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H.B. 108 Enrolled

             1     

HORMONE RESTORATION AMENDMENTS

             2     
2009 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Douglas C. Aagard

             5     
Senate Sponsor: Dennis E. Stowell

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends the Utah Controlled Substances Act and the Naturopathic Physician
             10      Practice Act to permit a naturopathic physician to, pursuant to a license issued by the
             11      Division of Occupational and Professional Licensing, prescribe or administer
             12      testosterone in specified forms for the purpose of restoring a low testosterone level to a
             13      normal level.
             14      Highlighted Provisions:
             15          This bill:
             16          .    adds "naturopathic physician" to the definition of "practitioner" in the Utah
             17      Controlled Substances Act in order to allow a naturopathic physician to prescribe
             18      only testosterone, in the form and for the purposes described in this bill;
             19          .    requires a naturopathic physician to keep a record of testosterone:
             20              .    received by the naturopathic physician; and
             21              .    administered, dispensed, or professionally used by the naturopathic physician,
             22      other than by a prescription;
             23          .    permits a naturopathic physician to prescribe or administer testosterone, pursuant
             24      to the requirements of federal and state law, if the testosterone is:
             25              .    bio-identical;
             26              .    designed to be administered topically, for transdermal absorption or
             27                  designed to be absorbed across the mucosal membranes of the mouth; and
             28              .    prescribed solely for the purpose of treating a patient with a low testosterone
             29      level in order to restore the patient to a normal testosterone level;


             30          .    provides that the provisions of Title 58, Chapter 71, Naturopathic Physician
             31      Practice Act, do not mandate health insurance coverage for the prescription or
             32      administration of testosterone by a naturopathic physician; and
             33          .    makes technical changes.
             34      Monies Appropriated in this Bill:
             35          None
             36      Other Special Clauses:
             37          None
             38      Utah Code Sections Affected:
             39      AMENDS:
             40          58-37-2, as last amended by Laws of Utah 2008, Chapter 382
             41          58-37-6, as last amended by Laws of Utah 2008, Chapters 3 and 382
             42          58-71-102, as last amended by Laws of Utah 2008, Chapter 382
             43          58-71-804, as enacted by Laws of Utah 1996, Chapter 282
             44     
             45      Be it enacted by the Legislature of the state of Utah:
             46          Section 1. Section 58-37-2 is amended to read:
             47           58-37-2. Definitions.
             48          (1) As used in this chapter:
             49          (a) "Administer" means the direct application of a controlled substance, whether by
             50      injection, inhalation, ingestion, or any other means, to the body of a patient or research subject
             51      by:
             52          (i) a practitioner or, in the practitioner's presence, by the practitioner's authorized
             53      agent; or
             54          (ii) the patient or research subject at the direction and in the presence of the
             55      practitioner.
             56          (b) "Agent" means an authorized person who acts on behalf of or at the direction of a
             57      manufacturer, distributor, or practitioner but does not include a motor carrier, public


             58      warehouseman, or employee of any of them.
             59          (c) "Consumption" means ingesting or having any measurable amount of a controlled
             60      substance in a person's body, but this Subsection (1)(c) does not include the metabolite of a
             61      controlled substance.
             62          (d) "Continuing criminal enterprise" means any individual, sole proprietorship,
             63      partnership, corporation, business trust, association, or other legal entity, and any union or
             64      groups of individuals associated in fact although not a legal entity, and includes illicit as well
             65      as licit entities created or maintained for the purpose of engaging in conduct which constitutes
             66      the commission of episodes of activity made unlawful by Title 58, Chapters 37, 37a, 37b, 37c,
             67      or 37d, which episodes are not isolated, but have the same or similar purposes, results,
             68      participants, victims, methods of commission, or otherwise are interrelated by distinguishing
             69      characteristics. Taken together, the episodes shall demonstrate continuing unlawful conduct
             70      and be related either to each other or to the enterprise.
             71          (e) "Control" means to add, remove, or change the placement of a drug, substance, or
             72      immediate precursor under Section 58-37-3 .
             73          (f) (i) "Controlled substance" means a drug or substance included in Schedules I, II,
             74      III, IV, or V of Section 58-37-4 , and also includes a drug or substance included in Schedules I,
             75      II, III, IV, or V of the federal Controlled Substances Act, Title II, P.L. 91-513, or any
             76      controlled substance analog.
             77          (ii) "Controlled substance" does not include:
             78          (A) distilled spirits, wine, or malt beverages, as those terms are defined or used in Title
             79      32A, Alcoholic Beverage Control Act, regarding tobacco or food;
             80          (B) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
             81      prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,
             82      norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
             83      transferred, or furnished as an over-the-counter medication without prescription; or
             84          (C) dietary supplements, vitamins, minerals, herbs, or other similar substances
             85      including concentrates or extracts, which are not otherwise regulated by law, which may


