Bill Text: CA SB816 | 2023-2024 | Regular Session | Chaptered

California Senate Bill 816

Bill Title: Professions and vocations.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2023-10-10 - Chaptered by Secretary of State. Chapter 723, Statutes of 2023. [SB816 Detail]

Download: California-2023-SB816-Chaptered.html

Senate Bill No. 816

CHAPTER 723

An act to amend Sections 2881.2, 2987, 2988, 4531.1, 4836.2, 5134, 5681, 5800, 5801, 5801.1, 5802, 5803, 5804, 5805, 5807, 5812, 12703.1, 12704, and 12709 of, to amend, renumber, and add Section 5811.1 of, and to amend, repeal, and add Sections 4119.01, 4119.11, 4128.2, 4161, 4202.5, 4210, and 4400 of, the Business and Professions Code, relating to professions and vocations, and making an appropriation therefor.

[ Approved by Governor October 10, 2023. Filed with Secretary of State October 10, 2023. ]

LEGISLATIVE COUNSEL'S DIGEST

SB 816, Roth. Professions and vocations.

(1) Existing law, the Vocational Nursing Practice Act, establishes in the Department of Consumer Affairs a Board of Vocational Nursing and Psychiatric Technicians of the State of California, which is charged with various licensing, regulatory, and disciplinary functions related to vocational nursing. Existing law, effective until January 1, 2025, sets forth an approval process for a vocational nursing school or program and authorizes the board to reduce the continuing approval fees, by no more than ¹/₂ of the established fee, for a program that experiences a reduction in state funding that directly leads to a reduction in enrollment capacity.

Existing law, the Psychiatric Technicians Law, also grants the board authority to license and regulate psychiatric technicians. That law, effective until January 1, 2025, similarly establishes an approval process for a school or program for psychiatric technicians and authorizes the board to reduce the continuing approval fees, by no more than ¹/₂ of the established fee, for a program that experiences a reduction in state funding that directly leads to a reduction in enrollment capacity.

This bill would instead authorize the board to reduce the continuing approval fees in the above-described circumstances for a program that experiences a reduction in enrollment capacity that directly leads to a reduction in state funding. The bill would revise related provisions to require the board to require a program to provide documentation for purposes of issuing the fee reduction.

(2) Existing law, the Psychology Licensing Law, imposes various fees on applicants for licensure and on licensees, including an application fee for registration as a psychologist of $50, a biennial renewal fee for registration as a psychologist of $400, an initial psychologist licensing fee in an amount not to exceed the renewal fee, an application fee for registration as a psychological associate of $75, an annual renewal fee for registration of a psychological associate of no more than $75, and a delinquency fee for each license type not to exceed $150. Existing law requires a licensed psychologist who holds an inactive license to pay a biennial renewal fee of no more than $40.

This bill would increase various fees imposed under the Psychology Licensing Law. In this regard, the bill would increase the application fee for registration as a psychologist to $236, the biennial renewal fee for registration as a psychologist to $795, the initial psychologist licensing fee to $231, the application fee for registration as a psychological associate to $424, and the annual renewal fee for registration of a psychological associate to $224. The bill would increase the maximum delinquency fee for each of these license types to $397.50. The bill would also establish an application fee in the amount of $127 for the California Psychology Law and Ethics Examination and a fee in the amount of $184 for Fingerprint Hard Card Processing for Out-of-State Applicants. The bill would increase the biennial renewal fee that a licensed psychologist with an inactive license must pay to $221.

(3) Existing law, until January 1, 2027, provides a comprehensive scheme for the certification and regulation of interior designers. Under existing law, a Certified Interior Designer may obtain a stamp from an interior design organization that includes a number that identifies and bears the name of the designer, and that stamp certifies that the Certified Interior Designer has provided the interior design organization with evidence of passage of an interior design examination and completion of certain interior design education or experience requirements.

