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(3) Irrigation solutions of 50 cubic centimeters or greater.
(d) This chapter does not apply to the storage of devices in
secure central or ward supply areas of a clinic, hospital,
institution, or establishment holding a currently valid and
unrevoked license or permit pursuant to Division 2 (commencing
with Section 1200) of the Health and Safety Code, or pursuant to
Chapter 2 (commencing with Section 3300) of Division 3 of, or
Part 2 (commencing with Section 6250) of Division 6 of, the
Welfare and Institutions Code.
(e) This chapter does not apply to the retail sale of vitamins,
mineral products, or combinations thereof or to foods,
supplements, or nutrients used to fortify the diet of humans or
other animals or poultry and labeled as such that are not subject
to Section 4022 and that are packaged or bottled in the
manufacturer’s or distributor’s container and labeled in
accordance with applicable federal and state labeling
requirements.
(f) This chapter does not apply to the furnishing of dangerous
drugs and dangerous devices to recognized schools of nursing.
These dangerous drugs and dangerous devices shall not include
controlled substances. The dangerous drugs and dangerous
devices shall be used for training purposes only, and not for the
cure, mitigation , or treatment of disease in humans. Recognized
schools of nursing for purposes of this subdivision are those
schools recognized as training facilities by the California Board of
Registered Nursing.
4058. Display of Original License
Every person holding a license issued under this chapter to
operate a premises shall display the original license and current
renewal license upon the licensed premises in a place where it
may be clearly read by the public.
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4059. Furnishing Dangerous Drugs or Devices Prohibited
Without Prescription: Exceptions
(a) A person may not furnish any dangerous drug, except upon
the prescription of a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7.
A person may not furnish any dangerous device, except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7.
(b) This section does not apply to the furnishing of any
dangerous drug or dangerous device by a manufacturer,
wholesaler, or pharmacy to each other or to a physician, dentist,
podiatrist, optometrist, veterinarian, or naturopathic doctor
pursuant to Section 3640.7, or to a laboratory under sales and
purchase records that correctly give the date, the names and
addresses of the supplier and the buyer, the drug or device, and
its quantity. This section does not apply to the furnishing of any
dangerous device by a manufacturer, wholesaler, or pharmacy to
a physical therapist acting within the scope of his or her license
under sales and purchase records that correctly provide the date
the device is provided, the names and addresses of the supplier
and the buyer, a description of the device, and the quantity
supplied.
(c) A pharmacist, or a person exempted pursuant to Section
4054, may distribute dangerous drugs and dangerous devices
directly to dialysis patients pursuant to regulations adopted by
the board. The board shall adopt any regulations as are necessary
to ensure the safe distribution of these drugs and devices to
dialysis patients without interruption thereof. A person who
violates a regulation adopted pursuant to this subdivision shall be
liable upon order of the board to surrender his or her personal
license. These penalties shall be in addition to penalties that may
be imposed pursuant to Section 4301. If the board finds any
dialysis drugs or devices distributed pursuant to this subdivision
to be ineffective or unsafe for the intended use, the board may
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institute immediate recall of any or all of the drugs or devices
distributed to individual patients.
(d) Home dialysis patients who receive any drugs or devices
pursuant to subdivision (c) shall have completed a full course of
home training given by a dialysis center licensed by the State
Department of Public Health. The physician prescribing the
dialysis products shall submit proof satisfactory to the
manufacturer or wholesaler that the patient has completed the
program.
(e) A pharmacist may furnish a dangerous drug authorized for
use pursuant to Section 2620.3 to a physical therapist. A record
containing the date, name and address of the buyer, and name
and quantity of the drug shall be maintained. This subdivision
shall not be construed to authorize the furnishing of a controlled
substance.
(f) A pharmacist may furnish electroneuromyographic needle
electrodes or hypodermic needles used for the purpose of
placing wire electrodes for kinesiological electromyographic
testing to physical therapists who are certified by the Physical
Therapy Board of California to perform tissue penetration in
accordance with Section 2620.5.
(g) Nothing in this section shall be construed as permitting a
licensed physical therapist to dispense or furnish a dangerous
device without a prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian.
(h) A veterinary food-animal drug retailer shall dispense, furnish,
transfer, or sell veterinary food-animal drugs only to another
veterinary food-animal drug retailer, a pharmacy, a veterinarian,
or to a veterinarian's client pursuant to a prescription from the
veterinarian for food-producing animals.
4059.5. Who May Order Dangerous Drugs or Devices:
Exceptions; Compliance With Laws of All Involved Jurisdictions
(a) Except as otherwise provided in this chapter, dangerous
drugs or dangerous devices may only be ordered by an entity
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licensed by the board and shall be delivered to the licensed
premises and signed for and received by a pharmacist. Where a
licensee is permitted to operate through a designated
representative, or in the case of a reverse distributor a
designated representative-reverse distributor, that individual
shall sign for and receive the delivery.
(b) A dangerous drug or dangerous device transferred, sold, or
delivered to a person within this state shall be transferred, sold,
or delivered only to an entity licensed by the board, to a
manufacturer, or to an ultimate user or the ultimate user's agent.
(c) Notwithstanding subdivisions (a) and (b), deliveries to a
hospital pharmacy may be made to a central receiving location
within the hospital. However, the dangerous drugs or dangerous
devices shall be delivered to the licensed pharmacy premises
within one working day following receipt by the hospital, and the
pharmacist on duty at that time shall immediately inventory the
dangerous drugs or dangerous devices.
(d) Notwithstanding any other law, a dangerous drug or
dangerous device may be ordered by and provided to a
manufacturer, physician, dentist, podiatrist, optometrist,
veterinarian, naturopathic doctor pursuant to Section 3640.7, or
laboratory, or a physical therapist acting within the scope of his
or her license. A person or entity receiving delivery of a
dangerous drug or dangerous device, or a duly authorized
representative of the person or entity, shall sign for the receipt of
the dangerous drug or dangerous device.
(e) A dangerous drug or dangerous device shall not be
transferred, sold, or delivered to a person outside this state,
whether foreign or domestic, unless the transferor, seller, or
deliverer does so in compliance with the laws of this state and of
the United States and of the state or country to which the
dangerous drugs or dangerous devices are to be transferred,
sold, or delivered. Compliance with the laws of this state and the
United States and of the state or country to which the dangerous
drugs or dangerous devices are to be delivered shall include, but
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not be limited to, determining that the recipient of the
dangerous drugs or dangerous devices is authorized by law to
receive the dangerous drugs or dangerous devices.
(f) Notwithstanding subdivision (a), a pharmacy may take
delivery of dangerous drugs and dangerous devices when the
pharmacy is closed and no pharmacist is on duty if all of the
following requirements are met:
(1) The drugs are placed in a secure storage facility in the same
building as the pharmacy.
(2) Only the pharmacist-in-charge or a pharmacist designated by
the pharmacist-in-charge has access to the secure storage facility
after dangerous drugs or dangerous devices have been delivered.
(3) The secure storage facility has a means of indicating whether
it has been entered after dangerous drugs or dangerous devices
have been delivered.
(4) The pharmacy maintains written policies and procedures for
the delivery of dangerous drugs and dangerous devices to a
secure storage facility.
(5) The agent delivering dangerous drugs and dangerous devices
pursuant to this subdivision leaves documents indicating the
name and amount of each dangerous drug or dangerous device
delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and
dangerous devices delivered to the secure storage facility. The
pharmacy shall also be responsible for obtaining and maintaining
records relating to the delivery of dangerous drugs and
dangerous devices to a secure storage facility.
