AB 1533

Bill Subjects

Abstract

(1) Existing law, the Pharmacy Law, provides for the licensure and regulation of the practice of pharmacy by the 13-member California State Board of Pharmacy, which is within the Department of Consumer Affairs. Existing law requires the Governor to appoint 7 competent pharmacists who reside in different parts of the state to serve as members of the board. Existing law requires the membership of the board to include at least one pharmacist representative from each of specified practice settings. Existing law authorizes the appointment of 6 public members, 4 of whom are appointed by the Governor, and the Senate Committee on Rules and the Speaker of the Assembly each appoint a public member, as prescribed. These provisions are repealed as of January 1, 2022. Under other existing law with respect to the department and its constituent boards, an appointing authority has power to remove from office at any time any member of any board appointed by the appointing authority for continued neglect of duties required by law, or for incompetence, or unprofessional or dishonorable conduct. This bill would require, in lieu of competence, that the Governor's pharmacist appointees to the board be licensees in good standing. The bill would specify that each appointing authority for the board has power to remove from office at any time any member of the board appointed by that authority for the reasons specified above. The bill, with regard to the practice settings represented on the board, would require at least one pharmacist representative from a compounding pharmacy specializing in human drug preparations. The bill would extend the repeal of those provisions to January 1, 2026. Existing law requires the principal office of the board to be located in Sacramento and requires the board to hold a meeting at least once in every 4 months. This bill would authorize members of the board to meet by teleconference, as prescribed. Existing law, until January 1, 2022, authorizes the board, with the approval of the Director of Consumer Affairs, to appoint a person exempt from civil service to be designated as an executive officer and to exercise the powers and perform the duties delegated by the board and vested in them by existing law. Under existing law, the board determines whether the executive officer is a member of the board. This bill would prohibit the executive officer from being a member of the board. The bill would extend the repeal of the board's executive officer provisions to January 1, 2026. (2) Existing law generally authorizes a pharmacist to dispense or furnish drugs only pursuant to a valid prescription, except as provided, such as existing authority to initiate and administer COVID-19 vaccinations and initiate and furnish HIV prophylaxis, as specified. This bill would authorize a pharmacist to initiate, adjust, or discontinue drug therapy for a patient under a collaborative practice agreement with any health care provider with prescriptive authority, as specified. The bill would authorize a pharmacist to provide medication-assisted treatment pursuant to a state protocol, to the extent authorized by federal law. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. Existing law authorizes a pharmacist recognized by the board as an advanced practice pharmacist to take certain actions, including initiating, adjusting, or discontinuing therapy in a specified manner. This bill would authorize an advanced practice pharmacist to initiate, adjust, or discontinue drug therapy without specifying the manner of such actions. (3) Existing law generally makes it unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription of a prescriber unless the person is a licensed pharmacist. Existing law authorizes the board to issue certain other licenses for activities relating to pharmacy, including a designated representative to provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer, a designated representative-3PL to provide sufficient and qualified supervision of a third-party logistics provider's place of business, and a designated representative-reverse distributor to provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. Existing law requires as a condition of licensure for each of these other licenses that the applicant be a high school graduate or possess a general education development certificate equivalent. This bill, with regard to that education requirement, would alternatively permit the applicant to have earned a degree from an accredited postsecondary institution. (4) Existing law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system (ADDS) , as defined, owned and operated by the pharmacy that need not be located at the same location as the pharmacy. Existing law prohibits the installation or operation of an ADDS unless the ADDS meets prescribed requirements, including that an ADDS be placed and operated in one of prescribed locations inside an enclosed building, as approved by the board. Existing law also authorizes specified licensed health clinics, including nonprofit and free clinics, to use an ADDS, operated under the authorization of a pharmacist, and under which the clinic is responsible for the safety and security of the drugs in the system. Existing law requires a pharmacy holding an ADDS license to complete an annual self-assessment, performed pursuant to specified regulations, evaluating the pharmacy's compliance with pharmacy law relating to the use of the ADDS. Existing law defines an "automated unit dose system" (AUDS) as an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. Existing law also provides a program to authorize a pharmacy located in the state to provide pharmacy services to the patients of covered entities, as defined, that are eligible for discount drug programs under federal law, as specified, through the use of an automated patient dispensing system (APDS) , as defined. Existing law requires a pharmacy holding an APDS license to complete an annual self-assessment, performed pursuant to specified regulations, evaluating the pharmacy's compliance with pharmacy law relating to the use of the APDS. This bill would authorize the location and operation of an AUDS in those locations authorized for an ADDS and, additionally, in a state-licensed facility with the statutory authority to provide pharmaceutical services or in a jail, youth detention facility, or other correctional facility where drugs are administered within the facility under the authority of the medical director. The bill would impose requirements for the operation of an AUDS. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. The bill would remove the requirements that the ADDS and APDS license self-assessments be annual. (5) Existing law requires a pharmacy that compounds sterile drug products to possess a sterile compounding pharmacy license, as provided. Existing law establishes procedures for the issuance of a cease and desist order to such a pharmacy that poses an immediate threat to the public health or safety. Those procedures authorize the owner to request a hearing to contest the order. Existing law requires such a hearing to be held no later than 5 days from the date the request of the owner is received by the board and requires the president of the board to render a written decision within 5 days of the hearing. Existing law establishes similar cease and desist order provisions for an outsourcing facility compounding sterile drug products or nonsterile drug products. Existing law also establishes similar cease and desist order provisions for unlicensed facilities. This bill would modify those hearing and decision deadlines to be 5 business days. (6) Existing law requires the board to license an outsourcing facility, as defined. Existing law requires an outsourcing facility to be licensed with the board before doing business within or into the state. Existing law prohibits an outsourcing facility from performing the duties of a pharmacy, such as filling individual prescriptions. Under this bill, in lieu of that prohibition, an outsourcing facility licensed by the board dispensing patient-specific compounded preparations pursuant to a prescription for an individual patient would not be required to be licensed as a pharmacy, but would otherwise be required to comply with the same requirements of a pharmacy. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. (7) Existing law requires a person located outside this state that ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into this state or sells, brokers, warehouses, or distributes dangerous drugs or devices within this state to be considered a nonresident wholesaler or a nonresident third-party logistics provider and requires such a wholesaler or provider to be licensed and comply with specific requirements. Existing law requires a nonresident wholesaler or nonresident third-party logistics provider to maintain a valid, unexpired license, permit, or registration to conduct the business of the wholesaler or nonresident third-party logistics provider in compliance with the laws of the state in which it is a resident and requires a license application to include a license verification from the licensing authority in the applicant's state of residence. This bill would authorize the board to waive the home state licensure requirement for a nonresident third-party logistics provider if the board inspects the location and finds it to be in compliance with existing requirements and any regulations adopted by the board or the applicant provides evidence of its accreditation by the Drug Distributor Accreditation program of the National Association of Boards of Pharmacy. The bill would require the nonresident third-party logistics provider to reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the location, as prescribed. (8) Existing law establishes specific provisions for applications for different categories of license, including grounds for denial. Other existing law relating to the powers of the department's constituent boards restricts the authority of a board within the department to deny a license, establishing prescribed circumstances under which denial is authorized for an applicant convicted of a crime or subjected to formal discipline. Existing law also requires such a board to follow established procedures for requesting or acting on an applicant's criminal history information. This bill, notwithstanding these restrictions and procedural requirements, would specifically authorize the board to deny an application for licensure if the applicant has been convicted of a crime or subjected to formal discipline that would be grounds for denial of a federal registration to distribute controlled substances. (9) Existing law prohibits the board from renewing a pharmacist license unless the applicant submits proof satisfactory to the board that they have successfully completed 30 hours of approved courses of continuing pharmacy education during the 2 years preceding the application for renewal. Existing law imposes requirements for the form and subject matter of the courses. This bill, commencing July 1, 2022, would require a pharmacist who prescribes a Schedule II controlled substance to have completed an education course on the risks of addiction associated with the use of Schedule II drugs. The bill would require that a pharmacist who has completed such a course within the last 4 years be deemed to have satisfied this requirement. (10) Existing law establishes requirements for disciplinary proceedings on, among other things, the suspension or revocation of licenses. This bill would require the board, by July 1, 2023, to convene a workgroup of interested stakeholders to discuss whether moving to a standard of care enforcement model would be feasible and appropriate for the regulation of pharmacy and make recommendations to the Legislature about the outcome of these discussions through a report submitted as prescribed. (11) Existing law authorizes the board to issue citations containing fines and orders of abatement for violations of specified law, as provided, including, where appropriate, the imposition of an administrative fine. This bill would prohibit such an administrative fine from being construed as a disciplinary action or discipline for purposes of licensure or the reporting of discipline for licensure. (12) Existing law establishes penalties for specific violations and provides for the recovery of those penalties by a civil action or by criminal prosecution. Unless another penalty is provided, a knowing violation of existing law is a misdemeanor and other violations are infractions, punishable as specified. This bill would authorize the board to bring an action for fines for 3rd or subsequent violations of materially similar provisions of existing law within 5 years by 3 or more pharmacies operating under common ownership or management within a chain community pharmacy, as defined, with a cap of $100,000 for a 3rd or subsequent violation. The bill would also authorize the board to bring an action against a chain community pharmacy operating under common ownership or management for fines, capped at $150,000, for any violation of existing law demonstrated to be the result of a written policy or which was expressly encouraged by the common owner or manager. The bill would also provide specified limitations and defenses to these actions, and describe the manner in which the fines are to be imposed. The bill would also require the board to provide information to the Legislature about these actions, as specified. (13) Existing law prohibits a person from conducting a pharmacy in this state without a license from the board and existing law requires this license to be renewed annually. Existing law requires a pharmacy that compounds sterile drug products to possess a sterile compounding pharmacy license, provides certain requirements for obtaining the license, and requires the license to be renewed annually. This bill would prohibit a pharmacy license from being renewed unless the applicant includes necessary matters identified by the board in the renewal application, as provided. This bill would also require a pharmacy located in California that distributes compounded human drug preparations interstate to meet certain conditions, including that the pharmacy must report information as specified and certify that the reporting requirements are satisfied in connection with and as a condition of renewal of the pharmacy's license. By expanding the crime of perjury, the bill would impose a state-mandated local program. (14) 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. (15) Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest. This bill would make legislative findings to that effect.