California Legislature—2015–16 Regular Session

Assembly Bill No. 1306

Introduced by Assembly Member Burke

February 27, 2015

An act to amend Sections 2725.1, 2746.2, 2746.5, 2746.51, 2746.52, 4061, 4076, and 4170 of, and to add Section 2746.6 to, the Business and Professions Code, relating to healing arts.

LEGISLATIVE COUNSEL’S DIGEST

AB 1306, as introduced, Burke. Healing arts: certified nurse-midwives: scope of practice.

(1) Existing law, the Nursing Practice Act, provides for the licensure and regulation of the practice of nursing by the Board of Registered Nursing and authorizes the board to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the board or the equivalent of those educational standards. The act makes the violation of any of its provisions a misdemeanor punishable upon conviction by imprisonment in the county jail for not less than 10 days nor more than one year, or by a fine of not less than $20 nor more than $1,000, or by both that fine and imprisonment.

This bill would additionally require an applicant for a certificate to practice nurse-midwifery to provide evidence of current advanced level national certification by a certifying body that meets standards established and approved by the board. This bill would also require the board to create and appoint a Nurse-Midwifery Advisory Council consisting of certified nurse-midwives in good standing with experience in hospital and nonhospital practice settings, a nurse-midwife educator, as specified, and a consumer of midwifery care. This bill would require the council to make recommendations to the board on all matters related to nurse-midwifery practice, education, and other matters specified by the board, and would require the council to meet regularly, but at least twice a year.

(2) The act authorizes a certified nurse-midwife, under the supervision of a licensed physician and surgeon, to attend cases of normal childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother, and immediate care for the newborn, and provides that the practice of nurse-midwifery constitutes the furthering or undertaking by a certified person, under the supervision of a licensed physician and surgeon who has current practice or training in obstetrics, to assist a woman in childbirth so long as progress meets criteria accepted as normal.

This bill would delete those provisions and would instead authorize a certified nurse-midwife to manage a full range of primary health care services for women from adolescence beyond menopause, including, but not limited to, gynecologic and family planning services. The bill would authorize a certified nurse-midwife to practice in all settings, including, but not limited to, a home. This bill would declare that the practice of nurse-midwifery within a health care system provides for consultation, collaboration, or referral as indicated by the health status of the client and the resources of the medical personnel available in the setting of care, and would provide that the practice of nurse-midwifery emphasizes informed consent, preventive care and early detection and referral of complications to a physician and surgeon. This bill would authorize a certified nurse-midwife to provide peripartum care in an out-of-hospital setting to low-risk women with uncomplicated singleton-term pregnancies who are expected to have uncomplicated birth.

(3) The act authorizes a certified nurse-midwife to furnish and order drugs or devices incidentally to the provision of family planning services, routine health care or perinatal care, and care rendered consistently with the certified nurse-midwife’s educational preparation in specified facilities and clinics, and only in accordance with standardized procedures and protocols, as specified.

This bill would delete the requirement that drugs or devices are furnished or ordered in accordance with standardized procedures and protocols. The bill would authorize a certified nurse-midwife to furnish and order drugs or devices in connection with care rendered in a home, and would authorize a certified nurse-midwife to directly procure supplies and devices, to order, obtain, and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to his or her practice as a certified nurse-midwife and that are consistent with nurse-midwifery education preparation.

(4) The act also authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a licensed acute care hospital and a licensed alternate birth center, if certain requirements are met, including, but not limited to, that episiotomies are performed pursuant to protocols developed and approved by the supervising physician and surgeon.

This bill would also authorize a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and 2nd-degree lacerations of the perineum in a patient’s home, and would delete all requirements that those procedures be performed pursuant to protocols developed and approved by the supervising physician and surgeon. The bill would require a certified nurse-midwife to provide emergency care to a patient during times when a physician and surgeon is unavailable.

