Amended in Assembly August 15, 2016

Amended in Assembly August 4, 2016

Amended in Assembly June 29, 2016

Amended in Assembly August 17, 2015

Amended in Assembly July 7, 2015

Amended in Senate April 16, 2015

Amended in Senate April 6, 2015

Senate Bill No. 538

Introduced by Senator Hueso

(Principal coauthor: Senator Block)

(Coauthor: Senator Stone)

(Coauthor: Assembly Member Nazarian)

February 26, 2015

An act to amend Sections 3640, 3640.5, and 3640.7 of the Business and Professions Code, relating to naturopathic doctors.

LEGISLATIVE COUNSEL’S DIGEST

SB 538, as amended, Hueso. Naturopathic doctors.

(1) Existing law, the Naturopathic Doctors Act, provides for the licensure and regulation of naturopathic doctors by the Naturopathic Medicine Committee in the Osteopathic Medical Board of California. Existing law authorizes a naturopathic doctor to perform certain tasks, including physical and laboratory examinations for diagnostic purposes and to order diagnostic imaging studies, consistent with naturopathic training as determined by the committee. Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling.

This bill would, instead, authorize a naturopathic doctor to perform certain tasks, consistent with the practice of naturopathic medicine, and would additionally authorize a naturopathic doctor to dispense, administer, order, prescribe, provide, or furnish devices and durable medical equipment consistent with the naturopathic training as determined by the committee.

(2) Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitation generally placed on controlled substances classified in Schedule V.

Existing law states that nothing in the Naturopathic Doctors Act or any other law shall be construed to prohibit a naturopathic doctor from furnishing or ordering drugs when, among other requirements, the naturopathic doctor is functioning pursuant to standardized procedure, as defined, or protocol developed and approved, as specified, and the Naturopathic Medicine Committee has certified that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be furnished or ordered. Existing law requires that the furnishing or ordering of drugs by a naturopathic doctor occur under the supervision of a physician and surgeon. Existing law also authorizes a naturopathic doctor to furnish or order controlled substances classified in Schedule III, IV, or V of the California Uniform Controlled Substances Act, but limits this authorization to those drugs agreed upon by the naturopathic doctor and physician and surgeon as specified in the standardized procedure. Existing law further requires that drugs classified in Schedule III be furnished or ordered in accordance with a patient-specific protocol approved by the treating or supervising physician.

This bill would instead provide that, except as specified, nothing in the provisions governing naturopathic doctors or any other law shall be construed to prohibit a naturopathic doctor from administering, furnishing, ordering, or prescribing drugs and would make a conforming change to the scope of the certification duties of the Naturopathic Medicine Committee. The bill would delete certain provisions described above restricting the authority of naturopathic doctors to furnish or order begin delete drugs, including the requirements that the naturopathic doctor function pursuant to a standardized procedure, or furnish or order drugs under the supervision of a physician and surgeon for Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled “for prescription only,” except chemotherapeutics, that is not classified. The bill would require the period of supervision of a naturopathic doctor for the administering, furnishing, ordering, or prescribing of Schedule III and Schedule IV drugs to be 12 months, after which the naturopathic doctor would be authorized to prescribe independently. The bill would waive from that supervision requirement a naturopathic doctor who has completed a residency program, as specified, or who has practiced for at least 12 months in another state where independent prescribing is within a naturopathic doctor’s scope of practice. end delete begin insert drugs. The bill would authorize a naturopathic doctor to administer, furnish, order, or prescribe Schedule III and Schedule IV controlled substances pursuant to a standardized procedure or protocol and under the supervision of a physician and surgeon, as specified. end insert

(3) Existing law, notwithstanding any provision of the Naturopathic Doctors Act, authorizes a naturopathic doctor to independently prescribe and administer certain things, including, among others, epinephrine to treat anaphylaxis.

This bill would begin delete additionally end delete authorize a naturopathic doctor to independently begin delete prescribe and administer all legend drugs and end delete begin insert administer, furnish, order, or prescribe end insert Schedule V controlled substances begin delete after 12 months of supervision, residency, or practice in a state that allows a naturopathic doctor to prescribe medications independently. end delete begin insert and any drug approved by the federal Food and Drug Administration and labeled “for prescription only,” except chemotherapeutics, that is not classified, after the completion of 12 months of physician and surgeon supervision, as specified, and would waive that supervision requirement for a naturopathic doctor who has completed a residency program, as specified, or who has a license in good standing and practiced for at least 12 months in another state where independent prescribing is within a naturopathic doctor’s scope of practice in that other state. end insert

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

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

SECTION 1.  

Section 3640 of the Business and Professions
Code is amended to read:

3640.  

