645) and may be increased to two thousand three hundred five dollars ($2,305). The fee for a temporary license shall be five hundred fifty dollars ($550) and may be increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to one thousand eight hundred fifty-five dollars ($1,855).
(v)The fee for the issuance of a nonresident sterile compounding pharmacy license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to three thousand one hundred eighty dollars ($3,180). In addition to paying that application fee, the nonresident sterile compounding pharmacy shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4127.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(w)The fee for the issuance of an outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing facility license shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the board. The fee for a temporary outsourcing facility license shall be seven hundred fifteen dollars ($715).
(x)The fee for the issuance of a nonresident outsourcing facility license shall be two thousand three hundred eighty dollars ($2,380) and may be increased to up to three thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal of a nonresident outsourcing facility license shall be two thousand two hundred seventy dollars ($2,270) and may be increased to up to three thousand one hundred eighty dollars ($3,180) by the board. In addition to paying that application fee, the nonresident outsourcing facility shall deposit, when submitting the application, a reasonable amount, as determined by the board, necessary to cover the boards estimated cost of performing the inspection required by Section 4129.2. If the required deposit is not submitted with the application, the application shall be deemed to be incomplete. If the actual cost of the inspection exceeds the amount deposited, the board shall provide to the applicant a written invoice for the remaining amount and shall not take action on the application until the full amount has been paid to the board. If the amount deposited exceeds the amount of actual and necessary costs incurred, the board shall remit the difference to the applicant.
(y)The fee for the issuance of a centralized hospital packaging license shall be eight hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars ($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z)This section shall become operative on July 1, 2017.
SEC. 3.SEC. 4.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.
(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 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 shall not be 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.
(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.
|
Date
|
Status
|
|---|---|
| Oct 9, 2017 | Chaptered by Secretary of State. Chapter 623, Statutes of 2017. |
| Oct 9, 2017 | Approved by the Governor. |
| Sep 20, 2017 | Enrolled and presented to the Governor at 4 p.m. |
| Sep 14, 2017 | Assembly amendments concurred in. (Ayes 39. Noes 1.) Ordered to engrossing and enrolling. |
| Sep 14, 2017 | In Senate. Concurrence in Assembly amendments pending. |
| Sep 13, 2017 | Read third time. Passed. Ordered to the Senate. |
| Sep 8, 2017 | Read third time and amended. |
| Sep 6, 2017 | Read second time. Ordered to third reading. |
| Sep 5, 2017 | Read second time and amended. Ordered to second reading. |
| Sep 1, 2017 | From committee: Do pass as amended. (Ayes 16. Noes 0.) (September 1). |
| Jul 19, 2017 | July 19 set for first hearing. Placed on APPR. suspense file. |
| Jul 11, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 16. Noes 0.) (July 11). Re-referred to Com. on APPR. |
| Jun 12, 2017 | Referred to Com. on B. & P. |
| Jun 1, 2017 | In Assembly. Read first time. Held at Desk. |
| May 31, 2017 | Read third time. Passed. (Ayes 40. Noes 0. Page 1355.) Ordered to the Assembly. |
| May 26, 2017 | Ordered to special consent calendar. |
| May 26, 2017 | Read second time. Ordered to third reading. |
| May 25, 2017 | From committee: Do pass. (Ayes 7. Noes 0. Page 1182.) (May 25). |
| May 19, 2017 | Set for hearing May 25. |
| Apr 17, 2017 | April 17 hearing: Placed on APPR. suspense file. |
| Apr 6, 2017 | Set for hearing April 17. |
| Apr 4, 2017 | Read second time and amended. Re-referred to Com. on APPR. |
| Apr 3, 2017 | From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 9. Noes 0. Page 585.) (April 3). |
| Mar 21, 2017 | Set for hearing April 3. |
| Mar 20, 2017 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on B., P. & E.D. |
| Feb 23, 2017 | Referred to Com. on B., P. & E.D. |
| Feb 15, 2017 | From printer. May be acted upon on or after March 17. |
| Feb 14, 2017 | Introduced. Read first time. To Com. on RLS. for assignment. To print. |
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Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 14, 2017 | Unfinished Business SB351 Roth et al. Concurrence | Senate Floor |
Passed |
|
| Sep 13, 2017 | SB 351 Roth Senate Third Reading By RIDLEY-THOMAS | Assembly Floor |
Passed |
|
| Sep 1, 2017 | Do pass as amended. | Assembly Standing Committee on Appropriations |
Passed |
|
| Jul 11, 2017 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
|
| May 31, 2017 | Special Consent Calendar # SB351 | Senate Floor |
Passed |
|
| May 25, 2017 | Do pass | Senate Standing Committee on Appropriations |
Passed |
|
| Apr 17, 2017 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Apr 3, 2017 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| Board of Pharmacy | ** Support | Apr 3, 2017 |
| California Board of Pharmacy | ** Support | Sep 14, 2017 |
| California Hospital Association | ** Support | Sep 14, 2017 |
| California Society of Health System Pharmacists | ** Support | Sep 14, 2017 |
| California State Board of Pharmacy | ** Support | May 27, 2017 |
| Providence Health & Services | ** Support | May 27, 2017 |
| Providence St. Joseph Health | ** Support | Sep 14, 2017 |
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB |
UNFINISHED BUSINESS
Bill No: SB 351
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/3/17
AYES: Hill, Bates, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/25/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
SENATE FLOOR: 40-0, 5/31/17 (Consent)
AYES: Allen, Anderson, Atkins, Bates, Beall, Berryhill, Bradford, Cannella, De León, Dodd, Fuller, Gaines, Galgiani, Glazer, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara, Leyva, McGuire, Mendoza, Mitchell, Monning, Moorlach, Morrell, Newman, Nguyen, Nielsen, Pan, Portantino, Roth, Skinner, Stern, Stone, Vidak, Wieckowski, Wiener, Wilk
ASSEMBLY FLOOR: 78-0, 9/13/17 - See last page for vote
SOURCE: California Board of Pharmacy
DIGEST:
This bill establishes a license for a hospital satellite compounding pharmacy and allows a general acute care hospital without a consolidated license to obtain multiple site licenses from the Board of Pharmacy.