This bill would, instead, establish the California Council for Interior Design Certification to carry out duties and responsibilities governing the stamp certification and regulation of interior designers. The bill would authorize the council to issue certifications pursuant to these provisions to applicants who provide satisfactory evidence of compliance with specified education, experience, and examination requirements. The bill would identify the individual as either a “Certified Interior Designer” or “Certified Commercial Interior Designer” if the designer has completed certain additional interior design courses and examination requirements for the commercial designation, as determined by the council.

This bill would authorize the council to adopt bylaws, rules, and procedures and establish reasonable application fees, renewal fees, and other fees related to the regulatory cost of providing services and carrying out the council’s duties. The bill would make other related and conforming changes to these provisions.

(4) Existing law, the Pharmacy Law, establishes the licensure and regulation of the practice of pharmacy, including, among others, pharmacies, wholesalers or third-party logistics providers, nonresident wholesalers or third-party logistic providers, centralized hospital packing pharmacies, sterile compounding pharmacies, and paramedics. Existing law specifies the fees for issuance or renewal of licenses issued pursuant to the Pharmacy Law, including, among others, pharmacy licenses, outsourcing facility licenses, and centralized hospital packaging licenses.

This bill would reorganize and revise the fee schedule for specified licenses issued pursuant to the Pharmacy Law to both increase and decrease the amounts charged for the original issuance and renewal of those licenses, as well as for temporary licenses. The bill would also establish the fee schedule for the application and licensing fees of remote dispensing site pharmacies. The bill would make these provisions operative on January 1, 2025.

(5) Existing law, the Veterinary Medicine Practice Act, provides for the regulation of the practice of veterinary medicine by the Veterinary Medical Board in the Department of Consumer Affairs. Existing law requires the board to adopt regulations establishing animal health care tasks that may be performed by licensed veterinarians, registered veterinary technicians, or veterinary assistants. Existing law establishes a process by which a veterinary assistant may apply for a controlled substance permit. Existing law prohibits the board from issuing a veterinary assistant controlled substance permit to any applicant with a state or federal felony controlled substance conviction. Existing law makes it a misdemeanor for any person to violate or aid or abet in the violation of the act.

This bill would delete the prohibition on the board issuing a veterinary assistant controlled substance permit to an applicant with a conviction, as described above. By expanding the application of the act, the violation of which is a crime, the bill would impose a state-mandated local program.

(6) Existing law establishes the California Board of Accountancy, which is within the Department of Consumer Affairs, and requires the board to license and regulate accountants in this state. Existing law imposes various fees on applicants for licensure as a certified public accountant and on certified public accountant licensees, including an application fee for a certified public accountant certificate in an amount not to exceed $250 and a biennial renewal fee for each permit to engage in the practice of public accountancy in an amount not to exceed $280. Existing law imposes a fee in an amount not to exceed $250 to each applicant for registration as a partnership or professional corporation. Existing law credits all moneys received by the board to the Accountancy Fund and continuously appropriates all money in that fund derived from fees.

This bill would increase various fees, including the application fee for a certified public accountant certificate to $700. The bill would adjust and increase the biennial renewal fee for each permit to engage in the practice of public accountancy that expires after June 30, 2024, to $340 for a certified public accountant and $400 for a partnership or professional corporation. The bill would adjust and increase the biennial renewal fee for each permit to engage in the practice of public accountancy that expires after June 30, 2026, to $400 for a certified public accountant and $520 for a partnership or professional corporation. The bill would increase the fee imposed on an applicant for registration as a partnership or professional corporation to no less than $250, but no more than $2,000. By increasing the fees deposited in a continuously appropriated fund, this bill would make an appropriation.

(7) Existing law establishes the California Architects Board within the Department of Consumer Affairs, and sets forth its powers and duties relating to the licensing and regulation of landscape architects, including the authority to issue licenses for the practice of landscape architecture. Existing law imposes various fees on applicants for licensure as a landscape architect and on landscape architect licensees, including an application fee not to exceed $100, a fee for the examination for a license to practice landscape architecture in an amount not to exceed the actual cost to the board to administer each exam, a fee not to exceed $400 for an original license, a fee not to exceed $50 for a duplicate license, and a renewal fee not to exceed $400.

