Amended in Senate April 16, 2015

Amended in Senate April 6, 2015

Senate Bill No. 538

Introduced by Senator Block

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(Coauthor: Senator Hueso)

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February 26, 2015

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

LEGISLATIVE COUNSEL’S DIGEST

SB 538, as amended, Block. 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, as specified. begin insert Under the act, a naturopathic doctor is authorized to dispense, administer, order, prescribe, furnish, or perform certain things, including health education and health counseling. The act also authorizes a naturopathic doctor to utilize routes of administration that include, among others, intramuscular. end insert

This bill would revise and recast those provisions and would expressly authorize a naturopathic doctor begin delete to order, perform, review, and interpret the results of diagnostic procedures commonly used by physicians and surgeons in general practice and end delete to dispense, administer, order, prescribe, provide, furnish, or perform parenteral therapy and minor begin delete procedures, among other duties. end delete begin insert procedures. end insert begin delete The bill would include cervical routes of administration among the authorized routes of administration. end delete The bill would define terms for those purposes. begin insert The bill would authorize a naturopathic doctor to use a cervical route of administration only for the purpose of administering barrier contraception. end insert

(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 begin delete furnishing, prescribing, administering, or ordering end delete begin insert administering, furnishing, ordering, or prescribing end insert 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 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 begin delete surgeon. end delete begin insert surgeon for Schedule IV through Schedule V controlled substances and for any drug approved by the federal Food and Drug Administration and labeled “for prescription only,” except chemotherapeutics, end insert begin insert that is not classified. 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:

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begin insert SECTION 1. end insert   

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

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 begin insert the practice of end insert naturopathic begin delete training as
determined by the committee, end delete begin insert medicine, end insert 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, begin delete and furnish end delete begin insert provide, furnish, end insert 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 begin delete equipment. end delete begin insert equipment
consistent with the naturopathic training as determined by the
committee. end insert

(4) Health education and health counseling.

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

end delete begin delete

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

end delete begin insert

(5) Parenteral therapy.

end insert begin insert

(6) Minor procedures.

end insert

(d) A naturopathic doctor may utilize routes of administration
that include oral, nasal, auricular, ocular, rectal, vaginal,
transdermal, intradermal, subcutaneous, intravenous, and
intramuscular. begin insert A naturopathic doctor may utilize a cervical route
of administration only for the purpose of administering barrier
contraception. end insert

(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) Nothing in this section shall 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).

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(g) For purposes of this section, the following terms have the
following meanings:

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(1) “Minor procedures” means care and operative procedures
relative to superficial lacerations, superficial clinically benign
lesions less than one centimeter and not located on the face, and
superficial abrasions, and the removal of foreign bodies located
in superficial structures and the topical and parenteral use of
substances consistent with the practice of naturopathic medicine,
in accordance with rules established by the Naturopathic Medicine
Committee. A naturopathic doctor may obtain samples of
superficial human tissue by means of shave, punch, or excisional
biopsy consistent with the practice of naturopathic medicine.
“Minor procedures” does not include general or spinal anesthesia,
sclerotherapy, or procedures involving the eye.

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(2) “Parenteral therapy” means the administration of
substances by means other than through the gastrointestinal tract,
including intravenous, subcutaneous, intramuscular, and other
areas of the body, excluding the ventral and dorsal body cavities.

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begin insert SEC. 2. end insert   

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

3640.5.  

begin delete Nothing end delete begin insert (a) end insert begin insert   end insert begin insert Except as set forth in this section, nothing end insert
in this chapter or any other provision of law shall be construed to
prohibit a naturopathic doctor from begin delete furnishing or ordering end delete
begin insert administering, furnishing, ordering, or prescribing end insert drugs when
begin delete all of the following apply: end delete begin insert functioning pursuant to this section. end insert

begin delete

(a) The drugs are furnihsed or ordered

end delete

begin insert (b) end insert begin insert   end insert begin insert Schedule III 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 end insert by a naturopathic
doctor in accordance with standardized procedures or protocols
developed by the naturopathic doctor and his or her supervising
physician and surgeon.

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(b)

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begin insert (c) end insert  The naturopathic doctor begin delete is functioning end delete begin insert shall function end insert pursuant
to begin insert a end insert standardized procedure, as defined by begin delete subdivisions (a), (b),
(d), (e), (h), and (i) of Section 2836.1 and paragraph (1) of
subdivision (c) of Section 2836.1, end delete begin insert paragraphs (1) and (2) of
subdivision (c) of Section 2725, end insert 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.

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(c)

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

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(d)

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begin insert (e) end insert  The begin delete furnishing or ordering end delete begin insert administering, furnishing,
ordering, or prescribing end insert of begin insert Schedule III end insert drugs by a naturopathic
doctor begin delete occurs end delete begin insert shall occur end insert 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:

(1) Collaboration on the development of the standardized
procedure.

(2) Approval of the standardized procedure.

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

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(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.

end insert begin delete

(e)

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

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(f) Drugs furnished or ordered

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begin insert (h) end insert begin insert   end insert begin insert Notwithstanding subdivision (c), drugs administered,
furnished, ordered, or prescribed end insert by a naturopathic doctor begin delete may end delete
begin insert without the supervision of a physician and surgeon shall end insert include
Schedule begin delete III end delete begin insert IV end insert through Schedule V controlled substances under
the California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety Code)
and begin delete shall be further limited to those drugs agreed upon by the
naturopathic doctor and physician and surgeon as specified in the
standardized procedure. When Schedule III controlled substances,
as defined in Section 11056 of the Health and Safety Code, are
furnished or ordered by a naturopathic doctor, the controlled
substances shall be furnished or ordered 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 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. end delete begin insert 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 insert

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(g)

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

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(h)

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begin insert (j) 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 begin delete following: end delete
begin insert following for Schedule III controlled substances. end insert

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

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

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(i)

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begin insert (k) 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.

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(j)

end delete

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

(1) A begin insert Schedule III end insert 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.

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SECTION 1.  

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

3640.  

(a) A naturopathic doctor may order, perform, review,
and interpret the results of diagnostic procedures commonly used
by physicians and surgeons in general practice, including:

(1) Venipuncture.

(2) Physical and orificial examinations.

(3) Electrocardiograms.

(4) Diagnostic imaging technique consistent with the practice
of naturopathic medicine.

(5) Phlebotomy.

(6) Clinical laboratory test and examinations, as described in
subdivision (e).

(7) Obtaining samples of human tissue, consistent with the
practice of naturopathic medicine.

(b) 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 naturopathic training as determined by the committee.

(4) Health education and health counseling.

(5) Parenteral therapy.

(6) Minor procedures.

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

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

(e) Nothing in this section shall 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).

(f) For purposes of this section:

(1) “Minor procedures” means care and operative procedures
relative to superficial laceration, lesions, and abrasions, and the
removal of foreign bodies located in superficial structures and
aspiration of joints, and the topical and parenteral use of substances
consistent with the practice of naturopathic medicine, in accordance
with rules established by the Naturopathic Medicine Committee.

(2) “Parenteral therapy” means the administration of substances
by means other than through the gastrointestinal tract, including
intravenous, subcutaneous, intramuscular, and other areas of the
body excluding the ventral and dorsal body cavities.

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 furnishing, prescribing, administering,
or ordering drugs.

(b) Drugs furnished or ordered by a naturopathic doctor may
include Schedule III through 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 that is not classified and labeled “for prescription
only” or words of similar import.

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

(d) 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 ordering and
furnishing a drug.

(e) 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.

(f) Notwithstanding any other provision of law, both of the
following shall apply:

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

(2) 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.

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