Assembly Amendments
remove chaptering conflicts and make other technical and conforming changes.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
- Prohibits the BOP from issuing more than one site license to a single premises except as follows: (BPC § 4107)
- To issue a veterinary food-animal drug retailer license;
- To issue a license to compound sterile drugs to a pharmacy; or,
- To issue a centralized hospital packaging license.
- Establishes a consolidated license for 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 specified. (Health and Safety Code (HSC) § 1250.8)
- Defines a hospital pharmacy as a pharmacy, licensed by BOP, 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 specified requirements. (BPC § 4029 (a))
- Provides, for hospitals operating under a consolidated license, that a hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant. As a condition of licensure by BOP, 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, as specified. The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. (BPC § 4029 (b))
- Requires a pharmacy that compounds sterile drug products to get a sterile compounding pharmacy license from BOP. States that a license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy. (BPC §§ 4127, 4127.1)
- Allows a centralized hospital packaging pharmacy (CHPP) to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. Authorizes a CHPP to prepare sterile compounded unit dose drugs and compounded unit dose drugs for administration to inpatients if each compounded unit dose drug is barcoded, and the CHPP obtains a specialty license from the BOP. (BPC §§ 4128, 4128.2)
- Defines “immediate supervision” as requiring a supervisor to be physically present while a task is being performed. (Title 22, California Code of Regulations (CCR), § 70065)
- Establishes supervision ratios of not less than one pharmacist on duty for a total of two pharmacy technicians on duty for the preparation of a prescription for an inpatient of a licensed health facility. (16 CCR § 1793.7)
This bill:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a “hospital satellite compounding pharmacy” (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license and fees, which shall be renewed annually and shall not be transferable.
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to do the following before issuing or renewing a HSCP license:
- Inspect the location and it is found to be in compliance with statutes and regulations adopted by the BOP;
- Review a current copy of the HSCP’s policies and procedures for sterile compounding;
- Review the HSCP’s completed self-assessment form; and,
- Receive a list of all products compounded by the HSCP since the last license renewal.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the Food and Drug Administration’s MedWatch program within 12 hours.
Background
Hospitals are regulated by the California Department of Public Health (DPH), while pharmacies within hospitals fall under the BOP’s jurisdiction; occasionally their licenses are co-dependent. This bill decouples the hospital pharmacy license from one type of DPH license and creates a new compounding license.
Current law prohibits the BOP from issuing more than one license per site, except for a compounding sterile drug license and CHPP license. This is because both licenses require that the facility first have an underlying pharmacy license.
Current law defines a “hospital pharmacy” as a pharmacy located within any licensed hospital’s main plant. The definition further allows that a hospital pharmacy may also include those pharmacies located physically outside the hospital’s main plant, but only if the hospital obtains a “consolidated license” through the DPH. These additional pharmacies under the consolidated license must provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located.
This bill allows a general acute care hospital to have multiple pharmacies on its campus by eliminating reference to the consolidated license in the definition of a hospital pharmacy. This also allows the hospital to obtain additional license types for facilities for which a pharmacy license is a prerequisite, like a sterile drug compounding license or a CHPP.
For hospitals whose business models do not match current sterile drug compounding or CHPP license requirements, this bill also establishes a new HSCP license. These hospitals may not want to get a CHPP license because their compounding facilities are close by and do not warrant many of the labeling and other controls necessary for a CHPP license, and would not qualify for a sterile compounding drug license because the location is not also licensed as a hospital. The HSCP license allows a satellite facility to compound sterile drugs only if it uses the hospital’s main pharmacy to obtain all its ingredients, have appropriate staffing and supervision, and administer the drugs only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided by the HSCP are directly related to the services or treatment plan administered in the physical plant.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Assembly Appropriations Committee, this bill may result in ongoing costs to BOP of $200,000 per year for an additional inspector if a significant number of HSCPs apply for licensure; approximately $50,000 per year in staff costs to process the new license type and one-time information technology costs of $50,000 for the BOP create a new license type and enforcement codes.
California Board of Pharmacy (source)
California Hospital Association
California Society of Health System Pharmacists
Providence St. Joseph Health
OPPOSITION: (Verified 9/13/17)
None received
ARGUMENTS IN SUPPORT: The BOP posits that in order to satisfy patients’ needs, hospitals must be granted flexibility to expand patient care services from inpatient acute care setting to an outpatient services oriented setting. Providing hospitals with the option to obtain additional hospital pharmacy licenses and/ or satellite compounding pharmacies strikes the ideal balance between hospital flexibility and ensuring patient health and safety.
