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4104. Licensed Employee, Theft or Impairment: Pharmacy
Procedures
(a) Every pharmacy shall have in place procedures for taking
action to protect the public when a licensed individual employed
by or with the pharmacy is discovered or known to be chemically,
mentally, or physically impaired to the extent it affects his or her
ability to practice the profession or occupation authorized by his
or her license, or is discovered or known to have engaged in the
theft, diversion, or self-use of dangerous drugs.
(b) Every pharmacy shall have written policies and procedures
for addressing chemical, mental, or physical impairment, as well
as theft, diversion, or self-use of dangerous drugs, among
licensed individuals employed by or with the pharmacy.
(c) Every pharmacy shall report and provide to the board, within
14 days of the receipt or development thereof the following
information with regard to any licensed individual employed by
or with the pharmacy:
(1) Any admission by a licensed individual of chemical, mental,
or physical impairment affecting his or her ability to practice.
(2) Any admission by a licensed individual of theft, diversion, or
self-use of dangerous drugs.
(3) Any video or documentary evidence demonstrating
chemical, mental, or physical impairment of a licensed individual
to the extent it affects his or her ability to practice.
(4) Any video or documentary evidence demonstrating theft,
diversion, or self-use of dangerous drugs by a licensed individual.
(5) Any termination based on chemical, mental, or physical
impairment of a licensed individual to the extent it affects his or
her ability to practice.
(6) Any termination of a licensed individual based on theft,
diversion, or self-use of dangerous drugs.
(d) The report required in subdivision (c) shall include sufficient
detail to inform the board of the facts upon which the report is
based, including an estimate of the type and quantity of all
dangerous drugs involved, the timeframe over which the losses
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are suspected, and the date of the last controlled substances
inventory. Upon request of the board, the pharmacy shall
prepare and submit an audit involving the dangerous drugs
suspected to be missing.
(e) Anyone making a report authorized or required by this
section shall have immunity from any liability, civil or criminal,
that might otherwise arise from the making of the report. Any
participant shall have the same immunity with respect to
participation in any administrative or judicial proceeding
resulting from the report.
4105. Retaining Records of Dangerous Drugs and Devices on
Licensed Premises; Temporary Removal; Waivers; Access to
Electronically Maintained Records
(a) All records or other documentation of the acquisition and
disposition of dangerous drugs and dangerous devices by any
entity licensed by the board shall be retained on the licensed
premises in a readily retrievable form.
(b) The licensee may remove the original records or
documentation from the licensed premises on a temporary basis
for license-related purposes. However, a duplicate set of those
records or other documentation shall be retained on the licensed
premises.
(c) The records required by this section shall be retained on the
licensed premises for a period of three years from the date of
making.
(d) (1) Any records that are maintained electronically shall be
maintained so that the pharmacist-in-charge, or the pharmacist
on duty if the pharmacist-in-charge is not on duty, shall, at all
times during which the licensed premises are open for business,
be able to produce a hardcopy and electronic copy of all records
of acquisition or disposition or other drug or dispensing-related
records maintained electronically.
(2) In the case of a veterinary food-animal drug retailer,
wholesaler, or third-party logistics provider, any records that are
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maintained electronically shall be maintained so that the
designated representative-in-charge or the responsible manager,
or the designated representative on duty or the designated
representative-3PL on duty if the designated representative-in-
charge or responsible manager is not on duty, shall, at all times
during which the licensed place of business is open for business,
be able to produce a hardcopy and electronic copy of all records
of acquisition or disposition or other drug or dispensing-related
records maintained electronically.
(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board
may, upon written request, grant to a licensee a waiver of the
requirements that the records described in subdivisions (a), (b),
and (c) be kept on the licensed premises.
(2) A waiver granted pursuant to this subdivision shall not affect
the board’s authority under this section or any other provision of
this chapter.
(f) When requested by an authorized officer of the law or by an
authorized representative of the board, the owner, corporate
officer, or manager of an entity licensed by the board shall
provide the board with the requested records within three
business days of the time the request was made. The entity may
request in writing an extension of this timeframe for a period not
to exceed 14 calendar days from the date the records were
requested. A request for an extension of time is subject to the
approval of the board. An extension shall be deemed approved if
the board fails to deny the extension request within two business
days of the time the extension request was made directly to the
board.
4106. License Verification Using Board Web Site
For purposes of license verification, a person may rely upon the
licensing information as it is displayed on the board's Internet
Web site that includes the issuance and expiration dates of any
license issued by the board.
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4106.5. Requirement for Safe Storage Products
(a) For purposes of this section, the following terms shall have
the following meanings:
(1) “Pharmacy” does not include a pharmacy that meets both of
the following requirements:
(A) It is owned and operated by a person or persons in which
the majority of the beneficial interest, as well as management
and control, resides with at least one board-licensed pharmacist,
as that term is defined in Section 4036, that exclusively oversees
the operations of the pharmacy.
(B) The owner and operator with the beneficial interest,
management, and control described in subparagraph (A) owns,
operates, and has management and control of no more than four
pharmacies.
