BILL NUMBER: AB 1306 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MAY 28, 2015
INTRODUCED BY Assembly Member Burke
( Coauthor: Assembly Member
Mark Stone )
FEBRUARY 27, 2015
An act to amend Sections 650.01, 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 amended, 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. This bill would also prohibit corpor
ations and other artificial legal entities from having
professional rights, privileges, or powers under the act, except as
specified.
(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 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
(6) Existing law prohibits a licensee, as defined, from referring
a person for laboratory, diagnostic, nuclear medicine, radiation
oncology, physical therapy, physical rehabilitation, psychometric
testing, home infusion therapy, or diagnostic imaging goods or
services if the licensee or his or her immediate family has a
financial interest with the person or entity that receives the
referral, and makes a violation of that prohibition punishable as a
misdemeanor. Under existing law the Medical Board of California is
required to review the facts and circumstances of any conviction for
violating the prohibition, and to take appropriate disciplinary
action if the licensee has committed unprofessional conduct.
This bill would include a certified nurse-midwife under the
definition of a licensee, which would expand the scope of an existing
crime and therefore impose a state-mandated local program. The bill
would also require the Board of Registered Nursing to review the
facts and circumstances of any conviction of a certified
nurse-midwife for violating that prohibition, and would require the
board to take appropriate disciplinary action if the certified
nurse-midwife has committed unprofessional conduct.
(7) 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 650.01 of the
Business and Professions Code is amended to read:
650.01. (a) Notwithstanding Section 650, or any other
provision of law, it is unlawful for a licensee to refer a
person for laboratory, diagnostic nuclear medicine, radiation
oncology, physical therapy, physical rehabilitation, psychometric
testing, home infusion therapy, or diagnostic imaging goods or
services if the licensee or his or her immediate family has a
financial interest with the person or in the entity that receives the
referral.
(b) For purposes of this section and Section 650.02, the following
shall apply:
(1) "Diagnostic imaging" includes, but is not limited to, all
X-ray, computed axial tomography, magnetic resonance imaging nuclear
medicine, positron emission tomography, mammography, and ultrasound
goods and services.
(2) A "financial interest" includes, but is not limited to, any
type of ownership interest, debt, loan, lease, compensation,
remuneration, discount, rebate, refund, dividend, distribution,
subsidy, or other form of direct or indirect payment, whether in
money or otherwise, between a licensee and a person or entity to whom
the licensee refers a person for a good or service specified in
subdivision (a). A financial interest also exists if there is an
indirect financial relationship between a licensee and the referral
recipient including, but not limited to, an arrangement whereby a
licensee has an ownership interest in an entity that leases property
to the referral recipient. Any financial interest transferred by a
licensee to any person or entity or otherwise established in any
person or entity for the purpose of avoiding the prohibition of this
section shall be deemed a financial interest of the licensee. For
purposes of this paragraph, "direct or indirect payment" shall not
include a royalty or consulting fee received by a physician and
surgeon who has completed a recognized residency training program in
orthopedics from a manufacturer or distributor as a result of his or
her research and development of medical devices and techniques for
that manufacturer or distributor. For purposes of this paragraph,
"consulting fees" means those fees paid by the manufacturer or
distributor to a physician and surgeon who has completed a recognized
residency training program in orthopedics only for his or her
ongoing services in making refinements to his or her medical devices
or techniques marketed or distributed by the manufacturer or
distributor, if the manufacturer or distributor does not own or
control the facility to which the physician is referring the patient.
A "financial interest" shall not include the receipt of capitation
payments or other fixed amounts that are prepaid in exchange for a
promise of a licensee to provide specified health care services to
specified beneficiaries. A "financial interest" shall not include the
receipt of remuneration by a medical director of a hospice, as
defined in Section 1746 of the Health and Safety Code, for specified
services if the arrangement is set out in writing, and specifies all
services to be provided by the medical director, the term of the
arrangement is for at least one year, and the compensation to be paid
over the term of the arrangement is set in advance, does not exceed
fair market value, and is not determined in a manner that takes into
account the volume or value of any referrals or other business
generated between parties.