(g) Notwithstanding subdivision (a), dangerous drugs and
devices and controlled substances may be ordered by a remote
dispensing site pharmacy licensed by the board and may be
signed for and received by a registered pharmacy technician, who
meets the qualifications of Section 4132, at the remote site. A
controlled substance signed for by a pharmacy technician under
this section shall be stored separately from existing inventory
until the time the controlled substance is reviewed and
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countersigned by a pharmacist. Any receipt and storage of a
controlled substance by a pharmacy technician pursuant to this
section shall be captured on video, and that video shall be made
accessible to the supervising pharmacy and maintained by the
remote dispensing site pharmacy for 120 days.
4060. Controlled Substance: Prescription Required; Exceptions
A person shall not possess any controlled substance, except that
furnished to a person upon the prescription of a physician,
dentist, podiatrist, optometrist, veterinarian, or naturopathic
doctor pursuant to Section 3640.7, or furnished pursuant to a
drug order issued by a certified nurse-midwife pursuant to
Section 2746.51, a nurse practitioner pursuant to Section 2836.1,
a physician assistant pursuant to Section 3502.1, a naturopathic
doctor pursuant to Section 3640.5, or a pharmacist pursuant to
Section 4052.1, 4052.2, or 4052.6. This section does not apply to
the possession of any controlled substance by a manufacturer,
wholesaler, third-party logistics provider, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian,
naturopathic doctor, certified nurse-midwife, nurse practitioner,
or physician assistant, if in stock in containers correctly labeled
with the name and address of the supplier or producer.
This section does not authorize a certified nurse-midwife, a
nurse practitioner, a physician assistant, or a naturopathic
doctor, to order his or her own stock of dangerous drugs and
devices.
4061. Distribution of a Drug as Sample; Written Request
Required
(a) No manufacturer's sales representative shall distribute any
dangerous drug or dangerous device as a complimentary sample
without the written request of a physician, dentist, podiatrist,
optometrist, veterinarian, or naturopathic doctor pursuant to
Section 3640.7. However, a certified nurse-midwife who
functions pursuant to a standardized procedure or protocol
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described in Section 2746.51, a nurse practitioner who functions
pursuant to a standardized procedure described in Section
2836.1, or protocol, a physician assistant who functions pursuant
to a protocol described in Section 3502.1, or a naturopathic
doctor who functions pursuant to a standardized procedure or
protocol described in Section 3640.5, may sign for the request
and receipt of complimentary samples of a dangerous drug or
dangerous device that has been identified in the standardized
procedure, protocol, or practice agreement. Standardized
procedures, protocols, and practice agreements shall include
specific approval by a physician. A review process, consistent
with the requirements of Section 2725, 3502.1, or 3640.5, of the
complimentary samples requested and received by a nurse
practitioner, certified nurse-midwife, physician assistant, or
naturopathic doctor, shall be defined within the standardized
procedure, protocol, or practice agreement.
(b) Each written request shall contain the names and addresses
of the supplier and the requester, the name and quantity of the
specific dangerous drug desired, the name of the certified nurse-
midwife, nurse practitioner, physician assistant, or naturopathic
doctor, if applicable, receiving the samples pursuant to this
section, the date of receipt, and the name and quantity of the
dangerous drugs or dangerous devices provided. These records
shall be preserved by the supplier with the records required by
Section 4059.
(c) Nothing in this section is intended to expand the scope of
practice of a certified nurse-midwife, nurse practitioner,
physician assistant, or naturopathic doctor.
4062. Furnishing Dangerous Drugs during Emergency; Mobile
Pharmacy
(a) Notwithstanding Section 4059 or any other law, a pharmacist
or a clinic licensed and acting under Section 4180 may, in good
faith, furnish a dangerous drug or dangerous device in reasonable
quantities without a prescription during a federal, state, or local
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emergency, to further the health and safety of the public. A
record containing the date, name, and address of the person to
whom the drug or device is furnished, and the name, strength,
and quantity of the drug or device furnished shall be maintained.
The pharmacist or clinic shall communicate this information to
the patient's attending physician as soon as possible.
Notwithstanding Section 4060 or any other law, a person may
possess a dangerous drug or dangerous device furnished without
prescription pursuant to this section.
(b) During a declared federal, state, or local emergency, the
board may waive application of any provisions of this chapter or
the regulations adopted pursuant to it if, in the board's opinion,
the waiver will aid in the protection of public health or the
provision of patient care.
(c) During a declared federal, state, or local emergency, the
board shall allow for the employment of a mobile pharmacy or
clinic in impacted areas in order to ensure the continuity of
patient care, if all of the following conditions are met:
(1) The mobile pharmacy or clinic shares common ownership
with at least one currently licensed pharmacy or clinic in good
standing.
(2) The mobile pharmacy or clinic retains records of dispensing,
as required by subdivision (a).
(3) A licensed pharmacist, or, in the case of a clinic, a
professional director, is on the premises and the mobile
pharmacy is under the control and management of a pharmacist,
or, in the case of a clinic, a professional director, while the drugs
are being dispensed.
(4) Reasonable security measures are taken to safeguard the
drug supply maintained in the mobile pharmacy or clinic.
(5) The mobile pharmacy or clinic is located within the declared
emergency area or affected areas.
(6) The mobile pharmacy or clinic ceases the provision of
services within 48 hours following the termination of the
declared emergency.
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(d) Notwithstanding any other law, the board may elect to
continue to waive application of any provision of this chapter for
up to 90 days following the termination of the declared
emergency if, in the board’s opinion, the continued waiver will
aid in the protection of the public health or in the provision of
patient care.
(e) (1) A pharmacy that is destroyed or severely damaged as a
result of a natural disaster or due to events that led to a declared
federal, state, or local emergency, may be relocated. The
relocation shall not be considered a transfer of ownership or
location under Section 4110, if no changes are made to the
management and control, or ownership, of the pharmacy and all
applicable laws and regulations are followed. Notification of the
relocation shall be provided to the board immediately upon
identification of the new location.
(2) For purposes of this section, “severely damaged” means
damage that renders the premises unsafe or unfit for entry or
occupation.
4063. Refill of Prescription for Dangerous Drug or Device
Requires Prescriber Authorization
No prescription for any dangerous drug or dangerous device
may be refilled except upon authorization of the prescriber. The
authorization may be given orally or at the time of giving the
original prescription. No prescription for any dangerous drug
that is a controlled substance may be designated refillable as
needed.
4064. Emergency Refill of Prescription without Prescriber
Authorization
(a) A prescription for a dangerous drug or dangerous device may
be refilled without the prescriber's authorization if the prescriber
is unavailable to authorize the refill and if, in the pharmacist's
professional judgment, failure to refill the prescription might
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interrupt the patient's ongoing care and have a significant
adverse effect on the patient's well-being.
(b) The pharmacist shall inform the patient that the prescription
was refilled pursuant to this section.
(c) The pharmacist shall inform the prescriber within a
reasonable period of time of any refills dispensed pursuant to
this section.
(d) Prior to refilling a prescription pursuant to this section, the
pharmacist shall make every reasonable effort to contact the
prescriber. The pharmacist shall make an appropriate record,
including the basis for proceeding under this section.
(e) The prescriber shall not incur any liability as the result of a
refilling of a prescription pursuant to this section.