This bill would increase the above-described fees imposed on landscape architect applicants and licensees. In this regard, the bill would impose an application fee of $100 and a fee for the California Supplemental Examination of not less than $350. The bill would authorize the board to increase the examination fee by regulation up to $400. The bill would increase the fee for an original license to $700. The bill would authorize the board to increase the fee by regulation up to $800. The bill would increase the fee for a duplicate license to $300 and would increase the renewal fee to be not less than $700. The bill would authorize the board to increase the original license fee by regulation up to $800.

(8) Existing law requires a person who weighs, measures, or counts a commodity and issues a statement or memorandum of the weight, measure, or count that is used as the basis for either the purchase or sale of that commodity or charge for service, to obtain a license as a weighmaster from the Department of Food and Agriculture, and imposes an annual license fee and various other requirements on weighmasters. Existing law, until January 1, 2024, requires a recycler or junk dealer who is an applicant for a new weighmaster license or a renewal of a weighmaster license to furnish specified additional information on the application, and requires a weighmaster who is a junk dealer or recycler to pay an additional annual fee of $500 to the department for each location at which the weighmaster operates, as specified. Existing law provides for license fees collected pursuant to these provisions to be deposited in the Department of Food and Agriculture Fund and continuously appropriated for the administration and enforcement of these provisions.

This bill would extend the operation of the requirements to furnish the additional application information and to pay the additional annual fee to January 1, 2028. By extending the collection of a fee deposited in a continuously appropriated fund, this bill would make an appropriation.

(9) This bill would incorporate additional changes to Section 5134 of the Business and Professions Code proposed by SB 887 to be operative only if this bill and SB 887 are enacted and this bill is enacted last.

(10) 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.

Vote: MAJORITY Appropriation: YES Fiscal Committee: YES Local Program: YES

The people of the State of California do enact as follows:

SECTION 1.

Section 2881.2 of the Business and Professions Code is amended to read:

2881.2.

(a) The approval process for a school or program shall be consistent with the following timelines:

(1) (A) Upon receipt of a letter of intent to submit an application for approval as a school or program of licensed vocational nursing, the board shall notify the proposed school or program of the steps in the approval process and provide an estimated wait time until active assignment to a nursing education consultant.

(B) Upon active assignment of a nursing education consultant, the school or program shall submit an initial application for approval within 60 days.

(2) (A) Within 30 days of the date the board receives an initial application for approval, the board shall notify the school or program whether the application is complete.

(B) A notice that an initial application is not complete shall specify what additional documents or payment of fees the school or program is required to submit to the board to make the application complete.

(3) Within 60 days from the date the board notifies the school or program that the initial application is not complete, the school or program shall provide the missing information. If a school or program fails to submit the required information, the board shall take the application out of consideration consistent with subdivision (c) of Section 2881.3. The board may provide a school or program with an additional 30 days to complete its application.

(4) Within six months of the date the board receives an initial application for approval as a school or program, the board shall approve the school or program, deny approval, or notify the school or program that corrective action is required.

(b) A school or program of vocational nursing seeking approval by the board shall remit to the board for deposit in the Vocational Nursing and Psychiatric Technicians Fund fees in accordance with the following schedule:

(1) The nonrefundable initial application fee shall be in an amount equal to the reasonable costs incurred by the board in reviewing and processing the application up to five thousand dollars ($5,000).

(2) (A) Except as provided in subparagraph (B), the final approval fee shall be in an amount equal to the reasonable costs incurred by the board in the application approval process up to fifteen thousand dollars ($15,000).

(B) The final approval fee for an applicant program that meets all of the following criteria shall be in an amount equal to the reasonable costs incurred by the board in the application approval process up to five thousand dollars ($5,000):

(i) The program is affiliated with an approved school or program that is in good standing.

(ii) The program utilizes the curriculum and policies approved by the board for the approved school or program.

(3) The continuing approval fee shall be in an amount equal to the reasonable costs incurred by the board in providing oversight and review of a school or program up to five thousand dollars ($5,000) once every four years.