(2) “Safe storage products” means a device or product made
with the purpose of storing prescription medications that
includes a locking mechanism that is accessible only by the
designated patient with a passcode, alphanumeric code, key, or
by another secure mechanism. A safe storage product includes,
but is not limited to, medicine lock boxes, locking medicine
cabinets, locking medication bags, and prescription locking vials.
(3) “Schedule II, III, or IV controlled substances” means any
substance defined as a Schedule II, III, or IV controlled substance
in Sections 11055, 11056, and 11057 of the Health and Safety
Code.
(b) A pharmacy that dispenses Schedule II, III, or IV controlled
substances shall display safe storage products in a place on the
building premises that is located close to the pharmacy.
(c) (1) The board shall assess a fine in an amount to be
determined by the board for a violation of this section.
(2) Notwithstanding paragraph (1), the board may choose not to
take administrative action against a pharmacy if it determines
that compliance with this section would create a financial
hardship on the pharmacy or that the pharmacy is temporarily
out of stock of safe storage products.
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(d) Section 4321 shall not apply to a violation of this section.
(e) This section shall remain in effect only until January 1, 2023,
and as of that date is repealed.
4107. One Site License per Premises; Exception
(a) The board shall not issue more than one site license to a
single premises except as follows:
(1) To issue a veterinary food-animal drug retailer license to a
wholesaler pursuant to Section 4196.
(2) To issue a license to compound sterile drugs to a pharmacy
pursuant to Section 4127.1 or 4127.2.
(3) To issue a centralized hospital packaging license pursuant to
Section 4128.
(4) To issue licenses to two independently owned clinics that
share a clinic office space pursuant to Section 4180.5.
(b) For the purposes of this subdivision, “premises” means a
location with its own address and an independent means of
ingress and egress.
4107.5. Counterfeit Dangerous Drugs or Device; Fraudulent
Transaction; Required Notice to Board
If a manufacturer, wholesaler, third-party logistics provider, or
pharmacy has reasonable cause to believe that a dangerous drug
or dangerous device in, or having been in, its possession is
counterfeit or the subject of a fraudulent transaction, the
manufacturer, wholesaler, third-party logistics provider, or
pharmacy shall notify the board within 72 hours of obtaining that
knowledge. This section shall apply to any dangerous drug or
dangerous device that has been sold or distributed in or through
this state.
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Article 7. Pharmacies
4110. License Required; Temporary Permit Upon Transfer of
Ownership; Mobile Pharmacy Requirements
(a) No person shall conduct a pharmacy in the State of California
unless they have obtained a license from the board. A license
shall be required for each pharmacy owned or operated by a
specific person. A separate license shall be required for each of
the premises of any person operating a pharmacy in more than
one location. The license shall be renewed annually. The license
shall not be renewed unless the applicant includes necessary
matters identified by the board in the renewal application,
including, but not limited to, notification to the board regarding
compounding practices, including compounded human drug
preparations distributed outside of the state. The board may, by
regulation, determine the circumstances under which a license
may be transferred.
(b) The board may, at its discretion, issue a temporary permit
upon the conditions and for any periods of time as the board
determines to be in the public interest. A temporary permit fee
shall be required in an amount established by the board as
specified in subdivision (a) of Section 4400. When needed to
protect public safety, a temporary permit may be issued for a
period not to exceed 180 days, and may be issued subject to
terms and conditions the board deems necessary. If the board
determines a temporary permit was issued by mistake or denies
the application for a permanent license or registration, the
temporary license or registration shall terminate upon either
personal service of the notice of termination upon the
permitholder or service by certified mail, return receipt
requested, at the permitholder’s address of record with the
board, whichever comes first. Neither for purposes of retaining a
temporary permit nor for purposes of any disciplinary or license
denial proceeding before the board shall the temporary
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permitholder be deemed to have a vested property right or
interest in the permit.
(c) The board may allow the temporary use of a mobile pharmacy
when a pharmacy is destroyed or damaged, the mobile pharmacy
is necessary to protect the health and safety of the public, and
the following conditions are met:
(1) The mobile pharmacy shall provide services only on or
immediately contiguous to the site of the damaged or destroyed
pharmacy.
(2) The mobile pharmacy is under the control and management
of the pharmacist-in-charge of the pharmacy that was destroyed
or damaged.
(3) A licensed pharmacist is on the premises while drugs are
being dispensed.
(4) Reasonable security measures are taken to safeguard the
drug supply maintained in the mobile pharmacy.
(5) The pharmacy operating the mobile pharmacy provides the
board with records of the destruction of, or damage to, the
pharmacy and an expected restoration date.
(6) Within three calendar days of restoration of the pharmacy
services, the board is provided with notice of the restoration of
the permanent pharmacy.
(7) The mobile pharmacy is not operated for more than 48 hours
following the restoration of the permanent pharmacy.
4111. Restrictions on Prescriber Ownership
(a) Except as otherwise provided in subdivision (b), (d), or (e),
the board shall not issue or renew a license to conduct a
pharmacy to any of the following:
(1) A person or persons authorized to prescribe or write a
prescription, as specified in Section 4040, in the State of
California.
