Code Section Group

Business and Professions Code - BPC

DIVISION 2. HEALING ARTS [500 - 4999.129]

  ( Division 2 enacted by Stats. 1937, Ch. 399. )

CHAPTER 9. Pharmacy [4000 - 4426]

  ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. )

ARTICLE 8. Telepharmacy Systems and Remote Dispensing Site Pharmacies [4130 - 4135]
  ( Article 8 added by Stats. 2017, Ch. 548, Sec. 7. )

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) 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) (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) 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) A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.

(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) 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) A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.

(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.

(Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

4131.
  

(a) A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.

(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) A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.

(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) 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) 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.

(Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

4132.
  

(a) In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall meet the qualifications promulgated by the board. The regulations developed by the board shall only apply to pharmacy technicians working at remote dispensing sites.

(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) A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:

(1) Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.

(2) Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.

(3) Identify, evaluate, or interpret a prescription.

(4) Interpret the clinical data in a patient medication record system or patient chart.

(5) Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.

(6) Supervise the packaging of drugs and check the packaging procedure and product upon completion.

(7) Perform any function that requires the professional judgment of a licensed pharmacist.

(8) Compound drug preparations.

(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.

(Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

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) 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) Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.

(d) A telepharmacy system shall be able to do all of the following:

(1) Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.

(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) Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.

(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) 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) 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) 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.

(Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

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) A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.

(c) All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.

(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) 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) 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) 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) A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.

(3) A comparison of paragraphs (1) and (2) in order to determine if there are any variances.

(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) 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) Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.

(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.

(Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

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) 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) The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.

(Added by Stats. 2017, Ch. 548, Sec. 7. (AB 401) Effective January 1, 2018.)

BPCBusiness and Professions Code - BPC8.