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Statutory Changes in Pharmacy Law Marcarian Law Firm
Statutory Changes in Pharmacy Law
Unless otherwise noted, the provisions take effect January 1, 2024.
Underline text is added language, Strikethrough text is deleted language.
Business and Professions Code
115.4.
(a) Notwithstanding any other law, on and after July 1, 2016, a board within the
department shall expedite, and may assist, the initial licensure process for an applicant
who supplies satisfactory evidence to the board that the applicant has served as an
active duty member of the Armed Forces of the United States and was honorably
discharged.
(b) Notwithstanding any other law, on and after July 1, 2024, a board within the
department shall expedite, and may assist, the initial licensure process for an applicant
who supplies satisfactory evidence to the board that the applicant is an active duty
member of a regular component of the Armed Forces of the United States enrolled in
the United States Department of Defense SkillBridge program as authorized under
Section 1143(e) of Title 10 of the United States Code.
(b)(c) A board may adopt regulations necessary to administer this section. section in
accordance with the provisions of Chapter 3.5 (commencing with Section 11340) of Part
1 of Division 3 of Title 2 of the Government Code.
115.8.
The Department of Consumer Affairs shall compile information on military,
veteran, military and spouse licensure into an annual report for the Legislature, which
shall be submitted in conformance with Section 9795 of the Government Code. The
report shall include all of the following: following for each license type of each board:
(a) The number of applications for a temporary license submitted by active duty
servicemembers, veterans, or military spouses per calendar fiscal year, pursuant to
Section 115.6.
(b) The number of applications for expedited licenses submitted by veterans and active
duty received from honorably discharged military members and military spouses
pursuant to Sections 115.4 and 115.5.
(c) The number of licenses issued and denied per calendar fiscal year pursuant to
Sections 115.4, 115.5, and 115.6.
(d) The number of licenses issued pursuant to Section 115.6 that were suspended or
revoked per calendar fiscal year.
(e) The number of applications for waived renewal fees received and granted pursuant
to Section 114.3 per calendar fiscal year.
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(f) The average length of time between application and issuance of licenses pursuant to
Sections 115.4, 115.5, and 115.6 per board and occupation.115.6.
805.9.
(a) A health facility licensed pursuant to Chapter 2 (commencing with Section 1250) of
Division 2 of the Health and Safety Code shall not deny staff privileges to, remove from
medical staff, or restrict the staff privileges of a person licensed by a healing arts board
in this state on the basis of a civil judgment, criminal conviction, or disciplinary action
imposed by another state if that judgment, conviction, or disciplinary action is based
solely on the application of another state’s law that interferes with a person’s right to
receive sensitive services that would be lawful if provided in this state.
(b) This section does not apply to a civil judgment, criminal conviction, or disciplinary
action imposed in another state based upon conduct in another state that would subject
a licensee to a similar claim, charge, or action under the laws of this state.
(c) For purposes of this section:
(1) “Healing arts board” means any board, division, or examining committee in the
Department of Consumer Affairs that licenses or certifies health professionals.
(2) “Sensitive services” has the same meaning as in Section 56.05 of the Civil Code.
850.1.
(a) A healing arts board shall not deny an application for licensure or suspend, revoke,
or otherwise impose discipline upon a licensee or health practitioner subject to this
division on the basis of a civil judgment, criminal conviction, or disciplinary action in
another state if that judgment, conviction, or disciplinary action is based solely on the
application of another state’s law that interferes with a person’s right to receive sensitive
services that would be lawful if provided in this state, regardless of the patient’s location.
(b) This section does not apply to a civil judgment, criminal conviction, or disciplinary
action imposed in another state based upon conduct in another state that would subject
an applicant, licensee, or health care practitioner subject to this division to a similar
claim, charge, or action under the laws of this state.
(c) For purposes of this section:
(1) “Healing arts board” means any board, division, or examining committee in the
Department of Consumer Affairs that licenses or certifies health professionals.
(2) “Sensitive services” has the same meaning as in Section 56.05 of the Civil Code.
852.
The performance, recommendation, or provision of any legally protected health care
activity, as defined in Section 1798.300 of the Civil Code, by a licensee or a health care
practitioner subject to this division acting within their scope of practice, for a patient who
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resides in a state in which the performance, recommendation, or provision of that legally
protected health care activity is illegal, shall not, by itself, constitute professional
misconduct under this division or any regulation governing the licensure, certification, or
authorization of that licensee or practitioner, nor shall any license, certification, or
authorization of a licensee or health care practitioner subject to this division be revoked,
suspended, or annulled or otherwise subject to any other penalty or discipline provided
in this division solely on the basis that the licensee or health care practitioner
performed, recommended, or provided any legally protected health care activity for a
patient who resides in a state in which the performance, recommendation, or provision
of that legally protected health service is illegal.
4052.04.
(a) In addition to the authority provided in Section 4052, a pharmacist may furnish
COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that
causes COVID-19.
(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a
pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines
published by the federal Food and Drug Administration in providing these patient care
services.
(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patient’s
primary care provider, or enter the appropriate information in a patient record system
shared with the primary care provider, as permitted by that primary care provider. If the
patient does not have a primary care provider, the pharmacist shall provide the patient
with a written record of the drugs furnished and advise the patient to consult a physician
of the patient’s choice.
(d) A pharmacist shall document, to the extent possible, the kind and amounts of
COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information
regarding any testing services provided, in the patient’s record in the record system
maintained by the pharmacy. The records shall be maintained for three years and shall
be available for inspection by all properly authorized personnel of the board.
(e) For purposes of this section, “COVID-19 oral therapeutics” means drugs that are
approved or authorized by the United States Food and Drug Administration for the
treatment of COVID-19 and administered orally.
(f) This section shall remain in effect only until January 1, 2025, and as of that date is
repealed.
4071.1.
(a) A prescriber, a prescriber’s authorized agent, or a pharmacist may electronically
enter a prescription or an order, as defined in Section 4019, into a pharmacy’s or
hospital’s computer from any location outside of the pharmacy or hospital with the
permission of the pharmacy or hospital. For purposes of this section, a “prescriber’s
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authorized agent” is a person licensed or registered under Division 2 (commencing with
Section 500).
(b) Nothing in this section shall This section does not reduce the existing authority of
other hospital personnel to enter medication orders or prescription orders into a
hospital’s computer.
(c) No A dangerous drug or dangerous device shall not be dispensed pursuant to a
prescription that has been electronically entered into a pharmacy’s computer without the
prior approval of a pharmacist.
(d)(1) A pharmacist located and licensed in the state may, on behalf of a health care
facility licensed pursuant to Chapter 2 (commencing with Section 1250) of Division 2 of
the Health and Safety Code, from a location outside of the facility, verify medication
chart orders for appropriateness before administration consistent with federal
requirements, as established in the health care facility’s policies and procedures.
(2)(A) A health care facility shall maintain a record of a pharmacist’s verification of
medication chart orders pursuant to this subdivision.
(B) A record maintained pursuant to subparagraph (A) shall meet the same
requirements as those described in Sections 4081 and 4105.
4110.5.
Notwithstanding any other provision of this article, a county, city and county, or special
hospital authority described in Chapter 5 (commencing with Section 101850) or Chapter
5.5 (commencing with Section 101852) of Part 4 of Division 101 of the Health and
Safety Code may operate a mobile unit one or more mobile units to provide prescription
medication within its jurisdiction to those individuals without fixed addresses, individuals
living in county-owned or city-and-county-owned or operated housing facilities, and
those enrolled in Medi-Cal plans operated by the county or a city and county, a health
district, or a joint powers authority pursuant to Chapter 7 (commencing with Section
14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the
Welfare and Institutions Code. The mobile unit shall be operated as an extension of a
pharmacy license held by the county, city and county, or special hospital authority.
The mobile pharmacist-in-charge shall determine the number of mobile units that are
appropriate for a particular pharmacy license. The mobile unit may dispense
prescription medication pursuant to a valid prescription, including a prescription of a
physician who practices in the mobile unit, if the county, city and county, or special
hospital authority meets all of the following requirements:
(a) A licensed pharmacist is on the premises and the mobile unit is under the control
and management of a pharmacist while prescription medications are being dispensed.
(b) All activities of the pharmacist, including the furnishing of medication by the
pharmacist, are consistent with Article 3 (commencing with Section 4050).
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(c) If a physician is practicing in the mobile unit, all prescribing by the physician meets
the requirements of the Medical Practice Act (Chapter 5 (commencing with Section
2000)).
(d)(1) The mobile unit does not carry or dispense controlled substances.
(2) Paragraph (1) does not apply to Schedule III, Schedule IV, or Schedule V controlled
substances approved by the United States Food and Drug Administration for the
treatment of opioid use disorder. Any controlled substance for the treatment of opioid
use disorder carried or dispensed in accordance with this paragraph shall be carried in
reasonable quantities based on prescription volume and stored securely in the mobile
pharmacy unit.
(e) Dangerous drugs shall not be left in the mobile unit during the hours that the mobile
unit is not in operation.
(f) At least 30 days prior to commencing operation of a mobile unit, a A county, city and
county, or special hospital authority shall notify the board of its intention to operate a
mobile unit. Notice shall also be given to the board at least 30 days prior to unit as soon
as possible, and no later than five business days after commencing operation of a
mobile unit. A county, city and county, or special hospital authority shall also notify the
board of its intention to discontinue operation of a mobile unit as soon as possible, and
at least one business day before discontinuing operation of a mobile unit.
4113.
(a) Every pharmacy shall designate a pharmacist-in-charge and, within 30 days thereof,
shall notify the board in writing of the identity and license number of that pharmacist and
the date he or she was they were designated.
(b) The proposed pharmacist-in-charge shall be subject to approval by the board. The
board shall not issue or renew a pharmacy license without identification of an approved
pharmacist-in-charge for the pharmacy.
(c)(1) The pharmacist-in-charge shall be responsible for a pharmacy’s compliance with
all state and federal laws and regulations pertaining to the practice of pharmacy.
(2) The pharmacist-in-charge may make staffing decisions to ensure sufficient
personnel are present in the pharmacy to prevent fatigue, distraction, or other
conditions that may interfere with a pharmacist’s ability to practice competently and
safely. If the pharmacist-in-charge is not available, a pharmacist on duty may adjust
staffing according to workload if needed. This paragraph does not apply to facilities of
the Department of Corrections and Rehabilitation.
(d) (1) The pharmacist-in-charge or pharmacist on duty shall immediately notify store
management of any conditions that present an immediate risk of death, illness, or
irreparable harm to patients, personnel, or pharmacy staff. Store management shall
take immediate and reasonable steps to address and resolve the conditions that
present an immediate risk of death, illness, or irreparable harm to patients, personnel,
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or pharmacy staff. If the conditions are not resolved within 24 hours, the pharmacist-in-
charge or pharmacist on duty shall ensure the board is timely notified.
(2) Nothing in this subdivision shall be construed as presenting, limiting, or restraining a
pharmacist-in-charge, pharmacy technician, or member of the public from
communication with the board, including filing a complaint.
(3) The conditions that present an immediate risk of death, illness, or irreparable harm
to patients, personnel, or pharmacy staff may include, but are not limited to, any of the
following:
(A) Workplace safety and health hazards that present an immediate risk of death,
illness, or irreparable harm to patients, personnel, or pharmacy staff.
(B) Sustained temperatures that could impact ambient temperature drug stability
according to manufacturer data on acceptable drug storage conditions.
(C) Vermin infestation that poses a risk to the safety or efficacy of medicine.
(4) If, after receipt of a notice described in paragraph (1) and an evaluation and
assessment of the relevant evidence, the executive officer has a reasonable belief that
conditions within a pharmacy exist that present an immediate risk of death, illness, or
irreparable harm to patients, personnel, or pharmacy staff, the executive officer may, in
conformance with the processes set forth in subdivisions (b) and (c) of Section 4127.3,
issue an order to the pharmacy to immediately cease and desist those pharmacy
operations that are affected by the conditions at issue. The cease and desist order shall
remain in effect until either the executive officer determines the conditions that
presented an immediate risk of death, illness, or irreparable harm to patients, personnel,
or pharmacy staff have been abated or for no more than 30 days, whichever is earlier.
Evidence of corrective actions taken shall be submitted by the pharmacy to correct the
conditions at issue. Failure to comply with a cease and desist order issued pursuant to
this section shall be unprofessional conduct pursuant to Section 4156.
(5) Nothing in this paragraph shall prevent the owner of the licensed premises from
closing a pharmacy to mitigate against a perceived immediate risk of death, illness, or
irreparable harm to patients, personnel, or pharmacy staff.
(6) Facilities of the Department of Corrections and Rehabilitation shall be exempt from
this subdivision.
(d)(e) Every pharmacy shall notify the board in writing, on a form designed by the board,
within 30 days of the date when a pharmacist-in-charge ceases to act as the
pharmacist-in-charge, and shall on the same form propose another pharmacist to take
over as the pharmacist-in-charge. The proposed replacement pharmacist-in-charge
shall be subject to approval by the board. If disapproved, the pharmacy shall propose
another replacement within 15 days of the date of disapproval and shall continue to
name proposed replacements until a pharmacist-in-charge is approved by the board.
(e)(f) If a pharmacy is unable, in the exercise of reasonable diligence, to identify within
30 days a permanent replacement pharmacist-in-charge to propose to the board on the
notification form, the pharmacy may instead provide on that form the name of any
pharmacist who is an employee, officer, or administrator of the pharmacy or the entity
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that owns the pharmacy and who is actively involved in the management of the
pharmacy on a daily basis, to act as the interim pharmacist-in-charge for a period not to
exceed 120 days. The pharmacy, or the entity that owns the pharmacy, shall be
prepared during normal business hours to provide a representative of the board with the
name of the interim pharmacist-in-charge with documentation of the active involvement
of the interim pharmacist-in-charge in the daily management of the pharmacy, and with
documentation of the pharmacy’s good faith efforts prior to naming the interim
pharmacist-in-charge to obtain a permanent pharmacist-in-charge. By no later than 120
days following the identification of the interim pharmacist-in-charge, the pharmacy shall
propose to the board the name of a pharmacist to serve as the permanent pharmacist-
in-charge. The proposed permanent pharmacist-in-charge shall be subject to approval
by the board. If disapproved, the pharmacy shall propose another replacement within 15
days of the date of disapproval, and shall continue to name proposed replacements until
a pharmacist-in-charge is approved by the board.
4113.1.
(a) Except as specified in subdivision (e), a community pharmacy licensed pursuant to
this article shall report, either directly or through a designated third party, including a
component patient safety organization as defined in Section 3.20 of Title 42 of the Code
of Federal Regulations, all medication errors to an entity approved by the board. A
community pharmacy shall submit the report no later than 14 days following the date of
discovery of the error. These reports are deemed confidential and are not subject to
discovery, subpoena, or disclosure pursuant to the California Public Records Act
(Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code),
except that the board may publish deidentified case summary information compiled from
the data in the reports so long as deidentification is done in accordance with the
requirements set forth in Section 164.514(b)(2) of Title 45 of the Code of Federal
Regulations, and includes omitting the name of the reporting pharmacy. The community
pharmacy shall maintain records demonstrating compliance with this requirement for
three years and shall make these records immediately available at the request of an
inspector. A medication error report made pursuant to this section shall not be subject to
investigation, discipline, or other enforcement action by the board based solely on a
report received pursuant to this section. However, if the board receives other
information regarding the medication error independent of the medication error report,
that information may serve as basis for discipline or other enforcement by the board.
(b) Any entity approved by the board shall have experience with the analysis of
medication errors that occur in the outpatient setting.
(c) For purposes of this section, “community pharmacy” includes any pharmacy that
dispenses medication to an outpatient, but does not include facilities of the Department
of Corrections and Rehabilitation.
(d) For purposes of this section, “medication error” includes any variation from a
prescription drug order not authorized by the prescriber, including, but not limited to,
errors involving the wrong drug, the wrong dose, the wrong patient, the wrong
directions, the wrong preparation, or the wrong route of administration. A medication
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error does not include any variation that is corrected prior to dispensing to the patient or
patient’s agent or any variation allowed by law.
(e) An outpatient hospital pharmacy shall not be required to report a medication error
that meets the requirements of an adverse event, as specified in subdivision (a), that
has been reported to the State Department of Public Health pursuant to Section 1279.1
of the Health and Safety Code. The State Department of Public Health may share a
report with the California State Board of Pharmacy.
4113.6.
(a) A chain community pharmacy subject to Section 4113.5 shall be staffed at all times
with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-
related services. The board shall not take action against a pharmacy for a violation of
this subdivision if any of the following conditions apply:
(1) The pharmacist on duty waives the requirement in writing during specified hours
based on workload need.
(2) The pharmacy is open beyond normal business hours, which is before 8:00 am and
after 7:00 pm. During the hours before 8:00 am and after 7:00 pm, the requirement shall
not apply.
(3) The pharmacy’s prescription volume per day on average is less than 75
prescriptions per day based on the average daily prescription volume for the past
calendar year. However, if the pharmacist is also expected to provide additional
pharmacy services such as immunizations, tests classified as waived under the federal
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a), or any
other ancillary services provided by law, this paragraph does not apply.
(b) Where staffing of pharmacist hours within a chain community pharmacy does not
overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be
established and publicly posted and included on the outgoing telephone message.
4115.
(a) A pharmacy technician may perform packaging, manipulative, repetitive, or other
nondiscretionary tasks only while assisting, and while under the direct supervision and
control of, a pharmacist. The pharmacist shall be responsible for the duties performed
under his or her their supervision by a technician.
(b)(1) In addition to the tasks specified in subdivision (a) a pharmacy technician may,
under the direct supervision and control of a pharmacist, prepare and administer
influenza and COVID-19 vaccines via injection or intranasally, prepare and administer
epinephrine, perform specimen collection for tests that are classified as waived under
CLIA, receive prescription transfers, and accept clarification on prescriptions under the
following conditions:
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(A) The pharmacy has scheduled another pharmacy technician to assist the pharmacist
by performing the tasks provided in subdivision (a).
(B) The pharmacy technician is certified pursuant to paragraph (4) of subdivision (a) of
Section 4202 and maintains that certification.
(C) The pharmacy technician has successfully completed at least six hours of practical
training approved by the Accreditation Council for Pharmacy Education and includes
hands-on injection technique, the recognition and treatment of emergency reactions to
vaccines, and an assessment of the pharmacy technician’s injection technique.
(D) The pharmacy technician is certified in basic life support.
(2) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42
U.S.C. Sec. 263a; Public Law 100-578).
(b)(c) This section does not authorize the performance of any tasks specified
in subdivision subdivisions (a) and (b) by a pharmacy technician without a pharmacist
on duty.
(c)(d) This section does not authorize a pharmacy technician to perform any act
requiring the exercise of professional judgment by a pharmacist.
(d)(e) The board shall adopt regulations to specify tasks pursuant to subdivision (a) that
a pharmacy technician may perform under the supervision of a pharmacist. Any
pharmacy that employs a pharmacy technician shall do so in conformity with the
regulations adopted by the board.
(e)(f) A person shall not act as a pharmacy technician without first being licensed by the
board as a pharmacy technician.
(f)(g) (1) A pharmacy with only one pharmacist shall have no more than one pharmacy
technician performing the tasks specified in subdivision (a). A pharmacy with only one
pharmacist shall have no more than one pharmacy technician performing the tasks
specified in subdivision (b). If a pharmacy technician is performing the tasks specified in
subdivision (b), a second pharmacy technician shall be assisting a pharmacist with
performing tasks specified in subdivision (a). The ratio of pharmacy technicians
performing the tasks specified in subdivision (a) to any additional pharmacist shall not
exceed 2:1, except that this ratio shall not apply to personnel performing clerical
functions pursuant to Section 4116 or 4117. This ratio is applicable to all practice
settings, except for an inpatient of a licensed health facility, a patient of a licensed home
health agency, as specified in paragraph (2), an inmate of a correctional facility of the
Department of Corrections and Rehabilitation, and for a person receiving treatment in a
facility operated by the State Department of State Hospitals, the State Department of
Developmental Services, or the Department of Veterans Affairs.
(2) The board may adopt regulations establishing the ratio of pharmacy technicians
performing the tasks specified in subdivision (a) to pharmacists applicable to the filling
of prescriptions of an inpatient of a licensed health facility and for a patient of a licensed
home health agency. Any ratio established by the board pursuant to this subdivision
shall allow, at a minimum, at least one pharmacy technician for a single pharmacist in a
pharmacy and two pharmacy technicians for each additional pharmacist, except that
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this ratio shall not apply to personnel performing clerical functions pursuant to Section
4116 or 4117.
(3) A pharmacist scheduled to supervise a second pharmacy technician may refuse to
supervise a second pharmacy technician if the pharmacist determines, in the exercise
of his or her their professional judgment, that permitting the second pharmacy
technician to be on duty would interfere with the effective performance of the
pharmacist’s responsibilities under this chapter. A pharmacist assigned to supervise a
second pharmacy technician shall notify the pharmacist pharmacist-in-charge in charge
in writing of his or her their determination, specifying the circumstances of concern with
respect to the pharmacy or the pharmacy technician that have led to the determination,
within a reasonable period, but not to exceed 24 hours, after the posting of the relevant
schedule. An entity employing a pharmacist shall not discharge, discipline, or otherwise
discriminate against any pharmacist in the terms and conditions of employment for
exercising or attempting to exercise in good faith the right established pursuant to this
paragraph.
(g)(h) Notwithstanding subdivisions (a) and (b), to (c), inclusive, the board shall by
regulation establish conditions to permit the temporary absence of a pharmacist for
breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of
the Industrial Welfare Commission without closing the pharmacy. During these
temporary absences, a pharmacy technician may, at the discretion of the pharmacist,
remain in the pharmacy but may only perform nondiscretionary tasks. The pharmacist
shall be responsible for a pharmacy technician and shall review any task performed by
a pharmacy technician during the pharmacist’s temporary absence. This subdivision
shall not be construed to authorize a pharmacist to supervise pharmacy technicians in
greater ratios than those described in subdivision (f).(g).
(h)(i) The pharmacist on duty shall be directly responsible for the conduct of a pharmacy
technician supervised by that pharmacist.
(i)(j) In a health care facility licensed under subdivision (a) of Section 1250 of the Health
and Safety Code, a pharmacy technician’s duties may include any of the following:
(1) Packaging emergency supplies for use in the health care facility and the hospital’s
emergency medical system or as authorized under Section 4119.
(2) Sealing emergency containers for use in the health care facility.
(3) Performing monthly checks of the drug supplies stored throughout the health care
facility. Irregularities shall be reported within 24 hours to the pharmacist in
charge pharmacist-in-charge and the director or chief executive officer of the health
care facility in accordance with the health care facility’s policies and procedures.
4119.01.
(a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that is also an
emergency medical services provider agency, may restock dangerous drugs or
dangerous devices into an emergency medical services automated drug delivery
system (EMSADDS) that is licensed by the board under this section. Dangerous drugs
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and dangerous devices stored or maintained in an EMSADDS shall be used for the sole
purpose of restocking a secured emergency pharmaceutical supplies container as
authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of
the following conditions are met:
(1) The emergency medical services provider agency obtains a license from the board
to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be
located on the premises of a fire department headquarters, a fire station, or at an
emergency medical services provider agency’s location. A separate license shall be
required for each location.
(A) As part of its license application, the emergency medical services provider agency
shall provide: the address where the EMSADDS will be located; the name of the
medical director responsible for overseeing the emergency medical services provider
agency; the name of any designated pharmacist or licensed designated paramedic who
is responsible for performing the duties as required under this section; the policies and
procedures detailing the provisions under which the EMSADDS will operate; and the
name and license number of the pharmacy or emergency medical services provider
agency wholesaler that will furnish the dangerous drugs and dangerous devices through
the EMSADDS.
(B) The application and initial license fee to operate EMSADDS shall be one hundred
dollars ($100) per machine. The license shall be renewed annually. The license fee may
not be transferred to a different location if the EMSADDS is moved. The penalty fee for
failure to renew an EMSADDS license shall be thirty-five dollars ($35).
(C) The application and renewal fee for a licensed wholesaler that is also an emergency
medical services provider agency shall be seven hundred eighty dollars ($780).
(2) Each EMSADDS shall collect, control, and maintain all transaction information
necessary to accurately track the movement of drugs into and out of the system for
purposes of security, accuracy, and accountability.
(3) The medical director and designated pharmacist, or the medical director and the
licensed designated paramedic, shall develop, adopt, and maintain policies and
procedures detailing the provisions under which the EMSADDS will operate. At a
minimum, the policies and procedures shall address (A) inventory controls, (B) training,
(C) storage and security of the dangerous drugs and dangerous devices, and (D)
safeguards to limit access to the EMSADDS to authorized staff only.
(4) The licensed EMSADDS operator shall limit access to the EMSADDS only to
employees of the operator who are licensed by the state and as authorized in this
section.
(A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a
licensed designated paramedic, each of whom may possess and transport dangerous
drugs or dangerous devices for that purpose. The transport of dangerous drugs or
dangerous devices for restocking into an EMSADDS shall be done in a secured manner
to prevent theft or unauthorized access, and shall be done under conditions appropriate
to meet storage and handling requirements of the dangerous drugs or dangerous
devices. While the dangerous drugs or dangerous devices may be transported,
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representatives shall not store a dangerous drug or dangerous device at an unlicensed
location.
(B) Only a medical director, a pharmacist, or a paramedic may remove dangerous drugs
or dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical
supplies container. This access shall be observed by a second person who is also a
paramedic, a pharmacist, or a medical director. Both the individual who removes
dangerous drugs or dangerous devices from the EMSADDS and the observer shall
record their participation in the removal of the dangerous drugs or dangerous devices
via their signatures or use of biometric identifiers. The restocking of the secured
emergency pharmaceutical supplies container from the EMSADDS shall occur at the
licensed location of the EMSADDS.
(C) A medical director, a pharmacist, or a licensed designated paramedic may remove
outdated dangerous drugs or dangerous devices from an EMSADDS. Any outdated
dangerous drugs or dangerous devices shall be provided to a licensed reverse
distributor for destruction.
(5) Every EMSADDS operator shall perform monthly inventory and inventory
reconciliation functions. The medical director, designated pharmacist, or licensed
designated paramedic shall perform a reconciliation and prepare a written report based
on written policies and procedures developed to maintain the security and quality of the
dangerous drugs and dangerous devices. The written inventory reconciliation report
shall include all of the following:
(A) A physical count of all quantities of dangerous drugs and dangerous devices stored
in the EMSADDS.
(B) A review of all dangerous drugs and dangerous devices added into and removed
from each EMSADDS since the last monthly inventory.
(C) A comparison of subparagraphs (A) and (B), and identification of any variances.
(D) A review of all individuals who accessed the EMSADDS since the last inventory and
identification of unauthorized individuals accessing the EMSADDS or suspicious
activity.
(E) Identification of possible causes of shortages and overages.
(6) The medical director and designated pharmacist, or medical director and licensed
designated paramedic, shall be jointly responsible for monthly review of the inventory
reconciliation report, the training, storage, and security of dangerous drugs and
dangerous devices, and the restocking of the EMSADDS. Any inventory losses from an
EMSADDS shall be reported to the board within seven days from identification of the
loss.
(7) In order for an individual to perform the functions of a licensed designated
paramedic described in this section, that individual shall be licensed by the board
pursuant to Section 4202.5. A paramedic who only restocks a secured emergency
pharmaceutical supplies container from an EMSADDS need not be licensed with the
board.
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(8) A record of each access to the EMSADDS, as well as all records used to compile an
inventory reconciliation report, shall be maintained at the operator’s location for at least
three years in a readily retrievable form. The records shall include the identity of every
individual who accessed the system or witnessed such access; the date of each access;
and the drug, dosage, form, strength, and quantity of dangerous drugs or dangerous
devices added or removed.
(b) A violation of any of the provisions of this section shall constitute unprofessional
conduct and provides the board the authority to take action against the EMSADDS
operator’s license.
(c) This section shall be repealed on January 1, 2025.
4119.01.
(a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that is also an
emergency medical services provider agency, may restock dangerous drugs or
dangerous devices into an emergency medical services automated drug delivery
system (EMSADDS) that is licensed by the board under this section. Dangerous drugs
and dangerous devices stored or maintained in an EMSADDS shall be used for the sole
purpose of restocking a secured emergency pharmaceutical supplies container as
authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of
the following conditions are met:
(1) The emergency medical services provider agency obtains a license from the board
to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be
located on the premises of a fire department headquarters, a fire station, or at an
emergency medical services provider agency’s location. A separate license shall be
required for each location. As part of its license application, the emergency medical
services provider agency shall provide: the address where the EMSADDS will be
located; the name of the medical director responsible for overseeing the emergency
medical services provider agency; the name of any designated pharmacist or licensed
designated paramedic who is responsible for performing the duties as required under
this section; the policies and procedures detailing the provisions under which the
EMSADDS will operate; and the name and license number of the pharmacy or
emergency medical services provider agency wholesaler that will furnish the dangerous
drugs and dangerous devices through the EMSADDS.