(2) A person or persons with whom a person or persons
specified in paragraph (1) shares a community or other financial
interest in the permit sought.
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(3) Any corporation that is controlled by, or in which 10 percent
or more of the stock is owned by a person or persons prohibited
from pharmacy ownership by paragraph (1) or (2).
(b) Subdivision (a) shall not preclude the issuance of a permit for
an inpatient hospital pharmacy to the owner of the hospital in
which it is located.
(c) The board may require any information the board deems is
reasonably necessary for the enforcement of this section.
(d) Subdivision (a) shall not preclude the issuance of a new or
renewal license for a pharmacy to be owned or owned and
operated by a person licensed on or before August 1, 1981,
under 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) and qualified on or before August 1,
1981, under subsection (d) of Section 1310 of Title XIII of the
federal Public Health Service Act, as amended, whose ownership
includes persons defined pursuant to paragraphs (1) and (2) of
subdivision (a).
(e) Subdivision (a) shall not preclude the issuance of a new or
renewal license for a pharmacy to be owned or owned and
operated by a pharmacist authorized to issue a drug order
pursuant to Section 4052.1, 4052.2, or 4052.6.
4112. Nonresident Pharmacy: Registration; Provision of
Information to Board; Maintaining Records; Patient
Consultation
(a) Any pharmacy located outside this state that ships, mails, or
delivers, in any manner, controlled substances, dangerous drugs,
or dangerous devices into this state shall be considered a
nonresident pharmacy.
(b) A person may not act as a nonresident pharmacy unless he
or she has obtained a license from the board. The board may
register a nonresident pharmacy that is organized as a limited
liability company in the state in which it is licensed.
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(c) A nonresident pharmacy shall disclose to the board the
location, names, and titles of (1) its agent for service of process in
this state, (2) all principal corporate officers, if any, (3) all general
partners, if any, and (4) all pharmacists who are dispensing
controlled substances, dangerous drugs, or dangerous devices to
residents of this state. A report containing this information shall
be made on an annual basis and within 30 days after any change
of office, corporate officer, partner, or pharmacist.
(d) All nonresident pharmacies shall comply with all lawful
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 pursuant to this
section. The nonresident pharmacy shall maintain, at all times, a
valid unexpired license, permit, or registration to conduct the
pharmacy in compliance with the laws of the state in which it is a
resident. As a prerequisite to registering with the board, the
nonresident pharmacy shall submit a copy of the most recent
inspection report resulting from an inspection conducted by the
regulatory or licensing agency of the state in which it is located.
(e) All nonresident pharmacies shall maintain records of
controlled substances, dangerous drugs, or dangerous devices
dispensed to patients in this state so that the records are readily
retrievable from the records of other drugs dispensed.
(f) Any pharmacy subject to this section shall, during its regular
hours of operation, but not less than six days per week, and for a
minimum of 40 hours per week, provide a toll-free telephone
service to facilitate communication between patients in this state
and a pharmacist at the pharmacy who has access to the
patient's records. This toll-free telephone number shall be
disclosed on a label affixed to each container of drugs dispensed
to patients in this state.
(g) A nonresident pharmacy shall not permit a pharmacist
whose license has been revoked by the board to manufacture,
compound, furnish, sell, dispense, or initiate the prescription of a
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dangerous drug or dangerous device, or to provide any
pharmacy-related service, to a person residing in California.
(h) The board shall adopt regulations that apply the same
requirements or standards for oral consultation to a nonresident
pharmacy that operates pursuant to this section and ships, mails,
or delivers any controlled substances, dangerous drugs, or
dangerous devices to residents of this state, as are applied to an
in-state pharmacy that operates pursuant to Section 4037 when
the pharmacy ships, mails, or delivers any controlled substances,
dangerous drugs, or dangerous devices to residents of this state.
The board shall not adopt any regulations that require face-to-
face consultation for a prescription that is shipped, mailed, or
delivered to the patient. The regulations adopted pursuant to
this subdivision shall not result in any unnecessary delay in
patients receiving their medication.
(i) The registration fee shall be the fee specified in subdivision
(a) of Section 4400.
(j) The registration requirements of this section shall apply only
to a nonresident pharmacy that ships, mails, or delivers
controlled substances, dangerous drugs, and dangerous devices
into this state pursuant to a prescription.
(k) Nothing in this section shall be construed to authorize the
dispensing of contact lenses by nonresident pharmacists except
as provided by Section 4124.
4113. Pharmacist-in-Charge: Notification to Board;
Responsibilities
(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 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.
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(c) 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.
(d) 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) 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 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
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of the date of disapproval, and shall continue to name proposed
replacements until a pharmacist-in-charge is approved by the
board.
4113.5. Community Pharmacies: Required Staffing
(a) A community pharmacy shall not require a pharmacist
employee to engage in the practice of pharmacy at any time the
pharmacy is open to the public, unless either another employee
of the pharmacy or, if the pharmacy is located within another
establishment, an employee of the establishment within which
the pharmacy is located, is made available to assist the
pharmacist at all times.
(b) This section shall not apply to any of the following:
(1) A hospital pharmacy, as defined in Section 4029 or 4056.