This bill would provide that a consultative relationship between a certified nurse-midwife and a physician and surgeon by it self is not a basis for finding the physician and surgeon liable for any acts or omissions on the part of the certified nurse-midwife. The bill would also update cross-references as needed.

(5) Because the act makes a violation of any of its provisions a misdemeanor, this bill would expand the scope of an existing crime and therefore this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

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

SECTION 1.  

Section 2725.1 of the Business and Professions
Code is amended to read:

2725.1.  

(a) Notwithstanding any other begin delete provision of end delete law, a
registered nurse may dispense drugs or devices upon an order by
a licensed physician and surgeon or an order by a certified
nurse-midwife, nurse practitioner, or physician assistant issued
pursuant to Section 2746.51, 2836.1, or 3502.1, respectively, if
the registered nurse is functioning within a licensed primary care
clinic as defined in subdivision (a) of Section 1204 of, or within
a clinic as defined in subdivision (b), (c), (h), or (j) of Section 1206
of, the Health and Safety Code.

(b) No clinic shall employ a registered nurse to perform
dispensing duties exclusively. No registered nurse shall dispense
drugs in a pharmacy, keep a pharmacy, open shop, or drugstore
for the retailing of drugs or poisons. No registered nurse shall
compound drugs. Dispensing of drugs by a registered nurse, except
a certified nurse-midwife who functions pursuant to begin delete a standardized
procedure or protocol described in end delete Section 2746.51 or a nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1, or protocol, shall not include
substances included in the California Uniform Controlled
Substances Act (Division 10 (commencing with Section 11000)
of the Health and Safety Code). Nothing in this section shall
exempt a clinic from the provisions of Article 13 (commencing
with Section 4180) of Chapter 9.

(c)  begin delete Nothing in this end delete begin insert This end insert section shall begin insert not end insert be construed to limit
any other authority granted to a certified nurse-midwife pursuant
to Article 2.5 (commencing with Section 2746), to a nurse
practitioner pursuant to Article 8 (commencing with Section 2834),
or to a physician assistant pursuant to Chapter 7.7 (commencing
with Section 3500).

(d)  begin delete Nothing in this end delete begin insert This end insert section shall begin insert not end insert be construed to affect
the sites or types of health care facilities at which drugs or devices
are authorized to be dispensed pursuant to Chapter 9 (commencing
with Section 4000).

SEC. 2.  

Section 2746.2 of the Business and Professions Code
is amended to read:

2746.2.  

begin insert (a) end insert begin insert   end insert Each applicant shall show by evidence satisfactory
to the board that he begin insert or she end insert has met the educational standards
established by the board or has at least the equivalent begin delete thereof. The
board is authorized to appoint a committee of qualified physicians
and nurses, including, but not limited to, obstetricians and
nurse-midwives, to develop the necessary standards relating to
educational requirements, ratios of nurse-midwives to supervising
physicians, and associated matters. end delete begin insert thereof, including evidence of
current advanced level national certification by a certifying body
that meets standards established and approved by the board. end insert

begin insert

(b) The board shall create and appoint a Nurse-Midwifery
Advisory Council consisting of certified nurse-midwives in good
standing with experience in hospital and nonhospital practice
settings, a nurse-midwife educator who has demonstrated
familiarity with consumer needs, collegial practice and
accompanied liability, and related educational standards in the
delivery of maternal-child health care, and a consumer of
midwifery care. The council shall make recommendations to the
board on all matters related to nurse-midwifery practice,
education, and other matters as specified by the board. The council
shall meet regularly, but at least twice a year.

end insert

SEC. 3.  

Section 2746.5 of the Business and Professions Code
is amended to read:

2746.5.  

