Bill Text: CA SB493 | 2013-2014 | Regular Session | Chaptered
Bill Title: Pharmacy practice.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2013-10-01 - Chaptered by Secretary of State. Chapter 469, Statutes of 2013. [SB493 Detail]
Download: California-2013-SB493-Chaptered.html
BILL NUMBER: SB 493 CHAPTERED
BILL TEXT
CHAPTER 469
FILED WITH SECRETARY OF STATE OCTOBER 1, 2013
APPROVED BY GOVERNOR OCTOBER 1, 2013
PASSED THE SENATE SEPTEMBER 12, 2013
PASSED THE ASSEMBLY SEPTEMBER 11, 2013
AMENDED IN ASSEMBLY SEPTEMBER 6, 2013
AMENDED IN ASSEMBLY SEPTEMBER 3, 2013
AMENDED IN ASSEMBLY AUGUST 19, 2013
AMENDED IN ASSEMBLY AUGUST 5, 2013
AMENDED IN SENATE MAY 28, 2013
AMENDED IN SENATE APRIL 24, 2013
AMENDED IN SENATE APRIL 1, 2013
INTRODUCED BY Senator Hernandez
FEBRUARY 21, 2013
An act to amend Sections 733, 4040, 4050, 4051, 4052, 4052.3,
4060, 4076, 4111, and 4174 of, and to add Sections 4016.5, 4052.6,
4052.8, 4052.9, 4210, and 4233 to, the Business and Professions Code,
relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 493, Hernandez. Pharmacy practice.
The Pharmacy Law provides for the licensing and regulation of
pharmacists by the California State Board of Pharmacy in the
Department of Consumer Affairs. The law specifies the functions
pharmacists are authorized to perform, including to administer,
orally or topically, drugs and biologicals pursuant to a prescriber's
order, and to administer immunizations pursuant to a protocol with a
prescriber. Pharmacists may also furnish emergency contraception
drug therapy pursuant to standardized procedures if they have
completed a training program. A violation of the Pharmacy Law is a
crime.
This bill, instead, would authorize a pharmacist to administer
drugs and biological products that have been ordered by a prescriber.
The bill would authorize pharmacists to perform other functions,
including, among other things, to furnish self-administered hormonal
contraceptives, nicotine replacement products, and prescription
medications not requiring a diagnosis that are recommended for
international travelers, as specified. Additionally, the bill would
authorize pharmacists to order and interpret tests for the purpose of
monitoring and managing the efficacy and toxicity of drug therapies,
and to independently initiate and administer routine vaccinations,
as specified. This bill also would establish board recognition for an
advanced practice pharmacist, as defined, would specify the criteria
for that recognition, and would specify additional functions that
may be performed by an advanced practice pharmacist, including, among
other things, performing patient assessments, and certain other
functions, as specified. The bill would authorize the board, by
regulation, to set the fee for the issuance and renewal of advanced
practice pharmacist recognition at the reasonable cost of regulating
advanced practice pharmacists pursuant to these provisions, not to
exceed $300.
Because a violation of these provisions would be a crime, the
bill would impose a state-mandated local program.
The bill would make other conforming and technical changes.
This bill would incorporate additional changes in Section 4076 of
the Business and Professions Code proposed by SB 205, that would
become operative only if SB 205 and this bill are both chaptered and
become effective on or before January 1, 2014, and this bill is
chaptered last.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 733 of the Business and Professions Code is
amended to read:
733. (a) A licentiate shall not obstruct a patient in obtaining a
prescription drug or device that has been legally prescribed or
ordered for that patient. A violation of this section constitutes
unprofessional conduct by the licentiate and shall subject the
licentiate to disciplinary or administrative action by his or her
licensing agency.
(b) Notwithstanding any other law, a licentiate shall dispense
drugs and devices, as described in subdivision (a) of Section 4024,
pursuant to a lawful order or prescription unless one of the
following circumstances exists:
(1) Based solely on the licentiate's professional training and
judgment, dispensing pursuant to the order or the prescription is
contrary to law, or the licentiate determines that the prescribed
drug or device would cause a harmful drug interaction or would
otherwise adversely affect the patient's medical condition.