ASSEMBLY FLOOR: 78-0, 9/13/17
AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bocanegra, Bonta, Brough, Burke, Caballero, Calderon, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dababneh, Dahle, Daly, Eggman, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon
NO VOTE RECORDED: Nazarian
9/14/17 10:07:57
**** END ****
SENATE THIRD READING
STR Bill Id:SB 351
Author:(Roth)
As Amended Ver:September 8, 2017
Majority vote
SENATE VOTE: 40-0
Committee | Votes | Ayes | Noes |
Business & Professions | 16-0 | Low, Brough, Arambula, Baker, Bloom, Chiu, Cunningham, Dahle, Eggman, Gipson, Grayson, Holden, Irwin, Mullin, Steinorth, Ting | |
Appropriations | 16-0 | Gonzalez Fletcher, Bigelow, Bloom, Bocanegra, Bonta, Brough, Calderon, Chau, Eggman, Fong, Friedman, Gallagher, Eduardo Garcia, Jones-Sawyer, Obernolte, Reyes |
SUMMARY: Allows a hospital to secure a second hospital pharmacy license from the Board of Pharmacy (BOP) and establishes the authority to issue a satellite sterile compounding pharmacy license to a location outside hospital's main physical plant as specified. Specifically this bill:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a "hospital satellite compounding pharmacy" (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license and fees
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to inspect the location, review a copy of policies for sterile compounding, and receive a list of all products compounded since the last license renewal before issuing or renewing a HSCP license.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the Food and Drug Administration's MedWatch program within 12 hours.
- Includes chaptering language to address conflicts with Senate Bill 752.
FISCAL EFFECT: According to the Assembly Appropriations Committee, the BOP will incur one-time information technology costs of $50,000 to create a new license type and enforcement codes (Pharmacy Board Contingent Fund). If a significant number of hospital satellite compounding pharmacies apply for licensure, the BOP may incur the following ongoing costs (Pharmacy Board Contingent Fund, with costs offset by licensure revenues):
- $200,000 per year for an additional inspector position.
- Approximately $50,000 per year in staff costs to process the new license type.
Purpose. This bill is sponsored by the Board of Pharmacy. According to the author, "My proposal will update pharmacy law to allow a hospital to obtain secondary pharmacy licenses- expanding the options for providing pharmaceutical services across today's hospital campuses, which is a less centralized model than existing law require. In addition, my bill will allow a hospital to obtain hospital satellite compounding pharmacy license to compound medications in areas closer to where the drug will be administered where the hospital pharmacy will serve as the general hub."
Background. Hospital Pharmacies. According to the Board, a hospital pharmacy is 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. 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.
Compounding. Drug manufacturers are regulated by the federal Food and Drug Administration (FDA). Compounding organizations are regulated by their respective states of residence. Compounding organizations also manufacture drugs, but are limited to producing small amounts in response to a specific patient's prescription. The Pharmacy Compounding Centers of America defines pharmacy compounding as the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioner's prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to customize a medication to meet the patient's specific needs.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0002071
SENATE THIRD READING
STR Bill Id:SB 351
Author:(Roth)
As Amended Ver:September 5, 2017
Majority vote
SENATE VOTE: 40-0
Committee | Votes | Ayes | Noes |
Business & Professions | 16-0 | Low, Brough, Arambula, Baker, Bloom, Chiu, Cunningham, Dahle, Eggman, Gipson, Grayson, Holden, Irwin, Mullin, Steinorth, Ting | |
Appropriations | 16-0 | Gonzalez Fletcher, Bigelow, Bloom, Bocanegra, Bonta, Brough, Calderon, Chau, Eggman, Fong, Friedman, Gallagher, Eduardo Garcia, Jones-Sawyer, Obernolte, Reyes |
SUMMARY: Allows a hospital to secure a second hospital pharmacy license from the Board of Pharmacy (BOP) and establishes the authority to issue a satellite sterile compounding pharmacy license to a location outside hospital's main physical plant as specified. Specifically this bill:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a "hospital satellite compounding pharmacy" (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license and fees
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to inspect the location, review a copy of policies for sterile compounding, and receive a list of all products compounded since the last license renewal before issuing or renewing a HSCP license.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the Food and Drug Administration's MedWatch program within 12 hours.
FISCAL EFFECT: According to the Assembly Appropriations Committee, the BOP will incur one-time information technology costs of $50,000 to create a new license type and enforcement codes (Pharmacy Board Contingent Fund). If a significant number of hospital satellite compounding pharmacies apply for licensure, the BOP may incur the following ongoing costs (Pharmacy Board Contingent Fund, with costs offset by licensure revenues):
- $200,000 per year for an additional inspector position.
- Approximately $50,000 per year in staff costs to process the new license type.
Purpose. This bill is sponsored by the Board of Pharmacy. According to the author, "My proposal will update pharmacy law to allow a hospital to obtain secondary pharmacy licenses- expanding the options for providing pharmaceutical services across today's hospital campuses, which is a less centralized model than existing law require. In addition, my bill will allow a hospital to obtain hospital satellite compounding pharmacy license to compound medications in areas closer to where the drug will be administered where the hospital pharmacy will serve as the general hub."
Background. Hospital Pharmacies. According to the Board, a hospital pharmacy is 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. 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.
Compounding. Drug manufacturers are regulated by the federal Food and Drug Administration (FDA). Compounding organizations are regulated by their respective states of residence. Compounding organizations also manufacture drugs, but are limited to producing small amounts in response to a specific patient's prescription. The Pharmacy Compounding Centers of America defines pharmacy compounding as the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to customize a medication to meet the patient's specific needs.
Analysis Prepared by: Jimmy Fremgen / B. & P. / (916) 319-3301 FN: 0001733
Date of Hearing: July 19, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
SBPCA Bill Id:SB 351
Author:(Roth) – As Amended Ver:April 4, 2017
Policy Committee: | Business and Professions | Vote: | 16 - 0 |
Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill creates a new Board of Pharmacy license type for hospital satellite compounding pharmacies, specifies conditions that must be met prior to licensure, and applies current initial licensure and renewal fees for nongovernmental sterile compounding pharmacies to the new license type.
