Pharmacy: remote dispensing site pharmacy: telepharmacy: shared clinic office space.

Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies. This bill would require the board to issue a remote dispensing site pharmacy license to a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would require a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would prohibit pharmacy services from being provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for one remote dispensing site pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified secure communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees. The bill would require a remote dispensing site pharmacy that dispenses more than 225 prescriptions per day, calculated each calendar year, to cease being a remote dispensing site pharmacy and authorizes the remote dispensing site pharmacy to become a full-service pharmacy if it meets all the requirements for licensure as a pharmacy. Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist. This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist. Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacy's compliance with all state and federal laws pertaining to the practice of pharmacy. This bill would authorize a pharmacist to serve as a pharmacist-in-charge of a pharmacy in addition to serving as a pharmacist-in-charge of a supervising pharmacy and would require the designated pharmacist-in-charge of the supervising pharmacy to also serve as the designated pharmacist-in-charge of the remote dispensing site pharmacy. The bill would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified. Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified. This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy. Existing law prohibits a person from acting as a wholesaler of any dangerous drug or dangerous device unless the wholesaler has obtained a license from the board. Subject to certain exceptions, existing federal law requires a person, who manufactures, distributes, dispenses, imports, or exports any controlled substance to obtain a registration and requires a registrant to inform the United States Drug Enforcement Administration of any suspicious orders. This bill would require a wholesaler to notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Existing law prohibits the board from issuing more than one site license to a single premises, except as specified. This bill, until January 1, 2021, would authorize the board to issue specified licenses to 2 independently owned clinics that share a clinic office space, as specified. The bill would make each clinic jointly and severally responsible for drug losses. The bill would require the applicants to provide the board with a copy of the co-location agreement and a one-time application fee of $750 for the licenses. The bill would require a new application and specified fees for any change in ownership in either clinic. The bill would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues have been sufficiently addressed, as specified. The bill would authorize the Department of Health Care Services to seek any federal approvals it deems necessary to implement this provision. The bill also would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed, as specified. Under existing law, the State Department of Public Health is responsible for the licensing and regulation of clinics, as defined. Existing law exempts from the licensing and regulation provisions any clinic directly conducted, maintained, or operated by the United States or by any of its departments, offices, or agencies, and specified primary care clinics directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city. This bill, until January 1, 2021, would authorize primary care clinics and specialty clinics to operate, as specified, in shared clinic space with the government clinics specified above. The bill would authorize the department to enter and inspect the shared space at any time, as specified. The bill would make the licensed primacy care clinic or specialty clinic responsible for any statutory or regulatory violations occurring on the premises. The bill would authorize the department to implement, interpret, or make specific these provisions by means of all-facility letters, or similar instructions, without taking regulatory action. Existing law makes a violation of any provision of the Pharmacy Law punishable as a crime. By expanding the scope of an existing crime, this bill would result in a state-mandated local program. This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by SB 752 to be operative only if this bill and SB 752 are enacted and this bill is enacted 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.