             86      contain naturally occurring amounts of chemical or substances listed in this chapter, or in rules
             87      adopted pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             88          (g) (i) "Controlled substance analog" means a substance the chemical structure of
             89      which is substantially similar to the chemical structure of a controlled substance listed in
             90      Schedules I and II of Section 58-37-4 , or in Schedules I and II of the federal Controlled
             91      Substances Act, Title II, P.L. 91-513:
             92          (A) which has a stimulant, depressant, or hallucinogenic effect on the central nervous
             93      system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central
             94      nervous system of controlled substances in the schedules set forth in Subsection (1)(f); or
             95          (B) which, with respect to a particular individual, is represented or intended to have a
             96      stimulant, depressant, or hallucinogenic effect on the central nervous system substantially
             97      similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of
             98      controlled substances in the schedules set forth in this Subsection (1).
             99          (ii) "Controlled substance analog" does not include:
             100          (A) a controlled substance currently scheduled in Schedules I through V of Section
             101      58-37-4 ;
             102          (B) a substance for which there is an approved new drug application;
             103          (C) a substance with respect to which an exemption is in effect for investigational use
             104      by a particular person under Section 505 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 355,
             105      to the extent the conduct with respect to the substance is permitted by the exemption;
             106          (D) any substance to the extent not intended for human consumption before an
             107      exemption takes effect with respect to the substance;
             108          (E) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
             109      prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,
             110      norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
             111      transferred, or furnished as an over-the-counter medication without prescription; or
             112          (F) dietary supplements, vitamins, minerals, herbs, or other similar substances
             113      including concentrates or extracts, which are not otherwise regulated by law, which may


             114      contain naturally occurring amounts of chemical or substances listed in this chapter, or in rules
             115      adopted pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             116          (h) "Conviction" means a determination of guilt by verdict, whether jury or bench, or
             117      plea, whether guilty or no contest, for any offense proscribed by Title 58, Chapters 37, 37a,
             118      37b, 37c, or 37d, or for any offense under the laws of the United States and any other state
             119      which, if committed in this state, would be an offense under Title 58, Chapters 37, 37a, 37b,
             120      37c, or 37d.
             121          (i) "Counterfeit substance" means:
             122          (i) any substance or container or labeling of any substance that without authorization
             123      bears the trademark, trade name, or other identifying mark, imprint, number, device, or any
             124      likeness of them, of a manufacturer, distributor, or dispenser other than the person or persons
             125      who in fact manufactured, distributed, or dispensed the substance which falsely purports to be
             126      a controlled substance distributed by, any other manufacturer, distributor, or dispenser; or
             127          (ii) any substance that is represented to be a controlled substance.
             128          (j) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a
             129      controlled substance or a listed chemical, whether or not an agency relationship exists.
             130          (k) "Department" means the Department of Commerce.
             131          (l) "Depressant or stimulant substance" means:
             132          (i) a drug which contains any quantity of barbituric acid or any of the salts of
             133      barbituric acid;
             134          (ii) a drug which contains any quantity of:
             135          (A) amphetamine or any of its optical isomers;
             136          (B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or
             137          (C) any substance which the Secretary of Health and Human Services or the Attorney
             138      General of the United States after investigation has found and by regulation designated
             139      habit-forming because of its stimulant effect on the central nervous system;
             140          (iii) lysergic acid diethylamide; or
             141          (iv) any drug which contains any quantity of a substance which the Secretary of