(2) The prescription drug or device is not in stock. If an order,
other than an order described in Section 4019, or prescription cannot
be dispensed because the drug or device is not in stock, the
licentiate shall take one of the following actions:
(A) Immediately notify the patient and arrange for the drug or
device to be delivered to the site or directly to the patient in a
timely manner.
(B) Promptly transfer the prescription to another pharmacy known
to stock the prescription drug or device that is near enough to the
site from which the prescription or order is transferred, to ensure
the patient has timely access to the drug or device.
(C) Return the prescription to the patient and refer the patient.
The licentiate shall make a reasonable effort to refer the patient to
a pharmacy that stocks the prescription drug or device that is near
enough to the referring site to ensure that the patient has timely
access to the drug or device.
(3) The licentiate refuses on ethical, moral, or religious grounds
to dispense a drug or device pursuant to an order or prescription. A
licentiate may decline to dispense a prescription drug or device on
this basis only if the licentiate has previously notified his or her
employer, in writing, of the drug or class of drugs to which he or
she objects, and the licentiate's employer can, without creating
undue hardship, provide a reasonable accommodation of the licentiate'
s objection. The licentiate's employer shall establish protocols that
ensure that the patient has timely access to the prescribed drug or
device despite the licentiate's refusal to dispense the prescription
or order. For purposes of this section, "reasonable accommodation"
and "undue hardship" shall have the same meaning as applied to those
terms pursuant to subdivision (l) of Section 12940 of the Government
Code.
(c) For the purposes of this section, "prescription drug or device"
has the same meaning as the definition in Section 4022.
(d) This section applies to emergency contraception drug therapy
and self-administered hormonal contraceptives described in Section
4052.3.
(e) This section imposes no duty on a licentiate to dispense a
drug or device pursuant to a prescription or order without payment
for the drug or device, including payment directly by the patient or
through a third-party payer accepted by the licentiate or payment of
any required copayment by the patient.
(f) The notice to consumers required by Section 4122 shall include
a statement that describes patients' rights relative to the
requirements of this section.
SEC. 2. Section 4016.5 is added to the Business and Professions
Code, to read:
4016.5. "Advanced practice pharmacist" means a licensed
pharmacist who has been recognized as an advanced practice pharmacist
by the board, pursuant to Section 4210. A board-recognized advanced
practice pharmacist is entitled to practice advanced practice
pharmacy, as described in Section 4052.6, within or outside of a
licensed pharmacy as authorized by this chapter.
SEC. 3. Section 4040 of the Business and Professions Code is
amended to read:
4040. (a) "Prescription" means an oral, written, or electronic
transmission order that is both of the following:
(1) Given individually for the person or persons for whom ordered
that includes all of the following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the
directions for use.
(C) The date of issue.
(D) Either rubber stamped, typed, or printed by hand or typeset,
the name, address, and telephone number of the prescriber, his or her
license classification, and his or her federal registry number, if a
controlled substance is prescribed.
(E) A legible, clear notice of the condition or purpose for which
the drug is being prescribed, if requested by the patient or
patients.
(F) If in writing, signed by the prescriber issuing the order, or
the certified nurse-midwife, nurse practitioner, physician assistant,
or naturopathic doctor who issues a drug order pursuant to Section
2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
who issues a drug order pursuant to Section 4052.1, 4052.2, or
4052.6.
(2) Issued by a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
if a drug order is issued pursuant to Section 2746.51, 2836.1,
3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
physician assistant, or naturopathic doctor licensed in this state,
or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist
licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the
prescriber for a dangerous drug, except for any Schedule II
controlled substance, that contains at least the name and signature
of the prescriber, the name and address of the patient in a manner
consistent with paragraph (2) of subdivision (a) of Section 11164 of
the Health and Safety Code, the name and quantity of the drug
prescribed, directions for use, and the date of issue may be treated
as a prescription by the dispensing pharmacist as long as any
additional information required by subdivision (a) is readily
retrievable in the pharmacy. In the event of a conflict between this
subdivision and Section 11164 of the Health and Safety Code, Section
11164 of the Health and Safety Code shall prevail.
(c) "Electronic transmission prescription" includes both image and
data prescriptions. "Electronic image transmission prescription"
means any prescription order for which a facsimile of the order is
received by a pharmacy from a licensed prescriber. "Electronic data
transmission prescription" means any prescription order, other than
an electronic image transmission prescription, that is electronically
transmitted from a licensed prescriber to a pharmacy.