(f) Notwithstanding Section 4060 or any other law, a person
may possess a dangerous drug or dangerous device furnished
without prescription pursuant to this section.
(g) During a proclaimed state of emergency, nothing in either
this section or any other provision of this chapter prohibits a
pharmacist, a clinic licensed under Section 4180, or a mobile
pharmacy or clinic described in subdivision (c) of Section 4062
from refilling a prescription if the prescriber is unavailable, or if
after a reasonable effort has been made, the pharmacist, clinic,
or mobile pharmacy is unable to contact the prescriber.
4064.5. Dispensing a 90-Day Supply of a Dangerous Drug or
Device; Requirements and Exceptions
(a) A pharmacist may dispense not more than a 90-day supply of
a dangerous drug other than a controlled substance pursuant to
a valid prescription that specifies an initial quantity of less than a
90-day supply followed by periodic refills of that amount if all of
the following requirements are satisfied:
(1) The patient has completed an initial 30-day supply of the
dangerous drug.
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(2) The total quantity of dosage units dispensed does not exceed
the total quantity of dosage units authorized by the prescriber on
the prescription, including refills.
(3) The prescriber has not specified on the prescription that
dispensing the prescription in an initial amount followed by
periodic refills is medically necessary.
(4) The pharmacist is exercising his or her professional
judgment.
(b) For purposes of this section, if the prescription continues the
same medication as previously dispensed in a 90-day supply, the
initial 30-day supply under paragraph (1) of subdivision (a) is not
required.
(c) A pharmacist dispensing an increased supply of a dangerous
drug pursuant to this section shall notify the prescriber of the
increase in the quantity of dosage units dispensed.
(d) In no case shall a pharmacist dispense a greater supply of a
dangerous drug pursuant to this section if the prescriber
personally indicates, either orally or in his or her own
handwriting, "No change to quantity," or words of similar
meaning. Nothing in this subdivision shall prohibit a prescriber
from checking a box on a prescription marked "No change to
quantity," provided that the prescriber personally initials the box
or checkmark. To indicate that an increased supply shall not be
dispensed pursuant to this section for an electronic data
transmission prescription as defined in subdivision (c) of Section
4040, a prescriber may indicate "No change to quantity," or
words of similar meaning, in the prescription as transmitted by
electronic data, or may check a box marked on the prescription
"No change to quantity." In either instance, it shall not be
required that the prohibition on an increased supply be manually
initialed by the prescriber.
(e) This section shall not apply to psychotropic medication or
psychotropic drugs as described in subdivision (d) of Section
369.5 of the Welfare and Institutions Code.
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(f) Except for the provisions of subdivision (d), this section does
not apply to FDA-approved, self-administered hormonal
contraceptives.
(1) A pharmacist shall dispense, at a patient’s request, up to a
12-month supply of an FDA-approved, self-administered
hormonal contraceptive pursuant to a valid prescription that
specifies an initial quantity followed by periodic refills.
(2) A pharmacist furnishing an FDA-approved, self-administered
hormonal contraceptive pursuant to Section 4052.3 under
protocols developed by the Board of Pharmacy may furnish, at
the patient’s request, up to a 12-month supply at one time.
(3) Nothing in this subdivision shall be construed to require a
pharmacist to dispense or furnish a drug if it would result in a
violation of Section 733.
(g) Nothing in this section shall be construed to require a health
care service plan, health insurer, workers’ compensation
insurance plan, pharmacy benefits manager, or any other person
or entity, including, but not limited to, a state program or state
employer, to provide coverage for a dangerous drug in a manner
inconsistent with a beneficiary’s plan benefit.
4065. Injection Card System; Requirements for Administration
(a) "Injection card system," as used in this section, means a
system that enables a facility to authorize an outpatient to
receive injections of controlled substances at the facility pursuant
to a prior written order by a physician, through the use of a card
that is maintained at the location in the facility where the
injections are administered.
(1) The injection card shall include, at a minimum, the following
information: the date of authorization, the number and
frequency of injections authorized, the name of the drug
including the strength and amount authorized, the names of the
prescribing physician and the patient, the date and time of each
injection, and the signature of the person administering the
injection.
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(2) In addition, the patient's medical record maintained by the
facility shall contain all of the information required under
Sections 4040 and 4070 and Chapter 1 (commencing with Section
70001) of Division 5 of Title 22 of the California Code of
Regulations.
(b) Notwithstanding any other provision of law, a licensed
health care facility may provide for the administration of
controlled substances through the use of an injection card
system for controlled substances.
(c) A facility that employs an injection card system shall have a
written protocol for the use of this system. The protocol shall be
developed by a team of health care professionals, including at
least one physician, one registered nurse, and one pharmacist.
The protocol shall provide for, but not be limited to, the
following:
(1) Identification of drugs to be included in the injection card
system.
(2) Distinction among classes of drugs.
(3) Periodic review of the efficacy of the injection card system,
including, but not limited to, its effectiveness and safety for
different classes of drugs.
(4) Determination as to whether each drug included in the
injection card system requires the presence of a physician or only
the ready availability of a physician.
(5) Implementation of recordkeeping systems that, at a
minimum, record each injection and each visit, provide for the
immediate entry of the injection in the patient's medical record,
provide a system for discontinuance of the order by the
prescribing physician, and allow for ready identification of
patterns of possible or actual patient abuse of controlled
substances and other potential adverse drug interactions.
(6) Retention of the injection card by the facility at all times
when a controlled substance is being administered.
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(7) Adequate initial evaluation of patients, including, but not
limited to, a determination as to whether each patient is a proper
subject for the injection card system.
(8) Ongoing medical evaluation of the patient's response to the
injection card system.
(9) That all injection cards shall become a permanent part of the
patient's medical record within 15 days from the date the last
authorized dose is administered.
(d) Nothing in this section shall be construed to prohibit the use,
or impose new requirements on the use, of an injection card
system for noncontrolled substances.
4066. Furnishing Dangerous Drugs to Master or First Officer of
Vessel
(a) Notwithstanding Section 4059, a wholesaler or pharmacy
may furnish dangerous drugs to the master or first officer of an
ocean vessel, pursuant to a written prescription. The requisition
shall be on the vessel's official stationery, signed by the vessel's
first officer. The drugs shall be maintained on board the vessel
and dispensed from medicine chests, first aid packets, or
dispensaries, pursuant to standardized procedures established by
a registered medical officer.
(b) Dangerous drugs shall be furnished in a sealed container to
the vessel's first officer, on proper identification, or delivered
aboard the vessel.
(c) Wholesalers or pharmacies engaging in the activities
authorized by this section shall give notice to the board within 30
days of undertaking the activity.
(d) Distribution of controlled substances shall be in accordance
with federal requirements contained in Section 1301.28 of Title
21 of the Code of Federal Regulations.
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4067. Internet; Dispensing Dangerous Drugs or Devices without
Prescription
(a) No person or entity shall dispense or furnish, or cause to be
dispensed or furnished, dangerous drugs or dangerous devices,
as defined in Section 4022, on the Internet for delivery to any
person in this state without a prescription issued pursuant to a
good faith prior examination of a human or animal for whom the
prescription is meant if the person or entity either knew or
reasonably should have known that the prescription was not
issued pursuant to a good faith prior examination of a human or
animal, or if the person or entity did not act in accordance with
Section 1761 of Title 16 of the California Code of Regulations.