             142      Health and Human Services or the Attorney General of the United States after investigation
             143      has found to have, and by regulation designated as having, a potential for abuse because of its
             144      depressant or stimulant effect on the central nervous system or its hallucinogenic effect.
             145          (m) "Dispense" means the delivery of a controlled substance by a pharmacist to an
             146      ultimate user pursuant to the lawful order or prescription of a practitioner, and includes
             147      distributing to, leaving with, giving away, or disposing of that substance as well as the
             148      packaging, labeling, or compounding necessary to prepare the substance for delivery.
             149          (n) "Dispenser" means a pharmacist who dispenses a controlled substance.
             150          (o) "Distribute" means to deliver other than by administering or dispensing a
             151      controlled substance or a listed chemical.
             152          (p) "Distributor" means a person who distributes controlled substances.
             153          (q) "Division" means the Division of Occupational and Professional Licensing created
             154      in Section 58-1-103 .
             155          (r) "Drug" means:
             156          (i) articles recognized in the official United States Pharmacopoeia, Official
             157      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             158      supplement to any of them;
             159          (ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
             160      of disease in man or other animals;
             161          (iii) articles, other than food, intended to affect the structure or function of man or
             162      other animals; and
             163          (iv) articles intended for use as a component of any articles specified in Subsection
             164      (1)(r)(i), (ii), or (iii); but does not include devices or their components, parts, or accessories.
             165          (s) "Drug dependent person" means any individual who unlawfully and habitually uses
             166      any controlled substance to endanger the public morals, health, safety, or welfare, or who is so
             167      dependent upon the use of controlled substances as to have lost the power of self-control with
             168      reference to the individual's dependency.
             169          (t) "Food" means:


             170          (i) any nutrient or substance of plant, mineral, or animal origin other than a drug as
             171      specified in this chapter, and normally ingested by human beings; and
             172          (ii) foods for special dietary uses as exist by reason of a physical, physiological,
             173      pathological, or other condition including but not limited to the conditions of disease,
             174      convalescence, pregnancy, lactation, allergy, hypersensitivity to food, underweight, and
             175      overweight; uses for supplying a particular dietary need which exist by reason of age including
             176      but not limited to the ages of infancy and childbirth, and also uses for supplementing and for
             177      fortifying the ordinary or unusual diet with any vitamin, mineral, or other dietary property for
             178      use of a food. Any particular use of a food is a special dietary use regardless of the nutritional
             179      purposes.
             180          (u) "Immediate precursor" means a substance which the Attorney General of the
             181      United States has found to be, and by regulation designated as being, the principal compound
             182      used or produced primarily for use in the manufacture of a controlled substance, or which is an
             183      immediate chemical intermediary used or likely to be used in the manufacture of a controlled
             184      substance, the control of which is necessary to prevent, curtail, or limit the manufacture of the
             185      controlled substance.
             186          (v) "Indian" means a member of an Indian tribe.
             187          (w) "Indian religion" means any religion:
             188          (i) the origin and interpretation of which is from within a traditional Indian culture or
             189      community; and
             190          (ii) which is practiced by Indians.
             191          (x) "Indian tribe" means any tribe, band, nation, pueblo, or other organized group or
             192      community of Indians, including any Alaska Native village, which is legally recognized as
             193      eligible for and is consistent with the special programs, services, and entitlements provided by
             194      the United States to Indians because of their status as Indians.
             195          (y) "Manufacture" means the production, preparation, propagation, compounding, or
             196      processing of a controlled substance, either directly or indirectly by extraction from substances
             197      of natural origin, or independently by means of chemical synthesis or by a combination of