(d) The use of commonly used abbreviations shall not invalidate an
otherwise valid prescription.
(e) Nothing in the amendments made to this section (formerly
Section 4036) at the 1969 Regular Session of the Legislature shall be
construed as expanding or limiting the right that a chiropractor,
while acting within the scope of his or her license, may have to
prescribe a device.
SEC. 4. Section 4050 of the Business and Professions Code is
amended to read:
4050. (a) In recognition of and consistent with the decisions of
the appellate courts of this state, the Legislature hereby declares
the practice of pharmacy to be a profession.
(b) Pharmacy practice is a dynamic, patient-oriented health
service that applies a scientific body of knowledge to improve and
promote patient health by means of appropriate drug use, drug-related
therapy, and communication for clinical and consultative purposes.
Pharmacy practice is continually evolving to include more
sophisticated and comprehensive patient care activities.
(c) The Legislature further declares that pharmacists are health
care providers who have the authority to provide health care
services.
SEC. 5. Section 4051 of the Business and Professions Code is
amended to read:
4051. (a) Except as otherwise provided in this chapter, it is
unlawful for any person to manufacture, compound, furnish, sell, or
dispense a dangerous drug or dangerous device, or to dispense or
compound a prescription pursuant to Section 4040 of a prescriber
unless he or she is a pharmacist under this chapter.
(b) Notwithstanding any other law, a pharmacist may authorize the
initiation of a prescription, pursuant to Section 4052.1, 4052.2,
4052.3, or 4052.6, and otherwise provide clinical advice, services,
information, or patient consultation, as set forth in this chapter,
if all of the following conditions are met:
(1) The clinical advice, services, information, or patient
consultation is provided to a health care professional or to a
patient.
(2) The pharmacist has access to prescription, patient profile, or
other relevant medical information for purposes of patient and
clinical consultation and advice.
(3) Access to the information described in paragraph (2) is secure
from unauthorized access and use.
SEC. 6. Section 4052 of the Business and Professions Code is
amended to read:
4052. (a) Notwithstanding any other law, a pharmacist may:
(1) Furnish a reasonable quantity of compounded drug product to a
prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer drugs and biological products that have been
ordered by a prescriber.
(4) Perform procedures or functions in a licensed health care
facility as authorized by Section 4052.1.
(5) Perform procedures or functions as part of the care provided
by a health care facility, a licensed home health agency, a licensed
clinic in which there is a physician oversight, a provider who
contracts with a licensed health care service plan with regard to the
care or services provided to the enrollees of that health care
service plan, or a physician, as authorized by Section 4052.2.
(6) Perform procedures or functions as authorized by Section
4052.6.
(7) Manufacture, measure, fit to the patient, or sell and repair
dangerous devices, or furnish instructions to the patient or the
patient's representative concerning the use of those devices.
(8) Provide consultation, training, and education to patients
about drug therapy, disease management, and disease prevention.
(9) Provide professional information, including clinical or
pharmacological information, advice, or consultation to other health
care professionals, and participate in multidisciplinary review of
patient progress, including appropriate access to medical records.
(10) Furnish the medications described in subparagraph (A) in
accordance with subparagraph (B):
(A) (1) Emergency contraception drug therapy and self-administered
hormonal contraceptives, as authorized by Section 4052.3.
(2) Nicotine replacement products, as authorized by Section
4052.9.
(3) Prescription medications not requiring a diagnosis that are
recommended by the federal Centers for Disease Control and Prevention
for individuals traveling outside of the United States.
(B) The pharmacist shall notify the patient's primary care
provider of any drugs or devices furnished to the patient, or enter
the appropriate information in a patient record system shared with
the primary care provider, as permitted by that primary care
provider. If the patient does not have a primary care provider, the
pharmacist shall provide the patient with a written record of the
drugs or devices furnished and advise the patient to consult a
physician of the patient's choice.
(11) Administer immunizations pursuant to a protocol with a
prescriber.
(12) Order and interpret tests for the purpose of monitoring and
managing the efficacy and toxicity of drug therapies. A pharmacist
who orders and interprets tests pursuant to this paragraph shall
ensure that the ordering of those tests is done in coordination with
the patient's primary care provider or diagnosing prescriber, as
appropriate, including promptly transmitting written notification to
the patient's diagnosing prescriber or entering the appropriate
information in a patient record system shared with the prescriber,
when available and as permitted by that prescriber.