(2) Each EMSADDS shall collect, control, and maintain all transaction information
necessary to accurately track the movement of drugs into and out of the system for
purposes of security, accuracy, and accountability.
(3) The medical director and designated pharmacist, or the medical director and the
licensed designated paramedic, shall develop, adopt, and maintain policies and
procedures detailing the provisions under which the EMSADDS will operate. At a
minimum, the policies and procedures shall address (A) inventory controls, (B) training,
(C) storage and security of the dangerous drugs and dangerous devices, and (D)
safeguards to limit access to the EMSADDS to authorized staff only.
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(4) The licensed EMSADDS operator shall limit access to the EMSADDS only to
employees of the operator who are licensed by the state and as authorized in this
section.
(A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a
licensed designated paramedic, each of whom may possess and transport dangerous
drugs or dangerous devices for that purpose. The transport of dangerous drugs or
dangerous devices for restocking into an EMSADDS shall be done in a secured manner
to prevent theft or unauthorized access, and shall be done under conditions appropriate
to meet storage and handling requirements of the dangerous drugs or dangerous
devices. While the dangerous drugs or dangerous devices may be transported,
representatives shall not store a dangerous drug or dangerous device at an unlicensed
location.
(B) Only a medical director, a pharmacist, or a paramedic may remove dangerous drugs
or dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical
supplies container. This access shall be observed by a second person who is also a
paramedic, a pharmacist, or a medical director. Both the individual who removes
dangerous drugs or dangerous devices from the EMSADDS and the observer shall
record their participation in the removal of the dangerous drugs or dangerous devices
via their signatures or use of biometric identifiers. The restocking of the secured
emergency pharmaceutical supplies container from the EMSADDS shall occur at the
licensed location of the EMSADDS.
(C) A medical director, a pharmacist, or a licensed designated paramedic may remove
outdated dangerous drugs or dangerous devices from an EMSADDS. Any outdated
dangerous drugs or dangerous devices shall be provided to a licensed reverse
distributor for destruction.
(5) Every EMSADDS operator shall perform monthly inventory and inventory
reconciliation functions. The medical director, designated pharmacist, or licensed
designated paramedic shall perform a reconciliation and prepare a written report based
on written policies and procedures developed to maintain the security and quality of the
dangerous drugs and dangerous devices. The written inventory reconciliation report
shall include all of the following:
(A) A physical count of all quantities of dangerous drugs and dangerous devices stored
in the EMSADDS.
(B) A review of all dangerous drugs and dangerous devices added into and removed
from each EMSADDS since the last monthly inventory.
(C) A comparison of subparagraphs (A) and (B), and identification of any variances.
(D) A review of all individuals who accessed the EMSADDS since the last inventory and
identification of unauthorized individuals accessing the EMSADDS or suspicious
activity.
(E) Identification of possible causes of shortages and overages.
(6) The medical director and designated pharmacist, or medical director and licensed
designated paramedic, shall be jointly responsible for monthly review of the inventory
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reconciliation report, the training, storage, and security of dangerous drugs and
dangerous devices, and the restocking of the EMSADDS. Any inventory losses from an
EMSADDS shall be reported to the board within seven days from identification of the
loss.
(7) In order for an individual to perform the functions of a licensed designated
paramedic described in this section, that individual shall be licensed by the board
pursuant to Section 4202.5. A paramedic who only restocks a secured emergency
pharmaceutical supplies container from an EMSADDS need not be licensed with the
board.
(8) A record of each access to the EMSADDS, as well as all records used to compile an
inventory reconciliation report, shall be maintained at the operator’s location for at least
three years in a readily retrievable form. The records shall include the identity of every
individual who accessed the system or witnessed such access; the date of each access;
and the drug, dosage, form, strength, and quantity of dangerous drugs or dangerous
devices added or removed.
(b) A violation of any of the provisions of this section shall constitute unprofessional
conduct and provides the board the authority to take action against the EMSADDS
operator’s license.
(c) This section shall become operative on January 1, 2025.
4119.11.
(a) A pharmacy located in the state may provide pharmacy services to the patients of a
“covered entity,” as defined in Section 256b of Title 42 of the United States Code,
through the use of an automated patient dispensing system located on the premises of
the covered entity or on the premises of medical professional practices under contract
to provide medical services to covered entity patients, which need not be the same
location as the pharmacy, if all of the following conditions are met:
(1) The pharmacy obtains a license from the board to operate the automated patient
dispensing system at the covered entity or affiliated site. As part of the application, the
pharmacy shall provide the address at which the automated patient dispensing system
shall be placed and identify the covered entity. A separate license shall be required for
each location and shall be renewed annually concurrent with the pharmacy license. The
application and renewal fee shall be three hundred dollars ($300) and may be increased
to five hundred dollars ($500). The board is authorized to lower the renewal fee to not
less than two hundred dollars ($200) if a lower fee level will provide sufficient resources
to support the regulatory activities.
(2) The pharmacy providing the pharmacy services to the patients of the covered entity,
including, unless otherwise prohibited by any other law, patients enrolled in the Medi-
Cal program, shall be under contract with that covered entity as described in Section
4126 to provide those pharmacy services through the use of the automated patient
dispensing system.
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(3) Drugs stored in an automated patient dispensing system shall be part of the
inventory of the pharmacy providing pharmacy services to the patients of the covered
entity and drugs dispensed from the automated patient dispensing system shall be
considered to have been dispensed by that pharmacy.
(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous
drugs stored in the automated patient dispensing system separate from other pharmacy
records.
(5) The pharmacy shall be solely responsible for the security, operation, and
maintenance of the automated patient dispensing system.
(6) The pharmacy shall provide training regarding the operation and use of the
automated patient dispensing system to both pharmacy and covered entity personnel
using the system.
(7) The operation of the automated patient dispensing system shall be under the
supervision of a licensed pharmacist acting on behalf of the pharmacy providing
services to the patients of the covered entity. The pharmacist need not be physically
present at the site of the automated patient dispensing system and may supervise the
system electronically.
(8) Notwithstanding Section 4107, the board may issue a license for the operation of an
automated patient dispensing system at an address for which it has issued another site
license.
(9) The board, within 30 days after receipt of an application for an automated patient
dispensing system license, shall conduct a prelicensure inspection at the proposed
location of the automated patient dispensing system. Relocation of the automated
patient dispensing system shall require a new application for licensure. Replacement of
an automated patient dispensing system shall require notice to the board within 30
days.
(10) The automated patient dispensing system license shall be canceled by operation of
law if the underlying pharmacy license is not current, valid, and active. Upon reissuance
or reinstatement of the underlying pharmacy license, a new application for an
automated patient dispensing system license may be submitted to the board.
(11) A pharmacy that holds an automated patient dispensing system license shall
advise the board in writing within 30 days if use of the automated patient dispensing
system is discontinued.
(b) For purposes of this section, the following definitions shall apply:
(1) An “automated drug delivery system” (ADDS) means a mechanical system that
performs operations or activities, other than compounding or administration, relative to
the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and
maintain all transaction information to accurately track the movement of drugs into and
out of the system for security, accuracy, and accountability.
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(2) An “automated patient dispensing system” (APDS) is an ADDS for storage and
dispensing of prescribed drugs directly to patients pursuant to prior authorization by a
pharmacist.
(3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of
unit doses of drugs for administration to patients by persons authorized to perform these
functions.
(c) (1) An automated patient dispensing system shall collect, control, and maintain all
transaction information to accurately track the movement of drugs into and out of the
system for security, accuracy, and accountability.
(2) Transaction information shall be made readily available in a downloadable format for
review and inspection by individuals authorized by law. These records shall be
maintained by the pharmacy for a minimum of three years.
(d) Drugs from the automated patient dispensing system may be dispensed directly to
the patient, if all of the following requirements are met:
(1) The pharmacy shall develop, implement, and annually review written policies and
procedures with respect to all of the following:
(A) Maintaining the security of the automated patient dispensing system and the
dangerous drugs and devices within that automated patient dispensing system.
(B) Determining and applying inclusion criteria regarding which drugs and devices are
appropriate for placement in the automated patient dispensing system and for which
patients.
(C) Ensuring that patients are aware that consultation with a pharmacist is available for
any prescription medication, including those delivered via the automated patient
dispensing system.
(D) Describing assignment of responsibilities to, and training of, pharmacy personnel,
and other personnel using the automated patient dispensing system at the location
where the automated patient dispensing system is placed, regarding maintenance and
filing procedures for the automated patient dispensing system.
(E) Orienting participating patients on the use of the automated patient dispensing
system, notifying patients when expected prescription medications are not available in
the automated patient dispensing system, and ensuring that patient use of the
automated patient dispensing system does not interfere with delivery of drugs and
devices.
(F) Ensuring delivery of drugs and devices to patients expecting to receive them from
the automated patient dispensing system if the automated patient dispensing system is
disabled or malfunctions.
(2) The automated patient dispensing system shall only be used for patients who have
signed a written consent demonstrating their informed consent to receive prescribed
drugs and devices from an automated patient dispensing system and whose use of the
automated patient dispensing system meet the criteria pursuant to paragraph (1).
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(3) The automated patient dispensing system shall have a means to identify each
patient and only release the identified patient’s drugs and devices to the patient or the
patient’s agent.
(4) A pharmacist shall perform all clinical services conducted as part of the dispensing
process, including, but not limited to, drug utilization review and consultation.
(5) Drugs shall be dispensed from the automated patient dispensing system only upon
authorization from a pharmacist after the pharmacist has reviewed the prescription and
the patient’s profile for potential contraindications and adverse drug reactions.
(6) All prescribed drugs and devices dispensed from the automated patient dispensing
system for the first time shall be accompanied by a consultation conducted by a
pharmacist licensed by the board via a telecommunications link that has two-way audio
and video.
(7) The automated patient dispensing system shall include a notice, prominently posted
on the automated patient dispensing system, that provides the name, address, and
telephone number of the pharmacy that holds the automated patient dispensing system
license for that automated patient dispensing system.
(8) The labels on all drugs dispensed by the automated patient dispensing system shall
comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the
California Code of Regulations.
(9) Any complaint, error, or omission involving the automated patient dispensing system
shall be reviewed as part of the pharmacy’s quality assurance program pursuant to
Section 4125.
(10) The board shall not issue a pharmacy more than 15 licenses for automated patient
dispensing system units under this section. Consistent with Section 4001.1, the board
may adopt regulations to reduce the number of automated patient dispensing system
licenses that may be issued to a pharmacy.
(11) The pharmacy holding the license for the automated patient dispensing system
shall maintain the policies and procedures developed pursuant to paragraph (1) for
three years after the last date of use of that automated patient dispensing system.
(e) Access to the automated patient dispensing system shall be controlled and tracked
using an identification or password system or biosensor. A system that is accessed via
a password system shall include a camera that records a picture of the individual
accessing the machine. Picture records shall be maintained for a minimum of 180 days.
(f) The automated patient dispensing system shall make a complete and accurate
record of all transactions that will include all users accessing the system and all drugs
added to, or removed from, the system.
(g) The stocking of an automated patient dispensing system shall be performed by a
pharmacist. If the automated patient dispensing system utilizes removable pockets,
cards, drawers, similar technology, or unit of use or single dose containers as defined
by the United States Pharmacopeia, the stocking system may be done outside of the
facility and be delivered to the facility, if all of the following conditions are met:
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(1) The task of placing drugs into the removable pockets, cards, drawers, similar
technology, or unit of use or single dose containers is performed by a pharmacist, or by
an intern pharmacist or a pharmacy technician working under the direct supervision of a
pharmacist.
(2) The removable pockets, cards, drawers, similar technology, or unit of use or single
dose containers are transported between the pharmacy and the facility in a secure
tamper-evident container.
(3) The pharmacy, in conjunction with the covered entity, has developed policies and
procedures to ensure that the removable pockets, cards, drawers, similar technology, or
unit of use or single dose containers are properly placed into the automated patient
dispensing system.
(h) Review of the drugs contained within, and the operation and maintenance of, the
automated patient dispensing system shall be done in accordance with law and shall be
the responsibility of the pharmacy. A pharmacist shall conduct the review on a monthly
basis, which shall include a physical inspection of the drugs in the automated patient
dispensing system, an inspection of the automated patient dispensing system machine
for cleanliness, and a review of all transaction records in order to verify the security and
accountability of the system.
(i) A pharmacy holding an automated patient dispensing system license shall complete
a self-assessment, performed pursuant to Section 1715 of Title 16 of the California
Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating
to the use of the automated patient dispensing system. All information regarding
operation, maintenance, compliance, error, omissions, or complaints pertaining to the
automated patient dispensing system shall be included in the self-assessment.
(j) The pharmacy shall comply with all recordkeeping and quality assurance
requirements pursuant to this chapter, and shall maintain those records within the
pharmacy holding the automated patient dispensing system license and separately from
other pharmacy records.
(k) This section shall be repealed on January 1, 2025.
4119.11.
(a) A pharmacy located in the state may provide pharmacy services to the patients of a
“covered entity,” as defined in Section 256b of Title 42 of the United States Code,
through the use of an automated patient dispensing system located on the premises of
the covered entity or on the premises of medical professional practices under contract
to provide medical services to covered entity patients, which need not be the same
location as the pharmacy, if all of the following conditions are met:
(1) The pharmacy obtains a license from the board to operate the automated patient
dispensing system at the covered entity or affiliated site. As part of the application, the
pharmacy shall provide the address at which the automated patient dispensing system
shall be placed and identify the covered entity. A separate license shall be required for
each location and shall be renewed annually concurrent with the pharmacy license.
2024 Summary of Law Changes
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(2) The pharmacy providing the pharmacy services to the patients of the covered entity,
including, unless otherwise prohibited by any other law, patients enrolled in the Medi-
Cal program, shall be under contract with that covered entity as described in Section
4126 to provide those pharmacy services through the use of the automated patient
dispensing system.
(3) Drugs stored in an automated patient dispensing system shall be part of the
inventory of the pharmacy providing pharmacy services to the patients of the covered
entity and drugs dispensed from the automated patient dispensing system shall be
considered to have been dispensed by that pharmacy.
(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous
drugs stored in the automated patient dispensing system separate from other pharmacy
records.
(5) The pharmacy shall be solely responsible for the security, operation, and
maintenance of the automated patient dispensing system.
(6) The pharmacy shall provide training regarding the operation and use of the
automated patient dispensing system to both pharmacy and covered entity personnel
using the system.
(7) The operation of the automated patient dispensing system shall be under the
supervision of a licensed pharmacist acting on behalf of the pharmacy providing
services to the patients of the covered entity. The pharmacist need not be physically
present at the site of the automated patient dispensing system and may supervise the
system electronically.
(8) Notwithstanding Section 4107, the board may issue a license for the operation of an
automated patient dispensing system at an address for which it has issued another site
license.
(9) The board, within 30 days after receipt of an application for an automated patient
dispensing system license, shall conduct a prelicensure inspection at the proposed
location of the automated patient dispensing system. Relocation of the automated
patient dispensing system shall require a new application for licensure. Replacement of
an automated patient dispensing system shall require notice to the board within 30
days.
(10) The automated patient dispensing system license shall be canceled by operation of
law if the underlying pharmacy license is not current, valid, and active. Upon reissuance
or reinstatement of the underlying pharmacy license, a new application for an
automated patient dispensing system license may be submitted to the board.
(11) A pharmacy that holds an automated patient dispensing system license shall
advise the board in writing within 30 days if use of the automated patient dispensing
system is discontinued.
(b) For purposes of this section, the following definitions shall apply:
(1) An “automated drug delivery system” (ADDS) means a mechanical system that
performs operations or activities, other than compounding or administration, relative to
2024 Summary of Law Changes
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the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and
maintain all transaction information to accurately track the movement of drugs into and
out of the system for security, accuracy, and accountability.
(2) An “automated patient dispensing system” (APDS) is an ADDS for storage and
dispensing of prescribed drugs directly to patients pursuant to prior authorization by a
pharmacist.
(3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of
unit doses of drugs for administration to patients by persons authorized to perform these
functions.
(c) (1) An automated patient dispensing system shall collect, control, and maintain all
transaction information to accurately track the movement of drugs into and out of the
system for security, accuracy, and accountability.
(2) Transaction information shall be made readily available in a downloadable format for
review and inspection by individuals authorized by law. These records shall be
maintained by the pharmacy for a minimum of three years.
(d) Drugs from the automated patient dispensing system may be dispensed directly to
the patient, if all of the following requirements are met:
(1) The pharmacy shall develop, implement, and annually review written policies and
procedures with respect to all of the following:
(A) Maintaining the security of the automated patient dispensing system and the
dangerous drugs and devices within that automated patient dispensing system.
(B) Determining and applying inclusion criteria regarding which drugs and devices are
appropriate for placement in the automated patient dispensing system and for which
patients.
(C) Ensuring that patients are aware that consultation with a pharmacist is available for
any prescription medication, including those delivered via the automated patient
dispensing system.
(D) Describing assignment of responsibilities to, and training of, pharmacy personnel,
and other personnel using the automated patient dispensing system at the location
where the automated patient dispensing system is placed, regarding maintenance and
filing procedures for the automated patient dispensing system.
(E) Orienting participating patients on the use of the automated patient dispensing
system, notifying patients when expected prescription medications are not available in
the automated patient dispensing system, and ensuring that patient use of the
automated patient dispensing system does not interfere with delivery of drugs and
devices.
(F) Ensuring delivery of drugs and devices to patients expecting to receive them from
the automated patient dispensing system if the automated patient dispensing system is
disabled or malfunctions.
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(2) The automated patient dispensing system shall only be used for patients who have
signed a written consent demonstrating their informed consent to receive prescribed
drugs and devices from an automated patient dispensing system and whose use of the
automated patient dispensing system meet the criteria pursuant to paragraph (1).
(3) The automated patient dispensing system shall have a means to identify each
patient and only release the identified patient’s drugs and devices to the patient or the
patient’s agent.
(4) A pharmacist shall perform all clinical services conducted as part of the dispensing
process, including, but not limited to, drug utilization review and consultation.
(5) Drugs shall be dispensed from the automated patient dispensing system only upon
authorization from a pharmacist after the pharmacist has reviewed the prescription and
the patient’s profile for potential contraindications and adverse drug reactions.
(6) All prescribed drugs and devices dispensed from the automated patient dispensing
system for the first time shall be accompanied by a consultation conducted by a
pharmacist licensed by the board via a telecommunications link that has two-way audio
and video.
(7) The automated patient dispensing system shall include a notice, prominently posted
on the automated patient dispensing system, that provides the name, address, and
telephone number of the pharmacy that holds the automated patient dispensing system
license for that automated patient dispensing system.
(8) The labels on all drugs dispensed by the automated patient dispensing system shall
comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the
California Code of Regulations.
(9) Any complaint, error, or omission involving the automated patient dispensing system
shall be reviewed as part of the pharmacy’s quality assurance program pursuant to
Section 4125.
(10) The board shall not issue a pharmacy more than 15 licenses for automated patient
dispensing system units under this section. Consistent with Section 4001.1, the board
may adopt regulations to reduce the number of automated patient dispensing system
licenses that may be issued to a pharmacy.
(11) The pharmacy holding the license for the automated patient dispensing system
shall maintain the policies and procedures developed pursuant to paragraph (1) for
three years after the last date of use of that automated patient dispensing system.
(e) Access to the automated patient dispensing system shall be controlled and tracked
using an identification or password system or biosensor. A system that is accessed via
a password system shall include a camera that records a picture of the individual
accessing the machine. Picture records shall be maintained for a minimum of 180 days.
(f) The automated patient dispensing system shall make a complete and accurate
record of all transactions that will include all users accessing the system and all drugs
added to, or removed from, the system.
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(g) The stocking of an automated patient dispensing system shall be performed by a
pharmacist. If the automated patient dispensing system utilizes removable pockets,
cards, drawers, similar technology, or unit of use or single dose containers as defined
by the United States Pharmacopeia, the stocking system may be done outside of the
facility and be delivered to the facility, if all of the following conditions are met:
(1) The task of placing drugs into the removable pockets, cards, drawers, similar
technology, or unit of use or single dose containers is performed by a pharmacist, or by
an intern pharmacist or a pharmacy technician working under the direct supervision of a
pharmacist.
(2) The removable pockets, cards, drawers, similar technology, or unit of use or single
dose containers are transported between the pharmacy and the facility in a secure
tamper-evident container.
(3) The pharmacy, in conjunction with the covered entity, has developed policies and
procedures to ensure that the removable pockets, cards, drawers, similar technology, or
unit of use or single dose containers are properly placed into the automated patient
dispensing system.
(h) Review of the drugs contained within, and the operation and maintenance of, the
automated patient dispensing system shall be done in accordance with law and shall be
the responsibility of the pharmacy. A pharmacist shall conduct the review on a monthly
basis, which shall include a physical inspection of the drugs in the automated patient
dispensing system, an inspection of the automated patient dispensing system machine
for cleanliness, and a review of all transaction records in order to verify the security and
accountability of the system.
(i) A pharmacy holding an automated patient dispensing system license shall complete
a self-assessment, performed pursuant to Section 1715 of Title 16 of the California
Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating
to the use of the automated patient dispensing system. All information regarding
operation, maintenance, compliance, error, omissions, or complaints pertaining to the
automated patient dispensing system shall be included in the self-assessment.
(j) The pharmacy shall comply with all recordkeeping and quality assurance
requirements pursuant to this chapter, and shall maintain those records within the
pharmacy holding the automated patient dispensing system license and separately from
other pharmacy records.
(k) This section shall become operative on January 1, 2025.
4128.2.
(a) In addition to the pharmacy license requirement described in Section 4110, a
centralized hospital packaging pharmacy shall obtain a specialty license from the board
prior to engaging in the functions described in Section 4128.
(b) An applicant seeking a specialty license pursuant to this article shall apply to the
board on forms established by the board.
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(c) Before issuing the specialty license, the board shall inspect the pharmacy and
ensure that the pharmacy is in compliance with this article and regulations established
by the board.
(d) A license to perform the functions described in Section 4128 may only be issued to a
pharmacy that is licensed by the board as a hospital pharmacy.
(e) A license issued pursuant to this article shall be renewed annually and is not
transferrable.
(f) An applicant seeking renewal of a specialty license shall apply to the board on forms
established by the board.
(g) A license to perform the functions described in Section 4128 shall not be renewed
until the pharmacy has been inspected by the board and found to be in compliance with
this article and regulations established by the board.
(h) Until July 1, 2017, the fee for issuance or annual renewal of a centralized hospital
packaging pharmacy license shall be six hundred dollars ($600) and may be increased
by the board to eight hundred dollars ($800).
(i) This section shall be repealed on January 1, 2025.
4128.2.
(a) In addition to the pharmacy license requirement described in Section 4110, a
centralized hospital packaging pharmacy shall obtain a specialty license from the board
prior to engaging in the functions described in Section 4128.
(b) An applicant seeking a specialty license pursuant to this article shall apply to the
board on forms established by the board.
(c) Before issuing the specialty license, the board shall inspect the pharmacy and
ensure that the pharmacy is in compliance with this article and regulations established
by the board.
(d) A license to perform the functions described in Section 4128 may only be issued to a
pharmacy that is licensed by the board as a hospital pharmacy.
(e) A license issued pursuant to this article shall be renewed annually and is not
transferrable.
(f) An applicant seeking renewal of a specialty license shall apply to the board on forms
established by the board.
(g) A license to perform the functions described in Section 4128 shall not be renewed
until the pharmacy has been inspected by the board and found to be in compliance with
this article and regulations established by the board.
(h) This section shall become operative on January 1, 2025.
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4161.
(a) A person located outside this state that (1) ships, sells, mails, warehouses,
distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells,
brokers, warehouses, or distributes dangerous drugs or devices within this state shall
be considered a nonresident wholesaler or a nonresident third-party logistics provider.
(b) A nonresident wholesaler or nonresident third-party logistics provider shall be
licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or
delivering dangerous drugs or dangerous devices to a site located in this state or
selling, brokering, warehousing, or distributing dangerous drugs or devices within this
state.
(c) (1) A separate license shall be required for each place of business owned or
operated by a nonresident wholesaler or nonresident third-party logistics provider from
or through which dangerous drugs or dangerous devices are shipped, sold, mailed,
warehoused, distributed, or delivered to a site located in this state or sold, brokered,
warehoused, or distributed within this state. Each place of business may only be issued
a single license by the board, except as provided in paragraph (2). A license shall be
renewed annually and shall not be transferable.
(2) A nonresident wholesaler and a nonresident third-party logistics provider under
common ownership may be licensed at the same place of business provided that all of
the following requirements are satisfied:
(A) The wholesaler and the third-party logistics provider each separately maintain the
records required under Section 4081.
(B) Dangerous drugs and dangerous devices owned by the wholesaler are not
commingled with the dangerous drugs and dangerous devices handled by the third-
party logistics provider.
(C) Any individual acting as a designated representative for the wholesaler is not
concurrently acting as a designated representative-3PL on behalf of the third-party
logistics provider. Nothing in this subparagraph shall be construed to prohibit an
individual from concurrently holding a license to act as a designated representative and
to act as a designated representative-3PL.
(D) The wholesaler has its own designated representative-in-charge responsible for the
operations of the wholesaler and the third-party logistics provider has its own
responsible manager responsible for the operations of the third-party logistics provider.
The same individual shall not concurrently serve as the responsible manager and the
designated representative-in-charge for a wholesaler and a third-party logistics provider
licensed at the same place of business.
(E) The third-party logistics provider does not handle the prescription drugs or
prescription devices owned by a prescriber.
(F) The third-party logistics provider is not a reverse third-party logistics provider.
(G) The wholesaler is not acting as a reverse distributor.
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(d) The following information shall be reported, in writing, to the board at the time of
initial application for licensure by a nonresident wholesaler or a nonresident third-party
logistics provider, on renewal of a nonresident wholesaler or nonresident third-party
logistics provider license, or within 30 days of a change in that information:
(1) Its agent for service of process in this state.
(2) Its principal corporate officers, as specified by the board, if any.
(3) Its general partners, as specified by the board, if any.
(4) Its owners if the applicant is not a corporation or partnership.
(e) A report containing the information in subdivision (d) shall be made within 30 days of
any change of ownership, office, corporate officer, or partner.
(f) A nonresident wholesaler or nonresident third-party logistics provider shall comply
with all directions and requests for information from the regulatory or licensing agency of
the state in which it is licensed, as well as with all requests for information made by the
board.
(g) A nonresident wholesaler or nonresident third-party logistics provider shall maintain
records of dangerous drugs and dangerous devices sold, traded, transferred,
warehoused, or distributed to persons in this state or within this state, so that the
records are in a readily retrievable form.
(h) A nonresident wholesaler or nonresident third-party logistics provider shall at all
times 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. An application for a nonresident wholesaler or
nonresident third-party logistics provider license in this state shall include a license
verification from the licensing authority in the applicant’s state of residence. The board
may 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 this
article 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 nonresident third-party logistics provider shall
reimburse the board for all actual and necessary costs incurred by the board in
conducting an inspection of the location, pursuant to subdivision (v) of Section 4400.
(i) (1) The board shall not issue or renew a nonresident wholesaler license until the
nonresident wholesaler identifies a designated representative-in-charge and notifies the
board in writing of the identity and license number of the designated representative-in-
charge.
(2) The board shall not issue or renew a nonresident third-party logistics provider
license until the nonresident third-party logistics provider identifies a responsible
manager and notifies the board in writing of the identity and license number of the
designated representative-3PL who will be the responsible manager.
(j) The designated representative-in-charge shall be responsible for the compliance of
the nonresident wholesaler with state and federal laws governing wholesalers. The
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responsible manager shall be responsible for the compliance of the nonresident third-
party logistics provider’s place of business with state and federal laws governing third-
party logistics providers. A nonresident wholesaler or nonresident third-party logistics
provider shall identify and notify the board of a new designated representative-in-charge
or responsible manager within 30 days of the date that the prior designated
representative-in-charge or responsible manager ceases to be the designated
representative-in-charge or responsible manager.
(k) The board may issue a temporary license, upon conditions and for periods of time as
the board determines to be in the public interest. A temporary license fee shall be five
hundred fifty dollars ($550) or another amount established by the board not to exceed
the annual fee for renewal of a license to compound sterile drug products. When
needed to protect public safety, a temporary license may be issued for a period not to
exceed 180 days, subject to terms and conditions that the board deems necessary. If
the board determines that a temporary license was issued by mistake or denies the
application for a permanent license, the temporary license shall terminate upon either
personal service of the notice of termination upon the licenseholder or service by
certified mail, return receipt requested, at the licenseholder’s address of record with the
board, whichever occurs first. Neither for purposes of retaining a temporary license, nor
for purposes of any disciplinary or license denial proceeding before the board, shall the
temporary licenseholder be deemed to have a vested property right or interest in the
license.
(l) The registration fee shall be the fee specified in subdivision (f) of Section 4400.
(m) This section shall be repealed on January 1, 2025.
4161.