             198      extraction and chemical synthesis.
             199          (z) "Manufacturer" includes any person who packages, repackages, or labels any
             200      container of any controlled substance, except pharmacists who dispense or compound
             201      prescription orders for delivery to the ultimate consumer.
             202          (aa) "Marijuana" means all species of the genus cannabis and all parts of the genus,
             203      whether growing or not; the seeds of it; the resin extracted from any part of the plant; and
             204      every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds,
             205      or resin. The term does not include the mature stalks of the plant, fiber produced from the
             206      stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt,
             207      derivative, mixture, or preparation of the mature stalks, except the resin extracted from them,
             208      fiber, oil or cake, or the sterilized seed of the plant which is incapable of germination. Any
             209      synthetic equivalents of the substances contained in the plant cannabis sativa or any other
             210      species of the genus cannabis which are chemically indistinguishable and pharmacologically
             211      active are also included.
             212          (bb) "Money" means officially issued coin and currency of the United States or any
             213      foreign country.
             214          (cc) "Narcotic drug" means any of the following, whether produced directly or
             215      indirectly by extraction from substances of vegetable origin, or independently by means of
             216      chemical synthesis, or by a combination of extraction and chemical synthesis:
             217          (i) opium, coca leaves, and opiates;
             218          (ii) a compound, manufacture, salt, derivative, or preparation of opium, coca leaves, or
             219      opiates;
             220          (iii) opium poppy and poppy straw; or
             221          (iv) a substance, and any compound, manufacture, salt, derivative, or preparation of
             222      the substance, which is chemically identical with any of the substances referred to in
             223      Subsection (1)(cc)(i), (ii), or (iii), except narcotic drug does not include decocainized coca
             224      leaves or extracts of coca leaves which do not contain cocaine or ecgonine.
             225          (dd) "Negotiable instrument" means documents, containing an unconditional promise


             226      to pay a sum of money, which are legally transferable to another party by endorsement or
             227      delivery.
             228          (ee) "Opiate" means any drug or other substance having an addiction-forming or
             229      addiction-sustaining liability similar to morphine or being capable of conversion into a drug
             230      having addiction-forming or addiction-sustaining liability.
             231          (ff) "Opium poppy" means the plant of the species papaver somniferum L., except the
             232      seeds of the plant.
             233          (gg) "Person" means any corporation, association, partnership, trust, other institution
             234      or entity or one or more individuals.
             235          (hh) "Poppy straw" means all parts, except the seeds, of the opium poppy, after
             236      mowing.
             237          (ii) "Possession" or "use" means the joint or individual ownership, control, occupancy,
             238      holding, retaining, belonging, maintaining, or the application, inhalation, swallowing,
             239      injection, or consumption, as distinguished from distribution, of controlled substances and
             240      includes individual, joint, or group possession or use of controlled substances. For a person to
             241      be a possessor or user of a controlled substance, it is not required that the person be shown to
             242      have individually possessed, used, or controlled the substance, but it is sufficient if it is shown
             243      that the person jointly participated with one or more persons in the use, possession, or control
             244      of any substances with knowledge that the activity was occurring, or the controlled substance
             245      is found in a place or under circumstances indicating that the person had the ability and the
             246      intent to exercise dominion and control over it.
             247          (jj) "Practitioner" means a physician, dentist, naturopathic physician, veterinarian,
             248      pharmacist, scientific investigator, pharmacy, hospital, or other person licensed, registered, or
             249      otherwise permitted to distribute, dispense, conduct research with respect to, administer, or
             250      use in teaching or chemical analysis a controlled substance in the course of professional
             251      practice or research in this state.
             252          (kk) "Prescribe" means to issue a prescription orally or in writing.
             253          (ll) "Prescription" means an order issued by a licensed practitioner, in the course of