(b) A pharmacist who is authorized to issue an order to initiate
or adjust a controlled substance therapy pursuant to this section
shall personally register with the federal Drug Enforcement
Administration.
(c) This section does not affect the applicable requirements of
law relating to either of the following:
(1) Maintaining the confidentiality of medical records.
(2) The licensing of a health care facility.
SEC. 7. Section 4052.3 of the Business and Professions Code is
amended to read:
4052.3. (a) (1) Notwithstanding any other law, a pharmacist may
furnish self-administered hormonal contraceptives in accordance with
standardized procedures or protocols developed and approved by both
the board and the Medical Board of California in consultation with
the American Congress of Obstetricians and Gynecologists, the
California Pharmacists Association, and other appropriate entities.
The standardized procedure or protocol shall require that the patient
use a self-screening tool that will identify patient risk factors
for use of self-administered hormonal contraceptives, based on the
current United States Medical Eligibility Criteria (USMEC) for
Contraceptive Use developed by the federal Centers for Disease
Control and Prevention, and that the pharmacist refer the patient to
the patient's primary care provider or, if the patient does not have
a primary care provider, to nearby clinics, upon furnishing a
self-administered hormonal contraceptive pursuant to this
subdivision, or if it is determined that use of a self-administered
hormonal contraceptive is not recommended.
(2) The board and the Medical Board of California are both
authorized to ensure compliance with this subdivision, and each board
is specifically charged with the enforcement of this subdivision
with respect to its respective licensees. This subdivision does not
expand the authority of a pharmacist to prescribe any prescription
medication.
(b) (1) Notwithstanding any other law, a pharmacist may furnish
emergency contraception drug therapy in accordance with either of the
following:
(A) Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.
(B) Standardized procedures or protocols developed and approved by
both the board and the Medical Board of California in consultation
with the American Congress of Obstetricians and Gynecologists, the
California Pharmacists Association, and other appropriate entities.
The board and the Medical Board of California are both authorized to
ensure compliance with this clause, and each board is specifically
charged with the enforcement of this provision with respect to its
respective licensees. This subdivision does not expand the authority
of a pharmacist to prescribe any prescription medication.
(2) Prior to performing a procedure authorized under this
subdivision, a pharmacist shall complete a training program on
emergency contraception that consists of at least one hour of
approved continuing education on emergency contraception drug
therapy.
(3) A pharmacist, pharmacist's employer, or pharmacist's agent
shall not directly charge a patient a separate consultation fee for
emergency contraception drug therapy services initiated pursuant to
this subdivision, but may charge an administrative fee not to exceed
ten dollars ($10) above the retail cost of the drug. Upon an oral,
telephonic, electronic, or written request from a patient or
customer, a pharmacist or pharmacist's employee shall disclose the
total retail price that a consumer would pay for emergency
contraception drug therapy. As used in this paragraph, total retail
price includes providing the consumer with specific information
regarding the price of the emergency contraception drugs and the
price of the administrative fee charged. This limitation is not
intended to interfere with other contractually agreed-upon terms
between a pharmacist, a pharmacist's employer, or a pharmacist's
agent, and a health care service plan or insurer. Patients who are
insured or covered and receive a pharmacy benefit that covers the
cost of emergency contraception shall not be required to pay an
administrative fee. These patients shall be required to pay
copayments pursuant to the terms and conditions of their coverage.
This paragraph shall become inoperative for dedicated emergency
contraception drugs if these drugs are reclassified as
over-the-counter products by the federal Food and Drug
Administration.
(4) A pharmacist shall not require a patient to provide
individually identifiable medical information that is not specified
in Section 1707.1 of Title 16 of the California Code of Regulations
before initiating emergency contraception drug therapy pursuant to
this subdivision.
(c) For each emergency contraception drug therapy or
self-administered hormonal contraception initiated pursuant to this
section, the pharmacist shall provide the recipient of the drug with
a standardized factsheet that includes, but is not limited to, the
indications and contraindications for use of the drug, the
appropriate method for using the drug, the need for medical followup,
and other appropriate information. The board shall develop this form
in consultation with the State Department of Public Health, the
American Congress of Obstetricians and Gynecologists, the California
Pharmacists Association, and other health care organizations. This
section does not preclude the use of existing publications developed
by nationally recognized medical organizations.