(c) If the board makes an initial determination that the cost of providing oversight and review of a school or program under this section is less than the amount of any fees required to be paid by that school or program, the board shall decrease the fees applicable to that institution to an amount that is proportional to the board’s reasonable costs associated with that school or program.

(d) The board may reduce the continuing approval fees, by no more than one-half of the established fee, for a program that experiences a reduction in enrollment capacity that directly leads to a reduction in state funding. The board shall require a program to provide documentation for the purposes of issuing the fee reduction.

(e) (1) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the board shall, without taking any further regulatory action, implement, interpret, or make specific this section by means of provider bulletins or similar instructions until emergency regulations are adopted pursuant to paragraph (2). The board shall provide written notice 30 days prior to the adoption of any instruction under this paragraph and post the notice on its internet website. It is the intent of the Legislature that the board have temporary authority as necessary to implement program changes until completion of the regulatory process.

(2) The board shall adopt emergency regulations no later than June 30, 2022. The adoption of regulations shall be deemed an emergency and necessary to avoid serious harm to the public peace, health, safety, or general welfare within the meaning of Section 11342.545 of the Government Code, and the board need not make a written finding of emergency as required by Section 11346.1 of the Government Code. Notwithstanding subdivisions (e) and (h) of Section 11346.1 of the Government Code, the board may annually readopt any emergency regulation authorized by this section that is the same as or substantially equivalent to an emergency regulation previously adopted pursuant to this section until January 1, 2024.

(3) The initial adoption of emergency regulations and the readoption of emergency regulations authorized by this section shall be submitted to the Office of Administrative Law for filing with the Secretary of State. The emergency regulations shall remain in effect for no more than one year from the date any regulation became effective as an emergency regulation.

(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.

SEC. 2.

Section 2987 of the Business and Professions Code is amended to read:

2987.

The amount of the fees prescribed by this chapter shall be determined by the board, and shall be as follows:

(a) The application fee for a psychologist shall be two hundred thirty-six dollars ($236).

(b) The examination and reexamination fees for the examinations shall be the actual cost to the board of developing, purchasing, and grading of each examination, plus the actual cost to the board of administering each examination.

(c) The application fee for the California Psychology Law and Ethics Examination (CPLEE) shall be one hundred twenty-seven dollars ($127).

(d) The initial license fee for a psychologist shall be two hundred thirty-one dollars ($231).

(e) The biennial renewal fee for a psychologist shall be seven hundred ninety-five dollars ($795). The board may adopt regulations to set the fee at a higher amount, up to a maximum of one thousand one hundred dollars ($1,100).

(f) The application fee for registration as a registered psychological associate under Section 2913 shall be four hundred twenty-four dollars ($424).

(g) The annual renewal fee for registration of a psychological associate shall be two hundred twenty-four dollars ($224). The board may adopt regulations to set the fee at a higher amount, up to a maximum of four hundred dollars ($400).

(h) The duplicate license or registration fee is five dollars ($5).

(i) The delinquency fee is 50 percent of the renewal fee for each license type, not to exceed three hundred ninety-seven dollars and fifty cents ($397.50).

(j) The endorsement fee is five dollars ($5).

(k) The file transfer fee is ten dollars ($10).

(l) The registration fee for a psychological testing technician shall be seventy-five dollars ($75).

(m) The annual renewal fee for a psychological testing technician is seventy-five dollars ($75).

(n) The fee for Fingerprint Hard Card Processing for Out of State Applicants shall be one hundred eighty-four dollars ($184). Applicants shall also pay the actual cost to the board of processing the fingerprint hard card with the Department of Justice and Federal Bureau of Investigation.

(o) The fee for a psychological associate to add or change their supervisor shall be two hundred ten dollars ($210). The fee shall be the actual cost to the board of processing the addition or change.

(p) Notwithstanding any other provision of law, the board may reduce any fee prescribed by this section, when, in its discretion, the board deems it administratively appropriate.

SEC. 3.

Section 2988 of the Business and Professions Code is amended to read:

2988.