(b) Notwithstanding any other provision of law, a violation of
this section may subject the person or entity that has committed
the violation to either a fine of up to twenty-five thousand dollars
($25,000) per occurrence pursuant to a citation issued by the
board or a civil penalty of twenty-five thousand dollars ($25,000)
per occurrence.
(c) The Attorney General may bring an action to enforce this
section and to collect the fines or civil penalties authorized by
subdivision (b).
(d) For notifications made on and after January 1, 2002, the
Franchise Tax Board, upon notification by the Attorney General
or the board of a final judgment in an action brought under this
section, shall subtract the amount of the fine or awarded civil
penalties from any tax refunds or lottery winnings due to the
person who is a defendant in the action using the offset authority
under Section 12419.5 of the Government Code, as delegated by
the Controller, and the processes as established by the Franchise
Tax Board for this purpose. That amount shall be forwarded to
the board for deposit in the Pharmacy Board Contingent Fund.
(e) Nothing in this section shall be construed to permit the
unlicensed practice of pharmacy, or to limit the authority of the
board to enforce any other provision of this chapter.
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(f) For the purposes of this section, "good faith prior
examination" includes the requirements for a physician and
surgeon in Section 2242 and the requirements for a veterinarian
in Section 2032.1 of Title 16 of the California Code of Regulations.
4068. Dispense Dangerous Drug or Controlled Substance to
Emergency Room Patient; Requirements
(a) Notwithstanding any provision of this chapter, a prescriber
may dispense a dangerous drug, including a controlled substance,
to an emergency room patient if all of the following apply:
(1) The hospital pharmacy is closed and there is no pharmacist
available in the hospital.
(2) The dangerous drug is acquired by the hospital pharmacy.
(3) The dispensing information is recorded and provided to the
pharmacy when the pharmacy reopens.
(4) The hospital pharmacy retains the dispensing information
and, if the drug is a schedule II, schedule III, or schedule IV
controlled substance, reports the dispensing information to the
Department of Justice pursuant to Section 11165 of the Health
and Safety Code.
(5) The prescriber determines that it is in the best interest of the
patient that a particular drug regimen be immediately
commenced or continued, and the prescriber reasonably believes
that a pharmacy located outside the hospital is not available and
accessible at the time of dispensing to the patient.
(6) The quantity of drugs dispensed to any patient pursuant to
this section are limited to that amount necessary to maintain
uninterrupted therapy during the period when pharmacy services
outside the hospital are not readily available or accessible, but
shall not exceed a 72-hour supply.
(7) The prescriber shall ensure that the label on the drug
contains all the information required by Section 4076.
(b) The prescriber shall be responsible for any error or omission
related to the drugs dispensed.
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Article 4. Requirements for Prescriptions
4070. Reduction of Oral or Electronic Prescription to Writing
(a) Except as provided in Section 4019 and subdivision (b), an
oral or an electronic data transmission prescription as defined in
subdivision (c) of Section 4040 shall as soon as practicable be
reduced to writing by the pharmacist and shall be filled by, or
under the direction of, the pharmacist. The pharmacist need not
reduce to writing the address, telephone number, license
classification, federal registry number of the prescriber or the
address of the patient or patients if the information is readily
retrievable in the pharmacy.
(b) A pharmacy receiving an electronic transmission prescription
shall not be required to reduce that prescription to writing or to
hard copy form if, for three years from the last date of furnishing
pursuant to that prescription or order, the pharmacy is able,
upon request by the board, to immediately produce a hard copy
report that includes for each date of dispensing of a dangerous
drug or dangerous device pursuant to that prescription or order:
(1) all of the information described in subparagraphs (A) to (E),
inclusive, of paragraph (1) of subdivision (a) of Section 4040, and
(2) the name or identifier of the pharmacist who dispensed the
dangerous drug or dangerous device. This subdivision shall not
apply to prescriptions for controlled substances classified in
Schedule II, III, IV, or V, except as permitted pursuant to Section
11164.5 of the Health and Safety Code.
(c) If only recorded and stored electronically, on magnetic
media, or in any other computerized form, the pharmacy's
computer system shall not permit the received information or
the dangerous drug or dangerous device dispensing information
required by this section to be changed, obliterated, destroyed, or
disposed of, for the record maintenance period required by law
once the information has been received by the pharmacy and
once the dangerous drug or dangerous device has been
dispensed. Once a dangerous drug or dangerous device has been
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dispensed, if the previously created record is determined to be
incorrect, a correcting addition may be made only by or with the
approval of a pharmacist. After a pharmacist enters the change
or enters his or her approval of the change into the computer,
the resulting record shall include the correcting addition and the
date it was made to the record, the identity of the person or
pharmacist making the correction, and the identity of the
pharmacist approving the correction.
(d) Nothing in this section shall impair the requirement to have
an electronically transmitted prescription transmitted only to the
pharmacy of the patient's choice or to have a written
prescription. This requirement shall not apply to orders for
medications to be administered in an acute care hospital.
4071. Prescriber May Authorize Agent to Transmit Prescription;
Schedule II Excluded
Notwithstanding any other provision of law, a prescriber may
authorize his or her agent on his or her behalf to orally or
electronically transmit a prescription to the furnisher. The
furnisher shall make a reasonable effort to determine that the
person who transmits the prescription is authorized to do so and
shall record the name of the authorized agent of the prescriber
who transmits the order. This section shall not apply to orders for
Schedule II controlled substances.
4071.1. Electronic Prescription Entry into Pharmacy or Hospital
Computer
(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 authorized agent" is a person licensed or registered
under Division 2 (commencing with Section 500). This subdivision
shall not apply to prescriptions for controlled substances
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classified in Schedule II, III, IV, or V, except as permitted pursuant
to Section 11164.5 of the Health and Safety Code.
(b) Nothing in this section shall reduce the existing authority of
other hospital personnel to enter medication orders or
prescription orders into a hospital's computer.
(c) No dangerous drug or dangerous device shall be dispensed
pursuant to a prescription that has been electronically entered
into a pharmacy's computer without the prior approval of a
pharmacist.
4072. Oral or Electronic Transmission of Prescription ―Health
Care Facility
(a) Notwithstanding any other provision of law, a pharmacist,
registered nurse, licensed vocational nurse, licensed psychiatric
technician, or other healing arts licentiate, if so authorized by
administrative regulation, who is employed by or serves as a
consultant for a licensed skilled nursing, intermediate care, or
other health care facility, may orally or electronically transmit to
the furnisher a prescription lawfully ordered by a person
authorized to prescribe drugs or devices pursuant to Sections
4040 and 4070. The furnisher shall take appropriate steps to
determine that the person who transmits the prescription is
authorized to do so and shall record the name of the person who
transmits the order. This section shall not apply to orders for
Schedule II controlled substances.
(b) In enacting this section, the Legislature recognizes and
affirms the role of the Department of Public Health in regulating
drug order processing requirements for licensed health care
facilities as set forth in Title 22 of the California Code of
Regulations as they may be amended from time to time.
4073. Substitution of Generic Drug ―Requirements and
Exceptions
(a) A pharmacist filling a prescription order for a drug product
prescribed by its trade or brand name may select another drug
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product with the same active chemical ingredients of the same
strength, quantity, and dosage form, and of the same generic
drug name as determined by the United States Adopted Names
(USAN) and accepted by the federal Food and Drug
Administration (FDA), of those drug products having the same
active chemical ingredients.