(a) A person located outside this state that (1) ships, sells, mails, warehouses,
distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells,
brokers, warehouses, or distributes dangerous drugs or devices within this state shall
be considered a nonresident wholesaler or a nonresident third-party logistics provider.
(b) A nonresident wholesaler or nonresident third-party logistics provider shall be
licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or
delivering dangerous drugs or dangerous devices to a site located in this state or
selling, brokering, warehousing, or distributing dangerous drugs or devices within this
state.
(c)(1) A separate license shall be required for each place of business owned or
operated by a nonresident wholesaler or nonresident third-party logistics provider from
or through which dangerous drugs or dangerous devices are shipped, sold, mailed,
warehoused, distributed, or delivered to a site located in this state or sold, brokered,
warehoused, or distributed within this state. Each place of business may only be issued
a single license by the board, except as provided in paragraph (2). A license shall be
renewed annually and shall not be transferable.
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(2) A nonresident wholesaler and a nonresident third-party logistics provider under
common ownership may be licensed at the same place of business provided that all of
the following requirements are satisfied:
(A) The wholesaler and the third-party logistics provider each separately maintain the
records required under Section 4081.
(B) Dangerous drugs and dangerous devices owned by the wholesaler are not
commingled with the dangerous drugs and dangerous devices handled by the third-
party logistics provider.
(C) Any individual acting as a designated representative for the wholesaler is not
concurrently acting as a designated representative-3PL on behalf of the third-party
logistics provider. Nothing in this subparagraph shall be construed to prohibit an
individual from concurrently holding a license to act as a designated representative and
to act as a designated representative-3PL.
(D) The wholesaler has its own designated representative-in-charge responsible for the
operations of the wholesaler and the third-party logistics provider has its own
responsible manager responsible for the operations of the third-party logistics provider.
The same individual shall not concurrently serve as the responsible manager and the
designated representative-in-charge for a wholesaler and a third-party logistics provider
licensed at the same place of business.
(E) The third-party logistics provider does not handle the prescription drugs or
prescription devices owned by a prescriber.
(F) The third-party logistics provider is not a reverse third-party logistics provider.
(G) The wholesaler is not acting as a reverse distributor.
(d) The following information shall be reported, in writing, to the board at the time of
initial application for licensure by a nonresident wholesaler or a nonresident third-party
logistics provider, on renewal of a nonresident wholesaler or nonresident third-party
logistics provider license, or within 30 days of a change in that information:
(1) Its agent for service of process in this state.
(2) Its principal corporate officers, as specified by the board, if any.
(3) Its general partners, as specified by the board, if any.
(4) Its owners if the applicant is not a corporation or partnership.
(e) A report containing the information in subdivision (d) shall be made within 30 days of
any change of ownership, office, corporate officer, or partner.
(f) A nonresident wholesaler or nonresident third-party logistics provider shall comply
with all directions and requests for information from the regulatory or licensing agency of
the state in which it is licensed, as well as with all requests for information made by the
board.
(g) A nonresident wholesaler or nonresident third-party logistics provider shall maintain
records of dangerous drugs and dangerous devices sold, traded, transferred,
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warehoused, or distributed to persons in this state or within this state, so that the
records are in a readily retrievable form.
(h) A nonresident wholesaler or nonresident third-party logistics provider shall at all
times 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. An application for a nonresident wholesaler or
nonresident third-party logistics provider license in this state shall include a license
verification from the licensing authority in the applicant’s state of residence. The board
may 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 this
article 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 nonresident third-party logistics provider shall
reimburse the board for all actual and necessary costs incurred by the board in
conducting an inspection of the location, pursuant to subdivision (v) of Section 4400.
(i)(1) The board shall not issue or renew a nonresident wholesaler license until the
nonresident wholesaler identifies a designated representative-in-charge and notifies the
board in writing of the identity and license number of the designated representative-in-
charge.
(2) The board shall not issue or renew a nonresident third-party logistics provider
license until the nonresident third-party logistics provider identifies a responsible
manager and notifies the board in writing of the identity and license number of the
designated representative-3PL who will be the responsible manager.
(j) The designated representative-in-charge shall be responsible for the compliance of
the nonresident wholesaler with state and federal laws governing wholesalers. The
responsible manager shall be responsible for the compliance of the nonresident third-
party logistics provider’s place of business with state and federal laws governing third-
party logistics providers. A nonresident wholesaler or nonresident third-party logistics
provider shall identify and notify the board of a new designated representative-in-charge
or responsible manager within 30 days of the date that the prior designated
representative-in-charge or responsible manager ceases to be the designated
representative-in-charge or responsible manager.
(k) The board may issue a temporary license, upon conditions and for periods of time as
the board determines to be in the public interest. When needed to protect public safety,
a temporary license may be issued for a period not to exceed 180 days, subject to
terms and conditions that the board deems necessary. If the board determines that a
temporary license was issued by mistake or denies the application for a permanent
license, the temporary license shall terminate upon either personal service of the notice
of termination upon the licenseholder or service by certified mail, return receipt
requested, at the licenseholder’s address of record with the board, whichever occurs
first. Neither for purposes of retaining a temporary license, nor for purposes of any
disciplinary or license denial proceeding before the board, shall the temporary
licenseholder be deemed to have a vested property right or interest in the license.
(l) The registration fee shall be the fee specified in subdivision (f) of Section 4400.
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(m) This section shall become operative on January 1, 2025.
4170.
(a) A prescriber shall not dispense drugs or dangerous devices to patients in the
prescriber’s office or place of practice unless all of the following conditions are met:
(1) The dangerous drugs or dangerous devices are dispensed to the prescriber’s own
patient, and the drugs or dangerous devices are not furnished by a nurse or physician
attendant.
(2) The dangerous drugs or dangerous devices are necessary in the treatment of the
condition for which the prescriber is attending the patient.
(3) The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or
otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.
(4) The prescriber fulfills all of the labeling requirements imposed upon pharmacists by
Section 4076, all of the recordkeeping requirements of this chapter, and all of the
packaging requirements of good pharmaceutical practice, including the use of childproof
containers.
(5) The prescriber does not use a dispensing device unless the prescriber personally
owns the device and the contents of the device, and personally dispenses the
dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded
in accordance with paragraph (4).
(6) The prescriber, before dispensing, offers to give a written prescription to the patient
that the patient may elect to have filled by the prescriber or by any pharmacy.
(7) The prescriber provides the patient with written disclosure that the patient has a
choice between obtaining the prescription from the dispensing prescriber or obtaining
the prescription at a pharmacy of the patient’s choice.
(8)(b) A certified nurse-midwife who functions pursuant to a standardized
procedure mutually agreed-upon policy or protocol described in Section 2746.51,
2746.5, a nurse practitioner who functions pursuant to a standardized procedure
described in Section 2836.1, or protocol, a physician assistant who functions pursuant
to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5,
may hand to a patient of the supervising physician and surgeon a properly labeled
prescription drug prepackaged by a physician and surgeon, a manufacturer as defined
in this chapter, or a pharmacist.
(b)(c) The Medical Board of California, the California State Board of Optometry,
the Bureau California Board of Naturopathic Medicine, the Dental Board of California,
the Podiatric Medical Board of California, the Osteopathic Medical Board of California,
the Board of Registered Nursing, the Veterinary Medical Board, and the Physician
Assistant Board shall have authority with the California State Board of Pharmacy to
ensure compliance with this section, and those boards are specifically charged with the
enforcement of this chapter with respect to their respective licensees.
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(c)(d) “Prescriber,” as used in this section, means a person, person who holds a
physician’s and surgeon’s certificate, a license to practice optometry, a license to
practice naturopathic medicine, a license to practice dentistry, a license to practice
veterinary medicine, a certificate to practice podiatry, or a certificate to practice as a
nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or a certificate
to practice as a nurse-midwife, and who is duly registered by the Medical Board of
California, the Osteopathic Medical Board of California, the California State Board of
Optometry, the Bureau California Board of Naturopathic Medicine, the Dental Board of
California, the Veterinary Medical Board, the Podiatric Medical Board of California, or
the Board of Registered Nursing.
4192.
(a) Each clinic that makes an application for a license under this article shall show
evidence that the professional director is responsible for the safe, orderly, and lawful
provision of pharmacy services. In carrying out the professional director’s
responsibilities, a consulting pharmacist shall be retained to approve the policies and
procedures in conjunction with the professional director and the administrator. In
addition, the consulting pharmacist shall be required to visit the clinic regularly and at
least quarterly. However, nothing in this section shall prohibit the consulting pharmacist
from visiting more than quarterly to review the application of policies and procedures
based on the agreement of all the parties approving the policies and procedures.
(b) The consulting pharmacist shall certify in writing quarterly that the clinic is, or is not,
operating in compliance with the requirements of this article. Each completed written
certification shall be kept on file in the clinic for three years and shall include
recommended corrective actions, if appropriate. Before July 1 of every odd-numbered
year, the consulting pharmacist shall complete a Surgical Clinic Self-Assessment Form
as determined by the board as a means to promote compliance through self-
examination and education. The self-assessment shall assess the clinic’s compliance
with current laws and regulations and include information on compounding practices as
specified on the most recent version of the Surgical Clinic Self-Assessment Form
approved by the board and posted on its internet website. The professional director of
the clinic and consulting pharmacist shall certify on the final page of the Surgical Clinic
Self-Assessment Form that they have read, reviewed, and completed self-assessment
to the best of their professional ability and acknowledge that failure to correct any
deficiency identified could result in action by the board. The completed form shall be
signed under penalty of perjury, kept on file in the clinic for three years, and made
available to the board or its designee, upon request.
(c) For the purposes of this article, “professional director” means a physician and
surgeon acting in his or her their capacity as medical director or a dentist or podiatrist
acting in his or her their capacity as a director in a clinic where only dental or podiatric
services are provided.
(d) Licensed clinics shall notify the board within 30 days of any change in professional
director on a form furnished by the board.
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4202.
(a) The board may issue a pharmacy technician license to an individual if the applicant is
a high school graduate or possesses a general educational development certificate
equivalent, and meets any one of the following requirements:
(1) Has obtained an associate’s degree in pharmacy technology.
(2) Has completed a course of training specified by the board.
(3) Has graduated from a school of pharmacy recognized by the board.
(4) Is certified by a pharmacy technician certifying organization offering a pharmacy
technician certification program accredited by the National Commission for Certifying
Agencies that is approved by the board.
(b) The board shall adopt regulations pursuant to this section for the licensure of
pharmacy technicians and for the specification of training courses as set out in paragraph
(2) of subdivision (a). Proof of the qualifications of any applicant for licensure as a
pharmacy technician shall be made to the satisfaction of the board and shall be
substantiated by any evidence required by the board.
(c) The board shall conduct a criminal background check of the applicant to determine if
an applicant has committed acts that would constitute grounds for denial of licensure,
pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5.
(d) The board may suspend or revoke a license issued pursuant to this section on any
ground specified in Section 4301.
(e) Once an individual is licensed as a pharmacist, the pharmacy technician registration
is no longer valid and the pharmacy technician license shall be returned to the board
within 15 days.
(f) This section shall remain in effect only until January 1, 2024, and as of that date is
repealed.
4202.
(a) The board may issue a pharmacy technician license to an individual if the applicant is
a high school graduate or possesses a general educational development certificate
equivalent, and meets any one of the following requirements:
(1) Has obtained an associate’s degree in pharmacy technology.
(2) Has completed a course of training specified by the board.
(3) Has graduated from a school of pharmacy recognized by the board.
(4) Is certified by a pharmacy technician certifying organization offering a pharmacy
technician certification program accredited by the National Commission for Certifying
Agencies that is approved by the board.
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(b) The board shall adopt regulations pursuant to this section for the licensure of
pharmacy technicians and for the specification of training courses as set out in paragraph
(2) of subdivision (a). Proof of the qualifications of any applicant for licensure as a
pharmacy technician shall be made to the satisfaction of the board and shall be
substantiated by any evidence required by the board.
(c) The board shall conduct a criminal background check of the applicant to determine if
an applicant has committed acts that would constitute grounds for denial of licensure,
pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5.
(d) The board shall not renew a pharmacy technician license unless the applicant submits
proof satisfactory to the board that the applicant has successfully completed at least one
hour of participation in a cultural competency course, as defined in Section 4231, during
the two years preceding the application for renewal.
(e) The board may suspend or revoke a license issued pursuant to this section on any
ground specified in Section 4301.
(f) Once an individual is licensed as a pharmacist, the pharmacy technician registration is
no longer valid and the pharmacy technician license shall be returned to the board within
15 days.
(g) This section shall become operative on January 1, 2024.
4202.5.
(a) The board may issue a designated paramedic license to an individual if he or she
holds they hold a license as a paramedic in this state and meets the criteria of this
section.
(b) The board shall conduct a criminal background check of the applicant to determine if
the applicant has committed acts that would constitute grounds for denial of licensure,
pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5.
(c) The board may suspend or revoke a license issued pursuant to this section on any
ground specified in Section 4301.
(d) A license issued under this section is dependent on the validity of the holder’s
paramedic license and shall be automatically suspended if the individual’s paramedic
license is expired, revoked, or otherwise invalidated by the issuing authority.
(e) The fee for application and issuance of an initial license as a designated paramedic
shall be one hundred forty dollars ($140) for a two-year license. The biennial renewal
shall be one hundred forty dollars ($140). The penalty fee for failure to renew an
authorized paramedic license shall be sixty-five dollars ($65).
(f) This section shall be repealed on January 1, 2025.
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4202.5.
(a) The board may issue a designated paramedic license to an individual if they hold a
license as a paramedic in this state and meets the criteria of this section.
(b) The board shall conduct a criminal background check of the applicant to determine if
the applicant has committed acts that would constitute grounds for denial of licensure,
pursuant to this chapter or Chapter 2 (commencing with Section 480) of Division 1.5.
(c) The board may suspend or revoke a license issued pursuant to this section on any
ground specified in Section 4301.
(d) A license issued under this section is dependent on the validity of the holder’s
paramedic license and shall be automatically suspended if the individual’s paramedic
license is expired, revoked, or otherwise invalidated by the issuing authority.
(e) This section shall become operative on January 1, 2025.
4204.
(a) Each application for a license under Section 4190 shall be made on a form furnished
by the board. The form of application for a license under this article shall contain the
name and address of the applicant, whether the applicant is licensed, the type of
services the facility will offer, the name of its professional director, the name of its
administrator, and the name of its consulting pharmacist.
(b) Each initial application shall contain a statement from a consulting pharmacist
certifying that the policies and procedures of the clinic’s drug distribution service,
relative to inventories, security procedures, training, protocol development,
recordkeeping, packaging, labeling, dispensing, and patient consultation are consistent
with the promotion and protection of health and safety of the public. Upon the filing of
the application and the payment of a fee in subdivision (s) of Section 4400, the board
shall make a thorough investigation to determine whether the applicant and the
premises for which application for a license is made qualify for a license. The board
shall also determine whether this article has been complied with, and shall investigate
all matters directly related to the issuance of the license. The board shall not however,
investigate any matters connected with the operation of a premises, including operating
hours, parking availability, or operating noise, except those matters relating to the
furnishing, sale, or dispensing of drugs or devices. The board shall deny an application
for a license if either the applicant or the premises for which application for a license is
made do not qualify for a license under this article.
(c) If the board determines that the applicant and the premises for which application for
a license is made qualify for a license under Section 4190, the executive officer of the
board shall issue a license authorizing the clinic to which it is issued to purchase drugs
at wholesale pursuant to Section 4190. The license shall be renewed annually upon
payment of a renewal fee prescribed in subdivision (s) of Section 4400 and shall not be
transferable. As part of the renewal process the consulting pharmacist shall certify
compliance with the quarterly inspections as required in Section 4192. Further, as part
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of the renewal process of every odd-numbered year, the most recent self-assessment
form completed as provided in Section 4192 shall also be provided to the board.
4210.
(a) A person who seeks recognition as an advanced practice pharmacist shall meet all
of the following requirements:
(1) Hold an active license to practice pharmacy issued pursuant to this chapter that is in
good standing.
(2) (A) Satisfy any two of the following criteria:
(i) Earn certification in a relevant area of practice, including, but not limited to,
ambulatory care, critical care, geriatric pharmacy, nuclear pharmacy, nutrition support
pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric
pharmacy, from an organization recognized by the Accreditation Council for Pharmacy
Education or another entity recognized by the board.
(ii) Complete a postgraduate residency through an accredited postgraduate institution
where at least 50 percent of the experience includes the provision of direct patient care
services with interdisciplinary teams.
(iii) Have provided clinical services to patients for at least one year under a collaborative
practice agreement or protocol with a physician, advanced practice pharmacist,
pharmacist practicing collaborative drug therapy management, or health system.
(B) For purposes of this paragraph, if, as a condition of completion of one of the
required criteria fulfillment of a second criterion is also required, that completion shall be
deemed to satisfy this paragraph.
(3) File an application with the board for recognition as an advanced practice
pharmacist.
(4) Pay the applicable fee to the board.
(b) An advanced practice pharmacist recognition issued pursuant to this section shall be
valid for two years, coterminous with the certificate holder’s license to practice
pharmacy.
(c) The board shall adopt regulations establishing the means of documenting
completion of the requirements in this section.
(d) The board shall, by regulation, set the fee for the issuance and renewal of advanced
practice pharmacist recognition at the reasonable cost of regulating advanced practice
pharmacists pursuant to this chapter. The fee shall not exceed three hundred dollars
($300).
(e) This section shall be repealed on January 1, 2025.
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4210.
(a) A person who seeks recognition as an advanced practice pharmacist shall meet all
of the following requirements:
(1) Hold an active license to practice pharmacy issued pursuant to this chapter that is in
good standing.
(2) (A) Satisfy any two of the following criteria:
(i) Earn certification in a relevant area of practice, including, but not limited to,
ambulatory care, critical care, geriatric pharmacy, nuclear pharmacy, nutrition support
pharmacy, oncology pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric
pharmacy, from an organization recognized by the Accreditation Council for Pharmacy
Education or another entity recognized by the board.
(ii) Complete a postgraduate residency through an accredited postgraduate institution
where at least 50 percent of the experience includes the provision of direct patient care
services with interdisciplinary teams.
(iii) Have provided clinical services to patients for at least one year under a collaborative
practice agreement or protocol with a physician, advanced practice pharmacist,
pharmacist practicing collaborative drug therapy management, or health system.
(B) For purposes of this paragraph, if, as a condition of completion of one of the
required criteria fulfillment of a second criterion is also required, that completion shall be
deemed to satisfy this paragraph.
(3) File an application with the board for recognition as an advanced practice
pharmacist.
(4) Pay the applicable fee to the board.
(b) An advanced practice pharmacist recognition issued pursuant to this section shall be
valid for two years, coterminous with the certificate holder’s license to practice
pharmacy.
(c) The board shall adopt regulations establishing the means of documenting
completion of the requirements in this section.
(d) This section shall become operative on January 1, 2025.
4231.
(a) The board shall not renew a pharmacist license unless the applicant submits proof
satisfactory to the board that the applicant has successfully completed 30 hours of
approved courses of continuing pharmacy education during the two years preceding the
application for renewal.
(b) Notwithstanding subdivision (a), the board shall not require completion of continuing
education for the first renewal of a pharmacist license.
(c) If an applicant for renewal of a pharmacist license submits the renewal application and
payment of the renewal fee but does not submit proof satisfactory to the board that the
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licensee has completed 30 hours of continuing pharmacy education, the board shall not
renew the license and shall issue the applicant an inactive pharmacist license. A licensee
with an inactive pharmacist license issued pursuant to this section may obtain an active
pharmacist license by paying the renewal fees due and submitting satisfactory proof to
the board that the licensee has completed 30 hours of continuing pharmacy education.
(d) If, as part of an investigation or audit conducted by the board, a pharmacist fails to
provide documentation substantiating the completion of continuing education as required
in subdivision (a), the board shall cancel the active pharmacist license and issue an
inactive pharmacist license in its place. A licensee with an inactive pharmacist license
issued pursuant to this section may obtain an active pharmacist license by paying the
renewal fees due and submitting satisfactory proof to the board that the licensee has
completed 30 hours of continuing pharmacy education.
(e) This section shall remain in effect only until January 1, 2024, and as of that date is
repealed.
4231.
(a) For purposes of this section, “cultural competency course” means a cultural
competency and humility course that meets the following criteria:
(1) The course focuses on patients who identify as lesbian, gay, bisexual, transgender,
gender nonconforming, or queer, or who question their sexual orientation or gender
identity and expression.
(2) The course is approved from an accreditation agency approved by the board.
(3) The course covers recognized health disparities faced by Black, Indigenous, and
people of color.
(4) The course contains elements demonstrating how sexual identity is directly impacted
through intersectionality.
(b) The board shall not renew a pharmacist license unless the applicant submits proof
satisfactory to the board that the applicant has successfully completed 30 hours of
approved courses of continuing pharmacy education, including at least one hour of
participation in a cultural competency course, during the two years preceding the
application for renewal.
(c) Notwithstanding subdivision (b), the board shall not require completion of continuing
education for the first renewal of a pharmacist license.
(d) If an applicant for renewal of a pharmacist license submits the renewal application and
payment of the renewal fee but does not submit proof satisfactory to the board that the
licensee has completed 30 hours of continuing pharmacy education, the board shall not
renew the license and shall issue the applicant an inactive pharmacist license. A licensee
with an inactive pharmacist license issued pursuant to this section may obtain an active
pharmacist license by paying the renewal fees due and submitting satisfactory proof to
the board that the licensee has completed 30 hours of continuing pharmacy education.
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(e) If, as part of an investigation or audit conducted by the board, a pharmacist fails to
provide documentation substantiating the completion of continuing education as required
in subdivision (b), the board shall cancel the active pharmacist license and issue an
inactive pharmacist license in its place. A licensee with an inactive pharmacist license
issued pursuant to this section may obtain an active pharmacist license by paying the
renewal fees due and submitting satisfactory proof to the board that the licensee has
completed 30 hours of continuing pharmacy education.
(f) This section shall become operative on January 1, 2024.
4301.
The board shall take action against any holder of a license who is guilty of
unprofessional conduct or whose license has been issued by mistake. Unprofessional
conduct includes, but is not limited to, any of the following:
(a) Procurement of a license by fraud or misrepresentation.
(b) Incompetence.
(c) Gross negligence.
(d) The clearly excessive furnishing of controlled substances in violation of subdivision
(a) of Section 11153 of the Health and Safety Code.
(e) The clearly excessive furnishing of controlled substances in violation of subdivision
(a) of Section 11153.5 of the Health and Safety Code. Factors to be considered in
determining whether the furnishing of controlled substances is clearly excessive shall
include, but not be limited to, the amount of controlled substances furnished, the
previous ordering pattern of the customer (including size and frequency of orders), the
type and size of the customer, and where and to whom the customer distributes its
product.
(f) The commission of any act involving moral turpitude, dishonesty, fraud, deceit, or
corruption, whether the act is committed in the course of relations as a licensee or
otherwise, and whether the act is a felony or misdemeanor or not.
(g) Knowingly making or signing any certificate or other document that falsely
represents the existence or nonexistence of a state of facts.
(h) The administering to oneself, of any controlled substance, or the use of any
dangerous drug or of alcoholic beverages to the extent or in a manner as to be
dangerous or injurious to oneself, to a person holding a license under this chapter, or to
any other person or to the public, or to the extent that the use impairs the ability of the
person to conduct with safety to the public the practice authorized by the license.
(i) Except as otherwise authorized by law, knowingly selling, furnishing, giving away, or
administering, or offering to sell, furnish, give away, or administer, any controlled
substance to an addict. a person with substance use disorder.
(j) The violation of any of the statutes of this state, of any other state, or of the United
States regulating controlled substances and dangerous drugs.
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(k) The conviction of more than one misdemeanor or any felony involving the use,
consumption, or self-administration of any dangerous drug or alcoholic beverage, or any
combination of those substances.
(l) The conviction of a crime substantially related to the qualifications, functions, and
duties of a licensee under this chapter. The record of conviction of a violation of Chapter
13 (commencing with Section 801) of Title 21 of the United States Code regulating
controlled substances or of a violation of the statutes of this state regulating controlled
substances or dangerous drugs shall be conclusive evidence of unprofessional conduct.
In all other cases, the record of conviction shall be conclusive evidence only of the fact
that the conviction occurred. The board may inquire into the circumstances surrounding
the commission of the crime, in order to fix the degree of discipline or, in the case of a
conviction not involving controlled substances or dangerous drugs, to determine if the
conviction is of an offense substantially related to the qualifications, functions, and
duties of a licensee under this chapter. A plea or verdict of guilty or a conviction
following a plea of nolo contendere is deemed to be a conviction within the meaning of
this provision. The board may take action when the time for appeal has elapsed, or the
judgment of conviction has been affirmed on appeal or when an order granting
probation is made suspending the imposition of sentence, irrespective of a subsequent
order under Section 1203.4 of the Penal Code allowing the person to withdraw his or
her their plea of guilty and to enter a plea of not guilty, or setting aside the verdict of
guilty, or dismissing the accusation, information, or indictment.
(m) The cash compromise of a charge of violation of Chapter 13 (commencing with
Section 801) of Title 21 of the United States Code regulating controlled substances or of
Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and
Institutions Code relating to the Medi-Cal program.
(n) The revocation, suspension, or other discipline by another state of a license to
practice pharmacy, operate a pharmacy, or do any other act for which a license is
required by this chapter that would be grounds for revocation, suspension, or other
discipline under this chapter. Any disciplinary action taken by the board pursuant to this
section shall be coterminous with action taken by another state, except that the term of
any discipline taken by the board may exceed that of another state, consistent with the
board’s enforcement guidelines. The evidence of discipline by another state is
conclusive proof of unprofessional conduct.
(o) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the
violation of or conspiring to violate any provision or term of this chapter or of the
applicable federal and state laws and regulations governing pharmacy, including
regulations established by the board or by any other state or federal regulatory agency.
(p) Actions or conduct that would have warranted denial of a license.
(q) Engaging in any conduct that subverts or attempts to subvert an investigation of the
board.
(r) The selling, trading, transferring, or furnishing of drugs obtained pursuant to Section
256b of Title 42 of the United States Code to any person a licensee knows or
reasonably should have known, not to be a patient of a covered entity, as defined
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in paragraph (4) of subsection (a) of Section 256bSection 256b(a)(4) of Title 42 of the
United States Code.
(s) The clearly excessive furnishing of dangerous drugs by a wholesaler to a pharmacy
that primarily or solely dispenses prescription drugs to patients of long-term care
facilities. Factors to be considered in determining whether the furnishing of dangerous
drugs is clearly excessive shall include, but not be limited to, the amount of dangerous
drugs furnished to a pharmacy that primarily or solely dispenses prescription drugs to
patients of long-term care facilities, the previous ordering pattern of the pharmacy, and
the general patient population to whom the pharmacy distributes the dangerous drugs.
That a wholesaler has established, and employs, a tracking system that complies with
the requirements of subdivision (b) of Section 4164 shall be considered in determining
whether there has been a violation of this subdivision. This provision shall not be
interpreted to require a wholesaler to obtain personal medical information or be
authorized to permit a wholesaler to have access to personal medical information
except as otherwise authorized by Section 56 and following of the Civil Code. For
purposes of this section, “long-term care facility” has the same meaning given the term
in Section 1418 of the Health and Safety Code.
(t) The acquisition of a nonprescription diabetes test device from a person that the
licensee knew or should have known was not the nonprescription diabetes test device’s
manufacturer or the manufacturer’s authorized distributor as identified in Section
4160.5.
(u) The submission of a reimbursement claim for a nonprescription diabetes test device
to a pharmaceutical benefit manager, health insurer, government agency, or other third-
party payor when the licensee knew or reasonably should have known that the diabetes
test device was not purchased either directly from the manufacturer or from the
nonprescription diabetes test device manufacturer’s authorized distributors as identified
in Section 4160.5.
(v) Actions or conduct that would subvert the efforts of a pharmacist to comply with laws
and regulations, or exercise professional judgment, including creating or allowing
conditions that may interfere with a pharmacist’s ability to practice with competency and
safety or creating or allowing an environment that may jeopardize patient care. This
subdivision does not apply to facilities of the Department of Corrections and
Rehabilitation.
(w) Actions or conduct that would subvert the efforts of a pharmacist-in-charge to
comply with laws and regulations, exercise professional judgment, or make
determinations about adequate staffing levels to safely fill prescriptions of the pharmacy
or provide other patient care services in a safe and competent manner. This subdivision
does not apply to facilities of the Department of Corrections and Rehabilitation.
(x) Actions or conduct that would subvert the efforts of a pharmacist intern or a
pharmacy technician to comply with laws or regulations.
(y) Establishing policies and procedures related to time guarantees to fill prescriptions
within a specified time unless those guarantees are required by law or to meet
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contractual requirements. This subdivision does not apply to facilities of the Department
of Corrections and Rehabilitation.
4316.5.