(3) For the purposes of this section, "immediate family" includes
the spouse and children of the licensee, the parents of the licensee,
and the spouses of the children of the licensee.
(4) "Licensee" means a physician as defined in Section 3209.3 of
the Labor Code. Code, and a certified
nurse-midwife as defined in Article 2.5 (commencing with Section
2746) of Chapter 6 of Division 2 of the Business and Professions
Code.
(5) "Licensee's office" means either of the following:
(A) An office of a licensee in solo practice.
(B) An office in which services or goods are personally provided
by the licensee or by employees in that office, or personally by
independent contractors in that office, in accordance with other
provisions of law. Employees and independent contractors shall be
licensed or certified when licensure or certification is required by
law.
(6) "Office of a group practice" means an office or offices in
which two or more licensees are legally organized as a partnership,
professional corporation, or not-for-profit corporation, licensed
pursuant to subdivision (a) of Section 1204 of the Health and Safety
Code, for which all of the following apply:
(A) Each licensee who is a member of the group provides
substantially the full range of services that the licensee routinely
provides, including medical care, consultation, diagnosis, or
treatment through the joint use of shared office space, facilities,
equipment, and personnel.
(B) Substantially all of the services of the licensees who are
members of the group are provided through the group and are billed in
the name of the group and amounts so received are treated as
receipts of the group, except in the case of a multispecialty clinic,
as defined in subdivision ( l ) of Section 1206 of the
Health and Safety Code, physician services are billed in the name of
the multispecialty clinic and amounts so received are treated as
receipts of the multispecialty clinic.
(C) The overhead expenses of, and the income from, the practice
are distributed in accordance with methods previously determined by
members of the group.
(c) It is unlawful for a licensee to enter into an arrangement or
scheme, such as a cross-referral arrangement, that the licensee
knows, or should know, has a principal purpose of ensuring referrals
by the licensee to a particular entity that, if the licensee directly
made referrals to that entity, would be in violation of this
section.
(d) No claim for payment shall be presented by an entity to any
individual, third party payer, or other entity for a good or service
furnished pursuant to a referral prohibited under this section.
(e) No insurer, self-insurer, or other payer shall pay a charge or
lien for any good or service resulting from a referral in violation
of this section.
(f) A licensee who refers a person to, or seeks consultation from,
an organization in which the licensee has a financial interest,
other than as prohibited by subdivision (a), shall disclose the
financial interest to the patient, or the parent or legal guardian of
the patient, in writing, at the time of the referral or request for
consultation.
(1) If a referral, billing, or other solicitation is between one
or more licensees who contract with a multispecialty clinic pursuant
to subdivision ( l ) of Section 1206 of the Health and
Safety Code or who conduct their practice as members of the same
professional corporation or partnership, and the services are
rendered on the same physical premises, or under the same
professional corporation or partnership name, the requirements of
this subdivision may be met by posting a conspicuous disclosure
statement at the registration area or by providing a patient with a
written disclosure statement.
(2) If a licensee is under contract with the Department of
Corrections or the California Youth Authority, and the patient is an
inmate or parolee of either respective department, the requirements
of this subdivision shall be satisfied by disclosing financial
interests to either the Department of Corrections or the California
Youth Authority.
(g) A violation of subdivision (a) shall be a misdemeanor.
The In the case of a licensee who is a
physician, the Medical Board of California shall review the
facts and circumstances of any conviction pursuant to subdivision (a)
and take appropriate disciplinary action if the licensee has
committed unprofessional conduct. In the case of a licensee who
is a certified nurse-midwife, the Board of Registered Nursing shall
review the facts and circumstances of any conviction pursuant to
subdivision (a) and take appropriate disciplinary action if the
licensee has committed unprofessional conduct. Violations of
this section may also be subject to civil penalties of up to five
thousand dollars ($5,000) for each offense, which may be enforced by
the Insurance Commissioner, Attorney General, or a district attorney.