             254      that practitioner's professional practice, for a controlled substance, other drug, or device which
             255      it dispenses or administers for use by a patient or an animal. The order may be issued by word
             256      of mouth, written document, telephone, facsimile transmission, computer, or other electronic
             257      means of communication as defined by rule.
             258          (mm) "Production" means the manufacture, planting, cultivation, growing, or
             259      harvesting of a controlled substance.
             260          (nn) "Securities" means any stocks, bonds, notes, or other evidences of debt or of
             261      property.
             262          (oo) "State" means the state of Utah.
             263          (pp) "Ultimate user" means any person who lawfully possesses a controlled substance
             264      for the person's own use, for the use of a member of the person's household, or for
             265      administration to an animal owned by the person or a member of the person's household.
             266          (2) If a term used in this chapter is not defined, the definition and terms of Title 76,
             267      Utah Criminal Code, shall apply.
             268          Section 2. Section 58-37-6 is amended to read:
             269           58-37-6. License to manufacture, produce, distribute, dispense, administer, or
             270      conduct research -- Issuance by division -- Denial, suspension, or revocation -- Records
             271      required -- Prescriptions.
             272          (1) (a) The division may adopt rules relating to the licensing and control of the
             273      manufacture, distribution, production, prescription, administration, dispensing, conducting of
             274      research with, and performing of laboratory analysis upon controlled substances within this
             275      state.
             276          (b) The division may assess reasonable fees to defray the cost of issuing original and
             277      renewal licenses under this chapter pursuant to Section 63J-1-303 .
             278          (2) (a) (i) Every person who manufactures, produces, distributes, prescribes,
             279      dispenses, administers, conducts research with, or performs laboratory analysis upon any
             280      controlled substance in Schedules II through V within this state, or who proposes to engage in
             281      manufacturing, producing, distributing, prescribing, dispensing, administering, conducting


             282      research with, or performing laboratory analysis upon controlled substances included in
             283      Schedules II through V within this state shall obtain a license issued by the division.
             284          (ii) The division shall issue each license under this chapter in accordance with a
             285      two-year renewal cycle established by rule. The division may by rule extend or shorten a
             286      renewal period by as much as one year to stagger the renewal cycles it administers.
             287          (b) Persons licensed to manufacture, produce, distribute, prescribe, dispense,
             288      administer, conduct research with, or perform laboratory analysis upon controlled substances
             289      in Schedules II through V within this state may possess, manufacture, produce, distribute,
             290      prescribe, dispense, administer, conduct research with, or perform laboratory analysis upon
             291      those substances to the extent authorized by their license and in conformity with this chapter.
             292          (c) The following persons are not required to obtain a license and may lawfully
             293      possess controlled substances under this section:
             294          (i) an agent or employee, except a sales representative, of any registered manufacturer,
             295      distributor, or dispenser of any controlled substance, if the agent or employee is acting in the
             296      usual course of the person's business or employment; however, nothing in this subsection shall
             297      be interpreted to permit an agent, employee, sales representative, or detail man to maintain an
             298      inventory of controlled substances separate from the location of the person's employer's
             299      registered and licensed place of business;
             300          (ii) a motor carrier or warehouseman, or an employee of a motor carrier or
             301      warehouseman, who possesses any controlled substance in the usual course of the person's
             302      business or employment; and
             303          (iii) an ultimate user, or any person who possesses any controlled substance pursuant
             304      to a lawful order of a practitioner.
             305          (d) The division may enact rules waiving the license requirement for certain
             306      manufacturers, producers, distributors, prescribers, dispensers, administrators, research
             307      practitioners, or laboratories performing analysis if consistent with the public health and
             308      safety.
             309          (e) A separate license is required at each principal place of business or professional