Notwithstanding any other law, the board may assess administrative fines and issue
orders of abatement to any unlicensed entity who engages in any action that requires
licensure under the jurisdiction of the board, not to exceed five thousand dollars
($5,000) for each occurrence pursuant to a citation issued by the board.
4400.
The amount of fees and penalties prescribed by this chapter, except as otherwise
provided, is that fixed by the board according to the following schedule:
(a) The fee for a pharmacy license shall be five hundred twenty dollars ($520) and may
be increased to five hundred seventy dollars ($570). The fee for the issuance of a
temporary pharmacy permit shall be two hundred fifty dollars ($250) and may be
increased to three hundred twenty-five dollars ($325).
(b) The fee for a pharmacy license annual renewal shall be six hundred sixty-five dollars
($665) and may be increased to nine hundred thirty dollars ($930).
(c) The fee for the pharmacist application and examination shall be two hundred sixty
dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d) The fee for regrading an examination shall be ninety dollars ($90) and may be
increased to one hundred fifteen dollars ($115). If an error in grading is found and the
applicant passes the examination, the regrading fee shall be refunded.
(e) The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and
may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist
biennial renewal shall be three hundred sixty dollars ($360) and may be increased to
five hundred five dollars ($505).
(f) The fee for a wholesaler or third-party logistics provider license and annual renewal
shall be seven hundred eighty dollars ($780) and may be increased to eight hundred
twenty dollars ($820). The application fee for any additional location after licensure of
the first 20 locations shall be three hundred dollars ($300) and may be decreased to no
less than two hundred twenty-five dollars ($225). A temporary license fee shall be seven
hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty
dollars ($550).
(g) The fee for a hypodermic license shall be one hundred seventy dollars ($170) and
may be increased to two hundred forty dollars ($240). The fee for a hypodermic license
renewal shall be two hundred dollars ($200) and may be increased to two hundred
eighty dollars ($280).
(h) (1) The fee for application, investigation, and issuance of a license as a designated
representative pursuant to Section 4053, as a designated representative-3PL pursuant
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to Section 4053.1, or as a designated representative-reverse distributor pursuant to
Section 4053.2 shall be one hundred fifty dollars ($150) and may be increased to two
hundred ten dollars ($210).
(2) The fee for the annual renewal of a license as a designated representative,
designated representative-3PL, or designated representative-reverse distributor shall be
two hundred fifteen dollars ($215) and may be increased to three hundred dollars
($300).
(i)(1) The fee for the application, investigation, and issuance of a license as a
designated representative for a veterinary food-animal drug retailer pursuant to Section
4053 shall be one hundred fifty dollars ($150) and may be increased to two hundred ten
dollars ($210).
(2) The fee for the annual renewal of a license as a designated representative for a
veterinary food-animal drug retailer shall be two hundred fifteen dollars ($215) and may
be increased to three hundred dollars ($300).
(j)(1) The application fee for a nonresident wholesaler or third-party logistics provider
license issued pursuant to Section 4161 shall be seven hundred eighty dollars ($780)
and may be increased to eight hundred twenty dollars ($820).
(2) For nonresident wholesalers or third-party logistics providers that have 21 or more
facilities operating nationwide the application fees for the first 20 locations shall be
seven hundred eighty dollars ($780) and may be increased to eight hundred twenty
dollars ($820). The application fee for any additional location after licensure of the first
20 locations shall be three hundred dollars ($300) and may be decreased to no less
than two hundred twenty-five dollars ($225). A temporary license fee shall be seven
hundred fifteen dollars ($715) and may be decreased to no less than five hundred fifty
dollars ($550).
(3) The annual renewal fee for a nonresident wholesaler license or third-party logistics
provider license issued pursuant to Section 4161 shall be seven hundred eighty dollars
($780) and may be increased to eight hundred twenty dollars ($820).
(k) The fee for evaluation of continuing education courses for accreditation shall be set
by the board at an amount not to exceed forty dollars ($40) per course hour.
(l) The fee for an intern pharmacist license shall be one hundred sixty-five dollars ($165)
and may be increased to two hundred thirty dollars ($230). The fee for transfer of intern
hours or verification of licensure to another state shall be twenty-five dollars ($25) and
may be increased to thirty dollars ($30).
(m) The board may waive or refund the additional fee for the issuance of a license
where the license is issued less than 45 days before the next regular renewal date.
(n) The fee for the reissuance of any license, or renewal thereof, that has been lost or
destroyed or reissued due to a name change shall be thirty-five dollars ($35) and may
be increased to forty-five dollars ($45).
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(o) The fee for processing an application to change information on a premises license
record shall be one hundred dollars ($100) and may be increased to one hundred thirty
dollars ($130).
(p) It is the intent of the Legislature that, in setting fees pursuant to this section, the
board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to
approximately one year’s operating expenditures.
(q) The fee for any applicant for a clinic license shall be five hundred twenty dollars
($520) for each license and may be increased to five hundred seventy dollars ($570).
The annual fee for renewal of the license shall be three hundred twenty-five dollars
($325) for each license and may be increased to three hundred sixty dollars ($360).
(r) The fee for the issuance of a pharmacy technician license shall be one hundred forty
dollars ($140) and may be increased to one hundred ninety-five dollars ($195). The fee
for renewal of a pharmacy technician license shall be one hundred forty dollars ($140)
and may be increased to one hundred ninety-five dollars ($195).
(s) The fee for a veterinary food-animal drug retailer license shall be four hundred thirty-
five dollars ($435) and may be increased to six hundred ten dollars ($610). The annual
renewal fee for a veterinary food-animal drug retailer license shall be three hundred
thirty dollars ($330) and may be increased to four hundred sixty dollars ($460).
(t) The fee for issuance of a retired license pursuant to Section 4200.5 shall be thirty-
five dollars ($35) and may be increased to forty-five dollars ($45).
(u) The fee for issuance of a sterile compounding pharmacy license or a hospital
satellite compounding pharmacy shall be one thousand six hundred forty-five dollars
($1,645) and may be increased to two thousand three hundred five dollars ($2,305).
The fee for a temporary license shall be five hundred fifty dollars ($550) and may be
increased to seven hundred fifteen dollars ($715). The annual renewal fee of the license
shall be one thousand three hundred twenty-five dollars ($1,325) and may be increased
to one thousand eight hundred fifty-five dollars ($1,855).
(v) The fee for the issuance of a nonresident sterile compounding pharmacy license
shall be two thousand three hundred eighty dollars ($2,380) and may be increased to
three thousand three hundred thirty-five dollars ($3,335). The annual renewal of the
license shall be two thousand two hundred seventy dollars ($2,270) and may be
increased to three thousand one hundred eighty dollars ($3,180). In addition to paying
that application fee, the nonresident sterile compounding pharmacy shall deposit, when
submitting the application, a reasonable amount, as determined by the board,
necessary to cover the board’s estimated cost of performing the inspection required by
Section 4127.2. If the required deposit is not submitted with the application, the
application shall be deemed to be incomplete. If the actual cost of the inspection
exceeds the amount deposited, the board shall provide to the applicant a written invoice
for the remaining amount and shall not take action on the application until the full
amount has been paid to the board. If the amount deposited exceeds the amount of
actual and necessary costs incurred, the board shall remit the difference to the
applicant.
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(w) The fee for the issuance of an outsourcing facility license shall be two thousand two
hundred seventy dollars ($2,270) and may be increased to up to three thousand one
hundred eighty dollars ($3,180) by the board. The fee for the renewal of an outsourcing
facility license shall be one thousand three hundred twenty-five dollars ($1,325) and
may be increased to up to one thousand eight hundred fifty-five dollars ($1,855) by the
board. The fee for a temporary outsourcing facility license shall be seven hundred
fifteen dollars ($715).
(x) The fee for the issuance of a nonresident outsourcing facility license shall be two
thousand three hundred eighty dollars ($2,380) and may be increased to up to three
thousand three hundred thirty-five dollars ($3,335) by the board. The fee for the renewal
of a nonresident outsourcing facility license shall be two thousand two hundred seventy
dollars ($2,270) and may be increased to up to three thousand one hundred eighty
dollars ($3,180) by the board. In addition to paying that application fee, the nonresident
outsourcing facility shall deposit, when submitting the application, a reasonable amount,
as determined by the board, necessary to cover the board’s estimated cost of
performing the inspection required by Section 4129.2. If the required deposit is not
submitted with the application, the application shall be deemed to be incomplete. If the
actual cost of the inspection exceeds the amount deposited, the board shall provide to
the applicant a written invoice for the remaining amount and shall not take action on the
application until the full amount has been paid to the board. If the amount deposited
exceeds the amount of actual and necessary costs incurred, the board shall remit the
difference to the applicant.
(y) The fee for the issuance of a centralized hospital packaging license shall be eight
hundred twenty dollars ($820) and may be increased to one thousand one hundred fifty
dollars ($1,150). The annual renewal of the license shall be eight hundred five dollars
($805) and may be increased to one thousand one hundred twenty-five dollars ($1,125).
(z) The fee for the issuance of a license to a correctional clinic pursuant to Article 13.5
(commencing with Section 4187) that is not owned by the state shall be five hundred
twenty dollars ($520) and may be increased to five hundred seventy dollars ($570). The
annual renewal fee for that correctional clinic license shall be three hundred twenty-five
dollars ($325) and may be increased to three hundred sixty dollars ($360).
(aa) Beginning on and after July 1, 2019, the fee for an ADDS license shall be two
hundred dollars ($200) and may be increased to two hundred fifty dollars ($250). The
fee for the annual renewal of the license shall be two hundred dollars ($200) and may
be increased to two hundred fifty dollars ($250).
(ab) This section shall become operative on July 1, 2021.
(ac) This section shall be repealed on January 1, 2025.
4400.
The amount of fees and penalties prescribed by this chapter, except as otherwise
provided, is that fixed by the board according to the following schedule:
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(a) (1) The fee for a pharmacy license shall be seven hundred fifty dollars ($750) and
may be increased to two thousand dollars ($2,000). The fee for the issuance of a
temporary pharmacy permit shall be one thousand six hundred dollars ($1,600) and
may be increased to two thousand seven hundred forty dollars ($2,740).
(2) The fee for a nonresident pharmacy license shall be two thousand four hundred
twenty-seven dollars ($2,427) and may be increased to three thousand four hundred
twenty-four dollars ($3,424). The fee for the issuance of a temporary nonresident
pharmacy permit shall be two thousand dollars ($2,000) and may be increased to two
thousand four hundred sixty-nine dollars ($2,469).
(b) (1) The fee for a pharmacy license annual renewal shall be one thousand twenty-five
dollars ($1,025) and may be increased to two thousand dollars ($2,000).
(2) The fee for a nonresident pharmacy license annual renewal shall be one thousand
twenty-five dollars ($1,025) and may be increased to two thousand dollars ($2,000).
(c) The fee for the pharmacist application and examination shall be two hundred sixty
dollars ($260) and may be increased to two hundred eighty-five dollars ($285).
(d) The fee for regrading an examination shall be one hundred fifteen dollars ($115) and
may be increased to two hundred dollars ($200). If an error in grading is found and the
applicant passes the examination, the regrading fee shall be refunded.
(e) The fee for a pharmacist license shall be one hundred ninety-five dollars ($195) and
may be increased to two hundred fifteen dollars ($215). The fee for a pharmacist
biennial renewal shall be four hundred fifty dollars ($450) and may be reduced to three
hundred sixty dollars ($360).
(f) The fee for a wholesaler or third-party logistics provider license and annual renewal
shall be one thousand dollars ($1,000) and may be increased to one thousand four
hundred eleven dollars ($1,411). A temporary license fee shall be seven hundred fifteen
dollars ($715) and may be increased to one thousand nine dollars ($1,009).
(g) The fee for a hypodermic license shall be five hundred fifty dollars ($550) and may
be increased to seven hundred seventy-five dollars ($775). The fee for a hypodermic
license renewal shall be four hundred dollars ($400) and may be increased to five
hundred sixty-one dollars ($561).
(h) (1) The fee for application, investigation, and issuance of a license as a designated
representative pursuant to Section 4053, as a designated representative-3PL pursuant
to Section 4053.1, or as a designated representative-reverse distributor pursuant to
Section 4053.2 shall be three hundred forty-five dollars ($345) and may be increased to
four hundred eighty-five dollars ($485).
(2) The fee for the annual renewal of a license as a designated representative,
designated representative-3PL, or designated representative-reverse distributor shall be
three hundred eighty-eight dollars ($388) and may be increased to five hundred forty-
seven dollars ($547).
(i) (1) The fee for the application, investigation, and issuance of a license as a
designated representative for a veterinary food-animal drug retailer pursuant to Section
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4053 shall be three hundred forty-five dollars ($345) and may be increased to four
hundred eighty-five dollars ($485).
(2) The fee for the annual renewal of a license as a designated representative for a
veterinary food-animal drug retailer shall be three hundred eighty-eight dollars ($388)
and may be increased to five hundred forty-seven dollars ($547).
(j) (1) The application fee for a nonresident wholesaler or third-party logistics provider
license issued pursuant to Section 4161 shall be one thousand dollars ($1,000) and
may be increased to one thousand four hundred eleven dollars ($1,411).
(2) A temporary license fee shall be seven hundred fifteen dollars ($715) and may be
increased to one thousand nine dollars ($1,009).
(3) The annual renewal fee for a nonresident wholesaler license or third-party logistics
provider license issued pursuant to Section 4161 shall be one thousand dollars ($1,000)
and may be increased to one thousand four hundred eleven dollars ($1,411).
(k) The fee for evaluation of continuing education courses for accreditation shall be set
by the board at an amount not to exceed forty dollars ($40) per course hour.
(l) The fee for an intern pharmacist license shall be one hundred seventy-five dollars
($175) and may be increased to two hundred forty-five dollars ($245). The fee for
transfer of intern hours or verification of licensure to another state shall be one hundred
twenty dollars ($120) and may be increased to one hundred sixty-eight dollars ($168).
(m) The board may waive or refund the additional fee for the issuance of a license
where the license is issued less than 45 days before the next regular renewal date.
(n) The fee for the reissuance of any license, or renewal thereof, that has been lost or
destroyed or reissued due to a name change shall be seventy-five dollars ($75) and
may be increased to one hundred dollars ($100).
(o) (1) The fee for processing an application to change information on a premises
license record shall be three hundred ninety-five dollars ($395) and may be increased to
five hundred fifty-seven dollars ($557).
(2) The fee for processing an application to change a name or correct an address on a
premises license record shall be two hundred six dollars ($206) and may be increased
to two hundred eighty-two dollars ($282).
(3) The fee for processing an application to change a pharmacist-in-charge, designated
representative-in-charge, or responsible manager on a premises license record shall be
two hundred fifty dollars ($250) and may be increased to three hundred fifty-three
dollars ($353).
(p) It is the intent of the Legislature that, in setting fees pursuant to this section, the
board shall seek to maintain a reserve in the Pharmacy Board Contingent Fund equal to
approximately one year’s operating expenditures.
(q) The fee for any applicant for a clinic license shall be six hundred twenty dollars
($620) and may be increased to eight hundred seventy-three dollars ($873). The annual
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fee for renewal of the license shall be four hundred dollars ($400) and may be increased
to five hundred sixty-one dollars ($561).
(r) The fee for the issuance of a pharmacy technician license shall be one hundred
twenty dollars ($120) and may be increased to one hundred sixty-five dollars ($165).
The fee for renewal of a pharmacy technician license shall be one hundred eighty
dollars ($180) and may be reduced to one hundred twenty-five dollars ($125).
(s) The fee for a veterinary food-animal drug retailer license shall be six hundred ten
dollars ($610) and may be increased to eight hundred twenty-five dollars ($825). The
annual renewal fee for a veterinary food-animal drug retailer license shall be four
hundred sixty dollars ($460) and may be increased to five hundred sixty-one dollars
($561). The fee for the temporary license shall be five hundred twenty dollars ($520)
and may be increased to seven hundred thirty-two dollars ($732).
(t) The fee for issuance of a retired license pursuant to Section 4200.5 shall be fifty
dollars ($50) and may be increased to one hundred dollars ($100).
(u) The fee for issuance of a sterile compounding pharmacy license or a hospital
satellite compounding pharmacy shall be three thousand eight hundred seventy-five
dollars ($3,875) and may be increased to five thousand four hundred sixty-six dollars
($5,466). The fee for a temporary license shall be one thousand sixty-five dollars
($1,065) and may be increased to one thousand five hundred three dollars ($1,503).
The annual renewal fee of the license shall be four thousand eighty-five dollars ($4,085)
and may be increased to five thousand seven hundred sixty-two dollars ($5,762).
(v) The fee for the issuance of a nonresident sterile compounding pharmacy license
shall be eight thousand five hundred dollars ($8,500) and may be increased to sixteen
thousand five hundred two dollars ($16,502). The annual renewal of the license shall be
eight thousand five hundred dollars ($8,500) and may be increased to seventeen
thousand forty dollars ($17,040). In addition to paying that application fee, the
nonresident sterile compounding pharmacy shall deposit, when submitting the
application, a reasonable amount, as determined by the board, necessary to cover the
board’s estimated cost of performing the inspection required by Section 4127.2. If the
required deposit is not submitted with the application, the application shall be deemed to
be incomplete. If the actual cost of the inspection exceeds the amount deposited, the
board shall provide to the applicant a written invoice for the remaining amount and shall
not take action on the application until the full amount has been paid to the board. If the
amount deposited exceeds the amount of actual and necessary costs incurred, the
board shall remit the difference to the applicant. The fee for a temporary license shall be
one thousand five hundred dollars ($1,500) and may be increased to two thousand
dollars ($2,000).
(w) The fee for the issuance of an outsourcing facility license shall be twenty-five
thousand dollars ($25,000) and may be increased to thirty-five thousand two hundred
fifty-six dollars ($35,256). The fee for the renewal of an outsourcing facility license shall
be twenty-five thousand dollars ($25,000) and may be increased to forty-one thousand
three hundred sixty-six dollars ($41,366). The fee for a temporary outsourcing facility
license shall be four thousand dollars ($4,000) and may be increased to five thousand
six hundred forty-two dollars ($5,642).
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(x) The fee for the issuance of a nonresident outsourcing facility license shall be twenty-
eight thousand five hundred dollars ($28,500) and may be increased to forty-two
thousand three hundred eighteen dollars ($42,318). The fee for the renewal of a
nonresident outsourcing facility license shall be twenty-eight thousand five hundred
dollars ($28,500) and may be increased to forty-six thousand three hundred fifty-three
dollars ($46,353). In addition to paying that application fee, the nonresident outsourcing
facility shall deposit, when submitting the application, a reasonable amount, as
determined by the board, necessary to cover the board’s estimated cost of performing
the inspection required by Section 4129.2. If the required deposit is not submitted with
the application, the application shall be deemed to be incomplete. If the actual cost of
the inspection exceeds the amount deposited, the board shall provide to the applicant a
written invoice for the remaining amount and shall not take action on the application
until the full amount has been paid to the board. If the amount deposited exceeds the
amount of actual and necessary costs incurred, the board shall remit the difference to
the applicant. The fee for a temporary nonresident outsourcing license shall be four
thousand dollars ($4,000) and may be increased to five thousand six hundred forty-two
dollars ($5,642).
(y) The fee for the issuance of a centralized hospital packaging license shall be three
thousand eight hundred fifteen dollars ($3,815) and may be increased to five thousand
three hundred eighteen dollars ($5,318). The annual renewal of the license shall be two
thousand nine hundred twelve dollars ($2,912) and may be increased to four thousand
one hundred seven dollars ($4,107).
(z)(1) The fee for the issuance of a license to a correctional clinic pursuant to Article
13.5 (commencing with Section 4187) shall be six hundred twenty dollars ($620) and
may be increased to eight hundred seventy-three dollars ($873). The annual renewal
fee for that correctional clinic license shall be four hundred dollars ($400) and may be
increased to five hundred sixty-one dollars ($561).
(2) The fee for the issuance of an ADDS license to a correctional clinic pursuant to
Article 13.5 (commencing with Section 4187) shall be five hundred dollars ($500) and
may be increased to seven hundred five dollars ($705). The annual renewal fee for the
correctional clinic ADDS shall be four hundred dollars ($400) and may be increased to
five hundred sixty-one dollars ($561).
(aa) The fee for an ADDS license shall be five hundred twenty-five dollars ($525) and
may be increased to seven hundred forty-one dollars ($741). The fee for the annual
renewal of the license shall be four hundred fifty-three dollars ($453) and may be
increased to six hundred thirty-nine dollars ($639).
(ab) The application and initial license fee for a remote dispensing site pharmacy
application shall be one thousand seven hundred thirty dollars ($1,730) and may be
increased to two thousand four hundred forty dollars ($2,440). The fee for the annual
renewal shall be one thousand twenty-five dollars ($1,025) and may be increased to two
thousand dollars ($2,000). The fee for a temporary license shall be eight hundred ninety
dollars ($890) and may be increased to one thousand one hundred ninety-nine dollars
($1,199).
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(ac) The application and initial license fee to operate EMSADDS shall be one hundred
fifty dollars ($150) and may be increased to three hundred eighty dollars ($380) per
machine. The fee for the annual renewal shall be two hundred dollars ($200) and may
be increased to two hundred seventy-three dollars ($273). The license fee may not be
transferred to a different location if the EMSADDS is moved. The application and
renewal fee for a licensed wholesaler that is also an emergency medical services
provider agency shall be eight hundred ten dollars ($810) and may be increased to one
thousand one hundred forty-three dollars ($1,143).
(ad) The fee for application and issuance of an initial license as a designated paramedic
shall be three hundred fifty dollars ($350) and may be increased to four hundred ninety-
four dollars ($494). The fee of biennial renewal shall be two hundred dollars ($200) and
may be increased to two hundred ninety-two dollars ($292).
(ae) The fee for an application for an advanced practice pharmacist license and renewal
of advanced practice pharmacist license shall be three hundred dollars ($300) and may
be increased to four hundred eighteen dollars ($418).
(af) This section shall become operative on January 1, 2025.
4427.8.
(a) This article shall become operative on July 1, 2019.
(b) On or before January 1, 2024,2025, as part of the board’s sunset evaluation
process, and notwithstanding Sections 9795 and 10231.5 of the Government Code, the
board shall report to the appropriate committees of the Legislature on the regulation of
ADDS units as provided in this article. At a minimum, this report shall require all of the
following:
(1) The use and dispersion of ADDS throughout the health care system.
(2) The number of ADDS inspections conducted by the board each year and the
findings from the inspections.
(3) Public safety concerns relating to the use of ADDS as identified by the board.
Civil Code
56.05.
For purposes of this part:
(a) “Authorization” means permission granted in accordance with Section 56.11 or 56.21
for the disclosure of medical information.
(b) “Authorized recipient” means a person who is authorized to receive medical
information pursuant to Section 56.10 or 56.20.
(c) “Confidential communications request” means a request by a subscriber or enrollee
that health care service plan communications containing medical information be
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communicated to them at a specific mail or email address or specific telephone number,
as designated by the subscriber or enrollee.
(d) “Contractor” means a person or entity that is a medical group, independent practice
association, pharmaceutical benefits manager, or a medical service organization and is
not a health care service plan or provider of health care. “Contractor” does not include
insurance institutions as defined in subdivision (k) of Section 791.02 of the Insurance
Code or pharmaceutical benefits managers licensed pursuant to the Knox-Keene Health
Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division
2 of the Health and Safety Code).
(e) “Enrollee” has the same meaning as that term is defined in Section 1345 of the
Health and Safety Code.
(f) “Expiration date or event” means a specified date or an occurrence relating to the
individual to whom the medical information pertains or the purpose of the use or
disclosure, after which the provider of health care, health care service plan,
pharmaceutical company, or contractor is no longer authorized to disclose the medical
information.
(f)(g) “Health care service plan” means an entity regulated pursuant to the Knox-Keene
Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of
Division 2 of the Health and Safety Code).
(g)(h) “Licensed health care professional” means a person licensed or certified pursuant
to Division 2 (commencing with Section 500) of the Business and Professions Code, the
Osteopathic Initiative Act or the Chiropractic Initiative Act, or Division 2.5 (commencing
with Section 1797) of the Health and Safety Code.
(h)(i) “Marketing” means to make a communication about a product or service that
encourages recipients of the communication to purchase or use the product or service.
“Marketing” does not include any of the following:
(1) Communications made orally or in writing for which the communicator does not
receive direct or indirect remuneration, including, but not limited to, gifts, fees,
payments, subsidies, or other economic benefits, from a third party for making the
communication.
(2) Communications made to current enrollees solely for the purpose of describing a
provider’s participation in an existing health care provider network or health plan
network of a Knox-Keene licensed health plan to which the enrollees already subscribe;
communications made to current enrollees solely for the purpose of describing if, and
the extent to which, a product or service, or payment for a product or service, is
provided by a provider, contractor, or plan or included in a plan of benefits of a Knox-
Keene licensed health plan to which the enrollees already subscribe; or
communications made to plan enrollees describing the availability of more cost-effective
pharmaceuticals.
(3) Communications that are tailored to the circumstances of a particular individual to
educate or advise the individual about treatment options, and otherwise maintain the
individual’s adherence to a prescribed course of medical treatment, as provided in
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Section 1399.901 of the Health and Safety Code, for a chronic and seriously debilitating
or life-threatening condition as defined in subdivisions (d) and (e) of Section 1367.21 of
the Health and Safety Code, if the health care provider, contractor, or health plan
receives direct or indirect remuneration, including, but not limited to, gifts, fees,
payments, subsidies, or other economic benefits, from a third party for making the
communication, if all of the following apply:
(A) The individual receiving the communication is notified in the communication in
typeface no smaller than 14-point type of the fact that the provider, contractor, or health
plan has been remunerated and the source of the remuneration.
(B) The individual is provided the opportunity to opt out of receiving future remunerated
communications.
(C) The communication contains instructions in typeface no smaller than 14-point type
describing how the individual can opt out of receiving further communications by calling
a toll-free number of the health care provider, contractor, or health plan making the
remunerated communications. Further communication shall not be made to an
individual who has opted out after 30 calendar days from the date the individual makes
the opt-out request.
(i)(j) “Medical information” means any individually identifiable information, in electronic
or physical form, in possession of or derived from a provider of health care, health care
service plan, pharmaceutical company, or contractor regarding a patient’s medical
history, mental health application information, reproductive or sexual health application
information, mental or physical condition, or treatment. “Individually identifiable” means
that the medical information includes or contains any element of personal identifying
information sufficient to allow identification of the individual, such as the patient’s name,
address, electronic mail address, telephone number, or social security number, or other
information that, alone or in combination with other publicly available information,
reveals the identity of the individual.
(j)(k) “Mental health application information” means information related to a consumer’s
inferred or diagnosed mental health or substance use disorder, as defined in Section
1374.72 of the Health and Safety Code, collected by a mental health digital service.
(k)(l) “Mental health digital service” means a mobile-based application or internet
website that collects mental health application information from a consumer, markets
itself as facilitating mental health services to a consumer, and uses the information to
facilitate mental health services to a consumer.
(l)(m) “Patient” means a natural person, whether or not still living, who received health
care services from a provider of health care and to whom medical information pertains.
(m)(n) “Pharmaceutical company” means a company or business, or an agent or
representative thereof, that manufactures, sells, or distributes pharmaceuticals,
medications, or prescription drugs. “Pharmaceutical company” does not include a
pharmaceutical benefits manager, as included in subdivision (c), or a provider of health
care.
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(n)(o) “Protected individual” means any adult covered by the subscriber’s health care
service plan or a minor who can consent to a health care service without the consent of
a parent or legal guardian, pursuant to state or federal law. “Protected individual” does
not include an individual that lacks the capacity to give informed consent for health care
pursuant to Section 813 of the Probate Code.
(o)(p) “Provider of health care” means a person licensed or certified pursuant to Division
2 (commencing with Section 500) of the Business and Professions Code; a person
licensed pursuant to the Osteopathic Initiative Act or the Chiropractic Initiative Act; a
person certified pursuant to Division 2.5 (commencing with Section 1797) of the Health
and Safety Code; or a clinic, health dispensary, or health facility licensed pursuant to
Division 2 (commencing with Section 1200) of the Health and Safety Code. “Provider of
health care” does not include insurance institutions as defined in subdivision (k) of
Section 791.02 of the Insurance Code.
(q) “Reproductive or sexual health application information” means information about a
consumer’s reproductive health, menstrual cycle, fertility, pregnancy, pregnancy
outcome, plans to conceive, or type of sexual activity collected by a reproductive or
sexual health digital service, including, but not limited to, information from which one
can infer someone’s pregnancy status, menstrual cycle, fertility, hormone levels, birth
control use, sexual activity, or gender identity.
(r) “Reproductive or sexual health digital service” means a mobile-based application or
internet website that collects reproductive or sexual health application information from
a consumer, markets itself as facilitating reproductive or sexual health services to a
consumer, and uses the information to facilitate reproductive or sexual health services
to a consumer.