(b) In no case shall a selection be made pursuant to this section
if the prescriber personally indicates, either orally or in his or her
own handwriting, "Do not substitute," or words of similar
meaning. Nothing in this subdivision shall prohibit a prescriber
from checking a box on a prescription marked "Do not
substitute"; provided that the prescriber personally initials the
box or checkmark. To indicate that a selection shall not be made
pursuant to this section for an electronic data transmission
prescription as defined in subdivision (c) of Section 4040, a
prescriber may indicate "Do not substitute," or words of similar
meaning, in the prescription as transmitted by electronic data, or
may check a box marked on the prescription "Do not substitute."
In either instance, it shall not be required that the prohibition on
substitution be manually initialed by the prescriber.
(c) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (b). The person
who selects the drug product to be dispensed pursuant to this
section shall assume the same responsibility for selecting the
dispensed drug product as would be incurred in filling a
prescription for a drug product prescribed by generic name.
There shall be no liability on the prescriber for an act or omission
by a pharmacist in selecting, preparing, or dispensing a drug
product pursuant to this section. In no case shall the pharmacist
select a drug product pursuant to this section unless the drug
product selected costs the patient less than the prescribed drug
product. Cost, as used in this subdivision, is defined to include
any professional fee that may be charged by the pharmacist.
(d) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from
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the federal government or pursuant to the California Medical
Assistance Program set forth in Chapter 7 (commencing with
Section 14000) of Part 3 of Division 9 of the Welfare and
Institutions Code.
(e) When a substitution is made pursuant to this section, the
use of the cost-saving drug product dispensed shall be
communicated to the patient and the name of the dispensed
drug product shall be indicated on the prescription label, except
where the prescriber orders otherwise.
4073.5. Substitution of Alternative Biological Product;
Requirements and Exceptions
(a) A pharmacist filling a prescription order for a prescribed
biological product may select an alternative biological product
only if all of the following:
(1) The alternative biological product is interchangeable.
(2) The prescriber does not personally indicate “Do not
substitute,” or words of similar meaning, in the manner provided
in subdivision (d).
(b) Within five days following the dispensing of a biological
product, a dispensing pharmacist or the pharmacists’ designee
shall make an entry of the specific biological product provided to
the patient, including the name of the biological product and the
manufacturer. The communication shall be conveyed by making
an entry that can be electronically accessed by the prescriber
through one or more of the following electronic records systems:
(1) An interoperable electronic medical records system.
(2) An electronic prescribing technology.
(3) A pharmacy benefit management system.
(4) A pharmacy record.
(c) Entry into an electronic records system as described in
subdivision (b) is presumed to provide notice to the prescriber.
(d) If the pharmacy does not have access to one or more of the
entry systems in subdivision (b), the pharmacist or the
pharmacist’s designee shall communicate the name of the
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biological product dispensed to the prescriber using facsimile,
telephone, electronic transmission, or other prevailing means,
except that communication shall not be required in this instance
to the prescriber when either of the following apply:
(1) There is no interchangeable biological product approved by
the federal Food and Drug Administration for the product
prescribed.
(2) A refill prescription is not changed from the product
dispensed on the prior filling of the prescription.
(e) In no case shall a selection be made pursuant to this section
if the prescriber personally indicates, either orally or in his or her
own handwriting, “Do not substitute,” or words of similar
meaning.
(1) This subdivision shall not prohibit a prescriber from checking
a box on a prescription marked “Do not substitute,” provided
that the prescriber personally initials the box or checkmark.
(2) To indicate that a selection shall not be made pursuant to
this section for an electronic data transmission prescription, as
defined in subdivision (c) of Section 4040, a prescriber may
indicate “Do not substitute,” or words of similar meaning, in the
prescription as transmitted by electronic data, or may check a
box marked on the prescription “Do not substitute.” In either
instance, it shall not be required that the prohibition on
substitution be manually initialed by the prescriber.
(f) Selection pursuant to this section is within the discretion of
the pharmacist, except as provided in subdivision (e). A
pharmacist who selects an alternative biological product to be
dispensed pursuant to this section shall assume the same
responsibility for substituting the biological product as would be
incurred in filling a prescription for a biological product
prescribed by name. There shall be no liability on the prescriber
for an act or omission by a pharmacist in selecting, preparing, or
dispensing a biological product pursuant to this section. In no
case shall the pharmacist select a biological product that meets
the requirements of subdivision (a) unless the cost to the patient
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of the biological product selected is the same or less than the
cost of the prescribed biological product. Cost, as used in this
subdivision, includes any professional fee that may be charged by
the pharmacist.
(g) This section shall apply to all prescriptions, including those
presented by or on behalf of persons receiving assistance from
the federal government or pursuant to the Medi-Cal Act set forth
in Chapter 7 (commencing with Section 14000) of Part 3 of
Division 9 of the Welfare and Institutions Code.
(h) When a selection is made pursuant to this section, the
substitution of a biological product shall be communicated to the
patient.
(i) The board shall maintain on its public Internet Web site a link
to the current list, if available, of biological products determined
by the federal Food and Drug Administration to be
interchangeable.
(j) For purposes of this section, the following terms shall have
the following meanings:
(1) “Biological product” has the same meaning that applies to
that term under Section 351 of the federal Public Health Service
Act (42 U.S.C. Sec. 262(i)).
(2) “Interchangeable” means a biological product that the
federal Food and Drug Administration has determined meets the
standards set forth in Section 262(k)(4) of Title 42 of the United
States Code, or has been deemed therapeutically equivalent by
the federal Food and Drug Administration as set forth in the
latest addition or supplement of the Approved Drug Products
with Therapeutic Equivalence Evaluations.
(3) “Prescription,” with respect to a biological product, means a
prescription for a product that is subject to Section 503(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(k) This section shall not prohibit the administration of
immunizations, as permitted in Sections 4052 and 4052.8.
(l) This section shall not prohibit a disability insurer or health
care service plan from requiring prior authorization or imposing
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other appropriate utilization controls in approving coverage for
any biological product.
(Added by Stats. 2015, Ch. 545, Sec. 1. Effective January 1, 2016.)
4074. Drug Risk: Informing Patient; Providing Consultation for
Discharge Medications
(a) A pharmacist shall inform a patient orally or in writing of the
harmful effects of a drug dispensed by prescription if both of the
following apply:
(1) The drug poses substantial risk to the person consuming the
drug when taken in combination with alcohol or the drug may
impair a person’s ability to drive a motor vehicle, whichever is
applicable.
(2) The drug is determined by the board pursuant to subdivision
(c) to be a drug or drug type for which this warning shall be given.
(b) In addition to the requirement described in subdivision (a),
on and after July 1, 2014, if a pharmacist exercising his or her
professional judgment determines that a drug may impair a
person’s ability to operate a vehicle or vessel, the pharmacist
shall include a written label on the drug container indicating that
the drug may impair a person’s ability to operate a vehicle or
vessel. The label required by this subdivision may be printed on
an auxiliary label that is affixed to the prescription container.
(c) The board may by regulation require additional information
or labeling.
(d) This section shall not apply to a drug furnished to a patient in
conjunction with treatment or emergency services provided in a
health facility or, except as provided in subdivision (e), to a drug
furnished to a patient pursuant to subdivision (a) of Section 4056.