(a) The certificate to practice nurse-midwifery
authorizes the begin delete holder, under the supervision of a licensed physician
and surgeon, to attend cases of normal childbirth and to provide
prenatal, intrapartum, and postpartum care, including
family-planning care, for the mother, and immediate care for the
newborn. end delete begin insert holder to manage a full range of primary health care
services for women from adolescence to beyond menopause. These
services include, but are not limited to, primary health care,
gynecologic and family planning services, preconception care,
care during pregnancy, childbirth, and the postpartum period,
immediate care of the newborn, and treatment of male partners
for sexually transmitted infections. A certified nurse-midwife is
authorized to practice in all settings, including, but not limited to,
private practice, clinics, hospitals, birth centers, and homes. end insert

(b) As used in this chapter, the practice of nurse-midwifery
begin delete constitutes the furthering or undertaking by any certified person,
under the supervision of a licensed physician and surgeon who has
current practice or training in obstetrics, to assist a woman in
childbirth so long as progress meets criteria accepted as normal.
All complications shall be referred to a physician immediately.
The practice of nurse-midwifery does not include the assisting of
childbirth by any artificial, forcible, or mechanical means, nor the
performance of any version. end delete begin insert within a health care system provides
for consultation, collaboration, or referral as indicated by the
health status of the patient and the resources and medical
personnel available in the setting of care. When providing
peripartum care in out-of-hospital settings, the certified
nurse-midwife shall only provide care to low-risk women with
uncomplicated singleton-term pregnancies who are expected to
have an uncomplicated birth. The practice of nurse-midwifery care
emphasizes informed consent, preventive care, and early detection
and referral of complications to physicians and surgeons. While
practicing in a hospital setting, the certified nurse-midwife shall
collaboratively care for women with more complex health needs. end insert

begin delete

(c) As used in this article, “supervision” shall not be construed
to require the physical presence of the supervising physician.

end delete begin delete

(d)

end delete

begin insert (c) end insert  A certified nurse-midwife is not authorized to practice
medicine and surgery by the provisions of this chapter.

begin delete

(e)

end delete

begin insert (d) end insert  Any regulations promulgated by a state department that
affect the scope of practice of a certified nurse-midwife shall be
developed in consultation with the board.

SEC. 4.  

Section 2746.51 of the Business and Professions Code
is amended to read:

2746.51.  

(a) Neither this chapter nor any other begin delete provision of end delete
law shall be construed to prohibit a certified nurse-midwife from
furnishing or ordering drugs or devices, including controlled
substances classified in Schedule II, III, IV, or V under the
California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety Code),
when begin delete all of the following apply: end delete

begin delete (1) end delete begin delete   end delete begin delete The end delete begin insert the end insert drugs or devices are furnished or ordered begin delete incidentally end delete
begin insert related end insert to the provision of any of the following:

begin delete

(A)

end delete

begin insert (1) end insert  Family planning services, as defined in Section 14503 of
the Welfare and Institutions Code.

begin delete

(B)

end delete

begin insert (2) end insert  Routine health care or perinatal care, as defined in
subdivision (d) of Section 123485 of the Health and Safety Code.

begin delete

(C)

end delete

begin insert (3) end insert  Care rendered, consistent with the certified nurse-midwife’s
educational preparation or for which clinical competency has been
established and maintained, to persons within a facility specified
in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the
Health and Safety Code, a clinic as specified in Section 1204 of
the Health and Safety Code, a general acute care hospital as defined
in subdivision (a) of Section 1250 of the Health and Safety Code,
a licensed birth center as defined in Section 1204.3 of the Health
and Safety Code, or a special hospital specified as a maternity
hospital in subdivision (f) of Section 1250 of the Health and Safety
Code.

begin insert

(4) Care rendered in a home pursuant to subdivision (a) of
Section 2746.5.

end insert begin delete

(2) The drugs or devices are furnished or ordered by a certified
nurse-midwife in accordance with standardized procedures or
protocols. For purposes of this section, standardized procedure
means a document, including protocols, developed and approved
by the supervising physician and surgeon, the certified
nurse-midwife, and the facility administrator or his or her designee.
The standardized procedure covering the furnishing or ordering
of drugs or devices shall specify all of the following:

end delete begin delete

(A) Which certified nurse-midwife may furnish or order drugs
or devices.