(p)(s) “Sensitive services” means all health care services related to mental or behavioral
health, sexual and reproductive health, sexually transmitted infections, substance use
disorder, gender affirming care, and intimate partner violence, and includes services
described in Sections 6924, 6925, 6926, 6927, 6928, 6929, and 6930 of the Family
Code, and Sections 121020 and 124260 of the Health and Safety Code, obtained by a
patient at or above the minimum age specified for consenting to the service specified in
the section.
(q)(t) “Subscriber” has the same meaning as that term is defined in Section 1345 of the
Health and Safety Code.
56.06.
(a) Any business organized for the purpose of maintaining medical information in order
to make the information available to an individual or to a provider of health care at the
request of the individual or a provider of health care, for purposes of allowing the
individual to manage their the individual’s information, or for the diagnosis and treatment
of the individual, shall be deemed to be a provider of health care subject to the
requirements of this part. However, this section shall not be construed to make a
business specified in this subdivision a provider of health care for purposes of any law
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other than this part, including laws that specifically incorporate by reference the
definitions of this part.
(b) Any business that offers software or hardware to consumers, including a mobile
application or other related device that is designed to maintain medical information in
order to make the information available to an individual or a provider of health care at
the request of the individual or a provider of health care, for purposes of allowing the
individual to manage their the individual’s information, or for the diagnosis, treatment, or
management of a medical condition of the individual, shall be deemed to be a provider
of health care subject to the requirements of this part. However, this section shall not be
construed to make a business specified in this subdivision a provider of health care for
purposes of any law other than this part, including laws that specifically incorporate by
reference the definitions of this part.
(c) Any business that is licensed pursuant to Division 10 (commencing with Section
26000) of the Business and Professions Code that is authorized to receive or receives
identification cards issued pursuant to Section 11362.71 of the Health and Safety Code
or information contained in a physician’s recommendation issued in accordance with
Article 25 (commencing with Section 2525) of Chapter 5 of Division 2 of the Business
and Professions Code shall be deemed to be a provider of health care subject to the
requirements of this part. However, this section shall not be construed to make a
business specified in this subdivision a provider of health care for purposes of any law
other than this part, including laws that specifically incorporate by reference the
definitions of this part.
(d) Any business that offers a mental health digital service to a consumer for the
purpose of allowing the individual to manage the individual’s information, or for the
diagnosis, treatment, or management of a medical condition of the individual, shall be
deemed to be a provider of health care subject to the requirements of this part.
However, this section shall not be construed to make a business specified in this
subdivision a provider of health care for purposes of any law other than this part,
including laws that specifically incorporate by reference the definitions of this part.
(e) Any business that offers a reproductive or sexual health digital service to a
consumer for the purpose of allowing the individual to manage the individual’s
information, or for the diagnosis, treatment, or management of a medical condition of
the individual, shall be deemed to be a provider of health care subject to the
requirements of this part. However, this section shall not be construed to make a
business specified in this subdivision a provider of health care for purposes of any law
other than this part, including, but not limited to, laws that specifically incorporate by
reference the definitions of this part.
(e)(f) Any business described in this section shall maintain the same standards of
confidentiality required of a provider of health care with respect to medical information
disclosed to the business.
(f)(g) Any business described in this section is subject to the penalties for improper use
and disclosure of medical information prescribed in this part.
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56.101.
(a) Every provider of health care, health care service plan, pharmaceutical company, or
contractor who creates, maintains, preserves, stores, abandons, destroys, or disposes
of medical information shall do so in a manner that preserves the confidentiality of the
information contained therein. Any provider of health care, health care service plan,
pharmaceutical company, or contractor who negligently creates, maintains, preserves,
stores, abandons, destroys, or disposes of medical information shall be subject to the
remedies and penalties provided under subdivisions (b) and (c) of Section 56.36.
(b)(1) An electronic health record system or electronic medical record system shall
do all of the following:
(A) Protect and preserve the integrity of electronic medical information.
(B) Automatically record and preserve any change or deletion of any electronically
stored medical information. The record of any change or deletion shall include the
identity of the person who accessed and changed the medical information, the date and
time the medical information was accessed, and the change that was made to the
medical information.
(2) A patient’s right to access or receive a copy of his or her the patient’s electronic
medical records upon request shall be consistent with applicable state and federal laws
governing patient access to, and the use and disclosures of, medical information.
(c)(1) A business, as described in Section 56.06, that electronically stores or maintains
medical information on the provision of sensitive services, including, but not limited to,
on an electronic health record system or electronic medical record system, on behalf of
a provider of health care, health care service plan, pharmaceutical company, contractor,
or employer, shall develop capabilities, policies, and procedures, on or before July 1,
2024, to enable all of the following:
(A) Limit user access privileges to information systems that contain medical information
related to gender affirming care, abortion and abortion-related services, and
contraception only to those persons who are authorized to access specified medical
information.
(B) Prevent the disclosure, access, transfer, transmission, or processing of medical
information related to gender affirming care, abortion and abortion-related services, and
contraception to persons and entities outside of this state in accordance to this part.
(C) Segregate medical information related to gender affirming care, abortion and
abortion-related services, and contraception from the rest of the patient’s record.
(D) Provide the ability to automatically disable access to segregated medical information
related to gender affirming care, abortion and abortion-related services, and
contraception by individuals and entities in another state.
(2) Any fees charged to providers of health care, health care service plans,
pharmaceutical company, contractors, employers, or patients to comply with this
subdivision shall be consistent with Section 171.302 of Title 45 of the Code of Federal
Regulations.
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(3) For the purposes of this subdivision, “gender affirming care” means gender affirming
health care and gender affirming mental health care as defined in subdivision (b) of
Section 16010.2 of the Welfare and Institutions Code.
(4) This subdivision does not apply to a provider of health care, as defined in Section
56.05.
(c)(d) This section shall apply to an “electronic medical record” or “electronic health
record” that meets the definition of “electronic health record,” as that term is defined in
Section 17921(5) of Title 42 of the United States Code.
56.108.
(a) Notwithstanding subdivisions (b) and (c) of Section 56.10 or subdivision (c) of
Section 56.20, a provider of health care, health care service plan, contractor, or
employer shall not release medical information related to an individual seeking or
obtaining an abortion in response to a subpoena or request if that subpoena or request
is based on either another state’s laws that interfere with a person’s rights under the
Reproductive Privacy Act (Article 2.5 (commencing with Section 123460) of Chapter 2
of Part 2 of Division 106 of the Health and Safety Code) or a foreign penal civil action,
as defined in Section 2029.200 of the Code of Civil Procedure.
(b) A provider of health care, health care service plan, contractor, or employer shall not
release medical information that would identify an individual or that is related to an
individual seeking or obtaining an abortion to law enforcement for either of the following
purposes, unless that release is pursuant to a subpoena not otherwise prohibited by
subdivision (a):
(1) Enforcement of another state’s law that would interfere with a person’s rights under
the Reproductive Privacy Act (Article 2.5 (commencing with Section 123460) of Chapter
2 of Part 2 of Division 106 of the Health and Safety Code).
(2) Enforcement of a foreign penal civil action, as defined in Section 2029.200 of the
Code of Civil Procedure.
(c) Notwithstanding subdivisions (b) and (c) of Section 56.10 or subdivision (c) of
Section 56.20, a provider of health care, health care service plan, contractor, or
employer shall not cooperate with any inquiry or investigation by, or provide medical
information to, any individual, agency, or department from another state or, to the extent
permitted by federal law, to a federal law enforcement agency that would identify an
individual and that is related to an individual seeking or obtaining an abortion or
abortion-related services that are lawful under the laws of this state, unless the request
for medical information is authorized under Section 56.110.
(d) This section does not prohibit compliance with the investigation of activity that is
punishable as a crime under the laws of this state.
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56.110.
(a) Notwithstanding subdivision (c) of Section 56.10, a provider of health care, health
care service plan, pharmaceutical company, contractor, or employer shall not knowingly
disclose, transmit, transfer, share, or grant access to medical information in an
electronic health records system or through a health information exchange that would
identify an individual and that is related to an individual seeking, obtaining, providing,
supporting, or aiding in the performance of an abortion that is lawful under the laws of
this state to any individual or entity from another state, unless the disclosure,
transmittal, transfer, sharing, or granting of access is authorized under any of the
following conditions:
(1) In accordance with a valid, written authorization pursuant to Section 56.11 that
clearly states that medical information on abortion or abortion-related services may be
disclosed, and only to the extent and for the purposes expressly stated in the
authorization.
(2) In accordance with paragraphs (2) and (3) of subdivision (c) of Section 56.10, to the
extent necessary to allow responsibility for payment to be determined and payment to
be made or to the extent that it is not further disclosed by the recipient in a way that
would violate this part.
(3) In accordance with paragraphs (4) and (5) of subdivision (c) of Section 56.10 for the
purpose of accreditation, in reviewing the competence or qualifications of health care
professionals, or in reviewing health care services with respect to medical necessity,
level of care, quality of care, or justification of charges.
(4) In accordance with paragraph (7) of subdivision (c) of Section 56.10, for the purpose
of bona fide research. Institutional Review Boards shall consider the potential harm to
the patient and the patient’s privacy when the research uses data that contains
information related to abortion or abortion-related services and the research is
performed out of state.
(b) Notwithstanding subdivision (a), the content of the health records containing medical
information described in subdivision (a) shall be disclosed to any of the following:
(1) A patient, or their personal representative, consistent with the Patient Access to
Health Records Act (Chapter 1 (commencing with Section 123100) of Part 1 of Division
106 of the Health and Safety Code).
(2) In response to an order of a California or federal court, but only to the extent clearly
stated in the order and consistent with Section 1543 of the Penal Code, if applicable,
and only if all information about the patient’s identity and records are protected from
public scrutiny through mechanisms, including, but not limited to, a sealed proceeding
or court record.
(3) When expressly required by federal law that preempts California law, but only to the
extent expressly required.
(c) Nothing in this section shall prohibit a provider of health care, health care service
plan, pharmaceutical company, contractor, or employer from cooperating or complying
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with the investigation of activity that is punishable as a crime under the laws of
California, and that took place in California.
(d) A provider of health care, as defined in Section 56.05, shall not be subject to liability
for damages or to civil or enforcement actions, including disciplinary actions, fines, or
penalties, for failure to meet the requirements of this section before January 31, 2026, if
the provider of health care is working diligently and in good faith to come into
compliance with this section.
Corporations Code
14700.
(a) No person shall acquire, directly or indirectly, any voting securities or assets of a
retail grocery firm or retail drug firm unless both parties give, or in the case of a tender
offer, the acquiring party gives, written notice to the Attorney General in accordance
with this part.
(b) For purposes of this part, the following definitions apply:
(1) “Acquiring party” means a person by whom or on whose behalf the merger or other
acquisition of control is to be effected and is either of the following:
(A) Is required to provide notice of the merger or acquisition to the Federal Trade
Commission or the United States Department of Justice pursuant to the federal Hart-
Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. Sec. 18a).
(B) Is acquiring more than a total of 20 retail drug firms or retail grocery firms.
(2) “Retail drug firm” means a person, as defined in Section 18 of the Labor Code,
including a proprietorship, joint venture, corporate officer or executive, that has one or
more businesses or establishments located within the state and is identified as a retail
business or establishment in the North American Industry Classification System within
the retail trade category 45611.
(3) “Retail grocery firm” means a person, as defined in Section 18 of the Labor Code,
including a proprietorship, joint venture, corporate officer or executive, that has one or
more businesses or establishments located within the state and is identified as a retail
business or establishment in the North American Industry Classification System within
the retail trade category 44511 and 455211.
14701.
(a) The written notice shall be filed with the Attorney General no less than 180 days
before the acquisition is made effective. The notice shall be made under oath or
affirmation, and shall comply with the requirements of subdivision (c).
(b) If any transaction requiring written notice pursuant to this subdivision commences
before the effective date of this section, the written notice shall be given to the Attorney
General within 30 days before the transaction is made effective. Upon receiving notice,
the Attorney General has 180 days to evaluate the transaction, during which time the
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effective date of the transaction shall be tolled. If any material change occurs in the
facts set forth in the written notice filed with the Attorney General, an amendment
setting forth the change and copies of all documents and other material relevant to the
change shall be filed with the Attorney General within two business days after the
amendment is made by, or provided to, the acquiring party.
(c) The notice required to be given to the Attorney General shall comply with either of
the following:
(1) If the acquiring party is required to file notice with the Federal Trade Commission or
the United States Department of Justice pursuant to the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 (15 U.S.C. Sec. 18a), the notice shall contain the same form
and additional documentary material required under that act and any implementing
regulations under that act.
(2) If the acquiring party is not required to file notice with the Federal Trade Commission
or the United States Department of Justice, as specified in paragraph (1), the notice
shall contain all of the following information:
(A) The name and address of each acquiring party and a report of the nature of its
business operations during the past five years or for a lesser period if the person and
their predecessors have been in existence less than five years.
(B) An informative description of the business intended to be done by the person and
the person’s subsidiaries, including, but not limited to, documents concerning its
business or corporate structure, governance, or management.
(C) A list of all individuals who are or have been selected to become directors or
executive officers or who perform or will perform functions appropriate to the positions.
(D) The source, nature, and amount of the consideration used or to be used in effecting
the merger or other acquisition of control, a description of any transaction in which funds
were or are to be obtained, including any pledge of the drug or grocery retail firm’s stock
or the stock of any of its subsidiaries or controlling affiliates, and the identity of persons
furnishing the consideration. If a source of the consideration is a loan made in the
lender’s ordinary course of business, the identity of the lender shall remain confidential
upon request of the person filing the statement.
(E) Fully audited financial information as to the earnings and financial condition of each
acquiring party for the preceding five fiscal years or for a lesser period if the acquiring
party and its predecessors have been in existence for less than five years, and similar
unaudited information as of a date not earlier than 90 days before the written notice.
(F) Any plans or proposals that an acquiring party may have to liquidate the retail
grocery or retail drug firms, to sell its assets or merge or consolidate it with any person,
or to make any other material change in its business or corporate structure or
management.
(G) The information required to assess the competitive effects of the proposed
acquisition, giving particular attention to the effects on the proposed chain retail grocery
store acquisition on consumers, including, but not limited to, consumer choice, food
pricing, access to food, and food deserts, and factors affecting the supply of
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experienced grocery workers, including wages, benefits, and unemployment and chain
retail pharmacy on patients, including, but not limited to, patient choice, medicine
pricing, access to medications, and factors affecting the supply of licensed pharmacists,
pharmacy technicians, and pharmacists-in-charge.
(H) Information required to assess the economic and community impact of any planned
divestiture or store closures, including, but not limited to, the impact on food deserts,
food supply, economic mobility, unemployment, and small businesses.
(d) The Attorney General shall charge the acquiring party a filing fee for the cost to the
Attorney General to receive, review, and analyze any notice under this section, which
shall not exceed the reasonable regulatory costs to the Attorney General incident to
performing its administrative duties under this section. The fee shall be based on the
size of the transaction as of the date of the filing of the notice, but shall not exceed
.00045 percent of the combined sales of the parties to the merger or acquisition for the
fiscal year prior to the filing of the notice.
(e) The Attorney General may use the notice, documents, and information disclosed
under to this section in a judicial action in state or federal court or an administrative
action involving the merger or acquisition.
14702.
(a) The Attorney General may adopt regulations to effectuate this part that are
necessary or appropriate for the protection of workers, consumers, and the public
interest.
(b) The regulations may specify exemptions from the notice requirement for acquisitions
that, by virtue of the size, business volume, or number of employees are unlikely to
materially affect competitive markets in California.
(c) The regulations may authorize the Attorney General to request additional materials.
(d) The regulations may authorize adjustments in the filing fee, based on the size of the
transaction, subject to the maximum amount set forth in subdivision (d) of Section
14701.
14703.
If the Attorney General determines that they cannot complete an evaluation of the
competitive effects of the acquisition before the parties intend to consummate the
acquisition, the Attorney General may seek an order from the Superior Court of the
County of Sacramento temporarily staying or preliminarily enjoining the acquisition for
such time as is reasonably necessary for the Attorney General to complete the analysis.
14704.
(a) For acquisitions to which Section 18a of Title 15 of the United States Code applies,
the Attorney General shall consider the extent to which information required to be
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submitted to the United States Department of Justice and the Federal Trade
Commission may satisfy some or all of the need to carry out the applicable state laws.
Any information that has been submitted to the Attorney General under provisions of
federal law rendering them confidential shall be deemed to be confidential under
California law.
(b) The submitting party may designate information submitted pursuant to this part as
privileged or confidential. If the Attorney General disputes any claim of privilege or
confidentiality, the Attorney General may give notice to the submitting party of that fact
and give the submitting party, or other person interested in the claim of privilege or
confidentiality, an opportunity to seek an order from the Superior Court of the County of
Sacramento requiring the Attorney General not to make the designated information
public. Except for information that the Attorney General agrees is privileged or
confidential, or the court so determines, the information shall be available to the public
under the California Public Records Act (Division 10 (commencing with Section
7920.000) of Title 1 of the Government Code).
(c) The Attorney General may disclose any notice and information filed under this part to
the attorney general of any other state, the Federal Trade Commission, the United
States Department of Justice, or to another state agency, as long as that other state
attorney general, state agency, or federal agency operates under a law substantially
similar to this statute to guarantee the privileged or confidential nature of the notice and
information disclosed.
14706.
Nothing in this section or any other law shall preclude the Attorney General or any
person from bringing an action pursuant to this article or any other law to enjoin or seek
divestiture of assets or ownership interests obtained in a completed acquisition or
otherwise to restore competition.
14707.
(a) The failure to provide written notice, amendment to written notice, or other material
required to be provided pursuant to this part shall be a violation of this part.
(b) In addition to any legal remedies the Attorney General may have, the Attorney
General shall be entitled to injunctive relief and other equitable remedies a court deems
appropriate for a violation of this part, shall be entitled to recover its attorney’s fees and
costs incurred in remedying each violation, and shall be entitled to civil penalties of up
to twenty thousand dollars ($20,000) for each day of noncompliance with the
requirements of Section 14700.
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Education Code
49414.7.
(a) School districts, county offices of education, and charter schools may provide
emergency stock albuterol inhalers, including, if necessary, single-use disposable
holding chambers, to school nurses or trained personnel who have volunteered
pursuant to subdivision (d), and school nurses or trained personnel may use an
emergency stock albuterol inhaler to provide emergency medical aid to persons
suffering, or reasonably believed to be suffering, from respiratory distress.
(b) For purposes of this section, the following definitions apply:
(1) “Albuterol” means a bronchodilator used to open the airways by relaxing the muscles
around the bronchial tubes.
(2) “Authorizing physician and surgeon” may include, but is not limited to, a physician
and surgeon employed by, or contracting with, a local educational agency, a medical
director of the local health department, or a local emergency medical services director.
(3) “Inhaler” means a device used for the delivery of prescribed asthma medication that
is inhaled.
(4) “Local educational agency” means a school district, county office of education, or
charter school.
(5) “Metered-dose inhaler (MDI)” means a pressurized sprayer that delivers a measured
amount of a medication.
(6) “Qualified supervisor of health” may include, but is not limited to, a school nurse.
(7) “Respiratory distress” means the sudden appearance of signs and symptoms of
difficulty breathing. Signs and symptoms of respiratory distress may include one or
more of the following:
(A) Complaints of a tight chest or chest pain.
(B) Wheezing or noisy breathing.
(C) Persistent coughing.
(D) Difficulty breathing.
(E) Appears to be in distress.
(F) Lips or fingernails turning blue.
(G) Shortness of breath.
(8) “Stock albuterol inhaler” means albuterol medication in the form of a metered-dose
inhaler (MDI) that is ordered by a health care provider and is not prescribed for a
specific person and also includes, if necessary, a single-use disposable holding
chamber.
(9) “Volunteer” or “trained personnel” means an employee who has volunteered to
administer stock albuterol inhalers to a person if the person is suffering, or reasonably
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believed to be suffering, from respiratory distress, has been designated by a school,
and has received training pursuant to subdivision (d).
(c) Each private elementary and secondary school in the state may voluntarily
determine whether or not to make emergency stock albuterol inhalers and trained
personnel available at its school. In making this determination, a school shall evaluate
the emergency medical response time to the school and determine whether initiating
emergency medical services is an acceptable alternative to stock albuterol inhalers and
trained personnel. A private elementary or secondary school choosing to exercise the
authority provided under this subdivision shall not receive state funds specifically for
purposes of this subdivision.
(d) (1) Each public and private elementary and secondary school in the state may
designate one or more volunteers to receive initial and annual refresher training, based
on the standards developed pursuant to subdivision (e), regarding the storage and
emergency use of a stock albuterol inhaler from the school nurse or other qualified
person designated by an authorizing physician and surgeon.
(2) Schools are encouraged and recommended to have a minimum of two trained
school employees.
(e)(1) The Superintendent shall establish, and post on the department’s internet
website, minimum standards of training for the administration of stock albuterol inhalers
that satisfies the requirements of paragraph (2). Every five years, or sooner as deemed
necessary by the Superintendent, the Superintendent shall review minimum standards
of training for the administration of stock albuterol inhalers that satisfy the requirements
of paragraph (2). For purposes of this subdivision, the Superintendent shall consult with
organizations and providers with expertise in administering stock albuterol inhalers and
administering medication in a school environment, including, but not limited to, the State
Department of Public Health, the Emergency Medical Services Authority, the American
Academy of Allergy, Asthma and Immunology, the California School Nurses
Organization, the California Medical Association, the American Academy of Pediatrics,
the California Society of Allergy, Asthma and Immunology, the American College of
Allergy, Asthma and Immunology, and others.
(2) Training established pursuant to this subdivision shall include all of the following:
(A) Techniques for recognizing symptoms of respiratory distress.
(B) Standards and procedures for the storage, restocking, and emergency use of stock
albuterol inhalers.
(C) Emergency followup procedures, including calling the emergency 911 telephone
number and contacting, if possible, the pupil’s parent or guardian and physician.
(D) Recommendations on the necessity of instruction and certification in
cardiopulmonary resuscitation.
(E) Written materials covering the information required under this subdivision.
(3) Training established pursuant to this subdivision shall be consistent with the most
recent guidelines for medication administration issued by the department.
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(4) Training established pursuant to this subdivision shall be provided to a volunteer
during the volunteer’s regular working hours and at no cost to the volunteer.
(5) A school shall retain for reference the written materials prepared under
subparagraph (E) of paragraph (2).
(f) Any local educational agency electing to utilize stock albuterol inhalers for
emergency aid shall distribute a notice at least once per school year to all staff that
contains the following information:
(1) A description of the volunteer request stating that the request is for volunteers to be
trained to administer a stock albuterol inhaler to a person if the person is suffering, or
reasonably believed to be suffering, from respiratory distress, as specified in subdivision
(b).
(2) A description of the training that the volunteer will receive pursuant to subdivision
(d).
(g)(1) A qualified supervisor of health at a local educational agency electing to utilize
stock albuterol inhalers for emergency aid shall obtain from an authorizing physician
and surgeon a prescription for each school for stock albuterol inhalers. A qualified
supervisor of health at a local educational agency shall be responsible for stocking the
stock albuterol inhalers and restocking it if it is used.
(2) If a local educational agency does not have a qualified supervisor of health, an
administrator at the local educational agency shall carry out the duties specified in
paragraph (1).
(3) A prescription pursuant to this subdivision may be filled by local or mail order
pharmacies or stock albuterol inhaler manufacturers.
(4) An authorizing physician and surgeon shall not be subject to professional review, be
liable in a civil action, or be subject to criminal prosecution for the issuance of a
prescription or order pursuant to this section, unless the physician and surgeon’s
issuance of the prescription or order constitutes gross negligence or willful or malicious
conduct.
(h) A school nurse or, if the school does not have a school nurse or the school nurse is
not onsite or available, a volunteer may administer a stock albuterol inhaler to a person
exhibiting potentially life-threatening symptoms of respiratory distress at school or a
school activity when a physician is not immediately available. If the stock albuterol
inhaler is used, it shall be restocked as soon as reasonably possible, but no later than
two weeks after it is used. Stock albuterol inhalers shall be restocked before their
expiration date.
(i) A volunteer shall initiate emergency medical services or other appropriate medical
followup in accordance with the training materials retained pursuant to paragraph (5) of
subdivision (e).
(j) (1) A local educational agency electing to utilize stock albuterol inhalers for
emergency aid shall not be liable for any civil damages resulting from any act or
omission, other than an act or omission constituting gross negligence or willful and
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wanton misconduct, in the emergency administration of an albuterol inhaler by any of its
school nurses or trained volunteers who have volunteered pursuant to subdivision (d).
(2) An employee who volunteers under this section shall be provided defense and
indemnification by the local educational agency for any and all civil liability, in
accordance with, but not limited to, that provided in Division 3.6 (commencing with
Section 810) of Title 1 of the Government Code. This information shall be reduced to
writing, provided to the volunteer, and retained in the volunteer’s personnel file.
(k) A state agency, the department, or a public school may accept gifts, grants, and
donations from any source for the support of the public school carrying out the
provisions of this section, including, but not limited to, the acceptance of stock albuterol
inhalers from a manufacturer or wholesaler.
Government Code
9795.
(a)(1)(A) Any report required or requested by law law, or identified in the Legislative
Analyst’s Supplemental Report of the Budget Act, to be submitted by a state or local
agency to the a committee of the Legislature or the Members of either house of the
Legislature generally, shall instead be submitted as a printed copy to the Secretary of
the Senate, as an electronic copy to the Chief Clerk of the Assembly, and as an
electronic or printed copy to the Legislative Counsel. Each report shall include a
summary of its contents, not to exceed one page in length. If the report is submitted by
a state agency, that agency shall also provide an electronic copy of the summary
directly to each member of the appropriate house or houses of the Legislature. Notice of
receipt of the report shall also be recorded in the journal of the appropriate house or
houses of the Legislature by the secretary or clerk of that house.
(B) Notwithstanding subparagraph (A), reports of the State Bar of California may be
submitted electronically to the Secretary of the Senate.
(2) In addition to to, and as part of of, the information made available to the public in
electronic form pursuant to Section 10248, the Legislative Counsel shall make available
a list of the reports submitted by state and local agencies, as specified in paragraph (1).
If the Legislative Counsel receives a request from a member of the public for a report
contained in the list, the Legislative Counsel is not required to provide a copy of the
report and may refer the requester to the state or local agency, as the case may be, that
authored the report, or to the California State Library as the final repository of public
information.
(b) No A report shall not be distributed to a Member of the Legislature unless
specifically requested by that Member.
(c) Compliance with subdivision (a) shall be deemed to be full compliance with
subdivision (c) of Section 10242.5.
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(d) A state agency report and summary subject to this section shall include an Internet
Web site where the report can be downloaded and telephone number to call to order a
hard copy of the report. A report submitted by a state agency subject to this section
shall also be posted at the agency’s Internet Web site.
(e) For purposes of this section, “report” includes any study or audit.
10248.
Public computer network; required legislative information.
(a) The Legislative Counsel shall, with the advice of the Assembly Committee on Rules
and the Senate Committee on Rules, make all of the following information available to
the public in electronic form:
(1) The legislative calendar, the schedule of legislative committee hearings, a list of
matters pending on the floors of both houses of the Legislature, and a list of the
committees of the Legislature and their members.
(2) The text of each bill introduced in each current legislative session, including each
amended, enrolled, and chaptered form of each bill.
(3) The bill history of each bill introduced and amended in each current legislative
session.
(4) The bill status of each bill introduced and amended in each current legislative
session.
(5) All bill analyses prepared by legislative committees in connection with each bill in
each current legislative session.
(6) All audiovisual recordings of legislative proceedings that have been caused to be
made by the Legislature in accordance with paragraph (2) of subdivision (c) of Section 7
of Article IV of the California Constitution. Each recording shall remain accessible to the
public through the Internet and downloadable for a minimum period of 20 years
following the date on which the recording was made and shall then be archived in a
secure format.
(7) All vote information concerning each bill in each current legislative session.
(8) Any veto message concerning a bill in each current legislative session.
(9) The California Codes.
(10) The California Constitution.
(11) All statutes enacted on or after January 1, 1993.
(12) A link to the list of state and local agency reports required by paragraph (2) of
subdivision (a) of Section 9795.
(b) The information identified in subdivision (a) shall be made available to the public by
means of access by way of the largest nonproprietary, nonprofit cooperative public
computer network. The information shall be made available in one or more formats and
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by one or more means in order to provide the greatest feasible access to the general
public in this state. Any person who accesses the information may access all or any part
of the information. The information may also be made available by any other means of
access that would facilitate public access to the information. The information that is
maintained in the legislative information system that is operated and maintained by the
Legislative Counsel shall be made available in the shortest feasible time after the
information is available in the information system. The information that is not maintained
in the information system shall be made available in the shortest feasible time after it is
available to the Legislative Counsel.
(c) Any documentation that describes the electronic digital formats of the information
identified in subdivision (a) and is available to the public shall be made available by
means of access by way of the computer network specified in subdivision (b).
(d) Personal information concerning a person who accesses the information may be
maintained only for the purpose of providing service to the person.
