Section § 4130

Explanation

This law allows the use of telepharmacy systems to dispense prescription drugs and offer counseling services at remote locations. A license to operate such a remote dispensing site can be issued if the area is medically underserved, which means there isn't a nearby pharmacy within 10 miles. These sites must be staffed only by licensed pharmacists or technicians. They can't operate in or displace state facilities or employees, and there's a one-license limit per supervising pharmacy. If a remote site dispenses more than 225 prescriptions daily, it must transition to a full-service pharmacy.

(a)CA Business & Professions Code § 4130(a) A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)CA Business & Professions Code § 4130(b) If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)Copy CA Business & Professions Code § 4130(c)
(1)Copy CA Business & Professions Code § 4130(c)(1) A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a “medically underserved area” means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)CA Business & Professions Code § 4130(c)(2) Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)CA Business & Professions Code § 4130(d) A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)CA Business & Professions Code § 4130(e) A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.
(f)CA Business & Professions Code § 4130(f) A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)CA Business & Professions Code § 4130(g) A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
(h)CA Business & Professions Code § 4130(h) If a remote dispensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.

Section § 4131

Explanation

This law outlines the requirements for providing telepharmacy services between a supervising pharmacy and a remote dispensing site pharmacy. A supervising pharmacy can only oversee one remote site and must be within 150 road miles unless otherwise approved. Both pharmacies must have the same owner. The remote site should have at least one qualified pharmacy technician if no pharmacist is present, and they must be supervised by a pharmacist using technology. The same pharmacist can be in charge of both locations, and both pharmacies must be adequately staffed to ensure safe operation.

(a)CA Business & Professions Code § 4131(a) A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.
(b)CA Business & Professions Code § 4131(b) A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)CA Business & Professions Code § 4131(c) A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(d)CA Business & Professions Code § 4131(d) Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)CA Business & Professions Code § 4131(e) Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.
(f)CA Business & Professions Code § 4131(f) Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.

Section § 4132

Explanation

This law outlines the requirements for pharmacy technicians working at remote dispensing sites in California. To qualify, technicians must have a valid pharmacy technician license, certification from an approved program, and either an associate's degree in pharmacy technology, a bachelor's degree, or completion of a specified training course. Additionally, they must have at least 2,000 hours of experience within the past two years. While at these sites, technicians can perform basic tasks under a pharmacist's supervision through a telepharmacy system but cannot perform tasks that require professional judgment or involve direct consultation with patients or prescribers. A supervising pharmacist can oversee up to two technicians at each site.

(a)CA Business & Professions Code § 4132(a) In addition to the requirements of Section 4202, a pharmacy technician shall satisfy each of the following requirements before working at a remote dispensing site pharmacy:
(1)CA Business & Professions Code § 4132(a)(1) Possess a pharmacy technician license that is in good standing.
(2)CA Business & Professions Code § 4132(a)(2) Possess and maintain a certification issued by a board-approved pharmacy technician certification program.
(3)CA Business & Professions Code § 4132(a)(3) Possess one of the following:
(A)CA Business & Professions Code § 4132(a)(3)(A) A minimum of an associate degree in pharmacy technology.
(B)CA Business & Professions Code § 4132(a)(3)(B) A minimum of a bachelor’s degree in any subject.
(C)CA Business & Professions Code § 4132(a)(3)(C) A certificate of completion from a course of training specified by regulations adopted by the board pursuant to Section 4202.
(4)CA Business & Professions Code § 4132(a)(4) Complete a minimum of 2,000 hours of experience working as a pharmacy technician within the two years preceding first commencing work in the remote dispensing site pharmacy.
(b)CA Business & Professions Code § 4132(b) Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)CA Business & Professions Code § 4132(c) A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)CA Business & Professions Code § 4132(c)(1) Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)CA Business & Professions Code § 4132(c)(2) Consult with a patient or their agent regarding a prescription, either before or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)CA Business & Professions Code § 4132(c)(3) Identify, evaluate, or interpret a prescription.
(4)CA Business & Professions Code § 4132(c)(4) Interpret the clinical data in a patient medication record system or patient chart.
(5)CA Business & Professions Code § 4132(c)(5) Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)CA Business & Professions Code § 4132(c)(6) Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)CA Business & Professions Code § 4132(c)(7) Perform any function that requires the professional judgment of a licensed pharmacist.
(8)CA Business & Professions Code § 4132(c)(8) Compound drug preparations.
(d)CA Business & Professions Code § 4132(d) Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacist’s ability to also supervise pharmacy technicians at the supervising pharmacy.

Section § 4133

Explanation

This law is about telepharmacy systems, which allow prescriptions to be filled remotely under supervision. It requires proper communication tools, like audio and video, to link the main pharmacy with remote locations. Before delivering any medication, pharmacists must review and approve it, and barcode technology should be used to ensure accuracy. Counseling for patients must be done via secure audio-visual means before they receive their medication. All actions and records related to prescriptions must be stored securely for at least three years, and everything must comply with privacy laws.

(a)CA Business & Professions Code § 4133(a) A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients.
(b)CA Business & Professions Code § 4133(b) A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)CA Business & Professions Code § 4133(c) Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.
(d)CA Business & Professions Code § 4133(d) A telepharmacy system shall be able to do all of the following:
(1)CA Business & Professions Code § 4133(d)(1) Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)CA Business & Professions Code § 4133(d)(2) Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)CA Business & Professions Code § 4133(d)(3) Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)CA Business & Professions Code § 4133(d)(4) Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)CA Business & Professions Code § 4133(d)(5) Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)CA Business & Professions Code § 4133(e) The video and audio communication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)CA Business & Professions Code § 4133(f) All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.

Section § 4134

Explanation

This law requires pharmacists to conduct monthly inspections and maintain a continuous inventory of controlled substances at remote dispensing sites to prevent loss. Controlled substances must be stored securely, and any inventory discrepancies must be reported and addressed. Regular reconciliation reports, including detailed checks of all Schedule II drugs, must be compiled every three months, reviewed, and kept on file for at least three years. If there's a loss of drugs, it's crucial to report it within specified timeframes and investigate the cause. Reports of any discrepancies or overages must be well-documented and signed by responsible parties.

(a)CA Business & Professions Code § 4134(a) A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)CA Business & Professions Code § 4134(b) A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)CA Business & Professions Code § 4134(c) All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)CA Business & Professions Code § 4134(d) A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)CA Business & Professions Code § 4134(e) The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)CA Business & Professions Code § 4134(f) A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)CA Business & Professions Code § 4134(f)(1) A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)CA Business & Professions Code § 4134(f)(2) A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)CA Business & Professions Code § 4134(f)(3) A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)CA Business & Professions Code § 4134(f)(4) All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)CA Business & Professions Code § 4134(g) A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.
(h)CA Business & Professions Code § 4134(h) Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)CA Business & Professions Code § 4134(i) The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.

Section § 4135

Explanation

This law sets rules for remote pharmacy locations that aren't always open. They need an alarm or monitoring system to protect their drugs and equipment when closed. Employees can't enter unless a pharmacist is there or available through telepharmacy. They also need a record of who comes in and out, which the head pharmacist should check regularly. Additionally, these locations must keep surveillance recordings (minus patient talks) for 120 days.

(a)CA Business & Professions Code § 4135(a) While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)CA Business & Professions Code § 4135(b) Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.
(c)CA Business & Professions Code § 4135(c) The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.