(e) A health facility shall establish and implement a written
policy to ensure that each patient shall receive information
regarding each drug given at the time of discharge and each drug
given pursuant to subdivision (a) of Section 4056. This
information shall include the use and storage of each drug, the
precautions and relevant warnings, and the importance of
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compliance with directions. This information shall be given by a
pharmacist or registered nurse, unless already provided by a
patient’s prescriber, and the written policy shall be developed in
collaboration with a physician, a pharmacist, and a registered
nurse. The written policy shall be approved by the medical staff.
Nothing in this subdivision or any other law shall be construed to
require that only a pharmacist provide this consultation.
4075. Proof of Identity Required - Oral or Electronic
Prescription
No prescription for a controlled substance transmitted by
means of an oral or electronically transmitted order shall be
furnished to any person unknown and unable to properly
establish his or her identity. The board may by regulation
establish procedures to prevent unauthorized persons from
receiving prescription drugs furnished to a patient or a
representative of the patient.
4076. Prescription Container - Requirements for Labeling
(a) A pharmacist shall not dispense a prescription except in a
container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife
who functions pursuant to a standardized procedure or protocol
described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in
Section 2836.1 or protocol, the physician assistant who functions
pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol
described in Section 3640.5, or the pharmacist who functions
pursuant to a policy, procedure, or protocol pursuant to Section
4052.1, 4052.2, or 4052.6 orders otherwise, either the
manufacturer’s trade name of the drug or the generic name and
the name of the manufacturer. Commonly used abbreviations
may be used. Preparations containing two or more active
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ingredients may be identified by the manufacturer’s trade name
or the commonly used name or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant
who functions pursuant to Section 3502.1, the naturopathic
doctor who functions pursuant to a standardized procedure or
protocol described in Section 3640.5, or the pharmacist who
functions pursuant to a policy, procedure, or protocol pursuant
to Section 4052.1, 4052.2, or 4052.6.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription
number or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed
if the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description
of the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules,
except as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall
be granted to a new drug for the first 120 days that the drug is on
the market and for the 90 days during which the national
reference file has no description on file.
(iii) Dispensed medications for which no physical description
exists in a commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
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(C) The information required by this paragraph may be printed
on an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same
labeling requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation,
for a patient in a skilled nursing, intermediate care, or other
health care facility, the requirements of this section will be
satisfied if the unit dose medication system contains the
aforementioned information or the information is otherwise
readily available at the time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
facility licensed pursuant to Section 1250 of the Health and
Safety Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified nurse-
midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner
who functions pursuant to a standardized procedure described in
Section 2836.1 or protocol, the physician assistant who functions
pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol
described in Section 3640.5, or the pharmacist who functions
pursuant to a policy, procedure, or protocol pursuant to Section
4052.1, 4052.2, or 4052.6.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and
Safety Code, it is not necessary to include the information
required in paragraph (11) of subdivision (a) when the
prescription drug is administered to a patient by a person
licensed under the Medical Practice Act (Chapter 5 (commencing
with Section 2000)), the Nursing Practice Act (Chapter 6
(commencing with Section 2700)), or the Vocational Nursing
Practice Act (Chapter 6.5 (commencing with Section 2840)), who
is acting within the scope of practice.
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(e) A pharmacist shall use professional judgment to provide a
patient with directions for use that enhance the patient’s
understanding of those directions, consistent with the
prescriber’s instructions.
(f) Notwithstanding subdivision (a) or any other law, a pharmacist
may dispense a drug prescribed pursuant to Section 120582 of
the Health and Safety Code and label the drug without the name
of an individual for whom the drug is intended if the prescription
includes the words “expedited partner therapy” or the letters
“EPT.”
(g) A pharmacist who prescribes, dispenses, furnishes, or
otherwise renders EPT, as authorized in subdivision (f), shall not
be liable in, and shall not be subject to, a civil, criminal, or
administrative action, sanction, or penalty for rendering EPT, if
the use of EPT is in compliance with this section, except in cases
of intentional misconduct, gross negligence, or wanton or
reckless activity.
(h) A pharmacist who provides EPT under this section shall
provide written notification that describes the right of an
individual who receives EPT to consult with a pharmacist about
the medication dispensed and additional information regarding
possible drug interactions.
4076.5. Standardized, Patient-Centered Prescription Labels;
Requirements
(a) The board shall promulgate regulations that require, on or
before January 1, 2011, a standardized, patient-centered,
prescription drug label on all prescription medicine dispensed to
patients in California.
(b) To ensure maximum public comment, the board shall hold
public meetings statewide that are separate from its normally
scheduled hearings in order to seek information from groups
representing consumers, seniors, pharmacists or the practice of
pharmacy, other health care professionals, and other interested
parties.
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(c) When developing the requirements for prescription drug
labels, the board shall consider all of the following factors:
(1) Medical literacy research that points to increased
understandability of labels.
(2) Improved directions for use.
(3) Improved font types and sizes.
(4) Placement of information that is patient-centered.
(5) The needs of patients with limited English proficiency.
(6) The needs of senior citizens.
(7) Technology requirements necessary to implement the
standards.
(d) The board may exempt from the requirements of regulations
promulgated pursuant to subdivision (a) prescriptions dispensed
to a patient in a health facility, as defined in Section 1250 of the
Health and Safety Code, if the prescriptions are administered by a
licensed health care professional. Prescriptions dispensed to a
patient in a health facility that will not be administered by a
licensed health care professional or that are provided to the
patient upon discharge from the facility shall be subject to the
requirements of this section and the regulations promulgated
pursuant to subdivision (a). Nothing in this subdivision shall alter
or diminish existing statutory and regulatory informed consent,
patients’ rights, or pharmaceutical labeling and storage
requirements, including, but not limited to, the requirements of
Section 1418.9 of the Health and Safety Code or Section 72357,
72527, or 72528 of Title 22 of the California Code of Regulations.
(e) (1) The board may exempt from the requirements of
regulations promulgated pursuant to subdivision (a) a
prescription dispensed to a patient if all of the following apply:
(A) The drugs are dispensed by a JCAHO-accredited home
infusion or specialty pharmacy.
(B) The patient receives health-professional-directed education
prior to the beginning of therapy by a nurse or pharmacist.
(C) The patient receives weekly or more frequent followup
contacts by a nurse or pharmacist.
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(D) Care is provided under a formal plan of care based upon a
physician and surgeon’s orders.
(2) For purposes of paragraph (1), home infusion and specialty
therapies include parenteral therapy or other forms of
administration that require regular laboratory and patient
monitoring.
4076.6. Patient-Centered Prescription Labels; Translated
Directions for Use; Requirements
(a) Upon the request of a patient or patient’s representative, a
dispenser shall provide translated directions for use, which shall
be printed on the prescription container, label, or on a
supplemental document. If translated directions for use appear
on a prescription container or label, the English-language version
of the directions for use shall also appear on the container or
label, whenever possible, and may appear on other areas of the
label outside the patient-centered area. When it is not possible
for the English-language directions for use to appear on the
container or label, it shall be provided on a supplemental
document.
(b) A dispenser may use translations made available by the
board pursuant to subdivision (b) of Section 1707.5 of Title 16 of
the California Code of Regulations to comply with this section.
(c) A dispenser shall not be required to provide translated
directions for use beyond the languages that the board has made
available or beyond the directions that the board has made
available in translated form.
(d) A dispenser may provide his or her own translated directions
for use to comply with the requirements of this section, and
nothing in this section shall be construed to prohibit a dispenser
from providing translated directions for use in languages beyond
those that the board has made available or beyond the directions
that the board has made available in translated form.