It also replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants, but which does not have a consolidated license, to obtain multiple pharmacy licenses.
FISCAL EFFECT:
- If a significant number of hospital satellite compounding pharmacies apply for licensure, the Board may incur the following ongoing costs (Pharmacy Board Contingent Fund, with costs offset by licensure revenues):
- $200,000 per year for an additional inspector position.
- Approximately $50,000 per year in staff costs to process the new license type.
- One-time information technology costs of $50,000 for the Board of Pharmacy create a new license type and enforcement codes (Pharmacy Board Contingent Fund).
COMMENTS:
- Purpose. This bill is sponsored by the Board of Pharmacy in order to allow more flexibility in hospital pharmacy licensing. It is supported by the California Society of Health System Pharmacists and Providence St. Joseph Health, and has no opposition.
- Background. Current law allows hospitals with multiple physical plants to obtain a consolidated hospital license by the Department of Public Health, and be issued multiple pharmacy licenses by the Board of Pharmacy. This bill would allow any licensed hospital to obtain multiple pharmacy licenses. In addition, this bill establishes a new license type, which allows a satellite facility to compound sterile drugs only if it uses the hospital’s main pharmacy to obtain all its ingredients, has appropriate staffing and supervision, administers the drugs only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located, and meets other requirements. Compounding is manufacture of drugs at a small scale, often for specific patient needs.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: July 11, 2017
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Evan Low, Chair
SBPCA Bill Id:SB 351
Author:(Roth) – As Amended Ver:April 4, 2017
SENATE VOTE: 40-0
SUBJECT: Hospital satellite compounding pharmacy: license: requirements
SUMMARY: Allows a hospital to secure a second hospital pharmacy license from the Board of Pharmacy (BOP) and establishes the authority to issue a satellite sterile compounding pharmacy license to a location outside hospital’s main physical plant as specified.
EXISTING LAW:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
- Prohibits the BOP from issuing more than one site license to a single premises except as follows: (BPC § 4107)
- To issue a veterinary food-animal drug retailer license;
- To issue a license to compound sterile drugs to a pharmacy; or,
- To issue a centralized hospital packaging license.
- Defines a general acute care hospital as a health facility having a governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including specified basic services, and which may include more than one physical plant maintained and operated on separate premises, as specified. (Health and Safety Code (HSC) § 1250 (a))
- Establishes a consolidated license for 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 specified. (HSC § 1250.8)
- Defines a hospital pharmacy as a pharmacy, licensed by BOP, 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 specified requirements. (BPC § 4029 (a))
- Provides, for hospitals operating under a consolidated license, a hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant. As a condition of licensure by BOP, 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, as specified. The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. (BPC § 4029 (b))
- Requires a pharmacy that compounds sterile drug products to get a sterile compounding pharmacy license from BOP. States that a license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy. (BPC §§ 4127, 4127.1)
- Allows a centralized hospital packaging pharmacy (CHPP) to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. Authorizes a CHPP to prepare sterile compounded unit dose drugs and compounded unit dose drugs for administration to inpatients if each compounded unit dose drug is barcoded, and the CHPP obtains a specialty license from the BOP. (BPC §§ 4128, 4128.2)
- Defines “immediate supervision” as requiring a supervisor to be physically present while a task is being performed. (Title 22, California Code of Regulations (CCR), § 70065)
- Establishes supervision ratios of not less than one pharmacist on duty for a total of two pharmacy technicians on duty for the preparation of a prescription for an inpatient of a licensed health facility. (16 CCR § 1793.7)
THIS BILL:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a “hospital satellite compounding pharmacy” (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license and fees, which shall be renewed annually and shall not be transferable.
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to do the following before issuing or renewing a HSCP license:
- Inspect the location and it is found to be in compliance with statutes and regulations adopted by the BOP;
- Review a current copy of the HSCP’s policies and procedures for sterile compounding;
- Review the HSCP’s completed self-assessment form; and,
- Receive a list of all products compounded by the HSCP since the last license renewal.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the Food and Drug Administration’s MedWatch program within 12 hours.
FISCAL EFFECT: According to the April 17, 2017 Senate Appropriations Committee analysis, this bill will result in: One-time costs of about $50,000 to revise existing information technology systems by the BOP to accommodate the new license category; One-time costs of $58,000 and ongoing costs of $50,000 per year to process new license applications by the BOP; and, potential ongoing costs of about $200,000 per year for inspections of licensed hospital satellite compounding pharmacies. The number of hospitals that would seek the new license type authorized in the bill is not known. If there are a significant number of additional license granted, the Board may need an additional inspector position.
COMMENTS:
Purpose. This bill is sponsored by the Board of Pharmacy. According to the author, “My proposal will update pharmacy law to allow a hospital to obtain secondary pharmacy licenses- expanding the options for providing pharmaceutical services across today’s hospital campuses, which is a less centralized model than existing law require. In addition, my bill will allow a hospital to obtain hospital satellite compounding pharmacy license to compound medications in areas closer to where the drug will be administered where the hospital pharmacy will serve as the general hub.”
Background. Hospital Pharmacies. According to the Board, a hospital pharmacy is 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. A hospital pharmacy may be located outside of the hospital, in another physical plant that is regulated under a hospital's consolidated license. 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. The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant.
Centralized Hospital Packaging Pharmacy. A CHPP may prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75 mile radius of each other. A CHPP license may be issued to a hospital that holds a current and valid license from the Board.
