CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 401

Introduced by Assembly Member Aguiar-Curry

February 09, 2017

An act to amend Sections 4059.5 and 4181 of, to add Sections 4044.3, 4044.6, and 4044.7 to, and to add Article 8 (commencing with Section 4130) to Chapter 9 of Division 2 of, the Business and Professions Code, relating to pharmacy.


LEGISLATIVE COUNSEL'S DIGEST


AB 401, as introduced, Aguiar-Curry. Pharmacy: remote dispensing site pharmacy: telepharmacy.
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 for certain purposes and authorizes the board to establish, by regulation, locations eligible for a remote dispensing site pharmacy, as specified. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to 3 remote dispensing site pharmacies and requires a pharmacist from the supervising pharmacy to, among other things, be capable of being on site at the remote dispensing pharmacy within 6 hours. The bill would require a remote dispensing site pharmacy to utilize specified security communications systems and security systems.
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 authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order.
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 no more than 3 remote dispensing site pharmacies, in addition to serving as a pharmacist-in-charge of a supervising pharmacy, and 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 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 makes a violation of any of its provisions punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
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: NO   Fiscal Committee: YES   Local Program: YES  

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


SECTION 1.

 Section 4044.3 is added to the Business and Professions Code, to read:

4044.3.
 “Remote Dispensing Site Pharmacy” means a licensed pharmacy that is operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.

SEC. 2.

 Section 4044.6 is added to the Business and Professions Code, to read:

4044.6.
 “Supervising pharmacy” means a licensed pharmacy that oversees the activities of a remote dispensing site pharmacy.

SEC. 3.

 Section 4044.7 is added to the Business and Professions Code, to read:

4044.7.
 “Telepharmacy” means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.

SEC. 4.

 Section 4059.5 of the Business and Professions Code is amended to read:

4059.5.
 (a) Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b) A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate user’s agent.
(c) Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d) Notwithstanding any other provision of law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e) A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f) Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1) The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2) Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3) The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4) The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5) The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g) Notwithstanding subdivision (a), dangerous drugs and devices may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site.

SEC. 5.

 Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:
Article  8. Telepharmacy and Remote Dispensing Site Pharmacies

4130.
 (a) 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 site is to be located.
(b) In order to further the goal of increasing access to dispensing and pharmaceutical care services, the board may establish, by regulation, locations eligible for a remote dispensing site pharmacy license that shall include medically underserved areas and populations and health profession shortage areas, as determined by the federal Department of Health and Human Services, the federal Health Resources and Services Administration, and health care facilities and clinics regulated by the state.

4131.
 (a) A pharmacy located in this state may serve as a supervising pharmacy to provide telepharmacy services for up to three remote dispensing site pharmacies.
(b) 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 electronically from the supervising pharmacy.
(c) Notwithstanding any law, a pharmacist may serve as the pharmacist-in-charge for no more than three remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.
(d) Notwithstanding any 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.
(e) A pharmacist from the supervising pharmacy shall be capable of being on site at the remote dispensing pharmacy within six hours of notice that his or her presence is required.

4132.
 (a) 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.
(b) In order to qualify to work at a remote dispensing site pharmacy, a registered pharmacy technician shall meet all additional qualifications as established by the board through regulation.
(c) 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.

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) The 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) The remote dispensing site shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 30 days.
(d) 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).
(e) The board shall certify acceptable video and audio communication systems for use in remote dispensing sites.

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) An audit of at least three controlled substances at the remote dispensing site pharmacy shall be completed and documented quarterly by a pharmacist from the supervising pharmacy.

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.
(c) If controlled substances are maintained or dispensed from the remote dispensing site pharmacy, the remote dispensing site pharmacy shall comply with all applicable state and federal requirements for the security and recordkeeping requirements of controlled substances.

SEC. 6.

 Section 4181 of the Business and Professions Code is amended to read:

4181.
 (a) Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health relating to the drug distribution service to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator.
(b) The dispensing of drugs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. regulations, including, but not limited to, Article 8 (Commencing with Section 4130).

SEC. 7.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.