(e) A dispenser shall be responsible for the accuracy of the
English-language directions for use provided to the patient. This
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section shall not affect a dispenser’s existing responsibility to
correctly label a prescription pursuant to Section 4076.
(f) For purposes of this section, a dispenser does not include a
veterinarian.
(Added by Stats. 2015, Ch. 784, Sec. 2. Effective January 1, 2016.)
4076.7. Caution Label Required for Drug Containing an Opioid
In addition to the requirements of Sections 4076 and 4076.5,
whenever a prescription drug containing an opioid is dispensed
to a patient for outpatient use, the pharmacy or practitioner
dispensing the drug shall prominently display on the label or
container, by means of a flag or other notification mechanism
attached to the container, a notice that states “Caution: Opioid.
Risk of overdose and addiction.”
4077. Dispensing Dangerous Drug in Incorrectly Labeled
Container
(a) Except as provided in subdivisions (b) and (c), no person shall
dispense any dangerous drug upon prescription except in a
container correctly labeled with the information required by
Section 4076.
(b) Physicians, dentists, podiatrists, and veterinarians may
personally furnish any dangerous drug prescribed by them to the
patient for whom prescribed, provided that the drug is properly
labeled to show all information required in Section 4076 except
the prescription number.
(c) Devices that bear the legend "Caution: federal law restricts
this device to sale by or on the order of a _____," or words of
similar meaning, are exempt from the requirements of Section
4076, and Section 111480 of the Health and Safety Code, when
provided to patients in skilled nursing facilities or intermediate
care facilities licensed pursuant to Chapter 2 (commencing with
Section 1250) of Division 2 of the Health and Safety Code.
(d) The following notification shall be affixed to all quantities of
dimethyl sulfoxide (DMSO) prescribed by a physician, or
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dispensed by a pharmacy pursuant to the order of a physician in
California: "Warning: DMSO may be hazardous to your health.
Follow the directions of the physician who prescribed the DMSO
for you."
(e) The label of any retail package of DMSO shall include
appropriate precautionary measures for proper handling and first
aid treatment and a warning statement to keep the product out
of reach of children.
4078. False or Misleading Label on Prescription
(a) (1) No person shall place a false or misleading label on a
prescription.
(2) No prescriber shall direct that a prescription be labeled with
any information that is false or misleading.
(b) Notwithstanding subdivision (a), a person may label a
prescription, or a prescriber may direct that a prescription be
labeled, with information about the drug that is false under
either of the following circumstances:
(1) If the labeling is a necessary part of a clinical or
investigational drug program approved by the federal Food and
Drug Administration or a legitimate investigational drug project
involving a drug previously approved by the federal Food and
Drug Administration.
(2) If, in the medical judgment of the prescriber, the labeling is
appropriate for the proper treatment of the patient.
(c) The furnisher of a prescription labeled pursuant to
subdivision (b) shall make, and retain for three years from the
date of making, a record stating the manner in which the
information on the prescription label varies from the actual drug
in the container and documenting the order of the prescriber to
so label the container. The prescriber shall make, and retain for
at least three years, a record of his or her order to so label the
container.
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4079. Availability of a Lower Retail Price for a Covered Drug
(a) A pharmacy shall inform a customer at the point of sale for a
covered prescription drug whether the retail price is lower than
the applicable cost-sharing amount for the prescription drug,
unless the pharmacy automatically charges the customer the
lower price.
(b) If the customer pays the retail price, the pharmacy shall
submit the claim to the health care service plan or health insurer
in the same manner as if the customer had purchased the
prescription drug by paying the cost-sharing amount when
submitted by the network pharmacy.
(c) The payment rendered shall constitute the applicable cost
sharing and shall apply to the deductible, if any, and also to the
maximum out-of-pocket limit in the same manner as if the
enrollee had purchased the prescription drug by paying the cost-
sharing amount.
(d) A contract provision that is inconsistent with this section is
void and unenforceable.
(e) 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.
(f) A violation of this provision shall not be grounds for
disciplinary action or a criminal action.
(g) This section shall become operative on January 1, 2020.
Article 5. Authority of Inspectors
4080. Stock of Dangerous Drugs and Devices Kept Open for
Inspection
All stock of any dangerous drug or dangerous device or of
shipments through a customs broker or carrier shall be, at all
times during business hours, open to inspection by authorized
officers of the law.
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4081. Records of Dangerous Drugs and Devices Kept Open for
Inspection; Maintenance of Records, Current Inventory;
Nonprescription Diabetes Test Devices
(a) All records of manufacture and of sale, acquisition, receipt,
shipment, or disposition of dangerous drugs or dangerous
devices shall be at all times during business hours open to
inspection by authorized officers of the law, and shall be
preserved for at least three years from the date of making. A
current inventory shall be kept by every manufacturer,
wholesaler, third-party logistics provider, pharmacy, veterinary
food-animal drug retailer, outsourcing facility, physician, dentist,
podiatrist, veterinarian, laboratory, licensed correctional clinic, as
defined in Section 4187, clinic, hospital, institution, or
establishment holding a currently valid and unrevoked certificate,
license, permit, registration, or exemption under Division 2
(commencing with Section 1200) of the Health and Safety Code
or under Part 4 (commencing with Section 16000) of Division 9 of
the Welfare and Institutions Code who maintains a stock of
dangerous drugs or dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler,
third-party logistics provider, or veterinary food-animal drug
retailer shall be jointly responsible, with the pharmacist-in-
charge, responsible manager, or designated representative-in-
charge, for maintaining the records and inventory described in
this section.
(c) The pharmacist-in-charge, responsible manager, or
designated representative-in-charge shall not be criminally
responsible for acts of the owner, officer, partner, or employee
that violate this section and of which the pharmacist-in-charge,
responsible manager, or designated representative-in-charge had
no knowledge, or in which he or she did not knowingly
participate.
(d) Pharmacies that dispense nonprescription diabetes test
devices pursuant to prescriptions shall retain records of
acquisition and sale of those nonprescription diabetes test
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devices for at least three years from the date of making. The
records shall be at all times during business hours open to
inspection by authorized officers of the law.
4082. Names of Owners, Managers and Employees Open for
Inspection
When called upon by an inspector, the owner or manager of any
entity licensed by the board, or other store, shop, building, or
premises retailing, wholesaling, or storing drugs or devices shall
furnish the inspector with the names of the owner or owners,
manager or managers, and employees together with a brief
statement of the capacity in which these persons are employed
on the premises.
4083. Orders of Correction
(a) An inspector may issue an order of correction to a licensee
directing the licensee to comply with this chapter or regulations
adopted pursuant to this chapter.
(b) The order of correction shall be in writing and shall describe
in detail the nature and facts of the violation, including a
reference to the statute or regulations violated.
(c) The order of correction shall inform the licensee that within
30 days of service of the order of correction, the licensee may do
either of the following:
(1) Submit a written request for an office conference with the
board's executive officer to contest the order of correction.
(A) Upon a timely request, the executive officer, or his or her
designee, shall hold an office conference with the licensee or the
licensee's legal counsel or authorized representative. Unless so
authorized by the executive officer, or his or her designee, no
individual other than the licensee's legal counsel or authorized
representative may accompany the licensee to the office
conference.
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(B) Prior to or at the office conference, the licensee may submit
to the executive officer declarations and documents pertinent to
the subject matter of the order of correction.