SEC. 8. Section 4052.6 is added to the Business and Professions
Code, to read:
4052.6. (a) A pharmacist recognized by the board as an advanced
practice pharmacist may do all of the following:
(1) Perform patient assessments.
(2) Order and interpret drug therapy-related tests.
(3) Refer patients to other health care providers.
(4) Participate in the evaluation and management of diseases and
health conditions in collaboration with other health care providers.
(5) Initiate, adjust, or discontinue drug therapy in the manner
specified in paragraph (4) of subdivision (a) of Section 4052.2.
(b) A pharmacist who adjusts or discontinues drug therapy shall
promptly transmit written notification to the patient's diagnosing
prescriber or enter the appropriate information in a patient record
system shared with the prescriber, as permitted by that prescriber. A
pharmacist who initiates drug therapy shall promptly transmit
written notification to, or enter the appropriate information into, a
patient record system shared with the patient's primary care
provider or diagnosing provider, as permitted by that provider.
(c) This section shall not interfere with a physician's order to
dispense a prescription drug as written, or other order of similar
meaning.
(d) Prior to initiating or adjusting a controlled substance
therapy pursuant to this section, a pharmacist shall personally
register with the federal Drug Enforcement Administration.
(e) A pharmacist who orders and interprets tests pursuant to
paragraph (2) of subdivision (a) shall ensure that the ordering of
those tests is done in coordination with the patient's primary care
provider or diagnosing prescriber, as appropriate, including promptly
transmitting written notification to the patient's diagnosing
prescriber or entering the appropriate information in a patient
record system shared with the prescriber, when available and as
permitted by that prescriber.
SEC. 9. Section 4052.8 is added to the Business and Professions
Code, to read:
4052.8. (a) In addition to the authority provided in paragraph
(11) of subdivision (a) of Section 4052, a pharmacist may
independently initiate and administer vaccines listed on the routine
immunization schedules recommended by the federal Advisory Committee
on Immunization Practices (ACIP), in compliance with individual ACIP
vaccine recommendations, and published by the federal Centers for
Disease Control and Prevention (CDC) for persons three years of age
and older.
(b) In order to initiate and administer an immunization described
in subdivision (a), a pharmacist shall do all of the following:
(1) Complete an immunization training program endorsed by the CDC
or the Accreditation Council for Pharmacy Education that, at a
minimum, includes hands-on injection technique, clinical evaluation
of indications and contraindications of vaccines, and the recognition
and treatment of emergency reactions to vaccines, and shall maintain
that training.
(2) Be certified in basic life support.
(3) Comply with all state and federal recordkeeping and reporting
requirements, including providing documentation to the patient's
primary care provider and entering information in the appropriate
immunization registry designated by the immunization branch of the
State Department of Public Health.
(c) A pharmacist administering immunizations pursuant to this
section, or paragraph (11) of subdivision (a) of Section 4052, may
also initiate and administer epinephrine or diphenhydramine by
injection for the treatment of a severe allergic reaction.
SEC. 10. Section 4052.9 is added to the Business and Professions
Code, to read:
4052.9. (a) A pharmacist may furnish nicotine replacement
products approved by the federal Food and Drug Administration for use
by prescription only in accordance with standardized procedures and
protocols developed and approved by both the board and the Medical
Board of California in consultation with other appropriate entities
and provide smoking cessation services if all of the following
conditions are met:
(1) The pharmacist maintains records of all prescription drugs and
devices furnished for a period of at least three years for purposes
of notifying other health care providers and monitoring the patient.
(2) The pharmacist notifies the patient's primary care provider of
any drugs or devices furnished to the patient, or enters the
appropriate information in a patient record system shared with the
primary care provider, as permitted by that primary care provider. If
the patient does not have a primary care provider, the pharmacist
provides the patient with a written record of the drugs or devices
furnished and advises the patient to consult a physician of the
patient's choice.
(3) The pharmacist is certified in smoking cessation therapy by an
organization recognized by the board.
(4) The pharmacist completes one hour of continuing education
focused on smoking cessation therapy biennially.