(2) A pharmacy located in a hospital facility, including, but not
limited to, a building where outpatient services are provided in
accordance with the hospital’s license.
(3) A pharmacy owned or operated by a federal, state, local, or
tribal government entity, including, but not limited to, a
correctional pharmacy, a University of California pharmacy, or a
pharmacy operated by the State Department of State Hospitals.
(4) A pharmacy owned by a person or persons who, collectively,
control the majority of the beneficial interest in no more than
four pharmacies in California.
(5) A pharmacy entirely owned and operated by a health care
service plan that exclusively contracts with no more than two
medical groups in the state to provide, or arrange for the
provision of, professional medical services to the enrollees of the
plan.
(6) A pharmacy that permits patients to receive medications at a
drive-through window when both of the following conditions are
met:
(A) A pharmacist is working during the times when patients may
receive medication only at the drive-through window.
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(B) The pharmacist’s employer does not require the pharmacist
to retrieve items for sale to patients if the items are located
outside the pharmacy. These items include, but are not limited
to, items for which a prescription is not required.
(7) Any other pharmacy from which controlled substances,
dangerous drugs, or dangerous devices are not furnished, sold, or
dispensed at retail.
(c) A violation of subdivision (a) is not subject to subdivision (a)
of Section 4321.
(d) The board shall not take action against a pharmacy for a
violation of this section if both of the following apply:
(1) Another employee is unavailable to assist the pharmacist
due to reasonably unanticipated circumstances, including, but
not limited to, illness, injury, family emergency, or the
employee’s termination or resignation.
(2) The pharmacy takes all reasonable action to make another
employee available to assist the pharmacist.
(e) This section shall not be construed to permit an employee
who is not licensed under this chapter to engage in any act for
which a license is required under this chapter.
4113.7. Prohibition on Quotas Related to Pharmacist or
Pharmacy Technician Duties
(a) A chain community pharmacy, as defined in subdivision
(c) of Section 4001, shall not establish a quota related to the
duties for which a pharmacist or pharmacy technician license is
required.
(b) A chain community pharmacy shall not, through employees,
contractors, or third parties, communicate the existence of
quotas, that are illegal pursuant to this section, to pharmacists or
pharmacy technicians who are employees of the chain
community pharmacy or with whom the chain community
pharmacy contracts.
(c)(1) For purposes of this section, “quota” means a fixed number
or formula related to the duties for which a pharmacist or
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pharmacy technician license is required, against which the chain
community pharmacy or its agent measures or evaluates the
number of times either an individual pharmacist or pharmacy
technician performs tasks or provides services while on duty.
“Quota” includes a fixed number or formula related to any of the
following:
(A) Prescriptions filled.
(B) Services rendered to patients.
(C) Programs offered to patients.
(D) Revenue obtained.
(2) For purposes of this section, “quota” does not mean any of
the following:
(A) A measurement of the revenue earned by a particular
licensed chain community pharmacy not calculated in relation to,
or measured by, the tasks performed, or services provided by,
individual pharmacists or pharmacy technicians.
(B) Any evaluation or measurement of the competence,
performance, or quality of care provided to patients of a
pharmacist or pharmacy technician if the evaluation does not use
quotas, as defined in paragraph (1).
(C) Any performance metric required by state or federal
regulators that does not use quotas, as defined in paragraph (1).
(d) This section does not prohibit a chain community pharmacy
from establishing policies and procedures that assist in assessing
the competency and performance of a pharmacist or pharmacy
technician in providing care to patients if the measurements used
are not, or do not include, quotas, as defined in subdivision (c).
4114. Intern Pharmacist: Activities Permitted
(a) An intern pharmacist may perform all functions of a
pharmacist at the discretion of and under the direct supervision
and control of a pharmacist whose license is in good standing
with the board.
(b) A pharmacist may not supervise more than two intern
pharmacists at any one time.
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4115. Pharmacy Technician: Activities Permitted; Required
Supervision; Activities Limited to Pharmacist; Registration;
Requirements for Registration; Ratio
(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 supervision by a
technician.
(b) This section does not authorize the performance of any tasks
specified in subdivision (a) by a pharmacy technician without a
pharmacist on duty.
(c) This section does not authorize a pharmacy technician to
perform any act requiring the exercise of professional judgment
by a pharmacist.
(d) 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) No person shall act as a pharmacy technician without first
being licensed by the board as a pharmacy technician.
(f) (1) A pharmacy with only one pharmacist shall have no more
than one pharmacy technician performing the 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
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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 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
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 in charge in writing of his
or her 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. No entity employing a pharmacist may 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) Notwithstanding subdivisions (a) and (b), 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
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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. Nothing in this subdivision shall be
construed to authorize a pharmacist to supervise pharmacy
technicians in greater ratios than those described in subdivision
(f).
(h) The pharmacist on duty shall be directly responsible for the
conduct of a pharmacy technician supervised by that pharmacist.
(i) 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 and the
director or chief executive officer of the health care facility in
accordance with the health care facility’s policies and
procedures.