             310      practice where the applicant manufactures, produces, distributes, dispenses, conducts research
             311      with, or performs laboratory analysis upon controlled substances.
             312          (f) The division may enact rules providing for the inspection of a licensee or
             313      applicant's establishment, and may inspect the establishment according to those rules.
             314          (3) (a) Upon proper application, the division shall license a qualified applicant to
             315      manufacture, produce, distribute, conduct research with, or perform laboratory analysis upon
             316      controlled substances included in Schedules I through V, unless it determines that issuance of
             317      a license is inconsistent with the public interest. The division shall not issue a license to any
             318      person to prescribe, dispense, or administer a Schedule I controlled substance. In determining
             319      public interest, the division shall consider whether or not the applicant has:
             320          (i) maintained effective controls against diversion of controlled substances and any
             321      Schedule I or II substance compounded from any controlled substance into other than
             322      legitimate medical, scientific, or industrial channels;
             323          (ii) complied with applicable state and local law;
             324          (iii) been convicted under federal or state laws relating to the manufacture,
             325      distribution, or dispensing of substances;
             326          (iv) past experience in the manufacture of controlled dangerous substances;
             327          (v) established effective controls against diversion; and
             328          (vi) complied with any other factors that the division establishes that promote the
             329      public health and safety.
             330          (b) Licenses granted under Subsection (3)(a) do not entitle a licensee to manufacture,
             331      produce, distribute, conduct research with, or perform laboratory analysis upon controlled
             332      substances in Schedule I other than those specified in the license.
             333          (c) (i) Practitioners shall be licensed to administer, dispense, or conduct research with
             334      substances in Schedules II through V if they are authorized to administer, dispense, or conduct
             335      research under the laws of this state.
             336          (ii) The division need not require a separate license for practitioners engaging in
             337      research with nonnarcotic controlled substances in Schedules II through V where the licensee


             338      is already licensed under this act in another capacity.
             339          (iii) With respect to research involving narcotic substances in Schedules II through V,
             340      or where the division by rule requires a separate license for research of nonnarcotic substances
             341      in Schedules II through V, a practitioner shall apply to the division prior to conducting
             342      research.
             343          (iv) Licensing for purposes of bona fide research with controlled substances by a
             344      practitioner considered qualified may be denied only on a ground specified in Subsection (4),
             345      or upon evidence that the applicant will abuse or unlawfully transfer or fail to safeguard
             346      adequately the practitioner's supply of substances against diversion from medical or scientific
             347      use.
             348          (v) Practitioners registered under federal law to conduct research in Schedule I
             349      substances may conduct research in Schedule I substances within this state upon furnishing
             350      the division evidence of federal registration.
             351          (d) Compliance by manufacturers, producers, and distributors with the provisions of
             352      federal law respecting registration, excluding fees, entitles them to be licensed under this
             353      chapter.
             354          (e) The division shall initially license those persons who own or operate an
             355      establishment engaged in the manufacture, production, distribution, dispensation, or
             356      administration of controlled substances prior to April 3, 1980, and who are licensed by the
             357      state.
             358          (4) (a) Any license pursuant to Subsection (2) or (3) may be denied, suspended, placed
             359      on probation, or revoked by the division upon finding that the applicant or licensee has:
             360          (i) materially falsified any application filed or required pursuant to this chapter;
             361          (ii) been convicted of an offense under this chapter or any law of the United States, or
             362      any state, relating to any substance defined as a controlled substance;
             363          (iii) been convicted of a felony under any other law of the United States or any state
             364      within five years of the date of the issuance of the license;
             365          (iv) had a federal license denied, suspended, or revoked by competent federal authority


             366      and is no longer authorized to engage in the manufacturing, distribution, or dispensing of
             367      controlled substances;
             368          (v) had the licensee's license suspended or revoked by competent authority of another
             369      state for violation of laws or regulations comparable to those of this state relating to the
             370      manufacture, distribution, or dispensing of controlled substances;
             371          (vi) violated any division rule that reflects adversely on the licensee's reliability and
             372      integrity with respect to controlled substances;
             373          (vii) refused inspection of records required to be maintained under this chapter by a
             374      person authorized to inspect them; or
             375          (viii) prescribed, dispensed, administered, or injected an anabolic steroid for the
             376      purpose of manipulating human hormonal structure so as to:
             377          (A) increase muscle mass, strength, or weight without medical necessity and without a
             378      written prescription by any practitioner in the course of the practitioner's professional practice;
             379      or
             380          (B) improve performance in any form of human exercise, sport, or game.
             381          (b) The division may limit revocation or suspension of a license to a particular
             382      controlled substance with respect to which grounds for revocation or suspension exist.
             383          (c) (i) Proceedings to deny, revoke, or suspend a license shall be conducted pursuant
             384      to this section and in accordance with the procedures set forth in Title 58, Chapter 1, Division
             385      of Occupational and Professional Licensing Act, and conducted in conjunction with the
             386      appropriate representative committee designated by the director of the department.
             387          (ii) Nothing in this Subsection (4)(c) gives the Division of Occupational and
             388      Professional Licensing exclusive authority in proceedings to deny, revoke, or suspend licenses,
             389      except where the division is designated by law to perform those functions, or, when not
             390      designated by law, is designated by the executive director of the Department of Commerce to
             391      conduct the proceedings.
             392          (d) (i) The division may suspend any license simultaneously with the institution of
             393      proceedings under this section if it finds there is an imminent danger to the public health or