A licensed psychologist who for reasons, including, but not limited to, retirement, ill health, or absence from the state, is not engaged in the practice of psychology, may apply to the board to request that their license be placed on an inactive status. A licensed psychologist who holds an inactive license shall pay a biennial renewal fee, fixed by the board, of two hundred twenty-one dollars ($221). The board may adopt regulations to set the fee at a higher amount, up to a maximum of four hundred dollars ($400). A psychologist holding an inactive license shall be exempt from continuing education requirements specified in Section 2915, but shall otherwise be subject to this chapter and shall not engage in the practice of psychology in this state. Licensees on inactive status who have not committed any acts or crimes constituting grounds for denial of licensure and have completed the continuing education requirements specified in Section 2915 may, upon their request, have their license to practice psychology placed on active status.

SEC. 4.

Section 4119.01 of the Business and Professions Code is amended to read:

4119.01.

(a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that is also an emergency medical services provider agency, may restock dangerous drugs or dangerous devices into an emergency medical services automated drug delivery system (EMSADDS) that is licensed by the board under this section. Dangerous drugs and dangerous devices stored or maintained in an EMSADDS shall be used for the sole purpose of restocking a secured emergency pharmaceutical supplies container as authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of the following conditions are met:

(A) As part of its license application, the emergency medical services provider agency shall provide: the address where the EMSADDS will be located; the name of the medical director responsible for overseeing the emergency medical services provider agency; the name of any designated pharmacist or licensed designated paramedic who is responsible for performing the duties as required under this section; the policies and procedures detailing the provisions under which the EMSADDS will operate; and the name and license number of the pharmacy or emergency medical services provider agency wholesaler that will furnish the dangerous drugs and dangerous devices through the EMSADDS.

(B) The application and initial license fee to operate EMSADDS shall be one hundred dollars ($100) per machine. The license shall be renewed annually. The license fee may not be transferred to a different location if the EMSADDS is moved. The penalty fee for failure to renew an EMSADDS license shall be thirty-five dollars ($35).

(C) The application and renewal fee for a licensed wholesaler that is also an emergency medical services provider agency shall be seven hundred eighty dollars ($780).

(2) Each EMSADDS shall collect, control, and maintain all transaction information necessary to accurately track the movement of drugs into and out of the system for purposes of security, accuracy, and accountability.

(3) The medical director and designated pharmacist, or the medical director and the licensed designated paramedic, shall develop, adopt, and maintain policies and procedures detailing the provisions under which the EMSADDS will operate. At a minimum, the policies and procedures shall address (A) inventory controls, (B) training, (C) storage and security of the dangerous drugs and dangerous devices, and (D) safeguards to limit access to the EMSADDS to authorized staff only.

(4) The licensed EMSADDS operator shall limit access to the EMSADDS only to employees of the operator who are licensed by the state and as authorized in this section.

(A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a licensed designated paramedic, each of whom may possess and transport dangerous drugs or dangerous devices for that purpose. The transport of dangerous drugs or dangerous devices for restocking into an EMSADDS shall be done in a secured manner to prevent theft or unauthorized access, and shall be done under conditions appropriate to meet storage and handling requirements of the dangerous drugs or dangerous devices. While the dangerous drugs or dangerous devices may be transported, representatives shall not store a dangerous drug or dangerous device at an unlicensed location.

(B) Only a medical director, a pharmacist, or a paramedic may remove dangerous drugs or dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical supplies container. This access shall be observed by a second person who is also a paramedic, a pharmacist, or a medical director. Both the individual who removes dangerous drugs or dangerous devices from the EMSADDS and the observer shall record their participation in the removal of the dangerous drugs or dangerous devices via their signatures or use of biometric identifiers. The restocking of the secured emergency pharmaceutical supplies container from the EMSADDS shall occur at the licensed location of the EMSADDS.

(C) A medical director, a pharmacist, or a licensed designated paramedic may remove outdated dangerous drugs or dangerous devices from an EMSADDS. Any outdated dangerous drugs or dangerous devices shall be provided to a licensed reverse distributor for destruction.