end delete begin delete

(B) Which drugs or devices may be furnished or ordered and
under what circumstances.

end delete begin delete

(C) The extent of physician and surgeon supervision.

end delete begin delete

(D) The method of periodic review of the certified
nurse-midwife’s competence, including peer review, and review
of the provisions of the standardized procedure.

end delete begin delete

(3) If Schedule II or III controlled substances, as defined in
Sections 11055 and 11056 of the Health and Safety Code, are
furnished or ordered by a certified nurse-midwife, the controlled
substances shall be furnished or ordered in accordance with a
patient-specific protocol approved by the treating or supervising
physician and surgeon. For Schedule II controlled substance
protocols, the provision for furnishing the Schedule II controlled
substance shall address the diagnosis of the illness, injury, or
condition for which the Schedule II controlled substance is to be
furnished.

end delete begin delete

(4) The furnishing or ordering of drugs or devices by a certified
nurse-midwife occurs under physician and surgeon supervision.
For purposes of this section, no physician and surgeon shall
supervise more than four certified nurse-midwives at one time.
Physician and surgeon supervision shall not be construed to require
the physical presence of the physician, but does include all of the
following:

end delete begin delete

(A) Collaboration on the development of the standardized
procedure or protocol.

end delete begin delete

(B) Approval of the standardized procedure or protocol.

end delete begin delete

(C) Availability by telephonic contact at the time of patient
examination by the certified nurse-midwife.

end delete

(b) (1) The furnishing or ordering of drugs or devices by a
certified nurse-midwife is conditional on the issuance by the board
of a number to the applicant who has successfully completed the
requirements of paragraph (2). The number shall be included on
all transmittals of orders for drugs or devices by the certified
nurse-midwife. The board shall maintain a list of the certified
nurse-midwives that it has certified pursuant to this paragraph and
the number it has issued to each one. The board shall make the list
available to the California State Board of Pharmacy upon its
request. Every certified nurse-midwife who is authorized pursuant
to this section to furnish or issue a drug order for a controlled
substance shall register with the United States Drug Enforcement
Administration.

(2) The board has certified in accordance with paragraph (1)
that the certified nurse-midwife has satisfactorily completed a
course in pharmacology covering the drugs or devices to be
furnished or ordered under this section. The board shall establish
the requirements for satisfactory completion of this paragraph.

begin delete

(3) A physician and surgeon may determine the extent of
supervision necessary pursuant to this section in the furnishing or
ordering of drugs and devices.

end delete begin delete

(4) A copy of the standardized procedure or protocol relating
to the furnishing or ordering of controlled substances by a certified
nurse-midwife shall be provided upon request to any licensed
pharmacist who is uncertain of the authority of the certified
nurse-midwife to perform these functions.

end delete begin delete

(5)

end delete

begin insert (3) end insert  Certified nurse-midwives who are certified by the board and
hold an active furnishing number, who are currently authorized
begin delete through standardized procedures or protocols end delete to furnish Schedule
II controlled substances, and who are registered with the United
States Drug Enforcement Administration shall provide
documentation of continuing education specific to the use of
Schedule II controlled substances in settings other than a hospital
based on standards developed by the board.