             394      safety.
             395          (ii) Suspension shall continue in effect until the conclusion of proceedings, including
             396      judicial review, unless withdrawn by the division or dissolved by a court of competent
             397      jurisdiction.
             398          (e) (i) If a license is suspended or revoked under this Subsection (4), all controlled
             399      substances owned or possessed by the licensee may be placed under seal in the discretion of
             400      the division.
             401          (ii) Disposition may not be made of substances under seal until the time for taking an
             402      appeal has lapsed, or until all appeals have been concluded, unless a court, upon application,
             403      orders the sale of perishable substances and the proceeds deposited with the court.
             404          (iii) If a revocation order becomes final, all controlled substances shall be forfeited.
             405          (f) The division shall notify promptly the Drug Enforcement Administration of all
             406      orders suspending or revoking a license and all forfeitures of controlled substances.
             407          (5) (a) Persons licensed under Subsection (2) or (3) shall maintain records and
             408      inventories in conformance with the record keeping and inventory requirements of federal and
             409      state law and any additional rules issued by the division.
             410          (b) (i) Every physician, dentist, naturopathic physician, veterinarian, practitioner, or
             411      other person who is authorized to administer or professionally use a controlled substance shall
             412      keep a record of the drugs received by him and a record of all drugs administered, dispensed,
             413      or professionally used by him otherwise than by a prescription.
             414          (ii) A person using small quantities or solutions or other preparations of those drugs
             415      for local application has complied with this Subsection (5)(b) if the person keeps a record of
             416      the quantity, character, and potency of those solutions or preparations purchased or prepared
             417      by him, and of the dates when purchased or prepared.
             418          (6) Controlled substances in Schedules I through V may be distributed only by a
             419      licensee and pursuant to an order form prepared in compliance with division rules or a lawful
             420      order under the rules and regulations of the United States.
             421          (7) (a) A person may not write or authorize a prescription for a controlled substance


             422      unless the person is:
             423          (i) a practitioner authorized to prescribe drugs and medicine under the laws of this
             424      state or under the laws of another state having similar standards; and
             425          (ii) licensed under this chapter or under the laws of another state having similar
             426      standards.
             427          (b) A person other than a pharmacist licensed under the laws of this state, or the
             428      pharmacist's licensed intern, as required by Sections 58-17b-303 and 58-17b-304 , may not
             429      dispense a controlled substance.
             430          (c) (i) A controlled substance may not be dispensed without the written prescription of
             431      a practitioner, if the written prescription is required by the federal Controlled Substances Act.
             432          (ii) That written prescription shall be made in accordance with Subsection (7)(a) and
             433      in conformity with Subsection (7)(d).
             434          (iii) In emergency situations, as defined by division rule, controlled substances may be
             435      dispensed upon oral prescription of a practitioner, if reduced promptly to writing on forms
             436      designated by the division and filed by the pharmacy.
             437          (iv) Prescriptions reduced to writing by a pharmacist shall be in conformity with
             438      Subsection (7)(d).
             439          (d) Except for emergency situations designated by the division, a person may not
             440      issue, fill, compound, or dispense a prescription for a controlled substance unless the
             441      prescription is signed by the prescriber in ink or indelible pencil or is signed with an electronic
             442      signature of the prescriber as authorized by division rule, and contains the following
             443      information:
             444          (i) the name, address, and registry number of the prescriber;
             445          (ii) the name, address, and age of the person to whom or for whom the prescription is
             446      issued;
             447          (iii) the date of issuance of the prescription; and
             448          (iv) the name, quantity, and specific directions for use by the ultimate user of the
             449      controlled substance.