4115.5. Pharmacy Technician Trainee; Placement; Supervision;
Requirements
(a) Notwithstanding any other law, a pharmacy technician
trainee may be placed in a pharmacy to complete an externship
for the purpose of obtaining practical training required to
become licensed as a pharmacy technician.
(b) (1) A pharmacy technician trainee participating in an
externship as described in subdivision (a) may perform the duties
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described in subdivision (a) of Section 4115 only under the direct
supervision and control of a pharmacist.
(2) A pharmacist supervising a pharmacy technician trainee
participating in an externship as described in subdivision (a) shall
be directly responsible for the conduct of the trainee.
(3) A pharmacist supervising a pharmacy technician trainee
participating in an externship as described in subdivision (a) shall
verify any prescription prepared by the trainee under supervision
of the pharmacist by initialing the prescription label before the
medication is disbursed to a patient or by engaging in other
verification procedures that are specifically approved by board
regulations.
(4) A pharmacist may only supervise one pharmacy technician
trainee at any given time.
(5) A pharmacist supervising a pharmacy technician trainee
participating in an externship as described in subdivision (a) shall
certify attendance for the pharmacy technician trainee and
certify that the pharmacy technician trainee has met the
educational objectives established by a California public
postsecondary education institution or the private postsecondary
vocational institution in which the trainee is enrolled, as
established by the institution.
(c) (1) Except as described in paragraph (2), an externship in
which a pharmacy technician trainee is participating as described
in subdivision (a) shall be for a period of no fewer than 120 hours
and no more than 140 hours.
(2) When an externship in which a pharmacy technician trainee
is participating as described in subdivision (a) involves rotation
between a community and hospital pharmacy for the purpose of
training the student in distinct practice settings, the externship
may be for a period of up to 340 hours.
(d) An externship in which a pharmacy technician trainee may
participate as described in subdivision (a) shall be for a period of
no more than six consecutive months in a community pharmacy
and for a total of no more than 12 months if the externship
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involves rotation between a community and hospital pharmacy.
The externship shall be completed while the trainee is enrolled in
a course of instruction at the institution.
(e) A pharmacy technician trainee participating in an externship
as described in subdivision (a) shall wear identification that
indicates the pharmacy technician trainee’s status as a trainee.
4116. Security of Dangerous Drugs and Devices in Pharmacy:
Pharmacist Responsibility for Individuals on Premises;
Regulations
(a) No person other than a pharmacist, an intern pharmacist, an
authorized officer of the law, or a person authorized to prescribe
shall be permitted in that area, place, or premises described in
the license issued by the board wherein controlled substances or
dangerous drugs or dangerous devices are stored, possessed,
prepared, manufactured, derived, compounded, dispensed, or
repackaged. However, a pharmacist shall be responsible for any
individual who enters the pharmacy for the purposes of receiving
consultation from the pharmacist or performing clerical,
inventory control, housekeeping, delivery, maintenance, or
similar functions relating to the pharmacy if the pharmacist
remains present in the pharmacy during all times as the
authorized individual is present.
(b) (1) The board may, by regulation, establish reasonable
security measures consistent with this section in order to prevent
unauthorized persons from gaining access to the area, place, or
premises or to the controlled substances or dangerous drugs or
dangerous devices therein.
(2) The board shall, by regulation, establish conditions for 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 and
removing authorized personnel from the pharmacy. These
conditions shall ensure the security of the pharmacy and its
operations during the temporary absence of the pharmacist and
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shall allow, at the discretion of the pharmacist, nonpharmacist
personnel to remain and perform any lawful activities during the
pharmacist's temporary absence.
4117. Admission to Area Where Narcotics are Stored, etc. -
Who May Enter
No person other than a pharmacist, an intern pharmacist, a
pharmacy technician, an authorized officer of the law, a person
authorized to prescribe, a registered nurse, a licensed vocational
nurse, a person who enters the pharmacy for purposes of
receiving consultation from a pharmacist, or a person authorized
by the pharmacist in charge to perform clerical, inventory
control, housekeeping, delivery, maintenance, or similar
functions relating to the pharmacy shall be permitted in that
area, place, or premises described in the license issued by the
board to a licensed hospital wherein controlled substances,
dangerous drugs, or dangerous devices are stored, possessed,
prepared, manufactured, derived, compounded, dispensed, or
repackaged.
4118. Waiving of Minimum Requirements by Board
(a) When, in the opinion of the board, a high standard of patient
safety, consistent with good patient care, can be provided by the
licensure of a pharmacy that does not meet all of the
requirements for licensure as a pharmacy, the board may waive
any licensing requirements.
(b) When, in the opinion of the board, a high standard of patient
safety, consistent with good patient care, can be provided by the
licensure of a hospital pharmacy, as defined by subdivision (a) of
Section 4029, that does not meet all of the requirements for
licensure as a hospital pharmacy, the board may waive any
licensing requirements. However, when a waiver of any
requirements is granted by the board, the pharmaceutical
services to be rendered by this pharmacy shall be limited to
patients registered for treatment in the hospital, whether or not
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they are actually staying in the hospital, or to emergency cases
under treatment in the hospital.