(c) Drugs or devices furnished or ordered by a certified
nurse-midwife may include Schedule II controlled substances
under the California Uniform Controlled Substances Act (Division
10 (commencing with Section 11000) of the Health and Safety
Code) begin delete under the following conditions: end delete

begin delete (1) end delete begin delete   end delete begin delete The end delete begin insert when the end insert drugs and devices are furnished or ordered in
accordance with requirements referenced in begin delete paragraphs (2) to (4),
inclusive, of subdivision (a) and in end delete paragraphs (1) to (3), inclusive,
of subdivision (b).

begin delete

(2) When Schedule II controlled substances, as defined in
Section 11055 of the Health and Safety Code, are furnished or
ordered by a certified nurse-midwife, the controlled substances
shall be furnished or ordered in accordance with a patient-specific
protocol approved by the treating or supervising physician and
surgeon.

end delete

(d) Furnishing of drugs or devices by a certified nurse-midwife
means the act of making a pharmaceutical agent or agents available
to the begin delete patient in strict accordance with a standardized procedure
or protocol. Use of the term “furnishing” in this section shall
include the following: end delete begin insert patient. end insert

begin delete

(1) The ordering of a drug or device in accordance with the
standardized procedure or protocol.

(2) Transmitting an order of a supervising physician and
surgeon.

end delete

(e) “Drug order” or “order” for purposes of this section means
an order for medication or for a drug or device that is dispensed
to or for an ultimate user, issued by a certified nurse-midwife as
an individual practitioner, within the meaning of Section 1306.03
of Title 21 of the Code of Federal Regulations. Notwithstanding
any other begin delete provision of end delete law, (1) a drug order issued pursuant to this
section shall be treated in the same manner as a prescription of begin delete the
supervising end delete begin insert a end insert physician; (2) all references to “prescription” in this
code and the Health and Safety Code shall include drug orders
issued by certified nurse-midwives; and (3) the signature of a
certified nurse-midwife on a drug order issued in accordance with
this section shall be deemed to be the signature of a prescriber for
purposes of this code and the Health and Safety Code.

begin insert

(f) A certified nurse-midwife is authorized to directly procure
supplies and devices, to order, obtain, and administer drugs and
diagnostic tests, to order laboratory and diagnostic testing, and
to receive reports that are necessary to his or her practice as a
certified nurse-midwife and consistent with nurse-midwifery
education preparation.

end insert

SEC. 5.  

Section 2746.52 of the Business and Professions Code
is amended to read:

2746.52.  

begin insert (a) end insert begin insert   end insert Notwithstanding Section 2746.5, the certificate
to practice nurse-midwifery authorizes the holder to perform and
repair episiotomies, and to repair first-degree and second-degree
lacerations of the perineum, in a licensed acute care hospital, as
defined in subdivision (a) of Section 1250 of the Health and Safety
Code, begin delete and end delete begin insert in end insert a licensed alternate birth center, as defined in
paragraph (4) of subdivision (b) of Section 1204 of the Health and
Safety Code, begin delete but only if all of the following conditions are met: end delete
begin insert and in a home pursuant to subdivision (a) of Section 2746.5. end insert

begin delete

(a) The supervising physician and surgeon and any backup
physician and surgeon is credentialed to perform obstetrical care
in the facility.

(b) The episiotomies are performed pursuant to protocols
developed and approved by all of the following:

(1) The supervising physician and surgeon.

(2) The certified nurse-midwife.

(3) The director of the obstetrics department or the director of
the family practice department, or both, if a physician and surgeon
in the obstetrics department or the family practice department is
a supervising physician and surgeon, or an equivalent person if
there is no specifically identified obstetrics department or family
practice department.

(4) The interdisciplinary practices committee, if applicable.

(5) The facility administrator or his or her designee.

(c)

end delete

begin insert (b) end insert  The begin delete protocols, and the procedures which shall be developed
pursuant to the protocols, shall relate to the performance and repair
of episiotomies and the repair of end delete begin insert certified nurse-midwife performing
and repairing end insert first-degree and second-degree lacerations of the
begin delete perineum, and end delete begin insert perineum end insert shall do begin delete all end delete begin insert both end insert of the following:

(1) Ensure that all complications are referred to a physician and
surgeon immediately.