(5) Every EMSADDS operator shall perform monthly inventory and inventory reconciliation functions. The medical director, designated pharmacist, or licensed designated paramedic shall perform a reconciliation and prepare a written report based on written policies and procedures developed to maintain the security and quality of the dangerous drugs and dangerous devices. The written inventory reconciliation report shall include all of the following:

(A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS.

(B) A review of all dangerous drugs and dangerous devices added into and removed from each EMSADDS since the last monthly inventory.

(D) A review of all individuals who accessed the EMSADDS since the last inventory and identification of unauthorized individuals accessing the EMSADDS or suspicious activity.

(E) Identification of possible causes of shortages and overages.

(6) The medical director and designated pharmacist, or medical director and licensed designated paramedic, shall be jointly responsible for monthly review of the inventory reconciliation report, the training, storage, and security of dangerous drugs and dangerous devices, and the restocking of the EMSADDS. Any inventory losses from an EMSADDS shall be reported to the board within seven days from identification of the loss.

(7) In order for an individual to perform the functions of a licensed designated paramedic described in this section, that individual shall be licensed by the board pursuant to Section 4202.5. A paramedic who only restocks a secured emergency pharmaceutical supplies container from an EMSADDS need not be licensed with the board.

(8) A record of each access to the EMSADDS, as well as all records used to compile an inventory reconciliation report, shall be maintained at the operator’s location for at least three years in a readily retrievable form. The records shall include the identity of every individual who accessed the system or witnessed such access; the date of each access; and the drug, dosage, form, strength, and quantity of dangerous drugs or dangerous devices added or removed.

(b) A violation of any of the provisions of this section shall constitute unprofessional conduct and provides the board the authority to take action against the EMSADDS operator’s license.

SEC. 5.

Section 4119.01 is added to the Business and Professions Code, to read:

4119.01.

(1) The emergency medical services provider agency obtains a license from the board to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be located on the premises of a fire department headquarters, a fire station, or at an emergency medical services provider agency’s location. A separate license shall be required for each location. As part of its license application, the emergency medical services provider agency shall provide: the address where the EMSADDS will be located; the name of the medical director responsible for overseeing the emergency medical services provider agency; the name of any designated pharmacist or licensed designated paramedic who is responsible for performing the duties as required under this section; the policies and procedures detailing the provisions under which the EMSADDS will operate; and the name and license number of the pharmacy or emergency medical services provider agency wholesaler that will furnish the dangerous drugs and dangerous devices through the EMSADDS.

(4) The licensed EMSADDS operator shall limit access to the EMSADDS only to employees of the operator who are licensed by the state and as authorized in this section.

(A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS.

(B) A review of all dangerous drugs and dangerous devices added into and removed from each EMSADDS since the last monthly inventory.

(D) A review of all individuals who accessed the EMSADDS since the last inventory and identification of unauthorized individuals accessing the EMSADDS or suspicious activity.

(E) Identification of possible causes of shortages and overages.

(b) A violation of any of the provisions of this section shall constitute unprofessional conduct and provides the board the authority to take action against the EMSADDS operator’s license.

SEC. 6.

Section 4119.11 of the Business and Professions Code is amended to read:

4119.11.

(a) A pharmacy located in the state may provide pharmacy services to the patients of a “covered entity,” as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:

(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.

(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.

(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.

(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.

(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.

(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.

(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.

(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.

(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.

(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.

(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.

(b) For purposes of this section, the following definitions shall apply:

(1) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.

(2) An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist.

(3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions.

(c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.

(2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.

(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient, if all of the following requirements are met:

(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:

(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.

(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.

(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.

(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.

(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.

(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system if the automated patient dispensing system is disabled or malfunctions.

(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).

(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.

(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.

(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions.

(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.

(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.

(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.

(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125.

(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.

(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.

(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.

(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.

(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility, if all of the following conditions are met:

(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.

(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.

(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.

(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. A pharmacist shall conduct the review on a monthly basis, which shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.

(i) A pharmacy holding an automated patient dispensing system license shall complete a self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.

(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records.

(k) This section shall be repealed on January 1, 2025.

SEC. 7.

Section 4119.11 is added to the Business and Professions Code, to read: