California Senate Bill SB538 Amended / Bill

 BILL NUMBER: SB 538AMENDED BILL TEXT AMENDED IN SENATE APRIL 16, 2015 AMENDED IN SENATE APRIL 6, 2015 INTRODUCED BY Senator Block  (   Coauthor:   Senator   Hueso   )  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.  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.  This bill would revise and recast those provisions and would expressly authorize a naturopathic doctor  to order, perform, review, and interpret the results of diagnostic procedures commonly used by physicians and surgeons in general practice and  to dispense, administer, order, prescribe, provide, furnish, or perform parenteral therapy and minor  procedures, among other duties.   procedures.   The bill would include cervical routes of administration among the authorized routes of administration.  The bill would define terms for those purposes.  The bill would authorize a naturopathic doctor to use   a cervical route of administration only for the purpose of administering barrier contraception.  (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  furnishing, prescribing, administering, or ordering   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 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.   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,   that is not classified.  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  training as determined by the committee,   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,  and furnish   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.   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.   (5) Parenteral therapy.   (6) Minor procedures.  (d) A naturopathic doctor may utilize routes of administration that include oral, nasal, auricular, ocular, rectal, vaginal, transdermal, intradermal, subcutaneous, intravenous, and intramuscular.  A naturopathic doctor may utilize a cervical route of administration only for the purpose of administering barrier contraception.  (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).  (g) For purposes of this section, the following terms have the following meanings:   (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.   (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.  Nothing   (a)     Except as set forth in this section, nothing  in this chapter or any other provision of law shall be construed to prohibit a naturopathic doctor from  furnishing or ordering   administering, furnishing, ordering, or prescribing  drugs when  all of the following apply:   functioning pursuant to this section.   (a) The drugs are furnihsed or ordered  (b)     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  by a naturopathic doctor in accordance with standardized procedures or protocols developed by the naturopathic doctor and his or her supervising physician and surgeon.  (b)   (c)  The naturopathic doctor  is functioning   shall function  pursuant to  a  standardized procedure, as defined by  subdivisions (a), (b), (d), (e), (h), and (i) of Section 2836.1 and paragraph (1) of subdivision (c) of Section 2836.1,   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.  (c)   (d)  The standardized procedure or protocol covering the  furnishing   administering, furnishing, ordering, or prescribing  of  Schedule III  drugs shall specify which naturopathic doctors may  furnish or order   administer, furnish, order, or prescribe Schedule III  drugs, which  Schedule III  drugs may be furnished or ordered   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.  (d)   (e)  The  furnishing or ordering   administering, furnishing, ordering, or prescribing  of  Schedule III  drugs by a naturopathic doctor  occurs   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: (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.  (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.   (e)   (g)  For purposes of this section, a physician and surgeon shall not supervise more than four naturopathic doctors at one time.  (f) Drugs furnished or ordered   (h)     Notwithstanding subdivision (c), drugs administered, furnished, ordered, or prescribed  by a naturopathic doctor  may   without the supervision of a physician and surgeon shall  include Schedule  III   IV 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  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.   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.   (g)   (i)  The committee  has certified   shall certify  that the naturopathic doctor has satisfactorily completed adequate coursework in pharmacology covering the drugs to be  furnished or ordered   administered, furnished, ordered, or prescribed  under this section. The committee shall establish the requirements for satisfactory completion of this subdivision.  (h)   (j)  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:   following for Schedule III controlled substances.  (1) Ordering a drug in accordance with the standardized procedure. (2) Transmitting an order of a supervising physician and surgeon.  (i)   (k)  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.  (j)   (l)  Notwithstanding any other  provision of  law,  all of  the following  shall  apply: (1) A  Schedule III  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.  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.