(2) Ensure immediate care of patients who are in need of care
beyond the scope of practice of the certified nurse midwife, or
begin insert provide end insert emergency care for times when begin delete the supervising end delete begin insert a end insert physician
and surgeon is not begin delete on the premises. end delete begin insert available. end insert

begin delete

(3) Establish the number of certified nurse-midwives that a
supervising physician and surgeon may supervise.

end delete

SEC. 6.  

Section 2746.6 is added to the Business and Professions
Code, to read:

2746.6.  

A consultative relationship between a certified
nurse-midwife and a physician and surgeon shall not, by it self,
provide the basis for finding a physician and surgeon liable for
any act or omission of the certified nurse-midwife.

SEC. 7.  

Section 4061 of the Business and Professions Code is
amended to read:

4061.  

(a)  begin delete No end delete begin insert A end insert manufacturer’s sales representative shall begin insert not end insert
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 begin delete a standardized procedure or protocol
described in end delete 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.

SEC. 8.  

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 begin delete a standardized procedure or protocol
described in end delete 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 begin delete a standardized
procedure or protocol described in end delete 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 begin delete a standardized procedure
or protocol described in end delete 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. 9.  

Section 4170 of the Business and Professions Code is
amended to read:

4170.  

(a)  begin delete No end delete begin insert A end insert prescriber shall begin insert not end insert dispense drugs or dangerous
devices to patients in his or her office or place of practice unless
all of the following conditions are met:

(1) The dangerous drugs or dangerous devices are dispensed to
the prescriber’s own patient, and the drugs or dangerous devices
are not furnished by a nurse or physician attendant.

(2) The dangerous drugs or dangerous devices are necessary in
the treatment of the condition for which the prescriber is attending
the patient.

(3) The prescriber does not keep a pharmacy, open shop, or
drugstore, advertised or otherwise, for the retailing of dangerous
drugs, dangerous devices, or poisons.

(4) The prescriber fulfills all of the labeling requirements
imposed upon pharmacists by Section 4076, all of the
recordkeeping requirements of this chapter, and all of the packaging
requirements of good pharmaceutical practice, including the use
of childproof containers.

(5) The prescriber does not use a dispensing device unless he
or she personally owns the device and the contents of the device,
and personally dispenses the dangerous drugs or dangerous devices
to the patient packaged, labeled, and recorded in accordance with
paragraph (4).

(6) The prescriber, prior to dispensing, offers to give a written
prescription to the patient that the patient may elect to have filled
by the prescriber or by any pharmacy.

(7) The prescriber provides the patient with written disclosure
that the patient has a choice between obtaining the prescription
from the dispensing prescriber or obtaining the prescription at a
pharmacy of the patient’s choice.

(8) A certified nurse-midwife who functions pursuant to begin delete a
standardized procedure or protocol described in end delete 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 Section 3502.1, or a
naturopathic doctor who functions pursuant to Section 3640.5,
may hand to a patient of the supervising physician and surgeon a
properly labeled prescription drug prepackaged by a physician and
surgeon, a manufacturer as defined in this chapter, or a pharmacist.

(b) The Medical Board of California, the State Board of
Optometry, the Bureau of Naturopathic Medicine, the Dental Board
of California, the Osteopathic Medical Board of California, the
Board of Registered Nursing, the Veterinary Medical Board, and
the Physician Assistant Committee shall have authority with the
California State Board of Pharmacy to ensure compliance with
this section, and those boards are specifically charged with the
enforcement of this chapter with respect to their respective
licensees.

(c) “Prescriber,” as used in this section, means a person, who
holds a physician’s and surgeon’s certificate, a license to practice
optometry, a license to practice naturopathic medicine, a license
to practice dentistry, a license to practice veterinary medicine, or
a certificate to practice podiatry, and who is duly registered by the
Medical Board of California, the State Board of Optometry, the
Bureau of Naturopathic Medicine, the Dental Board of California,
the Veterinary Medical Board, or the Board of Osteopathic
Examiners of this state.

SEC. 10.  

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.