Compounding. Drug manufacturers are regulated by the federal Food and Drug Administration (FDA). Compounding organizations are regulated by their respective states of residence. Compounding organizations also manufacture drugs, but are limited to producing small amounts in response to a specific patient’s prescription. The Pharmacy Compounding Centers of America defines pharmacy compounding as the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to customize a medication to meet the patient’s specific needs.
At one time, nearly all prescriptions were compounded. However, in the 1950’s and 1960’s, mass drug manufacturing gained popularity and the practice of compounding rapidly declined. The pharmacist’s role then changed from a practitioner who prepares medications to a dispenser of manufactured dosages. Pharmacists’ training in compounding medications also declined. In recent years, compounding has resurged in recognition that many mass-produced medications do not meet the needs of all patients.
REGISTERED SUPPORT:
Board of Pharmacy
California Society of Health System Pharmacists
Providence St. Joseph Health
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Le Ondra Clark Harvey Ph.D. / B. & P. / (916) 319-3301
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB |
THIRD READING
Bill No: SB 351
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/3/17
AYES: Hill, Bates, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/25/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
SOURCE: California Board of Pharmacy
DIGEST:
This bill establishes a license for a hospital satellite compounding pharmacy and allows a general acute care hospital without a consolidated license to obtain multiple site licenses from the Board of Pharmacy.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
- Prohibits the BOP from issuing more than one site license to a single premises except as follows: (BPC § 4107)
- To issue a veterinary food-animal drug retailer license;
- To issue a license to compound sterile drugs to a pharmacy; or,
- To issue a centralized hospital packaging license.
- Defines a general acute care hospital as a health facility having a governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including specified basic services, and which may include more than one physical plant maintained and operated on separate premises, as specified. (Health and Safety Code (HSC) § 1250 (a))
- Establishes a consolidated license for 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 specified. (HSC § 1250.8)
- Defines a hospital pharmacy as a pharmacy, licensed by BOP, 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 specified requirements. (BPC § 4029 (a))
- Provides, for hospitals operating under a consolidated license, a hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant. As a condition of licensure by BOP, 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, as specified. The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. (BPC § 4029 (b))
- Requires a pharmacy that compounds sterile drug products to get a sterile compounding pharmacy license from BOP. States that a license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy. (BPC §§ 4127, 4127.1)
- Allows a centralized hospital packaging pharmacy (CHPP) to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. Authorizes a CHPP to prepare sterile compounded unit dose drugs and compounded unit dose drugs for administration to inpatients if each compounded unit dose drug is barcoded, and the CHPP obtains a specialty license from the BOP. (BPC §§ 4128, 4128.2)
- Defines “immediate supervision” as requiring a supervisor to be physically present while a task is being performed. (Title 22, California Code of Regulations (CCR), § 70065)
- Establishes supervision ratios of not less than one pharmacist on duty for a total of two pharmacy technicians on duty for the preparation of a prescription for an inpatient of a licensed health facility. (16 CCR § 1793.7)
This bill:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a “hospital satellite compounding pharmacy” (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license and fees, which shall be renewed annually and shall not be transferable.
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to do the following before issuing or renewing a HSCP license:
- Inspect the location and it is found to be in compliance with statutes and regulations adopted by the BOP;
- Review a current copy of the HSCP’s policies and procedures for sterile compounding;
- Review the HSCP’s completed self-assessment form; and,
- Receive a list of all products compounded by the HSCP since the last license renewal.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the Food and Drug Administration’s MedWatch program within 12 hours.
Background
Hospitals are regulated by the California Department of Public Health (DPH), while pharmacies within hospitals fall under the BOP’s jurisdiction; occasionally their licenses are co-dependent. This bill decouples the hospital pharmacy license from one type of DPH license and creates a new compounding license.
Current law prohibits the BOP from issuing more than one license per site, except for a compounding sterile drug license and CHPP license. This is because both licenses require that the facility first have an underlying pharmacy license.
Current law defines a “hospital pharmacy” as a pharmacy located within any licensed hospital’s main plant. The definition further allows that a hospital pharmacy may also include those pharmacies located physically outside the hospital’s main plant, but only if the hospital obtains a “consolidated license” through the DPH. These additional pharmacies under the consolidated license must provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located.
This bill allows a general acute care hospital to have multiple pharmacies on its campus by eliminating reference to the consolidated license in the definition of a hospital pharmacy. This also allows the hospital to obtain additional license types for facilities for which a pharmacy license is a prerequisite, like a sterile drug compounding license or a CHPP.
For hospitals whose business models do not match current sterile drug compounding or CHPP license requirements, this bill also establishes a new HSCP license. These hospitals may not want to get a CHPP license because their compounding facilities are close by and do not warrant many of the labeling and other controls necessary for a CHPP license, and would not qualify for a sterile compounding drug license because the location is not also licensed as a hospital. The HSCP license allows a satellite facility to compound sterile drugs only if it uses the hospital’s main pharmacy to obtain all its ingredients, have appropriate staffing and supervision, and administer the drugs only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided by the HSCP are directly related to the services or treatment plan administered in the physical plant.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Appropriations Committee:
- One-time costs of about $50,000 to revise existing information technology systems by the BOP to accommodate the new license category (Pharmacy Board Contingent Fund).
- One-time costs of $58,000 and ongoing costs of $50,000 per year to process new license applications by the BOP (Pharmacy Board Contingent Fund).
- Potential ongoing costs of about $200,000 per year for inspections of licensed hospital satellite compounding pharmacies (Pharmacy Board Contingent Fund). The number of hospitals that would seek the new license type authorized in the bill is not known. If there are a significant number of additional license granted, the Board may need an additional inspector position.