(b) The board and the Medical Board of California are both
authorized to ensure compliance with this section, and each board is
specifically charged with the enforcement of this section with
respect to their respective licensees. Nothing in this section shall
be construed to expand the authority of a pharmacist to prescribe any
other prescription medication.
SEC. 11. Section 4060 of the Business and Professions Code is
amended to read:
4060. 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, 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.
SEC. 12. Section 4076 of the Business and Professions Code is
amended to read:
4076. (a) A pharmacist shall not dispense any 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 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 any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(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 his or her scope of practice.
SEC. 12.5. Section 4076 of the Business and Professions Code is
amended to read:
4076. (a) A pharmacist shall not dispense any 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 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 any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(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
health facility, as defined in 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 his or her scope of practice.
(e) This section shall remain in effect only until January 1,
2016, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2016, deletes or extends
that date.
SEC. 12.7. Section 4076 is added to the Business and Professions
Code, to read:
4076. (a) A pharmacist shall not dispense any 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 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 any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(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) The information required by paragraphs (1), (2), (3), (7), and
(10) of subdivision (a) shall be printed in at least a 12-point
typeface.
(c) 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.
(d) If a pharmacist dispenses a dangerous drug or device in a
health facility, as defined in 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.
(e) 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 his or her scope of practice.
(f) This section shall become operative on January 1, 2016.
SEC. 13. Section 4111 of the Business and Professions Code is
amended to read:
4111. (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.
(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.
SEC. 14. Section 4174 of the Business and Professions Code is
amended to read:
4174. Notwithstanding any other law, a pharmacist may dispense
drugs or devices upon the drug order of a nurse practitioner
functioning pursuant to Section 2836.1 or a certified nurse-midwife
functioning pursuant to Section 2746.51, a drug order of a physician
assistant functioning pursuant to Section 3502.1 or a naturopathic
doctor functioning pursuant to Section 3640.5, or the order of a
pharmacist acting under Section 4052.1, 4052.2, 4052.3, or 4052.6.
SEC. 15. Section 4210 is added to the Business and Professions
Code, to read:
4210. (a) A person who seeks recognition as an advanced practice
pharmacist shall meet all of the following requirements:
(1) Hold an active license to practice pharmacy issued pursuant to
this chapter that is in good standing.
(2) Satisfy any two of the following criteria:
(A) Earn certification in a relevant area of practice, including,
but not limited to, ambulatory care, critical care, geriatric
pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology
pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric
pharmacy, from an organization recognized by the Accreditation
Council for Pharmacy Education or another entity recognized by the
board.
(B) Complete a postgraduate residency through an accredited
postgraduate institution where at least 50 percent of the experience
includes the provision of direct patient care services with
interdisciplinary teams.
(C) Have provided clinical services to patients for at least one
year under a collaborative practice agreement or protocol with a
physician, advanced practice pharmacist, pharmacist practicing
collaborative drug therapy management, or health system.
(3) File an application with the board for recognition as an
advanced practice pharmacist.
(4) Pay the applicable fee to the board.
(b) An advanced practice pharmacist recognition issued pursuant to
this section shall be valid for two years, coterminous with the
certificate holder's license to practice pharmacy.
(c) The board shall adopt regulations establishing the means of
documenting completion of the requirements in this section.
(d) The board shall, by regulation, set the fee for the issuance
and renewal of advanced practice pharmacist recognition at the
reasonable cost of regulating advanced practice pharmacists pursuant
to this chapter. The fee shall not exceed three hundred dollars
($300).
SEC. 16. Section 4233 is added to the Business and Professions
Code, to read:
4233. A pharmacist who is recognized as an advanced practice
pharmacist shall complete 10 hours of continuing education each
renewal cycle in addition to the requirements of Section 4231. The
subject matter shall be in one or more areas of practice relevant to
the pharmacist's clinical practice.
SEC. 17. Sections 12.5 and 12.7 of this bill incorporate
amendments to Section 4076 of the Business and Professions Code
proposed by both this bill and Senate Bill 205. They shall only
become operative if (1) both bills are enacted and become effective
on or before January 1, 2014, (2) each bill amends Section 4076 of
the Business and Professions Code, and (3) this bill is enacted after
Senate Bill 205, in which case Section 12 of this bill shall not
become operative.
SEC. 18. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