(e) No fee or other charge may be imposed by the Legislative Counsel The Legislative
Counsel shall not impose a fee or other charge as a condition of accessing the
information that is accessible by way of the computer network specified in subdivision
(b).
(f) The electronic public access provided by way of the computer network specified in
subdivision (b) shall be in addition to other electronic or print distribution of the
information.
(g) No An action taken pursuant to this section shall be deemed to does not alter or
relinquish any copyright or other proprietary interest or entitlement of the State of
California relating to any of the information made available pursuant to this section.
54953.
(a) All meetings of the legislative body of a local agency shall be open and public, and
all persons shall be permitted to attend any meeting of the legislative body of a local
agency, except as otherwise provided in this chapter.
(b)(1) Notwithstanding any other provision of law, the legislative body of a local agency
may use teleconferencing for the benefit of the public and the legislative body of a local
agency in connection with any meeting or proceeding authorized by law. The
teleconferenced meeting or proceeding shall comply with all otherwise applicable
requirements of this chapter and all otherwise applicable provisions of law relating to a
specific type of meeting or proceeding.
(2) Teleconferencing, as authorized by this section, may be used for all purposes in
connection with any meeting within the subject matter jurisdiction of the legislative body.
If the legislative body of a local agency elects to use teleconferencing, the legislative
body of a local agency shall comply with all of the following:
(A) All votes taken during a teleconferenced meeting shall be by rollcall.
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(B) The teleconferenced meetings shall be conducted in a manner that protects the
statutory and constitutional rights of the parties or the public appearing before the
legislative body of a local agency.
(C) The legislative body shall give notice of the meeting and post agendas as otherwise
required by this chapter.
(D) The legislative body shall allow members of the public to access the meeting and
the agenda shall provide an opportunity for members of the public to address the
legislative body directly pursuant to Section 54954.3.
(3) If the legislative body of a local agency elects to use teleconferencing, it shall post
agendas at all teleconference locations. Each teleconference location shall be identified
in the notice and agenda of the meeting or proceeding, and each teleconference
location shall be accessible to the public. During the teleconference, at least a quorum
of the members of the legislative body shall participate from locations within the
boundaries of the territory over which the local agency exercises jurisdiction, except as
provided in subdivisions (d) and (e).
(c)(1) No legislative body shall take action by secret ballot, whether preliminary or final.
(2) The legislative body of a local agency shall publicly report any action taken and the
vote or abstention on that action of each member present for the action.
(3) Prior to taking final action, the legislative body shall orally report a summary of a
recommendation for a final action on the salaries, salary schedules, or compensation
paid in the form of fringe benefits of a local agency executive, as defined in subdivision
(d) of Section 3511.1, during the open meeting in which the final action is to be taken.
This paragraph shall not affect the public’s right under the California Public Records Act
(Division 10 (commencing with Section 7920.000) of Title 1) to inspect or copy records
created or received in the process of developing the recommendation.
(d)(1) Notwithstanding the provisions relating to a quorum in paragraph (3) of
subdivision (b), if a health authority conducts a teleconference meeting, members who
are outside the jurisdiction of the authority may be counted toward the establishment of
a quorum when participating in the teleconference if at least 50 percent of the number of
members that would establish a quorum are present within the boundaries of the
territory over which the authority exercises jurisdiction, and the health authority provides
a teleconference number, and associated access codes, if any, that allows any person
to call in to participate in the meeting and the number and access codes are identified in
the notice and agenda of the meeting.
(2) Nothing in this subdivision shall be construed as discouraging health authority
members from regularly meeting at a common physical site within the jurisdiction of the
authority or from using teleconference locations within or near the jurisdiction of the
authority. A teleconference meeting for which a quorum is established pursuant to this
subdivision shall be subject to all other requirements of this section.
(3) For purposes of this subdivision, a health authority means any entity created
pursuant to Sections 14018.7, 14087.31, 14087.35, 14087.36, 14087.38, and
14087.9605 of the Welfare and Institutions Code, any joint powers authority created
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pursuant to Article 1 (commencing with Section 6500) of Chapter 5 of Division 7 for the
purpose of contracting pursuant to Section 14087.3 of the Welfare and Institutions
Code, and any advisory committee to a county-sponsored health plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety
Code if the advisory committee has 12 or more members.
(e)(1) The legislative body of a local agency may use teleconferencing without
complying with the requirements of paragraph (3) of subdivision (b) if the legislative
body complies with the requirements of paragraph (2) of this subdivision in any either of
the following circumstances:
(A) The legislative body holds a meeting during a proclaimed state of emergency, and
state or local officials have imposed or recommended measures to promote social
distancing.
(B)(A) The legislative body holds a meeting during a proclaimed state of emergency for
the purpose of determining, by majority vote, whether as a result of the emergency,
meeting in person would present imminent risks to the health or safety of attendees.
(C)(B) The legislative body holds a meeting during a proclaimed state of emergency and
has determined, by majority vote, pursuant to subparagraph (B), (A), that, as a result of
the emergency, meeting in person would present imminent risks to the health or safety
of attendees.
(2) A legislative body that holds a meeting pursuant to this subdivision shall do all of the
following:
(A) In each instance in which notice of the time of the teleconferenced meeting is
otherwise given or the agenda for the meeting is otherwise posted, the legislative body
shall also give notice of the means by which members of the public may access the
meeting and offer public comment. The agenda shall identify and include an opportunity
for all persons to attend via a call-in option or an internet-based service option.
(B) In the event of a disruption that prevents the legislative body from broadcasting the
meeting to members of the public using the call-in option or internet-based service
option, or in the event of a disruption within the local agency’s control that prevents
members of the public from offering public comments using the call-in option or internet-
based service option, the legislative body shall take no further action on items
appearing on the meeting agenda until public access to the meeting via the call-in
option or internet-based service option is restored. Actions taken on agenda items
during a disruption that prevents the legislative body from broadcasting the meeting
may be challenged pursuant to Section 54960.1.
(C) The legislative body shall not require public comments to be submitted in advance
of the meeting and must provide an opportunity for the public to address the legislative
body and offer comment in real time.
(D) Notwithstanding Section 54953.3, an individual desiring to provide public comment
through the use of an internet website, or other online platform, not under the control of
the local legislative body, that requires registration to log in to a teleconference may be
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required to register as required by the third-party internet website or online platform to
participate.
(E)(i) A legislative body that provides a timed public comment period for each agenda
item shall not close the public comment period for the agenda item, or the opportunity to
register, pursuant to subparagraph (F), (D), to provide public comment until that timed
public comment period has elapsed.
(ii) A legislative body that does not provide a timed public comment period, but takes
public comment separately on each agenda item, shall allow a reasonable amount of
time per agenda item to allow public members the opportunity to provide public
comment, including time for members of the public to register pursuant to
subparagraph (F), (D), or otherwise be recognized for the purpose of providing public
comment.
(iii) A legislative body that provides a timed general public comment period that does not
correspond to a specific agenda item shall not close the public comment period or the
opportunity to register, pursuant to subparagraph (F), (D), until the timed general public
comment period has elapsed.
(3) If a state of emergency remains active, or state or local officials have imposed or
recommended measures to promote social distancing, in order to continue to
teleconference without compliance with paragraph (3) of subdivision (b), the legislative
body shall, not later than 30 45 days after teleconferencing for the first time pursuant to
subparagraph (A), (B), (A) or (C) (B) of paragraph (1), and every 30 45 days thereafter,
make the following findings by majority vote:
(A) The legislative body has reconsidered the circumstances of the state of emergency.
(B) Any of the following circumstances exist:
(i)(B) The state of emergency continues to directly impact the ability of the members to
meet safely in person.
(ii) State or local officials continue to impose or recommend measures to promote social
distancing.
(4) This subdivision shall not be construed to require the legislative body to provide a
physical location from which the public may attend or comment.
(f) (1) The legislative body of a local agency may use teleconferencing without
complying with paragraph (3) of subdivision (b) if, during the teleconference meeting, at
least a quorum of the members of the legislative body participates in person from a
singular physical location clearly identified on the agenda, which location shall be open
to the public and situated within the boundaries of the territory over which the local
agency exercises jurisdiction and the legislative body complies with all of the following:
(A) The legislative body shall provide at least one of the following as a means by which
the public may remotely hear and visually observe the meeting, and remotely address
the legislative body:
(i) A two-way audiovisual platform.
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(ii) A two-way telephonic service and a live webcasting of the meeting.
(B) In each instance in which notice of the time of the teleconferenced meeting is
otherwise given or the agenda for the meeting is otherwise posted, the legislative body
shall also give notice of the means by which members of the public may access the
meeting and offer public comment.
(C) The agenda shall identify and include an opportunity for all persons to attend and
address the legislative body directly pursuant to Section 54954.3 via a call-in option, via
an internet-based service option, and at the in-person location of the meeting.
(D) In the event of a disruption that prevents the legislative body from broadcasting the
meeting to members of the public using the call-in option or internet-based service
option, or in the event of a disruption within the local agency’s control that prevents
members of the public from offering public comments using the call-in option or internet-
based service option, the legislative body shall take no further action on items
appearing on the meeting agenda until public access to the meeting via the call-in
option or internet-based service option is restored. Actions taken on agenda items
during a disruption that prevents the legislative body from broadcasting the meeting
may be challenged pursuant to Section 54960.1.
(E) The legislative body shall not require public comments to be submitted in advance of
the meeting and must provide an opportunity for the public to address the legislative
body and offer comment in real time.
(F) Notwithstanding Section 54953.3, an individual desiring to provide public comment
through the use of an internet website, or other online platform, not under the control of
the local legislative body, that requires registration to log in to a teleconference may be
required to register as required by the third-party internet website or online platform to
participate.
(2) A member of the legislative body shall only participate in the meeting remotely
pursuant to this subdivision, if all of the following requirements are met:
(A) One of the following circumstances applies:
(i) The member notifies the legislative body at the earliest opportunity possible,
including at the start of a regular meeting, of their need to participate remotely for just
cause, including a general description of the circumstances relating to their need to
appear remotely at the given meeting. The provisions of this clause shall not be used by
any member of the legislative body for more than two meetings per calendar year.
(ii) The member requests the legislative body to allow them to participate in the meeting
remotely due to emergency circumstances and the legislative body takes action to
approve the request. The legislative body shall request a general description of the
circumstances relating to their need to appear remotely at the given meeting. A general
description of an item generally need not exceed 20 words and shall not require the
member to disclose any medical diagnosis or disability, or any personal medical
information that is already exempt under existing law, such as the Confidentiality of
Medical Information Act (Chapter 1 (commencing with Section 56) of Part 2.6 of Division
1 of the Civil Code). For the purposes of this clause, the following requirements apply:
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(I) A member shall make a request to participate remotely at a meeting pursuant to this
clause as soon as possible. The member shall make a separate request for each
meeting in which they seek to participate remotely.
(II) The legislative body may take action on a request to participate remotely at the
earliest opportunity. If the request does not allow sufficient time to place proposed
action on such a request on the posted agenda for the meeting for which the request is
made, the legislative body may take action at the beginning of the meeting in
accordance with paragraph (4) of subdivision (b) of Section 54954.2.
(B) The member shall publicly disclose at the meeting before any action is taken,
whether any other individuals 18 years of age or older are present in the room at the
remote location with the member, and the general nature of the member’s relationship
with any such individuals.
(C) The member shall participate through both audio and visual technology.
(3) The provisions of this subdivision shall not serve as a means for any member of a
legislative body to participate in meetings of the legislative body solely by
teleconference from a remote location for a period of more than three consecutive
months or 20 percent of the regular meetings for the local agency within a calendar
year, or more than two meetings if the legislative body regularly meets fewer than 10
times per calendar year.
(g) The legislative body shall have and implement a procedure for receiving and swiftly
resolving requests for reasonable accommodation for individuals with disabilities,
consistent with the federal Americans with Disabilities Act of 1990 (42 U.S.C. Sec.
12132), and resolving any doubt in favor of accessibility. In each instance in which
notice of the time of the meeting is otherwise given or the agenda for the meeting is
otherwise posted, the legislative body shall also give notice of the procedure for
receiving and resolving requests for accommodation.
(h) The legislative body shall conduct meetings subject to this chapter consistent with
applicable civil rights and nondiscrimination laws.
(i)(1) Nothing in this section shall prohibit a legislative body from providing the public
with additional teleconference locations.
(2) Nothing in this section shall prohibit a legislative body from providing members of the
public with additional physical locations in which the public may observe and address
the legislative body by electronic means.
(j) For the purposes of this section, the following definitions shall apply:
(1) “Emergency circumstances” means a physical or family medical emergency that
prevents a member from attending in person.
(2) “Just cause” means any of the following:
(A) A childcare or caregiving need of a child, parent, grandparent, grandchild, sibling,
spouse, or domestic partner that requires them to participate remotely. “Child,” “parent,”
“grandparent,” “grandchild,” and “sibling” have the same meaning as those terms do in
Section 12945.2.
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(B) A contagious illness that prevents a member from attending in person.
(C) A need related to a physical or mental disability as defined in Sections 12926 and
12926.1 not otherwise accommodated by subdivision (g).
(D) Travel while on official business of the legislative body or another state or local
agency.
(3) “Remote location” means a location from which a member of a legislative body
participates in a meeting pursuant to subdivision (f), other than any physical meeting
location designated in the notice of the meeting. Remote locations need not be
accessible to the public.
(4) “Remote participation” means participation in a meeting by teleconference at a
location other than any physical meeting location designated in the notice of the
meeting. Watching or listening to a meeting via webcasting or another similar electronic
medium that does not permit members to interactively hear, discuss, or deliberate on
matters, does not constitute remote participation.
(5) “State of emergency” means a state of emergency proclaimed pursuant to Section
8625 of the California Emergency Services Act (Article 1 (commencing with Section
8550) of Chapter 7 of Division 1 of Title 2).
(6) “Teleconference” means a meeting of a legislative body, the members of which are
in different locations, connected by electronic means, through either audio or video, or
both.
(7) “Two-way audiovisual platform” means an online platform that provides participants
with the ability to participate in a meeting via both an interactive video conference and a
two-way telephonic function.
(8) “Two-way telephonic service” means a telephone service that does not require
internet access, is not provided as part of a two-way audiovisual platform, and allows
participants to dial a telephone number to listen and verbally participate.
(9) “Webcasting” means a streaming video broadcast online or on television, using
streaming media technology to distribute a single content source to many simultaneous
listeners and viewers.
(k) This section shall remain in effect only until January 1, 2024, 2026, and as of that
date is repealed.
54953.
(a) All meetings of the legislative body of a local agency shall be open and public, and
all persons shall be permitted to attend any meeting of the legislative body of a local
agency, except as otherwise provided in this chapter.
(b) (1) Notwithstanding any other provision of law, the legislative body of a local agency
may use teleconferencing for the benefit of the public and the legislative body of a local
agency in connection with any meeting or proceeding authorized by law. The
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teleconferenced meeting or proceeding shall comply with all otherwise applicable
requirements of this chapter and all otherwise applicable provisions of law relating to a
specific type of meeting or proceeding.
(2) Teleconferencing, as authorized by this section, may be used for all purposes in
connection with any meeting within the subject matter jurisdiction of the legislative body.
If the legislative body of a local agency elects to use teleconferencing, the legislative
body of a local agency shall comply with all of the following:
(A) All votes taken during a teleconferenced meeting shall be by rollcall.
(B) The teleconferenced meetings shall be conducted in a manner that protects the
statutory and constitutional rights of the parties or the public appearing before the
legislative body of a local agency.
(C) The legislative body shall give notice of the meeting and post agendas as otherwise
required by this chapter.
(D) The legislative body shall allow members of the public to access the meeting and
the agenda shall provide an opportunity for members of the public to address the
legislative body directly pursuant to Section 54954.3.
(3) If the legislative body of a local agency elects to use teleconferencing, it shall post
agendas at all teleconference locations. Each teleconference location shall be identified
in the notice and agenda of the meeting or proceeding, and each teleconference
location shall be accessible to the public. During the teleconference, at least a quorum
of the members of the legislative body shall participate from locations within the
boundaries of the territory over which the local agency exercises jurisdiction, except as
provided in subdivisions (d) and (e).
(c) (1) No legislative body shall take action by secret ballot, whether preliminary or final.
(2) The legislative body of a local agency shall publicly report any action taken and the
vote or abstention on that action of each member present for the action.
(3) Prior to taking final action, the legislative body shall orally report a summary of a
recommendation for a final action on the salaries, salary schedules, or compensation
paid in the form of fringe benefits of a local agency executive, as defined in subdivision
(d) of Section 3511.1, during the open meeting in which the final action is to be taken.
This paragraph shall not affect the public’s right under the California Public Records Act
(Division 10 (commencing with Section 7920.000) of Title 1) to inspect or copy records
created or received in the process of developing the recommendation.
(d)(1) Notwithstanding the provisions relating to a quorum in paragraph (3) of
subdivision (b), if a health authority conducts a teleconference meeting, members who
are outside the jurisdiction of the authority may be counted toward the establishment of
a quorum when participating in the teleconference if at least 50 percent of the number of
members that would establish a quorum are present within the boundaries of the
territory over which the authority exercises jurisdiction, and the health authority provides
a teleconference number, and associated access codes, if any, that allows any person
to call in to participate in the meeting and the number and access codes are identified in
the notice and agenda of the meeting.
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(2) Nothing in this subdivision shall be construed as discouraging health authority
members from regularly meeting at a common physical site within the jurisdiction of the
authority or from using teleconference locations within or near the jurisdiction of the
authority. A teleconference meeting for which a quorum is established pursuant to this
subdivision shall be subject to all other requirements of this section.
(3) For purposes of this subdivision, a health authority means any entity created
pursuant to Sections 14018.7, 14087.31, 14087.35, 14087.36, 14087.38, and
14087.9605 of the Welfare and Institutions Code, any joint powers authority created
pursuant to Article 1 (commencing with Section 6500) of Chapter 5 of Division 7 for the
purpose of contracting pursuant to Section 14087.3 of the Welfare and Institutions
Code, and any advisory committee to a county-sponsored health plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety
Code if the advisory committee has 12 or more members.
(e)(1) The legislative body of a local agency may use teleconferencing without
complying with the requirements of paragraph (3) of subdivision (b) if the legislative
body complies with the requirements of paragraph (2) of this subdivision in any either of
the following circumstances:
(A) The legislative body holds a meeting during a proclaimed state of emergency, and
state or local officials have imposed or recommended measures to promote social
distancing.
(B)(A) The legislative body holds a meeting during a proclaimed state of emergency for
the purpose of determining, by majority vote, whether as a result of the emergency,
meeting in person would present imminent risks to the health or safety of attendees.
(C)(B) The legislative body holds a meeting during a proclaimed state of emergency and
has determined, by majority vote, pursuant to subparagraph (B), (A), that, as a result of
the emergency, meeting in person would present imminent risks to the health or safety
of attendees.
(2) A legislative body that holds a meeting pursuant to this subdivision shall do all of the
following:
(A) In each instance in which notice of the time of the teleconferenced meeting is
otherwise given or the agenda for the meeting is otherwise posted, the legislative body
shall also give notice of the means by which members of the public may access the
meeting and offer public comment. The agenda shall identify and include an opportunity
for all persons to attend via a call-in option or an internet-based service option.
(B) In the event of a disruption that prevents the legislative body from broadcasting the
meeting to members of the public using the call-in option or internet-based service
option, or in the event of a disruption within the local agency’s control that prevents
members of the public from offering public comments using the call-in option or internet-
based service option, the legislative body shall take no further action on items
appearing on the meeting agenda until public access to the meeting via the call-in
option or internet-based service option is restored. Actions taken on agenda items
during a disruption that prevents the legislative body from broadcasting the meeting
may be challenged pursuant to Section 54960.1.
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(C) The legislative body shall not require public comments to be submitted in advance
of the meeting and must provide an opportunity for the public to address the legislative
body and offer comment in real time.
(D) Notwithstanding Section 54953.3, an individual desiring to provide public comment
through the use of an internet website, or other online platform, not under the control of
the local legislative body, that requires registration to log in to a teleconference may be
required to register as required by the third-party internet website or online platform to
participate.
(E)(i) A legislative body that provides a timed public comment period for each agenda
item shall not close the public comment period for the agenda item, or the opportunity to
register, pursuant to subparagraph (F), (D), to provide public comment until that timed
public comment period has elapsed.
(ii) A legislative body that does not provide a timed public comment period, but takes
public comment separately on each agenda item, shall allow a reasonable amount of
time per agenda item to allow public members the opportunity to provide public
comment, including time for members of the public to register pursuant to
subparagraph (F), (D), or otherwise be recognized for the purpose of providing public
comment.
(iii) A legislative body that provides a timed general public comment period that does not
correspond to a specific agenda item shall not close the public comment period or the
opportunity to register, pursuant to subparagraph (F), (D), until the timed general public
comment period has elapsed.
(3) If a state of emergency remains active, or state or local officials have imposed or
recommended measures to promote social distancing, in order to continue to
teleconference without compliance with paragraph (3) of subdivision (b), the legislative
body shall, not later than 30 45 days after teleconferencing for the first time pursuant to
subparagraph (A), (B), (A) or (C) (B) of paragraph (1), and every 30 45 days thereafter,
make the following findings by majority vote:
(A) The legislative body has reconsidered the circumstances of the state of emergency.
(B) Any of the following circumstances exist:
(i)(B) The state of emergency continues to directly impact the ability of the members to
meet safely in person.
(ii) State or local officials continue to impose or recommend measures to promote social
distancing.
(4) This subdivision shall not be construed to require the legislative body to provide a
physical location from which the public may attend or comment.
(f)(1) The legislative body of a local agency may use teleconferencing without complying
with paragraph (3) of subdivision (b) if, during the teleconference meeting, at least a
quorum of the members of the legislative body participates in person from a singular
physical location clearly identified on the agenda, which location shall be open to the
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public and situated within the boundaries of the territory over which the local agency
exercises jurisdiction and the legislative body complies with all of the following:
(A) The legislative body shall provide at least one of the following as a means by which
the public may remotely hear and visually observe the meeting, and remotely address
the legislative body:
(i) A two-way audiovisual platform.
(ii) A two-way telephonic service and a live webcasting of the meeting.
(B) In each instance in which notice of the time of the teleconferenced meeting is
otherwise given or the agenda for the meeting is otherwise posted, the legislative body
shall also give notice of the means by which members of the public may access the
meeting and offer public comment.
(C) The agenda shall identify and include an opportunity for all persons to attend and
address the legislative body directly pursuant to Section 54954.3 via a call-in option, via
an internet-based service option, and at the in-person location of the meeting.
(D) In the event of a disruption that prevents the legislative body from broadcasting the
meeting to members of the public using the call-in option or internet-based service
option, or in the event of a disruption within the local agency’s control that prevents
members of the public from offering public comments using the call-in option or internet-
based service option, the legislative body shall take no further action on items
appearing on the meeting agenda until public access to the meeting via the call-in
option or internet-based service option is restored. Actions taken on agenda items
during a disruption that prevents the legislative body from broadcasting the meeting
may be challenged pursuant to Section 54960.1.
(E) The legislative body shall not require public comments to be submitted in advance of
the meeting and must provide an opportunity for the public to address the legislative
body and offer comment in real time.
(F) Notwithstanding Section 54953.3, an individual desiring to provide public comment
through the use of an internet website, or other online platform, not under the control of
the local legislative body, that requires registration to log in to a teleconference may be
required to register as required by the third-party internet website or online platform to
participate.
(2) A member of the legislative body shall only participate in the meeting remotely
pursuant to this subdivision, if all of the following requirements are met:
(A) One of the following circumstances applies:
(i) The member notifies the legislative body at the earliest opportunity possible,
including at the start of a regular meeting, of their need to participate remotely for just
cause, including a general description of the circumstances relating to their need to
appear remotely at the given meeting. The provisions of this clause shall not be used by
any member of the legislative body for more than two meetings per calendar year.
(ii) The member requests the legislative body to allow them to participate in the meeting
remotely due to emergency circumstances and the legislative body takes action to
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approve the request. The legislative body shall request a general description of the
circumstances relating to their need to appear remotely at the given meeting. A general
description of an item generally need not exceed 20 words and shall not require the
member to disclose any medical diagnosis or disability, or any personal medical
information that is already exempt under existing law, such as the Confidentiality of
Medical Information Act (Chapter 1 (commencing with Section 56) of Part 2.6 of Division
1 of the Civil Code). For the purposes of this clause, the following requirements apply:
(I) A member shall make a request to participate remotely at a meeting pursuant to this
clause as soon as possible. The member shall make a separate request for each
meeting in which they seek to participate remotely.
(II) The legislative body may take action on a request to participate remotely at the
earliest opportunity. If the request does not allow sufficient time to place proposed
action on such a request on the posted agenda for the meeting for which the request is
made, the legislative body may take action at the beginning of the meeting in
accordance with paragraph (4) of subdivision (b) of Section 54954.2.
(B) The member shall publicly disclose at the meeting before any action is taken,
whether any other individuals 18 years of age or older are present in the room at the
remote location with the member, and the general nature of the member’s relationship
with any such individuals.
(C) The member shall participate through both audio and visual technology.
(3) The provisions of this subdivision shall not serve as a means for any member of a
legislative body to participate in meetings of the legislative body solely by
teleconference from a remote location for a period of more than three consecutive
months or 20 percent of the regular meetings for the local agency within a calendar
year, or more than two meetings if the legislative body regularly meets fewer than 10
times per calendar year.
(g) The legislative body shall have and implement a procedure for receiving and swiftly
resolving requests for reasonable accommodation for individuals with disabilities,
consistent with the federal Americans with Disabilities Act of 1990 (42 U.S.C. Sec.
12132), and resolving any doubt in favor of accessibility. In each instance in which
notice of the time of the meeting is otherwise given or the agenda for the meeting is
otherwise posted, the legislative body shall also give notice of the procedure for
receiving and resolving requests for accommodation.
(h) The legislative body shall conduct meetings subject to this chapter consistent with
applicable civil rights and nondiscrimination laws.
(i)(1) Nothing in this section shall prohibit a legislative body from providing the public
with additional teleconference locations.
(2) Nothing in this section shall prohibit a legislative body from providing members of the
public with additional physical locations in which the public may observe and address
the legislative body by electronic means.
(j) For the purposes of this section, the following definitions shall apply:
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(1) “Emergency circumstances” means a physical or family medical emergency that
prevents a member from attending in person.
(2) “Just cause” means any of the following:
(A) A childcare or caregiving need of a child, parent, grandparent, grandchild, sibling,
spouse, or domestic partner that requires them to participate remotely. “Child,” “parent,”
“grandparent,” “grandchild,” and “sibling” have the same meaning as those terms do in
Section 12945.2.
(B) A contagious illness that prevents a member from attending in person.
(C) A need related to a physical or mental disability as defined in Sections 12926 and
12926.1 not otherwise accommodated by subdivision (g).
(D) Travel while on official business of the legislative body or another state or local
agency.
(E) An immunocompromised child, parent, grandparent, grandchild, sibling, spouse, or
domestic partner that requires them to participate remotely.
(3) “Remote location” means a location from which a member of a legislative body
participates in a meeting pursuant to subdivision (f), other than any physical meeting
location designated in the notice of the meeting. Remote locations need not be
accessible to the public.
(4) “Remote participation” means participation in a meeting by teleconference at a
location other than any physical meeting location designated in the notice of the
meeting. Watching or listening to a meeting via webcasting or another similar electronic
medium that does not permit members to interactively hear, discuss, or deliberate on
matters, does not constitute remote participation.
(5) “State of emergency” means a state of emergency proclaimed pursuant to Section
8625 of the California Emergency Services Act (Article 1 (commencing with Section
8550) of Chapter 7 of Division 1 of Title 2).
(6) “Teleconference” means a meeting of a legislative body, the members of which are
in different locations, connected by electronic means, through either audio or video, or
both.
(7) “Two-way audiovisual platform” means an online platform that provides participants
with the ability to participate in a meeting via both an interactive video conference and a
two-way telephonic function.
(8) “Two-way telephonic service” means a telephone service that does not require
internet access, is not provided as part of a two-way audiovisual platform, and allows
participants to dial a telephone number to listen and verbally participate.
(9) “Webcasting” means a streaming video broadcast online or on television, using
streaming media technology to distribute a single content source to many simultaneous
listeners and viewers.
(k) This section shall remain in effect only until January 1, 2024, 2026, and as of that
date is repealed.
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54953.
(a) All meetings of the legislative body of a local agency shall be open and public, and
all persons shall be permitted to attend any meeting of the legislative body of a local
agency, except as otherwise provided in this chapter.
(b)(1) Notwithstanding any other provision of law, the legislative body of a local agency
may use teleconferencing for the benefit of the public and the legislative body of a local
agency in connection with any meeting or proceeding authorized by law. The
teleconferenced meeting or proceeding shall comply with all otherwise applicable
requirements of this chapter and all otherwise applicable provisions of law relating to a
specific type of meeting or proceeding.