California State Board of Pharmacy (source)
California Hospital Association
Providence Health & Services
OPPOSITION: (Verified 5/22/17)
None received
ARGUMENTS IN SUPPORT: The California Board of Pharmacy posits that in order to satisfy patients’ needs, hospitals must be granted flexibility to expand patient care services from inpatient acute care setting to an outpatient services oriented setting. Providing hospitals with the option to obtain additional hospital pharmacy licenses and/ or satellite compounding pharmacies strikes the ideal balance between hospital flexibility and ensuring patient health and safety.
The California Hospital Association and Providence Health & Services writes that; SB 351 properly emphasizes the currently evolving state of patient care and treatment, particularly concerning pharmaceutical care delivery in the outpatient setting. Throughout California’s healthcare system, hospitals have been progressively providing a greater amount of oncology and infusion ambulatory care services in satellite facilities located outside of the hospital. These satellite facilities are regulated under the hospital’s consolidated license, and are permitted to operate only under specific conditions. This shift in patient care has been trending because it is a more efficient and effective form of healthcare. This bill allows hospitals additional options to license pharmaceutical services in a satellite or approved area. Specifically, by allowing hospitals to secure a second hospital pharmacy license and or a satellite sterile compounding pharmacy license, this bill will better enable hospitals to continue providing these services while increasing patient access to necessary medications.
5/27/17 15:46:46
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SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
SB 351 (Roth) - Hospital satellite compounding pharmacy: license: requirements
Version: April 4, 2017 | Policy Vote: B., P. & E.D. 9 - 0 |
Urgency: No | Mandate: Yes |
Hearing Date: April 17, 2017 | Consultant: Brendan McCarthy |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
SB 351 would establish a license category for a hospital satellite compounding pharmacy.
Fiscal Impact:
- One-time costs of about $50,000 to revise existing information technology systems by the Board of Pharmacy to accommodate the new license category (Pharmacy Board Contingent Fund).
- One-time costs of $58,000 and ongoing costs of $50,000 per year to process new license applications by the Board of Pharmacy (Pharmacy Board Contingent Fund).
- Potential ongoing costs of about $200,000 per year for inspections of licensed hospital satellite compounding pharmacies (Pharmacy Board Contingent Fund). The number of hospitals that would seek the new license type authorized in the bill is not known. If there are a significant number of additional license granted, the Board may need an additional inspector position.
Background:
Under current law, general acute care hospitals are licensed by the Department of Public Health. Hospitals can be licensed as a single premises or under a consolidated license that covers more than one physical plant. Pharmacies within hospitals are also licensed by the Board of Pharmacy. Generally, the Board of Pharmacy does not issue more than one license to a single premises, with some exceptions, such as a pharmacy that compounds sterile drugs.
Proposed Law:
SB 351 would establish a licensing category for a hospital satellite compounding pharmacy.
Specific provisions of the bill would:
- Revise the existing definition of a hospital pharmacy to allow a hospital with multiple physical plants, but without a consolidated license, to obtain multiple pharmacy licenses;
- Create a new license category for hospital satellite compounding pharmacies, as defined;
- Authorize the Board of Pharmacy to issue a hospital satellite compounding pharmacy, provided specified licensing and regulatory requirements are met;
- Requires licensees to pay a licensee fee and annual renewal fee equal to the fees currently assessed on nongovernmental sterile compounding pharmacies (initially set at $1,645 and $1,325, respectively, which can be raised by the Board to a maximum of $2,305 and $1,855, respectively).
Staff Comments:
Essentially, this bill would give hospitals more flexibility in how their pharmacies are licensed by the Board of Pharmacy, by eliminating the requirement that a hospital with multiple pharmacy sites on its campus have a consolidated license from the Department of Public Health. Similarly, the new license type created in the bill will allow hospitals to have a satellite compounding pharmacy (which would compound drugs for patients of the hospital) to be licensed as such.
The number of hospitals that would apply for the new hospital satellite compounding license is unknown. According to the Board, although the overall workload is not known yet, the licensing fees authorized in the bill would be sufficient to cover the licensing and enforcement workload incurred by the Board.
The only costs that may be incurred by a local agency relate to crimes and infractions. Under the California Constitution, such costs are not reimbursable by the state.
-- END --
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2017 - 2018 Regular
Bill No: SB 351 Hearing Date: April 3, 2017
Author: | Roth and Stone | ||
Version: |
| ||
Urgency: | Fiscal: | ||
Consultant: | |||
Subject: Hospital satellite compounding pharmacy: license: requirements
SUMMARY:
Establishes a license for a hospital satellite compounding pharmacy and allows a general acute care hospital without a consolidated license to obtain multiple site licenses from the Board of Pharmacy.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code § 4001)
- Prohibits the BOP from issuing more than one site license to a single premises except as follows:
- To issue a veterinary food-animal drug retailer license;
- To issue a license to compound sterile drugs to a pharmacy; or,
- To issue a centralized hospital packaging license. (BPC § 4107)
- Defines a general acute care hospital as a health facility having a governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including specified basic services, and which may include more than one physical plant maintained and operated on separate premises, as specified. (Health and Safety Code (HSC § 1250 (a))
- Establishes a consolidated license for 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 specified. (HSC § 1250.8)
- Defines a hospital pharmacy as a pharmacy, licensed by BOP, 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 specified requirements. (BPC § 4029 (a))
- For hospitals operating under a consolidated license, a hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant. As a condition of licensure by BOP, 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, as specified. The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. (BPC § 4029 (b))
- Requires a pharmacy that compounds sterile drug products to get a sterile compounding pharmacy license from BOP. States that a license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy. (BPC §§ 4127, 4127.1)
- Allows a centralized hospital packaging pharmacy (CHPP) to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. Authorizes a CHPP to prepare sterile compounded unit dose drugs and compounded unit dose drugs for administration to inpatients if each compounded unit dose drug is barcoded, and the CHPP obtains a specialty license from the BOP. (BPC §§ 4128, 4128.2)
- Defines “immediate supervision” as requiring a supervisor to be physically present while a task is being performed. (Title 22, California Code of Regulations (CCR), § 70065)
- Establishes supervision ratios of not less than one pharmacist on duty for a total of two pharmacy technicians on duty for the preparation of a prescription for an inpatient of a licensed health facility. (16 CCR § 1793.7)
This bill:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a “hospital satellite compounding pharmacy” (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license, which shall be renewed annually and shall not be transferable.