4118.5. Hospital Pharmacies: Medication Profiles or Lists for
High-Risk Patients
(a) A pharmacist at a hospital pharmacy shall obtain an accurate
medication profile or list for each high-risk patient upon
admission of the high-risk patient under the following conditions:
(1) The hospital has more than 100 beds.
(2) The accurate medication profile or list may be acquired by
the pharmacist during the hospital pharmacy’s hours of
operation.
(b) Notwithstanding any other law, a pharmacy technician or an
intern pharmacist may perform the task of obtaining an accurate
medication profile or list for a high-risk patient if both of the
following conditions are satisfied:
(1) The hospital pharmacy has a quality assurance program to
monitor competency.
(2) The hospital has established policies and procedures for
training and proctoring pharmacy technicians or intern
pharmacists by the hospital pharmacy department and the
pharmacy technician or intern pharmacist has completed that
training and proctoring.
(c) The hospital shall establish criteria regarding who is a high-
risk patient for purposes of this section, and shall determine the
timeframe for completion of the medication profile or list, based
on the patient populations served by the hospital.
(d) The board may adopt rules and regulations to carry out the
purposes and objectives of this section.
(e) This section shall not apply to the State Department of State
Hospitals.
(f) Nothing in this section shall be construed to prohibit a
healing arts licensee licensed pursuant to this division from
obtaining an accurate medication profile or list.
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4119. Furnish Prescription Drug to Licensed Health Care Facility
- Secured Emergency Supplies
(a) Notwithstanding any other law, a pharmacy may furnish a
dangerous drug or dangerous device to a licensed health care
facility for storage in a secured emergency pharmaceutical
supplies container maintained within the facility in accordance
with facility regulations of the State Department of Public Health
set forth in Title 22 of the California Code of Regulations and the
requirements set forth in Section 1261.5 of the Health and Safety
Code. These emergency supplies shall be approved by the
facility’s patient care policy committee or pharmaceutical service
committee and shall be readily available to each nursing station.
Section 1261.5 of the Health and Safety Code limits the number
of oral dosage form or suppository form drugs in these
emergency supplies to 48.
(b) Notwithstanding any other law, a pharmacy may furnish a
dangerous drug or a dangerous device to an approved service
provider within an emergency medical services system for
storage in a secured emergency pharmaceutical supplies
container, in accordance with the policies and procedures of the
local emergency medical services agency, if all of the following
are met:
(1) The dangerous drug or dangerous device is furnished
exclusively for use in conjunction with services provided in an
ambulance, or other approved emergency medical services
service provider, that provides prehospital emergency medical
services.
(2) The requested dangerous drug or dangerous device is within
the licensed or certified emergency medical technician’s scope of
practice as established by the Emergency Medical Services
Authority and set forth in Title 22 of the California Code of
Regulations.
(3) The approved service provider within an emergency medical
services system provides a written request that specifies the
name and quantity of dangerous drugs or dangerous devices.
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(4) The approved emergency medical services provider
administers dangerous drugs and dangerous devices in
accordance with the policies and procedures of the local
emergency medical services agency.
(5) The approved emergency medical services provider
documents, stores, and restocks dangerous drugs and dangerous
devices in accordance with the policies and procedures of the
local emergency medical services agency.
Records of each request by, and dangerous drugs or dangerous
devices furnished to, an approved service provider within an
emergency medical services system, shall be maintained by both
the approved service provider and the dispensing pharmacy for a
period of at least three years.
The furnishing of controlled substances to an approved
emergency medical services provider shall be in accordance with
the California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety
Code).
4119.01. Emergency Medical Services Automated Drug Delivery
Systems - Licensing; Fee; Restocking and Removing Drugs;
Inventory and Reconciliation; Record keeping; Licensed
Designated Paramedic
(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
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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
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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, 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,
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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.
(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
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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.
4119.2. Furnish Epinephrine Auto-Injectors to School;
Requirements
(a) Notwithstanding any other law, a pharmacy may furnish
epinephrine auto-injectors to a school district, county office of
education, or charter school pursuant to Section 49414 of the
Education Code if all of the following are met:
(1) The epinephrine auto-injectors are furnished exclusively for
use at a school district site, county office of education, or charter
school.
(2) A physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be
furnished.
(b) Records regarding the acquisition and disposition of
epinephrine auto-injectors furnished pursuant to subdivision (a)
shall be maintained by the school district, county office of
education, or charter school for a period of three years from the
date the records were created. The school district, county office
of education, or charter school shall be responsible for
monitoring the supply of epinephrine auto-injectors and ensuring
the destruction of expired epinephrine auto-injectors.