A violation of subdivision (c), (d), or (e) is a public offense and
is punishable upon conviction by a fine not exceeding fifteen
thousand dollars ($15,000) for each violation and appropriate
disciplinary action, including revocation of professional licensure,
by the Medical Board of California
California, the Board of Registered Nursing, or other
appropriate governmental agency.
(h) This section shall not apply to referrals for services that
are described in and covered by Sections 139.3 and 139.31 of the
Labor Code.
(i) This section shall become operative on January 1, 1995.
SECTION 1. SEC. 2. Section 2725.1 of
the Business and Professions Code is amended to read:
2725.1. (a) Notwithstanding any other 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 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) This section shall not 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) This section shall not 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. SEC. 3. Section 2746.2 of
the Business and Professions Code is amended to read:
2746.2. (a) Each applicant shall show by evidence satisfactory to
the board that he or she has met the educational standards
established by the board or has at least the equivalent thereof,
including evidence of current advanced level national certification
by a certifying body that meets standards established and approved by
the board.
(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.
(c) Corporations and other artificial legal entities shall have no
professional rights, privileges, or powers. However, the Board of
Registered Nursing may in its discretion, after such investigation
and review of such documentary evidence as it may require, and under
regulations adopted by it, grant approval of the employment of
licensees on a salary basis by licensed charitable institutions,
foundations, or clinics, if no charge for professional services
rendered patients is made by any such institution, foundation, or
clinic.
SEC. 3. SEC. 4. Section 2746.5 of
the Business and Professions Code is amended to read:
2746.5. (a) The certificate to practice nurse-midwifery
authorizes the 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.
(b) As used in this chapter, the practice of nurse-midwifery
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.
(c) A certified nurse-midwife is not authorized to practice
medicine and surgery by the provisions of this chapter.
(d) 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. SEC. 5. Section 2746.51 of
the Business and Professions Code is amended to read:
2746.51. (a) Neither this chapter nor any other 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 the drugs or devices are
furnished or ordered related to the provision of any of the
following:
(1) Family planning services, as defined in Section 14503 of the
Welfare and Institutions Code.
(2) Routine health care or perinatal care, as defined in
subdivision (d) of Section 123485 of the Health and Safety Code.
(3) 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.
(4) Care rendered in a home pursuant to subdivision (a) of Section
2746.5.
(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.
(3) Certified nurse-midwives who are certified by the board and
hold an active furnishing number, who are currently authorized 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) when
the drugs and devices are furnished or ordered in accordance with
requirements referenced in paragraphs (1) to (3), inclusive, of
subdivision (b).
(d) Furnishing of drugs or devices by a certified nurse-midwife
means the act of making a pharmaceutical agent or agents available to
the patient.
(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 law, (1) a drug order issued pursuant to this section shall be
treated in the same manner as a prescription of a 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.
(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.
SEC. 5. SEC. 6. Section 2746.52 of
the Business and Professions Code is amended to read:
2746.52. (a) 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, in a licensed alternate birth center, as defined in paragraph
(4) of subdivision (b) of Section 1204 of the Health and Safety Code,
and in a home pursuant to subdivision (a) of Section 2746.5.
(b) The certified nurse-midwife performing and repairing
first-degree and second-degree lacerations of the perineum shall do
both 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,
nurse-midwife, or provide emergency care for
times when a physician and surgeon is not available.
SEC. 6. SEC. 7. 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. SEC. 8. Section 4061 of the
Business and Professions Code is amended to read:
4061. (a) A manufacturer's sales representative shall not
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 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. SEC. 9. 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 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 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 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. SEC. 10. Section 4170 of the
Business and Professions Code is amended to read:
4170. (a) A prescriber shall not 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 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. SEC. 11. 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.