(C) The office conference is intended to be an informal
proceeding and shall not be subject to the provisions of the
Administrative Procedure Act (Chapter 3.5 (commencing with
Section 11340), Chapter 4 (commencing with Section 11370),
Chapter 4.5 (commencing with Section 11400), and Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2
of the Government Code).
(D) The executive officer, or his or her designee, may affirm,
modify, or withdraw the order of correction. Within 14 calendar
days from the date of the office conference, the executive
officer, or his or her designee, shall personally serve or send by
certified mail to the licensee's address of record with the board a
written decision. This decision shall be deemed the final
administrative decision concerning the order of correction.
(E) Judicial review of the decision may be had by filing a petition
for a writ of mandate in accordance with the provisions of
Section 1094.5 of the Code of Civil Procedure within 30 days of
the date the decision was personally served or sent by certified
mail. The judicial review shall extend to the question of whether
or not there was a prejudicial abuse of discretion in the issuance
of the order of correction.
(2) Comply with the order of correction and submit a written
corrective action plan to the inspector documenting compliance.
If an office conference is not requested pursuant to this section,
compliance with the order of correction shall not constitute an
admission of the violation noted in the order of correction.
(d) The order of correction shall be served upon the licensee
personally or by certified mail at the licensee's address of record
with the board. If the licensee is served by certified mail, service
shall be effective upon deposit in the United States mail.
(e) The licensee shall maintain and have readily available on the
pharmacy premises a copy of the order of correction and
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corrective action plan for at least three years from the date of
issuance of the order of correction.
(f) Nothing in this section shall in any way limit the board's
authority or ability to do any of the following:
(1) Issue a citation pursuant to Section 125.9, 148, or 4067 or
pursuant to Section 1775, 1775.15, 1777, or 1778 of Title 16 of
the California Code of Regulations.
(2) Issue a letter of admonishment pursuant to Section 4315.
(3) Institute disciplinary proceedings pursuant to Article 19
(commencing with Section 4300).
(g) Unless a writ of mandate is filed, a citation issued, a letter of
admonishment issued, or a disciplinary proceeding instituted, an
order of correction shall not be considered a public record and
shall not be disclosed pursuant to a request under the California
Public Records Act (Chapter 3.5 (commencing with Section 6250)
of Division 7 of Title 1 of the Government Code).
4084. Adulterated, Misbranded or Counterfeit Dangerous Drug
or Device
(a) When a board inspector finds, or has probable cause to
believe, that any dangerous drug or dangerous device is
adulterated, misbranded, or counterfeit, the board inspector
shall affix a tag or other marking to that dangerous drug or
dangerous device. The board inspector shall give notice to the
person that the dangerous drug or dangerous device bearing the
tag or marking has been embargoed.
(b) When a board inspector has found that an embargoed
dangerous drug or dangerous device is not adulterated,
misbranded, or counterfeit, a board inspector shall remove the
tag or other marking.
(c) A board inspector may secure a sample or specimen of a
dangerous drug or dangerous device. If the board inspector
obtains a sample prior to leaving the premises, the board
inspector shall leave a receipt describing the sample.
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(d) For the purposes of this article, "counterfeit" shall have the
meaning defined in Section 109905 of the Health and Safety
Code.
(e) For the purposes of this article, "adulterated" shall have the
meaning defined in Article 2 (commencing with Section 111250)
of Chapter 6 of Part 5 of Division 104 of the Health and Safety
Code.
(f) For the purposes of this article, "misbranded" shall have the
meaning defined in Article 3 (commencing with Section 111330)
of Chapter 6 of Part 5 of Division 104 of the Health and Safety
Code.
4084.1. Embargo of Nonprescription Diabetes Test Devices
The board may embargo any nonprescription diabetes test
device that a board inspector finds or has probable cause to
believe 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. For the
purposes of this section, the board shall embargo these products
following the same procedures and protections used for
adulterated, misbranded, or counterfeit drugs or dangerous
devices in Sections 4084, 4085, and 4086.
4085. Unlawful to Remove, Sell, or Dispose of Embargoed
Dangerous Drugs or Dangerous Devices
(a) It is unlawful for any person to remove, sell, or dispose of an
embargoed dangerous drug or dangerous device without
permission of the board.
(b) When a board inspector has reasonable cause to believe,
that the embargo will be violated, a board inspector may remove
the embargoed dangerous drug or dangerous device from the
premises.
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4086. Adulterated or Counterfeit Dangerous Drug or Dangerous
Device; Court Proceedings
(a) If a dangerous drug or dangerous device is alleged to be
adulterated or counterfeit, the board shall commence
proceedings in the superior court in whose jurisdiction the
dangerous drug or dangerous device is located, for
condemnation of the dangerous drug or dangerous device.
(b) If the court finds that an embargoed dangerous drug or
dangerous device is adulterated or counterfeit, the dangerous
drug or dangerous device shall, after entry of the judgment, be
destroyed at the expense of the claimant or owner, under the
supervision of the board. All court costs and fees and all
reasonable costs incurred by the board in investigating and
prosecuting the action, including, but not limited to, the costs of
storage and testing, shall be paid by the claimant or owner of the
dangerous drug or dangerous device.
(c) A superior court of this state may condemn any dangerous
drug or dangerous device pursuant to this article. In the absence
of an order, the dangerous drug or dangerous device may be
destroyed under the supervision of the board who has the
written consent of the owner, his or her attorney, or authorized
representative. If the board cannot ascertain ownership of the
dangerous drug or dangerous device within 30 days of
establishing an embargo, the board may destroy the dangerous
drug or dangerous device.
Article 6. General Requirements
4100. Change of Address or Name - Notification to Board
Within 30 days after changing his or her address of record with
the board or after changing his or her name according to law, a
pharmacist, intern pharmacist, technician, designated
representative, designated representative-3PL, or designated
representative-reverse distributor shall notify the executive
officer of the board of the change of address or change of name.
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4101. Pharmacist-in-Charge, Designated Representative-in-
Charge: Termination of Employment; Notification to Board
(a) A pharmacist may take charge of and act as the pharmacist-
in-charge of a pharmacy upon application by the pharmacy and
approval by the board. A pharmacist-in-charge who ceases to act
as the pharmacist-in-charge of the pharmacy shall notify the
board in writing within 30 days of the date of that change in
status.
(b) A designated representative or a pharmacist may take
charge of, and act as, the designated representative-in-charge of
a wholesaler or veterinary food-animal drug retailer upon
application by the wholesaler or veterinary food-animal drug
retailer and approval by the board. A designated representative-
in-charge who ceases to act as the designated representative-in-
charge at that entity shall notify the board in writing within 30
days of the date of that change in status.
(c) A designated representative-3PL may take charge of, and act
as, the responsible manager of a third-party logistics provider
upon application by the third-party logistics provider and
approval by the board. A responsible manager who ceases to act
as the responsible manager at that entity shall notify the board in
writing within 30 days of the date of that change in status.
4103. Blood Pressure―Taking by Pharmacist
Notwithstanding Section 2038, or any other provision of law, a
pharmacist may take a person's blood pressure and may inform
the person of the results, render an opinion as to whether the
reading is within a high, low, or normal range, and may advise
the person to consult a physician of the person's choice.
Pharmacists rendering this service shall utilize commonly
accepted community standards in rendering opinions and
referring patients to physicians. Enforcement of this section is
vested in the Board of Pharmacy of the State of California. Any
pharmacist who performs this service shall not be in violation of
Section 2052.
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