4119.3. Furnish Epinephrine Auto-Injectors to First Responder
or Lay Rescuer; Requirements
(a) Notwithstanding any other law, a pharmacy may dispense
epinephrine auto-injectors to a prehospital emergency medical
care person or lay rescuer for the purpose of rendering
emergency care in accordance with Section 1797.197a of the
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Health and Safety Code, if both of the following requirements are
met:
(1) A physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be
dispensed to a person described in subdivision (b) of Section
1797.197a of the Health and Safety Code. The physician and
surgeon may issue the prescription only upon presentation of a
current certificate demonstrating that the person is trained and
qualified under Section 1797.197a of the Health and Safety Code
to administer an epinephrine auto-injector to another person in
an emergency situation. The prescription shall specify that the
dispensed epinephrine auto-injector is for “First Aid Purposes
Only” and that the named recipient is a “Section 1797.197a
Responder.” A new prescription shall be written for any
additional epinephrine auto-injectors required.
(2) (A) The pharmacy shall label each epinephrine auto-injector
dispensed with all of the following:
(i) The name of the person to whom the prescription was issued.
(ii) The designations “Section 1797.197a Responder” and “First
Aid Purposes Only.”
(iii) The dosage, use, and expiration date.
(B) Each dispensed prescription shall include the manufacturer’s
product information sheet for the epinephrine auto-injector.
(b) The person described in subdivision (b) of Section 1797.197a
of the Health and Safety Code receiving epinephrine auto-
injectors pursuant to this section shall make and maintain a
record for five years reflecting dates of receipt, use, and
destruction of each auto-injector dispensed, the name of any
person to whom epinephrine was administered using an auto-
injector, and the circumstances and manner of destruction of any
auto-injectors.
(c) The epinephrine auto-injectors dispensed pursuant to this
section may be used only for the purpose, and under the
circumstances, described in Section 1797.197a of the Health and
Safety Code.
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4119.4. Epinephrine Auto-injector; Labeling; Records
Requirements
(a) Notwithstanding any other law, a pharmacy may furnish
epinephrine auto-injectors to an authorized entity, for the
purpose of rendering emergency care in accordance with Section
1797.197a of the Health and Safety Code, if both of the following
requirements are met:
(1) The epinephrine auto-injectors are furnished exclusively for
use by, or in connection with, an authorized entity.
(2) An authorized health care provider provides a prescription
that specifies the quantity of epinephrine auto-injectors to be
furnished to an authorized entity described in subdivision (a) of
Section 1797.197a of the Health and Safety Code. A new
prescription shall be written for any additional epinephrine auto-
injectors required for use.
(b) The pharmacy shall label each epinephrine auto-injector
dispensed with all of the following:
(1) The name of the person or entity to whom the prescription
was issued.
(2) The designations “Section 1797.197a Responder” and “First
Aid Purposes Only.”
(3) The dosage, use, and expiration date.
(c) Each dispensed prescription shall include the manufacturer’s
product information sheet for the epinephrine auto-injector.
(d) Records regarding the acquisition and disposition of
epinephrine auto-injectors furnished pursuant to subdivision (a)
shall be maintained by the authorized entity for a period of three
years from the date the records were created. The authorized
entity shall be responsible for monitoring the supply of
epinephrine auto-injectors and ensuring the destruction of
expired epinephrine auto-injectors.
(e) The epinephrine auto-injector dispensed pursuant to this
section may be used only for the purpose, and under the
circumstances, described in Section 1797.197a of the Health and
Safety Code.
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(f) For purposes of this section, “epinephrine auto-injector”
means a disposable delivery device designed for the automatic
injection of a premeasured dose of epinephrine into the human
body to prevent or treat a life-threatening allergic reaction.
4119.5. Transfer or Repackaging Dangerous Drugs by Pharmacy
(a) A pharmacy can transfer a reasonable supply of dangerous
drugs to another pharmacy.
(b) A pharmacy may repackage and furnish to a prescriber a
reasonable quantity of dangerous drugs and dangerous devices
for prescriber office use.
4119.6. Health Care Facility; Stocking of Emergency
Pharmaceutical Supplies Container and Emergency Medical
System Supplies
An intern pharmacist under the direct supervision and control,
as defined in Section 4023.5, of a pharmacist may stock,
replenish, and inspect the emergency pharmaceutical supplies
container and the emergency medical system supplies of a health
care facility licensed under subdivision (a) of Section 1250 of the
Health and Safety Code.
4119.7. Health Care Facility; Inspection of Drugs; Furnishing Per
Standing Orders, etc.
(a) Notwithstanding any other law, a hospital pharmacy serving
a health care facility licensed under subdivision (a) of Section
1250 of the Health and Safety Code may furnish a dangerous
drug or dangerous device pursuant to preprinted or electronic
standing orders, order sets, and protocols established under the
policies and procedures of the health care facility, as approved
according to the policies of the health care facility’s governing
body, if the order is dated, timed, and authenticated in the
medical record of the patient to whom the dangerous drug or
dangerous device will be provided.
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(b) A health care facility shall store and maintain drugs in
accordance with national standards regarding the storage area
and refrigerator or freezer temperature, and otherwise pursuant
to the manufacturer’s guidelines. The health care facility’s
policies and procedures shall specify these storage parameters.
(c) An intern pharmacist under the direct supervision and
control, as defined in Section 4023.5, of a pharmacist, may
inspect the drugs maintained in the health care facility at least
once per month. The health care facility shall establish specific
written policies and procedures for inspections pursuant to this
subdivision.
(d) For purposes of this section, “health care facility” means a
health facility licensed under subdivision (a) of Section 1250 of
the Health and Safety Code.
4119.8. Naloxone Hydrochloride Furnished to School District,
County Office of Education or Charter School; Records
Requirements
(a) Notwithstanding any other law, a pharmacy may furnish
naloxone hydrochloride or another opioid antagonist to a school
district, county office of education, or charter school pursuant to
Section 49414.3 of the Education Code if all of the following are
met:
(1) The naloxone hydrochloride or another opioid antagonist is
furnished exclusively for use at a school district schoolsite,
county office of education schoolsite, or charter school.
(2) A physician and surgeon provides a written order that
specifies the quantity of naloxone hydrochloride or another
opioid antagonist to be furnished.
(b) Records regarding the acquisition and disposition of
naloxone hydrochloride or another opioid antagonist furnished
pursuant to subdivision (a) shall be maintained by the school
district, county office of education, or charter school for a period
of three years from the date the records were created. The
school district, county office of education, or charter school shall
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be responsible for monitoring the supply of naloxone
hydrochloride or another opioid antagonist and ensuring the
destruction of expired naloxone hydrochloride or another opioid
antagonist.
4119.9. Naloxone Hydrochloride Furnished to a Law
Enforcement Agency
Notwithstanding any other law, a pharmacy, wholesaler, or
manufacturer may furnish naloxone hydrochloride or other
opioid antagonists to a law enforcement agency if both of the
following are met:
(a) The naloxone hydrochloride or other opioid antagonist is
furnished exclusively for use by employees of the law
enforcement agency who have completed training, provided by
the law enforcement agency, in administering naloxone
hydrochloride or other opioid antagonists.
(b) Records regarding the acquisition and disposition of
naloxone hydrochloride or other opioid antagonists furnished
pursuant to this section shall be maintained by the law
enforcement agency for a period of three years from the date the
records were created. The law enforcement agency shall be
responsible for monitoring the supply of naloxone hydrochloride
or other opioid antagonists and ensuring the destruction of
expired naloxone hydrochloride or other opioid antagonists.
4119.10. Conditions Permitting Pharmacies to Perform CLIA-
Waived Tests
A pharmacy located in the state may use pharmacists to perform
FDA-approved or -authorized tests that are classified as waived
pursuant to the federal Clinical Laboratory Improvement
Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations
adopted thereunder by the federal Health Care Financing
Administration, under all of the following conditions:
(a) The pharmacy is appropriately licensed as a laboratory under
Section 1265.
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(b) The pharmacy maintains policies and procedures that do all of
the following:
(1) Establish the initial training requirements, including
specimen collection techniques relevant to a test being
performed at the pharmacy, and ongoing training.
(2) Establish safety precautions necessary to protect pharmacy
staff and consumers and to reduce the risk of transmission,
consistent with Cal-OSHA and CDC requirements, including, but
not limited to, provisions for the use of personal protective
equipment, cleaning and sanitizing procedures, appropriate
biohazard waste requirements, and space requirements for
pharmacy staff and consumers.
(3) Ensure the availability of dedicated physically distanced
space or other segregated space that provides for privacy during
the testing process and private consultation with the pharmacist,
and limits potential contamination of other consumers in the
pharmacy.
(4) Establish requirements for providing test results to the
patient in a nonverbal manner, complying with mandatory
reporting requirements to local and state reporting systems, and
notifying the patient’s health care providers if consent is
provided, and referral to licensed sources of care for
confirmation, diagnosis, and treatment as appropriate for follow-
up to positive test results. A health care provider shall not be
held personally liable for test results, or for any actions or
inactions related to test results they did not receive, have
knowledge of, or otherwise have access to.
(5) Establish requirements for the pharmacist-in-charge serving
as the pharmacy laboratory director to report any reportable
disease or condition identified in Section 120130 of the Health
and Safety Code or the regulations adopted under that section.
(6) Ensure documentation of testing equipment maintenance
and calibration.
(7) Ensure appropriate storage and handling of specimens,
testing reagents, and other supplies or equipment that require
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specialized storage or handling. Specimen collection shall not
include vaginal swab, venipuncture, or the collection of seminal
fluid.
(c) The test is authorized to be administered by a pharmacist
pursuant to paragraph (1) of subdivision (b) of Section 4052.4.
(d) The pharmacist-in-charge does both of the following:
(1) Annually reviews the policies and procedures maintained
pursuant to subdivision (b), assesses the pharmacy’s compliance
with its policies, and documents corrective actions to be taken
when noncompliance is found.
(2) Maintains documentation of the annual review and
assessment in a readily retrievable format for a period of three
years from the date of completion.
(e) The pharmacy maintains documentation related to
performing tests that demonstrates compliance with this section,
which shall include the name of the pharmacist performing the
test, the results of the test, and communication of results to a
patient’s primary medical provider, and is maintained in a readily
retrievable format for a period of three years from the date of
creation.
4119.11. Automated Patient Dispensing Systems
(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
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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.
(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.
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(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.
(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.
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(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.
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(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).
(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.
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(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:
(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.
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(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.
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