(a) A naturopathic doctor may order and perform
physical and laboratory examinations for diagnostic purposes,
including, but not limited to, phlebotomy, clinical laboratory tests,
speculum examinations, orificial examinations, and physiological
function tests.

(b) A naturopathic doctor may order diagnostic imaging studies,
including X-ray, ultrasound, mammogram, bone densitometry,
and others, consistent with the practice of naturopathic medicine,
but shall refer the studies to an appropriately licensed health care
professional to conduct the study and interpret the results.

(c) A naturopathic doctor may dispense, administer, order,
prescribe, provide, furnish, or perform the following:

(1) Food, extracts of food, nutraceuticals, vitamins, amino acids,
minerals, enzymes, botanicals and their extracts, botanical
medicines, homeopathic medicines, all dietary supplements and
nonprescription drugs as defined by the Federal Food, Drug, and
Cosmetic Act, consistent with the routes of administration
identified in subdivision (d).

(2) Hot or cold hydrotherapy; naturopathic physical medicine
inclusive of the manual use of massage, stretching, resistance, or
joint play examination but exclusive of small amplitude movement
at or beyond the end range of normal joint motion; electromagnetic
energy; colon hydrotherapy; and therapeutic exercise.

(3) Devices, including, but not limited to, therapeutic devices,
barrier contraception, and durable medical equipment consistent
with the naturopathic training as determined by the committee.

(4) Health education and health counseling.

(5) Repair and care incidental to superficial lacerations and
abrasions, except suturing.

(6) Removal of foreign bodies located in the superficial tissues.

(d) A naturopathic doctor may utilize routes of administration
that include oral, nasal, auricular, ocular, rectal, vaginal,
transdermal, intradermal, subcutaneous, intravenous, and
intramuscular.

(e) The committee may establish regulations regarding ocular
or intravenous routes of administration that are consistent with the
education and training of a naturopathic doctor.

(f) This section shall not exempt a naturopathic doctor from
meeting applicable licensure requirements for the performance of
clinical laboratory tests, including the requirements imposed under
Chapter 3 (commencing with Section 1200).

SEC. 2.  

Section 3640.5 of the Business and Professions Code
is amended to read:

3640.5.  

(a) Except as set forth in this section, nothing in this
chapter or any other law shall be construed to prohibit a
naturopathic doctor from administering, furnishing, ordering, or
prescribing drugs when functioning pursuant to this section.

(b) Schedule III and Schedule IV controlled substances under
the California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety Code)
shall be administered, furnished, ordered, and prescribed by a
naturopathic doctor in accordance with standardized procedures
or protocols developed by the naturopathic doctor and his or her
supervising physician and surgeon.

(c) The naturopathic doctor shall function pursuant to a
standardized procedure, as defined by paragraphs (1) and (2) of
subdivision (c) of Section 2725, or protocol. The standardized
procedure or protocol shall be developed and approved by the
supervising physician and surgeon, the naturopathic doctor, and,
where applicable, the facility administrator or his or her designee.

(d) The standardized procedure or protocol covering the
administering, furnishing, ordering, or prescribing of Schedule III
and Schedule IV drugs shall specify which naturopathic doctors
may administer, furnish, order, or prescribe Schedule III and
Schedule IV drugs, which Schedule III through Schedule IV drugs
may be administered, furnished, ordered, or prescribed and under
what circumstances, the extent of physician and surgeon
supervision, the method of periodic review of the naturopathic
doctor’s competence, including peer review, which shall be subject
to the reporting requirement in Section 805, and review of the
provisions of the standardized procedure.

(e)  begin delete (1) end delete begin delete   end delete The administering, furnishing, ordering, or prescribing
of Schedule III and Schedule IV drugs by a naturopathic doctor
shall occur under physician and surgeon supervision. Physician
and surgeon supervision shall not be construed to require the
physical presence of the physician, but does include all of the
following:

begin delete

(A)

end delete

begin insert (1) end insert  Collaboration on the development of the standardized
procedure.

begin delete

(B)

end delete

begin insert (2) end insert  Approval of the standardized procedure.

begin delete

(C)

end delete

begin insert (3) end insert  Availability by telephonic contact at the time of patient
examination by the naturopathic doctor.

begin delete

(2) The period of supervision under this subdivision shall last
12 months, after which the naturopathic doctor may prescribe
independently.

end delete begin delete

(3) The supervision requirement under this subdivision shall be
waived if either:

end delete begin delete

(A) The naturopathic doctor has completed a residency program
of at least 12 months that is approved by the National Council on
Naturopathic Medical Education or any other agency approved by
the committee.

end delete begin delete

(B) The naturopathic doctor has practiced for at least 12 months
in another state where independent prescribing is within the scope
of practice of a naturopathic doctor.

end delete

(f) When Schedule III controlled substances, as defined in
Section 11056 of the Health and Safety Code, are administered,
furnished, ordered, or prescribed by a naturopathic doctor, the
controlled substances shall be administered, furnished, ordered,
or prescribed in accordance with a patient-specific protocol
approved by the treating or supervising physician. A copy of the
section of the naturopathic doctor’s standardized procedure or
protocol relating to controlled substances shall be provided, upon
request, to a licensed pharmacist who dispenses drugs when there
is uncertainty about the naturopathic doctor furnishing the order.