(2) Teleconferencing, as authorized by this section, may be used for all purposes in
connection with any meeting within the subject matter jurisdiction of the legislative body.
If the legislative body of a local agency elects to use teleconferencing, the legislative
body of a local agency shall comply with all of the following:
(A) All votes taken during a teleconferenced meeting shall be by rollcall.
(B) The teleconferenced meetings shall be conducted in a manner that protects the
statutory and constitutional rights of the parties or the public appearing before the
legislative body of a local agency.
(C) The legislative body shall give notice of the meeting and post agendas as otherwise
required by this chapter.
(D) The legislative body shall allow members of the public to access the meeting and
the agenda shall provide an opportunity for members of the public to address the
legislative body directly pursuant to Section 54954.3.
(3) If the legislative body of a local agency elects to use teleconferencing, it shall post
agendas at all teleconference locations. Each teleconference location shall be identified
in the notice and agenda of the meeting or proceeding, and each teleconference
location shall be accessible to the public. During the teleconference, at least a quorum
of the members of the legislative body shall participate from locations within the
boundaries of the territory over which the local agency exercises jurisdiction, except as
provided in subdivision (d). subdivisions (d) and (e).
(c) (1) No legislative body shall take action by secret ballot, whether preliminary or final.
(2) The legislative body of a local agency shall publicly report any action taken and the
vote or abstention on that action of each member present for the action.
(3) Prior to taking final action, the legislative body shall orally report a summary of a
recommendation for a final action on the salaries, salary schedules, or compensation
paid in the form of fringe benefits of a local agency executive, as defined in subdivision
(d) of Section 3511.1, during the open meeting in which the final action is to be taken.
This paragraph shall not affect the public’s right under the California Public Records Act
(Division 10 (commencing with Section 7920.000) of Title 1) to inspect or copy records
created or received in the process of developing the recommendation.
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(d) (1) Notwithstanding the provisions relating to a quorum in paragraph (3) of
subdivision (b), if a health authority conducts a teleconference meeting, members who
are outside the jurisdiction of the authority may be counted toward the establishment of
a quorum when participating in the teleconference if at least 50 percent of the number of
members that would establish a quorum are present within the boundaries of the
territory over which the authority exercises jurisdiction, and the health authority provides
a teleconference number, and associated access codes, if any, that allows any person
to call in to participate in the meeting and the number and access codes are identified in
the notice and agenda of the meeting.
(2) Nothing in this subdivision shall be construed as discouraging health authority
members from regularly meeting at a common physical site within the jurisdiction of the
authority or from using teleconference locations within or near the jurisdiction of the
authority. A teleconference meeting for which a quorum is established pursuant to this
subdivision shall be subject to all other requirements of this section.
(3) For purposes of this subdivision, a health authority means any entity created
pursuant to Sections 14018.7, 14087.31, 14087.35, 14087.36, 14087.38, and
14087.9605 of the Welfare and Institutions Code, any joint powers authority created
pursuant to Article 1 (commencing with Section 6500) of Chapter 5 of Division 7 for the
purpose of contracting pursuant to Section 14087.3 of the Welfare and Institutions
Code, and any advisory committee to a county-sponsored health plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety
Code if the advisory committee has 12 or more members.
(e)(1) The legislative body of a local agency may use teleconferencing without
complying with the requirements of paragraph (3) of subdivision (b) if, during the
teleconference meeting, at least a quorum of the members of the legislative body
participates in person from a singular physical location clearly identified on the agenda,
which location shall be open to the public and situated within the boundaries of the
territory over which the local agency exercises jurisdiction and the legislative body
complies with all of the following: if the legislative body complies with the requirements
of paragraph (2) of this subdivision in either of the following circumstances:
(A) The legislative body shall provide at least one of the following as a means by which
the public may remotely hear and visually observe the meeting, and remotely address
the legislative body: holds a meeting during a proclaimed state of emergency for the
purpose of determining, by majority vote, whether as a result of the emergency, meeting
in person would present imminent risks to the health or safety of attendees.
(i)(B) A two-way audiovisual platform. The legislative body holds a meeting during a
proclaimed state of emergency and has determined, by majority vote, pursuant to
subparagraph (A), that, as a result of the emergency, meeting in person would present
imminent risks to the health or safety of attendees.
(ii)(2) A two-way telephonic service and a live webcasting of the meeting. legislative
body that holds a meeting pursuant to this subdivision shall do all of the following:
(B)(A) In each instance in which notice of the time of the teleconferenced meeting is
otherwise given or the agenda for the meeting is otherwise posted, the legislative body
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shall also give notice of the means by which members of the public may access the
meeting and offer public comment. The agenda shall identify and include an opportunity
for all persons to attend via a call-in option or an internet-based service option.
(C) The agenda shall identify and include an opportunity for all persons to attend and
address the legislative body directly pursuant to Section 54954.3 via a call-in option, via
an internet-based service option, and at the in-person location of the meeting.
(D)(B) In the event of a disruption that prevents the legislative body from broadcasting
the meeting to members of the public using the call-in option or internet-based service
option, or in the event of a disruption within the local agency’s control that prevents
members of the public from offering public comments using the call-in option or internet-
based service option, the legislative body shall take no further action on items
appearing on the meeting agenda until public access to the meeting via the call-in
option or internet-based service option is restored. Actions taken on agenda items
during a disruption that prevents the legislative body from broadcasting the meeting
may be challenged pursuant to Section 54960.1.
(E)(C) The legislative body shall not require public comments to be submitted in
advance of the meeting and must provide an opportunity for the public to address the
legislative body and offer comment in real time.
(F)(D) Notwithstanding Section 54953.3, an individual desiring to provide public
comment through the use of an internet website, or other online platform, not under the
control of the local legislative body, that requires registration to log in to a
teleconference may be required to register as required by the third-party internet
website or online platform to participate.
(2) A member of the legislative body shall only participate in the meeting remotely
pursuant to this subdivision, if all of the following requirements are met:
(A) One of the following circumstances applies:
(E)(i) The member notifies the legislative body at the earliest opportunity possible,
including at the start of a regular meeting, of their need to participate remotely for just
cause, including a general description of the circumstances relating to their need to
appear remotely at the given meeting. The provisions of this clause shall not be used by
any member of the legislative body for more than two meetings per calendar year. A
legislative body that provides a timed public comment period for each agenda item shall
not close the public comment period for the agenda item, or the opportunity to register,
pursuant to subparagraph (D), to provide public comment until that timed public
comment period has elapsed.
(ii) A legislative body that does not provide a timed public comment period, but takes
public comment separately on each agenda item, shall allow a reasonable amount of
time per agenda item to allow public members the opportunity to provide public
comment, including time for members of the public to register pursuant to subparagraph
(D), or otherwise be recognized for the purpose of providing public comment.
(iii) A legislative body that provides a timed general public comment period that does not
correspond to a specific agenda item shall not close the public comment period or the
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opportunity to register, pursuant to subparagraph (D), until the timed general public
comment period has elapsed.
(ii)(3) The member requests If a state of emergency remains active, in order to continue
to teleconference without compliance with paragraph (3) of subdivision (b), the
legislative body to allow them to participate in the meeting remotely due to emergency
circumstances and the legislative body takes action to approve the request. The
legislative body shall request a general description of the circumstances relating to their
need to appear remotely at the given meeting. A general description of an item
generally need not exceed 20 words and shall not require the member to disclose any
medical diagnosis or disability, or any personal medical information that is already
exempt under existing law, such as the Confidentiality of Medical Information Act
(Chapter 1 (commencing with Section 56) of Part 2.6 of Division 1 of the Civil Code).
For the purposes of this clause, the following requirements apply: shall, not later than 45
days after teleconferencing for the first time pursuant to subparagraph (A) or (B) of
paragraph (1), and every 45 days thereafter, make the following findings by majority
vote:
(I) A member shall make a request to participate remotely at a meeting pursuant to this
clause as soon as possible. The member shall make a separate request for each
meeting in which they seek to participate remotely.
(II)(A) The legislative body may take action on a request to participate remotely at the
earliest opportunity. If the request does not allow sufficient time to place proposed
action on such a request on the posted agenda for the meeting for which the request is
made, the legislative body may take action at the beginning of the meeting in
accordance with paragraph (4) of subdivision (b) of Section 54954.2. has reconsidered
the circumstances of the state of emergency.
(B) The member shall publicly disclose at the meeting before any action is taken
whether any other individuals 18 years of age or older are present in the room at the
remote location with the member, and the general nature of the member’s relationship
with any such individuals. state of emergency continues to directly impact the ability of
the members to meet safely in person.
(C) The member shall participate through both audio and visual technology.
(3)(4) The provisions of this This subdivision shall not serve as a means for any
member of a legislative body to participate in meetings of be construed to require the
legislative body solely by teleconference from a remote location for a period of more
than three consecutive months or 20 percent of the regular meetings for the local
agency within a calendar year, or more than two meetings if the legislative body
regularly meets fewer than 10 times per calendar year. to provide a physical location
from which the public may attend or comment.
(f) The legislative body shall have and implement a procedure for receiving and swiftly
resolving requests for reasonable accommodation for individuals with disabilities,
consistent with the federal Americans with Disabilities Act of 1990 (42 U.S.C. Sec.
12132), and resolving any doubt in favor of accessibility. In each instance in which
notice of the time of the meeting is otherwise given or the agenda for the meeting is
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otherwise posted, the legislative body shall also give notice of the procedure for
receiving and resolving requests for accommodation.
(g) The legislative body shall conduct meetings subject to this chapter consistent with
applicable civil rights and nondiscrimination laws.
(h) (1) Nothing in this section shall prohibit a legislative body from providing the public
with additional teleconference locations.
(2) Nothing in this section shall prohibit a legislative body from providing members
of the public with additional physical locations in which the public may observe and
address the legislative body by electronic means.
(i) For the purposes of this section, the following definitions shall apply:
(1) “Emergency circumstances” means a physical or family medical emergency that
prevents a member from attending in person.
(2) “Just cause” means any of the following:
(A) A childcare or caregiving need of a child, parent, grandparent, grandchild, sibling,
spouse, or domestic partner that requires them to participate remotely. “Child,” “parent,”
“grandparent,” “grandchild,” and “sibling” have the same meaning as those terms do in
Section 12945.2.
(B) A contagious illness that prevents a member from attending in person.
(C) A need related to a physical or mental disability as defined in Sections 12926 and
12926.1 not otherwise accommodated by subdivision (f).
(D) Travel while on official business of the legislative body or another state or local
agency.
(3)(1) “Remote location” means a location from which a member of a legislative body
participates in a meeting pursuant to subdivision (e), other than any physical meeting
location designated in the notice of the meeting. Remote locations need not be
accessible to the public. “State of emergency” means a state of emergency proclaimed
pursuant to Section 8625 of the California Emergency Services Act (Article 1
(commencing with Section 8550) of Chapter 7 of Division 1 of Title 2).
(4) “Remote participation” means participation in a meeting by teleconference at a
location other than any physical meeting location designated in the notice of the
meeting. Watching or listening to a meeting via webcasting or another similar electronic
medium that does not permit members to interactively hear, discuss, or deliberate on
matters, does not constitute remote participation.
(5)(2) “Teleconference” means a meeting of a legislative body, the members of which
are in different locations, connected by electronic means, through either audio or video,
or both.
(6) “Two-way audiovisual platform” means an online platform that provides participants
with the ability to participate in a meeting via both an interactive video conference and a
two-way telephonic function.
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(7) “Two-way telephonic service” means a telephone service that does not require
internet access, is not provided as part of a two-way audiovisual platform, and allows
participants to dial a telephone number to listen and verbally participate.
(8) “Webcasting” means a streaming video broadcast online or on television, using
streaming media technology to distribute a single content source to many simultaneous
listeners and viewers.
(j) This section shall become operative January 1, 2024, shall remain in effect only until
January 1, 2026, and as of that date is repealed.2026.
54953.
(a) All meetings of the legislative body of a local agency shall be open and public, and
all persons shall be permitted to attend any meeting of the legislative body of a local
agency, except as otherwise provided in this chapter.
(b) (1) Notwithstanding any other provision of law, the legislative body of a local agency
may use teleconferencing for the benefit of the public and the legislative body of a local
agency in connection with any meeting or proceeding authorized by law. The
teleconferenced meeting or proceeding shall comply with all requirements of this
chapter and all otherwise applicable provisions of law relating to a specific type of
meeting or proceeding.
(2) Teleconferencing, as authorized by this section, may be used for all purposes in
connection with any meeting within the subject matter jurisdiction of the legislative body.
All votes taken during a teleconferenced meeting shall be by rollcall.
(3) If the legislative body of a local agency elects to use teleconferencing, it shall post
agendas at all teleconference locations and conduct teleconference meetings in a
manner that protects the statutory and constitutional rights of the parties or the public
appearing before the legislative body of a local agency. Each teleconference location
shall be identified in the notice and agenda of the meeting or proceeding, and each
teleconference location shall be accessible to the public. During the teleconference, at
least a quorum of the members of the legislative body shall participate from locations
within the boundaries of the territory over which the local agency exercises jurisdiction,
except as provided in subdivision (d). The agenda shall provide an opportunity for
members of the public to address the legislative body directly pursuant to Section
54954.3 at each teleconference location.
(4) For the purposes of this section, “teleconference” means a meeting of a legislative
body, the members of which are in different locations, connected by electronic means,
through either audio or video, or both. Nothing in this section shall prohibit a local
agency from providing the public with additional teleconference locations.
(c) (1) No legislative body shall take action by secret ballot, whether preliminary or final.
(2) The legislative body of a local agency shall publicly report any action taken and the
vote or abstention on that action of each member present for the action.
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(3) Prior to taking final action, the legislative body shall orally report a summary of a
recommendation for a final action on the salaries, salary schedules, or compensation
paid in the form of fringe benefits of a local agency executive, as defined in subdivision
(d) of Section 3511.1, during the open meeting in which the final action is to be taken.
This paragraph shall not affect the public’s right under the California Public Records Act
(Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1) to inspect or copy
records created or received in the process of developing the recommendation.
(d) (1) Notwithstanding the provisions relating to a quorum in paragraph (3) of
subdivision (b), if a health authority conducts a teleconference meeting, members who
are outside the jurisdiction of the authority may be counted toward the establishment of
a quorum when participating in the teleconference if at least 50 percent of the number of
members that would establish a quorum are present within the boundaries of the
territory over which the authority exercises jurisdiction, and the health authority provides
a teleconference number, and associated access codes, if any, that allows any person
to call in to participate in the meeting and the number and access codes are identified in
the notice and agenda of the meeting.
(2) Nothing in this subdivision shall be construed as discouraging health authority
members from regularly meeting at a common physical site within the jurisdiction of the
authority or from using teleconference locations within or near the jurisdiction of the
authority. A teleconference meeting for which a quorum is established pursuant to this
subdivision shall be subject to all other requirements of this section.
(3) For purposes of this subdivision, a health authority means any entity created
pursuant to Sections 14018.7, 14087.31, 14087.35, 14087.36, 14087.38, and
14087.9605 of the Welfare and Institutions Code, any joint powers authority created
pursuant to Article 1 (commencing with Section 6500) of Chapter 5 of Division 7 for the
purpose of contracting pursuant to Section 14087.3 of the Welfare and Institutions
Code, and any advisory committee to a county-sponsored health plan licensed pursuant
to Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety
Code if the advisory committee has 12 or more members.
(e) This section shall become operative January 1, 2026.
Health and Safety Code
1220.1
(a) An application for licensure made pursuant to this chapter shall not be denied, nor
shall any license issued pursuant to this chapter be suspended, revoked, or otherwise
limited, on the basis of a civil judgment, criminal conviction, or disciplinary action
imposed by another state if that judgment, conviction, or disciplinary action is based
solely on the application of another state’s law that interferes with a person’s right to
receive sensitive services that would be lawful if provided in this state.
(b) This section does not apply to a civil judgment, criminal conviction, or disciplinary
action imposed by another state based upon conduct in another state that would subject
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an applicant, licensee, or health care practitioner subject to this division to a similar
claim, charge, or action under the laws of this state.
(c) For purposes of this section, “sensitive services” has the same meaning as in
Section 56.05 of the Civil Code.
1265.11.
(a) An application for licensure made pursuant to this chapter shall not be denied, nor
shall any license issued pursuant to this chapter be suspended, revoked, or otherwise
limited, on the basis of a civil judgment, criminal conviction, or disciplinary action
imposed by another state if that judgment, conviction, or disciplinary action is based
solely on the application of another state’s law that interferes with a person’s right to
receive sensitive services that would be lawful if provided in this state.
(b) This section does not apply to a civil judgment, criminal conviction, or disciplinary
action imposed by another state based upon conduct in another state that would subject
an applicant, licensee, or health care practitioner subject to this division to a similar
claim, charge, or action under the laws of this state.
(c) For purposes of this section, “sensitive services” has the same meaning as in
Section 56.05 of the Civil Code.
1342.73.
(a)(1) With respect to an individual or group health care service plan contract subject to
Section 1367.006, the copayment, coinsurance, or any other form of cost sharing for a
covered outpatient prescription drug for an individual prescription for a supply of up to
30 days shall not exceed two hundred fifty dollars ($250), except as provided in
paragraphs (2) and (3).
(2) With respect to products with actuarial value at, or equivalent to, the bronze level,
cost sharing for a covered outpatient prescription drug for an individual prescription for a
supply of up to 30 days shall not exceed five hundred dollars ($500), except as provided
in paragraph (3).
(3) For a health care service plan contract that is a “high deductible health plan” under
the definition set forth in Section 223(c)(2) of Title 26 of the United States Code,
paragraphs (1) and (2) of this subdivision shall apply only once an enrollee’s deductible
has been satisfied for the year.
(4) For a nongrandfathered individual or small group health care service plan contract,
the annual deductible for outpatient drugs, if any, shall not exceed twice the amount
specified in paragraph (1) or (2), respectively.
(5) For purposes of paragraphs (1) and (2), “any other form of cost sharing” shall not
include a deductible.
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(6) A copayment or percentage coinsurance shall not exceed 50 percent of the cost to
the plan, as described in Section 1300.67.24 of Title 28 of the California Code of
Regulations.
(7) If there is a generic equivalent to a brand name drug, a plan shall ensure that the
enrollee is subject to the lowest cost sharing that would be applied, whether or not both
the generic equivalent and the brand name drug are on the formulary. This paragraph
shall not be construed to require both the generic equivalent and the brand name drug
to be on the formulary.
(b)(1) If a health care service plan contract for a nongrandfathered individual or small
group product maintains a drug formulary grouped into tiers that includes a fourth tier, a
health care service plan contract shall use the following definitions for each tier of the
drug formulary:
(A) Tier one shall consist of most generic drugs and low-cost preferred brand name
drugs.
(B) Tier two shall consist of nonpreferred generic drugs, preferred brand name drugs,
and any other drugs recommended by the health care service plan’s pharmacy and
therapeutics committee based on safety, efficacy, and cost.
(C) Tier three shall consist of nonpreferred brand name drugs or drugs that are
recommended by the health care service plan’s pharmacy and therapeutics committee
based on safety, efficacy, and cost, or that generally have a preferred and often less
costly therapeutic alternative at a lower tier.
(D) Tier four shall consist of drugs that are biologics, drugs that the Food and Drug
Administration of the United States Department of Health and Human Services or the
manufacturer requires to be distributed through a specialty pharmacy, drugs that require
the enrollee to have special training or clinical monitoring for self-administration, or
drugs that cost the health plan more than six hundred dollars ($600) net of rebates for a
one-month supply.
(2) In placing specific drugs on specific tiers, or choosing to place a drug on the
formulary, the health care service plan shall take into account comply with the other
provisions of this section and this chapter.
(3) A health care service plan contract may maintain a drug formulary with fewer than
four tiers. A health care service plan contract shall not maintain a drug formulary with
more than four tiers.
(4) This section shall not be construed to limit a health care service plan from placing
any drug in a lower tier.
(c) This section does not apply to a health care service plan contract with the State
Department of Health Care Services.
(d) This section shall remain in effect only until January 1, 2024, and as of that date is
repealed, unless a later enacted statute that is enacted before January 1, 2024, deletes
or extends that date.
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1367.206.
(a) If there is more than one drug that is clinically appropriate for the treatment of a
medical condition, a health care service plan that provides coverage for prescription
drugs may require step therapy.
(b) A health care service plan shall expeditiously grant a request for a step therapy
exception within the applicable time limit required by Section 1367.241 if a prescribing
provider submits necessary justification and supporting clinical documentation
supporting the provider’s determination that the required prescription drug is
inconsistent with good professional practice for provision of medically necessary
covered services to the enrollee, taking into consideration the enrollee’s needs and
medical history, along with the professional judgment of the enrollee’s provider. The
basis of the provider’s determination may include, but is not limited to, any of the
following criteria:
(1) The required prescription drug is contraindicated or is likely, or expected, to cause
an adverse reaction or physical or mental harm to the enrollee in comparison to the
requested prescription drug, based on the known clinical characteristics of the enrollee
and the known characteristics and history of the enrollee’s prescription drug regimen.
(2) The required prescription drug is expected to be ineffective based on the known
clinical characteristics of the enrollee and the known characteristics and history of the
enrollee’s prescription drug regimen.
(3) The enrollee has tried the required prescription drug while covered by their current
or previous health coverage or Medicaid, and that prescription drug was discontinued
due to lack of efficacy or effectiveness, diminished effect, or an adverse reaction. The
health care service plan may require the submission of documentation demonstrating
that the enrollee tried the required prescription drug before it was discontinued.
(4) The required prescription drug is not clinically appropriate for the enrollee because
the required drug is expected to do any of the following, as determined by the enrollee’s
prescribing provider:
(A) Worsen a comorbid condition.
(B) Decrease the capacity to maintain a reasonable functional ability in performing daily
activities.
(C) Pose a significant barrier to adherence to, or compliance with, the enrollee’s drug
regimen or plan of care.
(5) The enrollee is stable on a prescription drug selected by the enrollee’s prescribing
provider for the medical condition under consideration while covered by their current or
previous health coverage or Medicaid.
(c) A health care provider or prescribing provider may appeal a denial of an exception
request for coverage of a nonformulary drug, prior authorization request, or step therapy
exception request consistent with the health care service plan’s current utilization
management processes.
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(d) An enrollee or the enrollee’s designee or guardian may appeal a denial of an
exception request for coverage of a nonformulary drug, prior authorization request, or
step therapy exception request by filing a grievance under Section 1368.
(e)(1) This section does not prohibit either of the following: a health care provider from
prescribing a prescription drug that is clinically appropriate.
(1)(2) A This section does not prohibit a health care service plan or utilization review
organization from requiring an enrollee to try an AB-rated generic equivalent equivalent,
biosimilar, as defined in Section 262(i)(2) of Title 42 of the United States Code, or
interchangeable biological product product, as defined in Section 262(i)(3) of Title 42 of
the United States Code, before providing coverage for the equivalent branded
prescription drug.
(2)(3) A health care provider from prescribing a prescription drug that is clinically
appropriate. Paragraph (2) does not prohibit or supersede a step therapy exception
request as described in subdivision (b).
(f) This section does not require or authorize a health care service plan that contracts
with the State Department of Health Care Services to provide services to Medi-Cal
beneficiaries to provide coverage for prescription drugs that are not required pursuant to
those programs or contracts, or to limit or exclude any prescription drugs that are
required by those programs or contracts.
(g) For purposes of this section, “step therapy exception” means a decision to override a
generally applicable step therapy protocol in favor of coverage of the prescription drug
prescribed by a health care provider for an individual enrollee.
(h) Commencing January 1, 2022, a health care service plan contract with a utilization
review organization, medical group, or other contracted entity that performs utilization
review or utilization management functions on a health care service plan’s behalf shall
include terms that require the contracted entity to comply with this section and Section
1367.241.
1368.5.
(a) Every health care service plan that offers coverage for a service that is within the
scope of practice of a duly licensed pharmacist may shall pay or reimburse the cost of
the service performed by a pharmacist for the plan if the pharmacist otherwise provides
services for the plan. at an in-network pharmacy or a pharmacist at an out-of-network
pharmacy if the health care service plan has an out-of-network pharmacy benefit.
(b) Payment or reimbursement may be made pursuant to this section for a service
performed by a duly licensed pharmacist only when all of the following conditions are
met:
(1) The service performed is within the lawful scope of practice of the pharmacist.
(2) The coverage otherwise provides reimbursement for identical services performed by
other licensed health care providers.
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(c) Nothing in this section shall require the plan to pay a claim to more than one
provider for duplicate service or be interpreted to limit physician reimbursement.
1649.1.
Unless the context requires otherwise, the following definitions shall apply to for
purposes of this chapter:
(a) “Compassionate Use Act of 1996” means the initiative measure enacted by the
approval of Proposition 215 at the November 5, 1996, statewide general election and
found at Section 11362.5, and any amendments to that act.
(b) (1) Except as provided in paragraph (2), “health care facility” means a health facility
specified in subdivision (a), (c), (f), (i), or (n) of Section 1250.1250 or a home health
agency licensed pursuant to Chapter 8 (commencing with Section 1725) of Division 2.
(2) The meaning of “health care facility” shall not include any of the following:
(A) A chemical dependency recovery hospital.
(B) A state hospital.
(C) An emergency department of a health care facility, as specified in subdivision (a) of
Section 1250, while the patient is receiving emergency services and care.
(c) “Home health agency” means a private or public organization, including, but not
limited to, any partnership, corporation, political subdivision of the state, or other
government agency within the state, that provides, or arranges for the provision of,
skilled nursing services, to persons in their temporary or permanent place of residence
and is licensed pursuant to Chapter 8 (commencing with Section 1725) of Division 2.
(c)(d) “Medicinal cannabis” means cannabis or a cannabis product used in compliance
with the Compassionate Use Act of 1996 and Article 2.5 (commencing with Section
11362.7) of Chapter 6 of Division 10.
(d)(e) “Patient” means an individual who is terminally ill. “Patient” does not include an
individual receiving emergency services and care, as defined in Section 1317.1.meets
one or both of the following criteria:
(1) Is terminally ill.
(2) Is over 65 years of age with a chronic disease for which the patient has received a
physician’s assessment declaring that the patient has a serious medical condition, as
defined by subdivision (h) of Section 11362.7 and that the use of medicinal cannabis is
appropriate.
(e)(f) “Terminally ill” means a medical condition resulting in a prognosis of life of one
year or less, if the disease follows its natural course.
1649.2.
A (a) Except as provided in subdivision (b), a health care facility shall permit patient use
of medical cannabis medicinal cannabis, as indicated by the attending physician, as
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defined by Section 11362.7, in the patient’s medical record and shall do all of the
following:
(1)(A) A home health agency shall prohibit smoking or vaping immediately before or
while home health agency staff are present in the residence.
(a)(B) Prohibit All other health facilities shall prohibit smoking or vaping as methods to
use medicinal cannabis.
(b)(2) Include the use of medicinal cannabis within the patient’s medical records.
(c)(3) Require a patient to provide a copy of the patient’s valid identification card, as
described in Section 11362.715, or a copy of that patient’s written documentation as
defined in Section 11362.7.
(d)(4) Require a patient or a primary caregiver, as defined in Section 11362.7, to be
responsible for acquiring, retrieving, administering, and removing medicinal cannabis.
(e)(5) Require medicinal cannabis to be stored securely at all times in a locked
container in the patient’s room, other designated area, or with the patient’s primary
caregiver. This requirement does not apply to a home health agency.
(f)(6) Prohibit health care professionals and facility staff, professionals, health care
facility staff, and home health agency staff, including, but not limited to, physicians,
nurses, and pharmacists, from administering medicinal cannabis or retrieving medicinal
cannabis from storage.
(g)(7) Develop and disseminate written guidelines Develop, disseminate, and train
health facility staff on the written guidelines developed by the facility for the use and
disposal of medicinal cannabis within the health care facility pursuant to this
chapter. This requirement does not apply to a home health agency.
(8) Ensure that a patient is not denied admission to the health care facility in whole or in
part because of the patient’s use of medicinal cannabis.
(b) Notwithstanding subdivision (a), a general acute care hospital specified in
subdivision (a) of Section 1250 shall not permit a patient with a chronic disease to use
medicinal cannabis.
1649.3.
(a) Upon discharge, all remaining medicinal cannabis shall be removed by the patient or
patient’s primary caregiver. If a patient cannot remove the medicinal cannabis and does
not have a primary caregiver that is available to remove the medicinal cannabis, the
product shall be stored in a locked container until it is disposed of in accordance with
the health facility policy and procedure governing medicinal cannabis.
(b) Subdivision (a) does not apply to a home health agency licensed pursuant to
Chapter 8 (commencing with Section 1725) of Division 2.
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1649.6.
(a) If a federal regulatory agency, the United States Department of Justice (US DOJ), or
the federal Centers for Medicare and Medicaid Services (CMS) takes one of the
following actions, or makes an inquiry about the health care facility’s activities pursuant
to Section 1649.2, a health care facility may suspend compliance with Section 1649.2
until the regulatory agency, the US DOJ, or CMS notifies the health care facility that it
may resume permitting the use of medicinal cannabis within the facility:
(1) A federal regulatory agency or the US DOJ initiates enforcement action action,
including a notice to suspend funding, against a health care facility related to the
facility’s compliance with a state-regulated medical marijuana program.