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to do the following before issuing or renewing a HSCP license:
- Inspect the location and it is found to be in compliance with statutes and regulations adopted by the BOP;
- Review a current copy of the HSCP’s policies and procedures for sterile compounding;
- Review the HSCP’s completed self-assessment form; and,
- Receive a list of all products compounded by the HSCP since the last license renewal.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the FDA’s MedWatch program within 12 hours.
FISCAL EFFECT:
Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
- Purpose. This bill is sponsored by the Board of Pharmacy. According to the Author’s office, “As hospital pharmacy service areas expand to service areas outside of the acute care hospital, current limitations with obtaining licensure from the BOP could be impeding patient care relating to pharmaceutical services. This bill creates options for hospitals to secure additional licenses by the BOP as they deem necessary to provide pharmaceutical services in the best interest of registered hospital patients.”
- Background. Hospitals are regulated by the California Department of Public Health (DPH) while pharmacies within hospitals fall under the BOP’s jurisdiction; occasionally their licenses are co-dependent. This bill decouples the hospital pharmacy license from a type of DPH license and creates a new type of compounding license.
Current law prohibits the BOP from issuing more than one license per site, except for a compounding sterile drug license and CHPP license. This is because both licenses require that the facility first have an underlying pharmacy license.
Current law defines a “hospital pharmacy” as a pharmacy located within any licensed hospital’s main plant. The definition further allows that a hospital pharmacy may also include those pharmacies located physically outside the hospital’s main plant, but only if the hospital obtains a “consolidated license” through the DPH. These additional pharmacies under the consolidated license must provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located.
This bill allows a general acute care hospital to have multiple pharmacies on its campus by eliminating reference to the consolidated license in the definition of a hospital pharmacy. This also allows the hospital to obtain additional license types for facilities for which a pharmacy license is a prerequisite, like a sterile drug compounding license or a CHPP.
For hospitals whose business models do not match current sterile drug compounding or CHPP license requirements, this bill also establishes a new HSCP license. These hospitals may not want to get a CHPP license because their compounding facilities are close by and do not warrant many of the labeling and other controls necessary for a CHPP license, and would not qualify for a sterile compounding drug license because the location is not also licensed as a hospital. The HSCP license allows a satellite facility to compound sterile drugs only if it uses the hospital’s main pharmacy to obtain all its ingredients, have appropriate staffing and supervision, and administer the drugs only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided by the HSCP are directly related to the services or treatment plan administered in the physical plant.
- Arguments in Support. BOP writes, “As hospital patient care services expand beyond the inpatient acute care setting to one involving outpatient services, the board believes it is important to provide hospitals with the flexibility they need to meet the needs of their patients.”
Providence Health & Services writes, “Many hospitals and health systems are providing more oncology and/or infusion ambulatory care services in facilities located outside of the hospital in another physical plant space. This provides more efficient and effective care at less costs and higher patient satisfaction.”
- Author’s Amendments. The author is proposing to add a fee of $1,645, which may be increased to $2,305, to support the creation and regulation of this new license type. This is the same fee BOP charges to license a nongovernmental sterile compounding pharmacy.
SUPPORT AND OPPOSITION:
Support:
Board of Pharmacy (Sponsor)
California Hospital Association
Providence Health & Services
Opposition:
None on file as of March 30, 2017.
-- END --
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2017 - 2018 Regular
Bill No: Hearing Date: April 3, 2017
Author: | and Stone | ||
Version: | March 20, 2017 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | Sarah Huchel | ||
Subject:
SUMMARY:
Establishes a license for a hospital satellite compounding pharmacy and allows a general acute care hospital without a consolidated license to obtain multiple site licenses from the Board of Pharmacy.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code § 4001)
- Prohibits the BOP from issuing more than one site license to a single premises except as follows:
- To issue a veterinary food-animal drug retailer license;
- To issue a license to compound sterile drugs to a pharmacy; or,
- To issue a centralized hospital packaging license. (BPC § 4107)
- Defines a general acute care hospital as a health facility having a governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including specified basic services, and which may include more than one physical plant maintained and operated on separate premises, as specified. (Health and Safety Code (HSC § 1250 (a))
- Establishes a consolidated license for 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 specified. (HSC § 1250.8)
- Defines a hospital pharmacy as a pharmacy, licensed by BOP, 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 specified requirements. (BPC § 4029 (a))
- For hospitals operating under a consolidated license, a hospital pharmacy also includes a pharmacy that may be located outside of the hospital in another physical plant. As a condition of licensure by BOP, 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, as specified. The pharmacy services provided shall be directly related to the services or treatment plan administered in the physical plant. (BPC § 4029 (b))
- Requires a pharmacy that compounds sterile drug products to get a sterile compounding pharmacy license from BOP. States that a license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy. (BPC §§ 4127, 4127.1)
- Allows a centralized hospital packaging pharmacy (CHPP) to prepare medications for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if the hospitals are under common ownership and located within a 75-mile radius of each other. Authorizes a CHPP to prepare sterile compounded unit dose drugs and compounded unit dose drugs for administration to inpatients if each compounded unit dose drug is barcoded, and the CHPP obtains a specialty license from the BOP. (BPC §§ 4128, 4128.2)
- Defines “immediate supervision” as requiring a supervisor to be physically present while a task is being performed. (Title 22, California Code of Regulations (CCR), § 70065)
- Establishes supervision ratios of not less than one pharmacist on duty for a total of two pharmacy technicians on duty for the preparation of a prescription for an inpatient of a licensed health facility. (16 CCR § 1793.7)
This bill:
- Replaces a reference in the definition of a hospital pharmacy to allow a general acute care hospital with multiple physical plants but which does not have a consolidated license to obtain multiple licenses per premises, as specified.