(g) For purposes of this section, a physician and surgeon shall
not supervise more than four naturopathic doctors at one time.

begin delete

(h) Notwithstanding subdivision (c), drugs administered,
furnished, ordered, or prescribed by a naturopathic doctor without
the supervision of a physician and surgeon shall include Schedule
V controlled substances under the California Uniform Controlled
Substances Act (Division 10 (commencing with Section 11000)
of the Health and Safety Code) and any drug approved by the
federal Food and Drug Administration and labeled “for prescription
only” or words of similar import, except chemotherapeutics, that
is not classified.

end delete begin delete

(i)

end delete

begin insert (h) end insert  The committee shall certify that the naturopathic doctor has
satisfactorily completed adequate coursework in pharmacology
covering the drugs to be administered, furnished, ordered, or
prescribed under this section. The committee shall establish the
requirements for satisfactory completion of this subdivision.

begin delete

(j)

end delete

begin insert (i) end insert  Use of the term “furnishing” in this section, in health facilities
defined in subdivisions (b), (c), (d), (e), and (i) of Section 1250 of
the Health and Safety Code, shall include both of the following
for Schedule III through Schedule IV controlled substances.

(1) Ordering a drug in accordance with the standardized
procedure.

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

begin delete

(k)

end delete

begin insert (j) end insert  For purposes of this section, “drug order” or “order” means
an order for medication which is dispensed to or for an ultimate
user, issued by a naturopathic doctor as an individual practitioner,
within the meaning of Section 1306.02 of Title 21 of the Code of
Federal Regulations.

begin delete

(l)

end delete

begin insert (k) end insert  Notwithstanding any other law, all of the following shall
apply:

(1) A Schedule III through Schedule IV drug order issued
pursuant to this section shall be treated in the same manner as a
prescription of the supervising physician.

(2) All references to prescription in this code and the Health
and Safety Code shall include drug orders issued by naturopathic
doctors.

(3) The signature of a naturopathic doctor 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.

SEC. 3.  

Section 3640.7 of the Business and Professions Code
is amended to read:

3640.7.  

begin insert (a) end insert begin insert   end insert Notwithstanding the requirements of Section
3640.5 or any other provision of this chapter, a naturopathic doctor
may independently prescribe and administer the following:

begin delete

(a)

end delete

begin insert (1) end insert  Epinephrine to treat anaphylaxis.

begin delete

(b)

end delete

begin insert (2) end insert  Natural and synthetic hormones.

begin delete

(c)

end delete

begin insert (3) end insert  Vitamins, minerals, amino acids, glutathione, botanicals and
their extracts, homeopathic medicines, electrolytes, sugars, and
diluents that may be administered utilizing routes of administration,
pursuant to subdivision (d) of Section 3640, only when such
substances are chemically identical to those for sale without a
prescription.

begin delete

(d) All legend drugs and Schedule V controlled substances after
12 months of supervision, residency, or practice in another state
that allows a naturopathic doctor to prescribe medications
independently.

end delete begin insert

(b) (1) A naturopathic doctor may independently administer,
furnish, order, or prescribe Schedule V controlled substances
under the California Uniform Controlled Substances Act (Division
10 (commencing with Section 11000) of the Health and Safety
Code) and any drug approved by the federal Food and Drug
Administration and labeled “for prescription only” or words of
similar import, except chemotherapeutics, that is not classified,
after the completion of 12 consecutive months of supervision by a
physician and surgeon for the substances and drugs specified in
this subdivision. The supervision required by this subdivision shall
follow the same procedures or protocols as those described in
Section 3640.5 for other prescription medications.

end insert begin insert

(2) The supervision requirement under this subdivision shall be
waived if either:

end insert begin insert

(A) The naturopathic doctor has completed a residency program
of at least 12 months that is approved by the Council on
Naturopathic Medical Education or any other agency approved
by the committee.

end insert begin insert

(B) The naturopathic doctor has a license in good standing and
has practiced for at least 12 months in another state where
independent prescribing of the substances and drugs described in
this chapter is permitted for a licensed naturopathic doctor in that
other state.

end insert