(2) A federal regulatory agency, the US DOJ, or CMS issues a rule rule, guidance, or
otherwise provides notification to the health care facility that expressly prohibits the use
of medical marijuana in health care facilities or otherwise prohibits compliance with a
state-regulated medical marijuana program.
(b) This section does not permit a health care facility to prohibit patient use of medicinal
cannabis due solely to the fact that cannabis is a Schedule I drug pursuant to the
federal Uniform Controlled Substances Act, or other federal constraints on the use of
medicinal cannabis that were in existence prior to the enactment of this chapter.
1799.113.
(a)(1) A person who, in good faith and not for compensation, renders emergency
treatment at the scene of an opioid overdose or suspected opioid overdose by
administering an opioid antagonist shall not be liable for civil damages resulting from an
act or omission related to the rendering of the emergency treatment.
(2) A person who, in good faith and not for compensation, furnishes an opioid
antagonist to a person for use at the scene of an opioid overdose or suspected opioid
overdose shall not be liable for civil damages resulting from an act or omission related
to the furnishing of the opioid antagonist.
(b) This section does not apply to an act or omission related to the rendering of
emergency treatment at the scene of an opioid overdose or suspected opioid overdose
by means of an opioid antagonist that constitutes gross negligence or willful or wanton
misconduct.
(c) For purposes of this section, both of the following apply:
(1) A person who renders emergency treatment by means of an opioid antagonist, or
who furnishes an opioid antagonist at the scene of an opioid overdose or suspected
opioid overdose, and who is not compensated for doing so, but receives compensation
for other actions as a result of their unrelated employment, is not “rendering emergency
medical care or furnishing opioid antagonist for compensation.”
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(2) “Opioid antagonist” means naloxone hydrochloride or any other opioid antagonist
that is approved by the United States Food and Drug Administration for the treatment of
an opioid overdose.
11150.3.
(a) Notwithstanding any other law, if a substance listed in Schedule I of Section 11054
is excluded from Schedule I of the federal Controlled Substances Act and placed on a
schedule of the act other than Schedule I, or if a product composed of one of these
substances is approved by the federal Food and Drug Administration and either placed
on a schedule of the act other than Schedule I, or exempted from one or more
provisions of the act, so as to permit a physician, pharmacist, or other authorized
healing arts licensee acting within their scope of practice, to prescribe, furnish, or
dispense that product, the physician, pharmacist, or other authorized healing arts
licensee who prescribes, furnishes, or dispenses that product in accordance with federal
law shall be deemed to be in compliance with state law governing those acts.
(b) For purposes of this chapter, upon the effective date of any of the changes in federal
law described in subdivision (a), notwithstanding any other state law, a product
composed of the excluded substance may be prescribed, furnished, dispensed,
transferred, transported, possessed, or used in accordance with federal law and is
authorized pursuant to state law.
(c) This section does not apply to cannabis or a cannabis product, as defined in Section
26001 of the Business and Professions Code. However, cannabis or cannabis products
may be authorized pursuant to Section 11150.2.
11165.4.
(a)(1)(A)(i) A health care practitioner authorized to prescribe, order, administer, or
furnish a controlled substance shall consult the patient activity report or information from
the patient activity report obtained from the CURES database to review a patient’s
controlled substance history for the past 12 months before prescribing a Schedule II,
Schedule III, or Schedule IV controlled substance to the patient for the first time and at
least once every six months thereafter if the prescriber renews the prescription and the
substance remains part of the treatment of the patient.
(ii) If a health care practitioner authorized to prescribe, order, administer, or furnish a
controlled substance is not required, pursuant to an exemption described in subdivision
(c), to consult the patient activity report from the CURES database the first time the
health care practitioner prescribes, orders, administers, or furnishes a controlled
substance to a patient, the health care practitioner shall consult the patient activity
report from the CURES database to review the patient’s controlled substance history
before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled
substance to the patient and at least once every six months thereafter if the prescriber
renews the prescription and the substance remains part of the treatment of the patient.
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(iii) A health care practitioner who did not directly access the CURES database to
perform the required review of the controlled substance use report shall document in the
patient’s medical record that they reviewed the CURES database generated report
within 24 hours of the controlled substance prescription that was provided to them by
another authorized user of the CURES database.
(B) For purposes of this paragraph, “first time” means the initial occurrence in which a
health care practitioner, in their role as a health care practitioner, intends to prescribe,
order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled
substance to a patient and has not previously prescribed a controlled substance to the
patient.
(2) A health care practitioner shall review a patient’s controlled substance history that
has been obtained from the CURES database no earlier than 24 hours, or the previous
business day, before the health care practitioner prescribes, orders, administers, or
furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.
(b) The duty to consult the CURES database, as described in subdivision (a), does not
apply to veterinarians or pharmacists.
(c) The duty to consult the CURES database, as described in subdivision (a), does not
apply to a health care practitioner in any of the following circumstances:
(1) If a health care practitioner prescribes, orders, or furnishes a controlled substance to
be administered to a patient in any of the following facilities or during a transfer between
any of the following facilities, or for use while on facility premises:
(A) A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of
Division 2.
(B) An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248)
of Division 2.
(C) A health facility, as described in Chapter 2 (commencing with Section 1250) of
Division 2.
(D) A county medical facility, as described in Chapter 2.5 (commencing with Section
1440) of Division 2.
(E) Another medical facility, including, but not limited to, an office of a health care
practitioner and an imaging center.
(F) A correctional clinic, as described in Section 4187 of the Business and Professions
Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and
Professions Code.
(2) If a health care practitioner prescribes, orders, administers, or furnishes a controlled
substance in the emergency department of a general acute care hospital and the
quantity of the controlled substance does not exceed a nonrefillable seven-day supply
of the controlled substance to be used in accordance with the directions for use.
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(3) If a health care practitioner prescribes, orders, administers, or furnishes
buprenorphine or other controlled substance containing buprenorphine in the
emergency department of a general acute care hospital.
(3)(4) If a health care practitioner prescribes, orders, administers, or furnishes a
controlled substance to a patient as part of the patient’s treatment for a surgical,
radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled
substance does not exceed a nonrefillable seven-day supply of the controlled substance
to be used in accordance with the directions for use, in any of the following facilities:
(A) A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of
Division 2.
(B) An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248)
of Division 2.
(C) A health facility, as described in Chapter 2 (commencing with Section 1250) of
Division 2.
(D) A county medical facility, as described in Chapter 2.5 (commencing with Section
1440) of Division 2.
(E) A place of practice, as defined in Section 1658 of the Business and Professions
Code.
(F) Another medical facility where surgical procedures are permitted to take place,
including, but not limited to, the office of a health care practitioner.
(4)(5) If a health care practitioner prescribes, orders, administers, or furnishes a
controlled substance to a patient who is terminally ill, as defined in subdivision (c) of
Section 11159.2.
(5)(6) (A) If all of the following circumstances are satisfied:
(i) It is not reasonably possible for a health care practitioner to access the information in
the CURES database in a timely manner.
(ii) Another health care practitioner or designee authorized to access the CURES
database is not reasonably available.
(iii) The quantity of controlled substance prescribed, ordered, administered, or furnished
does not exceed a nonrefillable seven-day supply of the controlled substance to be
used in accordance with the directions for use and no refill of the controlled substance is
allowed.
(B) A health care practitioner who does not consult the CURES database under
subparagraph (A) shall document the reason they did not consult the database in the
patient’s medical record.
(6)(7) If the CURES database is not operational, as determined by the department, or
cannot be accessed by a health care practitioner because of a temporary technological
or electrical failure. A health care practitioner shall, without undue delay, seek to correct
the cause of the temporary technological or electrical failure that is reasonably within
the health care practitioner’s control.
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(7)(8) If the CURES database cannot be accessed because of technological limitations
that are not reasonably within the control of a health care practitioner.
(8)(9) If consultation of the CURES database would, as determined by the health care
practitioner, result in a patient’s inability to obtain a prescription in a timely manner and
thereby adversely impact the patient’s medical condition, provided that the quantity of
the controlled substance does not exceed a nonrefillable seven-day supply if the
controlled substance were used in accordance with the directions for use.
(d) (1) A health care practitioner who fails to consult the CURES database, as described
in subdivision (a), shall be referred to the appropriate state professional licensing board
solely for administrative sanctions, as deemed appropriate by that board.
(2) This section does not create a private cause of action against a health care
practitioner. This section does not limit a health care practitioner’s liability for the
negligent failure to diagnose or treat a patient.
(e) All applicable state and federal privacy laws govern the duties required by this
section.
(f) The provisions of this section are severable. If any provision of this section or its
application is held invalid, that invalidity shall not affect other provisions or applications
that can be given effect without the invalid provision or application.
(g) This section shall become operative on July 1, 2021, or upon the date the
department promulgates regulations to implement this section and posts those
regulations on its internet website, whichever date is earlier.
11870.
For purposes of this chapter, the following definitions apply:
(a) “Amusement park” means a gated facility that requires a ticket for entry, has
attendance greater than 1,000,000 visitors annually, and operates 10 or more
amusement rides regulated under Sections 7900 to 7919, inclusive, and Sections 7920
to 7932, inclusive, of the Labor Code.
(b) “Auto-injector” means a disposable delivery device designed for the automatic
injection of a premeasured dose of an opioid antagonist into the human body and
approved by the United States Food and Drug Administration for layperson use.
(c) “Opioid antagonist” means naloxone hydrochloride or another drug approved by the
United States Food and Drug Administration that, when administered, negates or
neutralizes in whole or in part the pharmacological effects of an opioid in the body, and
has been approved for the treatment of an opioid overdose.
11871.
Each stadium, concert venue, and amusement park shall, at all times, maintain
unexpired doses of naloxone hydrochloride or any other opioid antagonist on its
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premises and ensure that at least two employees are aware of the location of the
naloxone hydrochloride or other opioid antagonist.
11872.
(a)(1) Notwithstanding any other law except for Division 5 (commencing with Section
6300) of the Labor Code and Chapters 3.2 (commencing with Section 330), 3.3
(commencing with Section 345), 3.5 (commencing with Section 401), 4 (commencing
with Section 450), and 7 (commencing with Section 14000) of Division 1 of Title 8 of the
California Code of Regulations, a person who, in good faith, administers naloxone
hydrochloride or another opioid antagonist by nasal spray or by auto-injector on the
premises of a stadium, concert venue, or amusement park to a person who appears to
be experiencing an opioid overdose shall not be liable in a civil action, or be subject to
criminal prosecution for their acts or omissions in administering the naloxone
hydrochloride or another opioid antagonist.
(2)(A) The protection specified in subdivision (a) shall not apply in a case of gross
negligence or willful and wanton misconduct of the person who renders emergency care
treatment by the use of naloxone hydrochloride or another opioid antagonist.
(B) Subparagraph (A) shall not apply to an employee of a stadium, concert venue, or
amusement park, or an employee of an entity that owns, occupies, or operates a
stadium, concert venue, or amusement park.
(b) Notwithstanding any other law except for Division 5 (commencing with Section 6300)
of the Labor Code and Chapters 3.2 (commencing with Section 330), 3.3 (commencing
with Section 345), 3.5 (commencing with Section 401), 4 (commencing with Section
450), and 7 (commencing with Section 14000) of Division 1 of Title 8 of the California
Code of Regulations, a stadium, concert venue, or amusement park, or its employees,
or an entity that owns, occupies, or operates a stadium, concert venue, or amusement
park, or its employees, shall not be liable in a civil action, or be subject to criminal
prosecution, for the administration of naloxone hydrochloride or another opioid
antagonist on the premises of the stadium, concert venue, or amusement park,
including by an employee of the stadium, concert venue, or amusement park, or by an
employee of the entity that owns, occupies, or operates the stadium, concert venue, or
amusement park.
(c) Notwithstanding any other law except for Division 5 (commencing with Section 6300)
of the Labor Code and Chapters 3.2 (commencing with Section 330), 3.3 (commencing
with Section 345), 3.5 (commencing with Section 401), 4 (commencing with Section
450), and 7 (commencing with Section 14000) of Division 1 of Title 8 of the California
Code of Regulations, a stadium, concert venue, or amusement park, or its employees,
or an entity that owns, occupies, or operates a stadium, concert venue, or amusement
park, or its employees, shall have no obligation to administer naloxone hydrochloride or
another opioid antagonist in the event of an apparent opioid overdose on the premises
of the stadium, concert venue, or amusement park, and shall not be liable in a civil
action, or be subject to criminal prosecution, if they fail to identify an apparent opioid
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overdose or fail to administer naloxone hydrochloride or another opioid antagonist on
the premises of the stadium, concert venue, or amusement park.
Article 3. Prescription Drug Pricing for Covered Entities
127470.
For purposes of this article:
(a) “Covered drug” means a drug purchased by a covered entity that is subject to the
federal pricing requirements set forth in Section 256b of Title 42 of the United States
Code.
(b) “Covered entity” means a provider defined as a covered entity in Section 256b of
Title 42 of the United States Code.
(c) “Pharmacy benefit manager” has the same meaning as defined in Section 4430 of
the Business and Professions Code and includes a wholly or partially owned or
controlled subsidiary of a pharmacy benefit manager.
(d) “Specified pharmacy” means a pharmacy owned by, or under contract with, a
covered entity that is registered with the 340B discount drug purchasing program to
dispense covered drugs on behalf of the covered entity, whether in person or via mail.
127471.
(a) A pharmacy benefit manager shall not impose any requirements, conditions, or
exclusions that do either of the following:
(1) Discriminate against a covered entity or a specified pharmacy in connection with
dispensing covered drugs.
(2) Prevent a covered entity from retaining the benefit of discounted pricing for the
purchase of covered drugs.
(b) Discrimination prohibited pursuant to subdivision (a) includes, but is not limited to, all
of the following:
(1) Payment terms, reimbursement methodologies, or other terms and conditions that
distinguish between covered drugs and other drugs, account for the availability of
discounts under the 340B discount drug purchasing program described in Section 256b
of Title 42 of the United States Code in determining reimbursement, or are less
favorable than the payment terms or reimbursement methodologies for similarly situated
entities that are not furnishing or dispensing covered drugs.
(2) Terms or conditions applied to covered entities or specified pharmacies based on
the furnishing or dispensing of covered drugs or their status as a covered entity or
specified pharmacy, including restrictions or requirements for participation in specialty,
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standard, or preferred pharmacy networks, or requirements related to the frequency or
scope of audits.
(3) Refusing to contract with or terminating a contract with a covered entity or specified
pharmacy, or otherwise excluding a covered entity or specified pharmacy from a
specialty, standard or preferred network, on the basis that the entity or pharmacy is a
covered entity or a specified pharmacy or for reasons other than those that apply
equally to entities or pharmacies that are not covered entities or specified pharmacies.
(4) Retaliation against a covered entity or specified pharmacy based on its exercise of
any right or remedy under this article.
(5) Interfering with an individual’s choice to receive a covered drug from a covered entity
or specified pharmacy, whether in person or via direct delivery, mail, or other form of
shipment.
(6) Restricting or prohibiting a covered entity from raising a grievance or speaking
publicly about any pharmacy benefit manager that violates this subdivision or from filing
a legal action against a pharmacy benefit manager for violating this subdivision.
(c) This section does not apply to the Medi-Cal program or the federal Medicare
Program but does apply to pharmacy benefit managers that contract with managed care
organizations that serve Medi-Cal or Medicare members.
(d) The provisions of this section shall not be waived, voided, or nullified by contract.
(e) This article shall only be implemented to the extent that it is consistent with Section
256b of Title 42 of the United States Code or any rules or regulations adopted
thereunder.
Insurance Code
10123.1932
(a)(1) With respect to an individual or group policy of health insurance subject to Section
10112.28, the copayment, coinsurance, or any other form of cost sharing for a covered
outpatient prescription drug for an individual prescription for a supply of up to 30 days
shall not exceed two hundred fifty dollars ($250), except as provided in paragraphs (2)
and (3).
(2) With respect to products with actuarial value at or equivalent to the bronze level,
cost sharing for a covered outpatient prescription drug for an individual prescription for a
supply of up to 30 days shall not exceed five hundred dollars ($500), except as provided
in paragraph (3).
(3) For a policy of health insurance that is a “high deductible health plan” under the
definition set forth in Section 223(c)(2) of Title 26 of the United States Code, paragraphs
(1) and (2) of this subdivision applies shall apply only once an insured’s deductible has
been satisfied for the year.
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(4) For a nongrandfathered individual or small group policy of health insurance, the
annual deductible for outpatient drugs, if any, shall not exceed twice the amount
specified in paragraph (1) or (2), respectively.
(5) For purposes of paragraphs (1) and (2), “any other form of cost sharing” shall not
include a deductible.
(6) A copayment or percentage coinsurance shall not exceed 50 percent of the cost to
the insurer, as described in Section 1300.67.24 of Title 28 of the California Code of
Regulations.
(7) If there is a generic equivalent to a brand name drug, an insurer shall ensure that the
insured is subject to the lowest cost sharing that would be applied, whether or not both
the generic equivalent and the brand name drug are on the formulary. This paragraph
shall not be construed to require both the generic equivalent and the brand name drug
to be on the formulary.
(b) (1) If a policy of health insurance offered, sold, or renewed in the nongrandfathered
individual or small group market maintains a drug formulary grouped into tiers that
includes a fourth tier, a policy of health insurance shall use the following definitions for
each tier of the drug formulary:
(A) Tier one shall consist of most generic drugs and low-cost preferred brand name
drugs.
(B) Tier two shall consist of nonpreferred generic drugs, preferred brand name drugs,
and any other drugs recommended by the health insurer’s pharmacy and therapeutics
committee based on safety, efficacy, and cost.
(C) Tier three shall consist of nonpreferred brand name drugs or drugs that are
recommended by the health insurer’s pharmacy and therapeutics committee based on
safety, efficacy, and cost, or that generally have a preferred and often less costly
therapeutic alternative at a lower tier.
(D) Tier four shall consist of drugs that are biologics, drugs that the Food and Drug
Administration of the United States Department of Health and Human Services or the
manufacturer requires to be distributed through a specialty pharmacy, drugs that require
the insured to have special training or clinical monitoring for self-administration, or drugs
that cost the health insurer more than six hundred dollars ($600) net of rebates for a
one-month supply.
(2) In placing specific drugs on specific tiers, or choosing to place a drug on the
formulary, the insurer shall take into account comply with the other provisions of this
section and this part.
(3) A policy of health insurance may maintain a drug formulary with fewer than four tiers.
A policy of health insurance shall not maintain a drug formulary with more than four
tiers.
(4) This section shall not be construed to limit a health insurer from placing any drug in
a lower tier.
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(c) This section shall remain in effect only until January 1, 2024, and as of that date is
repealed, unless a later enacted statute that is enacted before January 1, 2024, deletes
or extends that date.
10123.201.
(a) A policy of health insurance that covers outpatient prescription drugs shall cover
medically necessary drugs. The policy may provide for step therapy and prior
authorization consistent with Section 1342.7 of the Health and Safety Code and any
regulations adopted pursuant to that section.
(b)(1) Commencing January 1, 2017, an insurer shall maintain a pharmacy and
therapeutics committee that shall be responsible for developing, maintaining, and
overseeing any drug formulary list. If the insurer delegates responsibility for the
formulary to any entity, the obligation of the insurer to comply with this part shall not be
waived.
(2) The pharmacy and therapeutics committee board membership shall conform with
both of the following:
(A) Represent a sufficient number of clinical specialties to adequately meet the needs of
insureds.
(B) Consist of a majority of individuals who are practicing physicians, practicing
pharmacists, and other practicing health professionals who are licensed to prescribe
drugs.
(3) Members of the board shall abstain from voting on any issue in which the member
has a conflict of interest with respect to the issuer or a pharmaceutical manufacturer.
(4) At least 20 percent of the board membership shall not have a conflict of interest with
respect to the issuer or any pharmaceutical manufacturer.
(5) The pharmacy and therapeutics committee shall meet at least quarterly and shall
maintain written documentation of the rationale for its decisions regarding the
development of, or revisions to, the formulary drug list.
(6) The pharmacy and therapeutics committee shall do all of the following:
(A) Develop and document procedures to ensure appropriate drug review and inclusion.
(B) Base clinical decisions on the strength of the scientific evidence and standards of
practice, including assessing peer-reviewed medical literature, pharmacoeconomic
studies, outcomes research data, and other related information.
(C) Consider the therapeutic advantages of drugs in terms of safety and efficacy when
selecting formulary drugs.
(D) Review policies that guide exceptions and other utilization management processes,
including drug utilization review, quantity limits, and therapeutic interchange.
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(E) Evaluate and analyze treatment protocols and procedures related to the insurer’s
formulary at least annually.
(F) Review and approve all clinical prior authorization criteria, step therapy protocols,
and quantity limit restrictions applied to each covered drug.
(G) Review new United States Food and Drug Administration-approved drugs and new
uses for existing drugs.
(H) Ensure the insurer’s formulary drug list or lists cover a range of drugs across a
broad distribution of therapeutic categories and classes and recommended drug
treatment regimens that treat all disease states and does not discourage enrollment by
any group of insureds.
(I) Ensure the insurer’s formulary drug list or lists provide appropriate access to drugs
that are included in broadly accepted treatment guidelines and that are indicative of
general best practices at the time.
(7) This subdivision shall be interpreted consistent with federal guidance issued under
paragraph (3) of subdivision (a) of Section 156.122 of Title 45 of the Code of Federal
Regulations. This subdivision shall apply to the individual, small group, and large group
markets.
(c)(1) A health insurer may impose prior authorization requirements on prescription drug
benefits, consistent with the requirements of this part.
(2)(A) If there is more than one drug that is clinically appropriate for the treatment of a
medical condition, a health insurer may require step therapy.
(B) A health insurer shall expeditiously grant a request for a step therapy exception
within the applicable time limit required by Section 10123.191 if a prescribing provider
submits necessary justification and supporting clinical documentation supporting the
provider’s determination that the required prescription drug is inconsistent with good
professional practice for provision of medically necessary covered services to the
insured, taking into consideration the insured’s needs and medical history, along with
the professional judgment of the insured’s provider. The basis of the provider’s
determination may include, but is not limited to, any of the following criteria:
(i) The required prescription drug is contraindicated or is likely, or expected, to cause an
adverse reaction or physical or mental harm to the insured in comparison to the
requested prescription drug, based on the known clinical characteristics of the insured
and the known characteristics and history of the insured’s prescription drug regimen.
(ii) The required prescription drug is expected to be ineffective based on the known
clinical characteristics of the insured and the known characteristics and history of the
insured’s prescription drug regimen.
(iii) The insured has tried the required prescription drug while covered by their current or
previous health coverage or Medicaid, and that prescription drug was discontinued due
to lack of efficacy or effectiveness, diminished effect, or an adverse reaction. The health
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insurer may require the submission of documentation demonstrating that the insured
tried the required prescription drug before it was discontinued.
(iv) The required prescription drug is not clinically appropriate for the insured because
the required drug is expected to do any of the following, as determined by the insured’s
prescribing provider:
(I) Worsen a comorbid condition.
(II) Decrease the capacity to maintain a reasonable functional ability in performing daily
activities.
(III) Pose a significant barrier to adherence to, or compliance with, the insured’s drug
regimen or plan of care.
(v) The insured is stable on a prescription drug selected by the insured’s prescribing
provider for the medical condition under consideration while covered by their current or
previous health coverage or Medicaid.
(C)(i) This section does not prohibit either of the following: a health care provider from
prescribing a prescription drug that is clinically appropriate.
(i)(ii) An This section does not prohibit an insurer or utilization review organization from
requiring an insured to try an AB-rated generic equivalent equivalent, biosimilar, as
defined in Section 262(i)(2) of Title 42 of the United States Code, or interchangeable
biological product product, as defined in Section 262(i)(3) of Title 42 of the United
States Code, before providing coverage for the equivalent branded prescription drug.
(ii)(iii) A health care provider from prescribing a prescription drug that is clinically
appropriate. Clause (ii) does not prohibit or supersede a step therapy exception request
as described in subparagraph (B) of paragraph (2) of subdivision (c).
(3) An insurer shall provide coverage for the medically necessary dosage and quantity
of the drug prescribed for the treatment of a medical condition consistent with
professionally recognized standards of practice.
(4) For plan years commencing on or after January 1, 2017, an insurer that provides
essential health benefits shall allow an insured to access prescription drug benefits at
an in-network retail pharmacy unless the prescription drug is subject to restricted
distribution by the United States Food and Drug Administration or requires special
handling, provider coordination, or patient education that cannot be provided by a retail
pharmacy. A nongrandfathered individual or small group health insurer may charge an
insured a different cost sharing for obtaining a covered drug at a retail pharmacy, but all
cost sharing shall count toward the policy’s annual limitation on cost sharing consistent
with Section 10112.28.
(d) A health care provider or prescribing provider may file an internal appeal of a denial
of an exception request for coverage of a nonformulary drug, prior authorization
request, or step therapy exception request consistent with the health insurer’s current
utilization management processes.
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(e) An insured or the insured’s designee or guardian may appeal a denial of an
exception request for coverage of a nonformulary drug, prior authorization request, or
step therapy exception request by filing an internal appeal with the health insurer
pursuant to Section 2719 of the federal Public Health Service Act (42 U.S.C. Sec.
300gg-19) and any subsequent rules or regulations issued thereunder.
(f) Every health insurer that provides prescription drug benefits shall maintain all of the
following information, which shall be made available to the commissioner upon request:
(1) The complete drug formulary or formularies of the insurer, if the insurer maintains a
formulary, including a list of the prescription drugs on the formulary of the insurer by
major therapeutic category with an indication of whether any drugs are preferred over
other drugs.
(2) Records developed by the pharmacy and therapeutics committee of the insurer, or
by others responsible for developing, modifying, and overseeing formularies, including
medical groups, individual practice associations, and contracting pharmaceutical benefit
management companies, used to guide the drugs prescribed for the insureds of the
insurer, that fully describe the reasoning behind formulary decisions.
(3) Any insurer arrangements with prescribing providers, medical groups, individual
practice associations, pharmacists, contracting pharmaceutical benefit management
companies, or other entities that are associated with activities of the insurer to
encourage formulary compliance or otherwise manage prescription drug benefits.
(g) If an insurer provides prescription drug benefits, the commissioner shall, as part of
its market conduct examination, review the performance of the insurer in providing
those benefits, including, but not limited to, a review of the procedures and information
maintained pursuant to this section, and describe the performance of the insurer as part
of its report issued as part of its market conduct examination.
(h) The commissioner shall not publicly disclose any information reviewed pursuant to
this section that is determined by the commissioner to be confidential pursuant to state
law.
(i) For purposes of this section, the following definitions shall apply:
(1) “Authorization” means approval by the health insurer to provide payment for the
prescription drug.
(2) “Step therapy” means a type of protocol that specifies the sequence in which
different prescription drugs for a given medical condition and medically appropriate for a
particular patient are to be prescribed.
(3) “Step therapy exception” means a decision to override a generally applicable step
therapy protocol in favor of coverage of the prescription drug prescribed by a health
care provider for an individual insured.
(4) “Utilization review organization” means an entity that conducts utilization review,
other than a health insurer performing its own utilization review.
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(j) Nonformulary prescription drugs shall include any drug for which an insured’s
copayment or out-of-pocket costs are different than the copayment for a formulary
prescription drug, except as otherwise provided by law or regulation.
(k) This section does not affect an insured’s or policyholder’s eligibility to submit a
complaint to the department for review or to apply to the department for an independent
medical review under Article 3.5 (commencing with Section 10169).
(l) This section does not restrict or impair the application of any other provision of this
part.
(m) This section and Section 10123.191 apply to both the health insurer and a utilization
review organization that performs utilization review or utilization management functions
on the insurer’s behalf. Commencing January 1, 2022, a contract between a health
insurer and a utilization review organization that performs utilization review or utilization
management functions on the insurer’s behalf shall include terms that require the
utilization review organization to comply with this section and Section 10123.191.
10125.1.
(a) Every insurer issuing group disability insurance that covers hospital, medical, or
surgical expenses that offers coverage for a service that is within the scope of practice
of a duly licensed pharmacist may shall pay or reimburse the cost of the service
performed by a pharmacist for the insurer if the pharmacist otherwise provides services
for the insurer. at an in-network pharmacy or a pharmacist at an out-of-network
pharmacy if the insurer has an out-of-network pharmacy benefit.
(b) Payment or reimbursement may be made pursuant to this section for a service
performed by a duly licensed pharmacist only when all of the following conditions are
met:
(1) The service performed is within the lawful scope of practice of the pharmacist.
(2) The coverage otherwise provides reimbursement for identical services performed by
other licensed health care providers.
(c) Nothing in this section shall require the insurer to pay a claim to more than one
provider for duplicate service or be interpreted to limit physician reimbursement.
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