- Defines a “hospital satellite compounding pharmacy” (HSCP) as an area licensed by the BOP to perform sterile compounding that is separately licensed by the BOP and is located outside of a general acute care hospital in another physical plant.
- Establishes a HSCP license, which shall be renewed annually and shall not be transferable.
- Limits a HSCP to compounding sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided shall be directly related to the services or treatment plan administered in the physical plant.
- Requires BOP to do the following before issuing or renewing a HSCP license:
- Inspect the location and it is found to be in compliance with statutes and regulations adopted by the BOP;
- Review a current copy of the HSCP’s policies and procedures for sterile compounding;
- Review the HSCP’s completed self-assessment form; and,
- Receive a list of all products compounded by the HSCP since the last license renewal.
- Requires a HSCP to do all of the following:
- Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy;
- Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty;
- Ensure immediate supervision by a pharmacist of licensed ancillary staff involved in sterile compounding;
- Provide to the BOP, within 12 hours, any recall notice issued by the HCSP for sterile drug products it has compounded; and,
- Report to the BOP, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the HCSP. Unexpected adverse effects shall also be reported to the FDA’s MedWatch program within 12 hours.
FISCAL EFFECT:
Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
- Purpose. This bill is sponsored by the Board of Pharmacy. According to the Author’s office, “As hospital pharmacy service areas expand to service areas outside of the acute care hospital, current limitations with obtaining licensure from the BOP could be impeding patient care relating to pharmaceutical services. This bill creates options for hospitals to secure additional licenses by the BOP as they deem necessary to provide pharmaceutical services in the best interest of registered hospital patients.”
- Background. Hospitals are regulated by the California Department of Public Health (DPH) while pharmacies within hospitals fall under the BOP’s jurisdiction; occasionally their licenses are co-dependent. This bill decouples the hospital pharmacy license from a type of DPH license and creates a new type of compounding license.
Current law prohibits the BOP from issuing more than one license per site, except for a compounding sterile drug license and CHPP license. This is because both licenses require that the facility first have an underlying pharmacy license.
Current law defines a “hospital pharmacy” as a pharmacy located within any licensed hospital’s main plant. The definition further allows that a hospital pharmacy may also include those pharmacies located physically outside the hospital’s main plant, but only if the hospital obtains a “consolidated license” through the DPH. These additional pharmacies under the consolidated license must provide pharmaceutical services only to registered hospital patients who are on the premises of the same physical plant in which the pharmacy is located.
This bill allows a general acute care hospital to have multiple pharmacies on its campus by eliminating reference to the consolidated license in the definition of a hospital pharmacy. This also allows the hospital to obtain additional license types for facilities for which a pharmacy license is a prerequisite, like a sterile drug compounding license or a CHPP.
For hospitals whose business models do not match current sterile drug compounding or CHPP license requirements, this bill also establishes a new HSCP license. These hospitals may not want to get a CHPP license because their compounding facilities are close by and do not warrant many of the labeling and other controls necessary for a CHPP license, and would not qualify for a sterile compounding drug license because the location is not also licensed as a hospital. The HSCP license allows a satellite facility to compound sterile drugs only if it uses the hospital’s main pharmacy to obtain all its ingredients, have appropriate staffing and supervision, and administer the drugs only to registered hospital patients who are on the premises of the same physical plant in which the HSCP is located, and the services provided by the HSCP are directly related to the services or treatment plan administered in the physical plant.
- Arguments in Support. BOP writes, “As hospital patient care services expand beyond the inpatient acute care setting to one involving outpatient services, the board believes it is important to provide hospitals with the flexibility they need to meet the needs of their patients.”
Providence Health & Services writes, “Many hospitals and health systems are providing more oncology and/or infusion ambulatory care services in facilities located outside of the hospital in another physical plant space. This provides more efficient and effective care at less costs and higher patient satisfaction.”
- Author’s Amendments. The author is proposing to add a fee of $1,645, which may be increased to $2,305, to support the creation and regulation of this new license type. This is the same fee BOP charges to license a nongovernmental sterile compounding pharmacy.
SUPPORT AND OPPOSITION:
Support:
Board of Pharmacy
Providence Health & Services
Opposition:
None on file as of March 30, 2017.
-- END --
Discussed in Hearing
2MIN
Senate Floor
2MIN
Assembly Floor
1H
Assembly Standing Committee on Appropriations
48MIN
Senate Standing Committee on Appropriations
42SEC
Senate Standing Committee on Appropriations
4MIN
Senate Standing Committee on Business, Professions and Economic Development
Bill Author
Bill Co-Author(s):