             450          (e) A prescription may not be written, issued, filled, or dispensed for a Schedule I
             451      controlled substance.
             452          (f) Except when administered directly to an ultimate user by a licensed practitioner,
             453      controlled substances are subject to the following restrictions:
             454          (i) (A) A prescription for a Schedule II substance may not be refilled.
             455          (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
             456      one-month's supply, as directed on the daily dosage rate of the prescriptions.
             457          (ii) A Schedule III or IV controlled substance may be filled only within six months of
             458      issuance, and may not be refilled more than six months after the date of its original issuance or
             459      be refilled more than five times after the date of the prescription unless renewed by the
             460      practitioner.
             461          (iii) All other controlled substances in Schedule V may be refilled as the prescriber's
             462      prescription directs, but they may not be refilled one year after the date the prescription was
             463      issued unless renewed by the practitioner.
             464          (iv) Any prescription for a Schedule II substance may not be dispensed if it is not
             465      presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
             466      after the date the prescription was issued, or 30 days after the dispensing date, if that date is
             467      specified separately from the date of issue.
             468          (v) A practitioner may issue more than one prescription at the same time for the same
             469      Schedule II controlled substance, but only under the following conditions:
             470          (A) no more than three prescriptions for the same Schedule II controlled substance
             471      may be issued at the same time;
             472          (B) no one prescription may exceed a 30-day supply;
             473          (C) a second or third prescription shall include the date of issuance and the date for
             474      dispensing; and
             475          (D) unless the practitioner determines there is a valid medical reason to the contrary,
             476      the date for dispensing a second or third prescription may not be fewer than 30 days from the
             477      dispensing date of the previous prescription.


             478          (vi) Each prescription for a controlled substance may contain only one controlled
             479      substance per prescription form and may not contain any other legend drug or prescription
             480      item.
             481          (g) An order for a controlled substance in Schedules II through V for use by an
             482      inpatient or an outpatient of a licensed hospital is exempt from all requirements of this
             483      Subsection (7) if the order is:
             484          (i) issued or made by a prescribing practitioner who holds an unrestricted registration
             485      with the federal Drug Enforcement Administration, and an active Utah controlled substance
             486      license in good standing issued by the division under this section, or a medical resident who is
             487      exempted from licensure under Subsection 58-1-307 (1)(c);
             488          (ii) authorized by the prescribing practitioner treating the patient and the prescribing
             489      practitioner designates the quantity ordered;
             490          (iii) entered upon the record of the patient, the record is signed by the prescriber
             491      affirming the prescriber's authorization of the order within 48 hours after filling or
             492      administering the order, and the patient's record reflects the quantity actually administered;
             493      and
             494          (iv) filled and dispensed by a pharmacist practicing the pharmacist's profession within
             495      the physical structure of the hospital, or the order is taken from a supply lawfully maintained
             496      by the hospital and the amount taken from the supply is administered directly to the patient
             497      authorized to receive it.
             498          (h) A practitioner licensed under this chapter may not prescribe, administer, or
             499      dispense a controlled substance to a child, without first obtaining the consent required in
             500      Section 78B-3-406 of a parent, guardian, or person standing in loco parentis of the child
             501      except in cases of an emergency. For purposes of this Subsection (7)(h), "child" has the same
             502      meaning as defined in Section 78A-6-105 , and "emergency" means any physical condition
             503      requiring the administration of a controlled substance for immediate relief of pain or suffering.
             504          (i) A practitioner licensed under this chapter may not prescribe or administer dosages
             505      of a controlled substance in excess of medically recognized quantities necessary to treat the


             506      ailment, malady, or condition of the ultimate user.
             507          (j) A practitioner licensed under this chapter may not prescribe, administer, or
             508      dispense any controlled substance to another person knowing that the other person is using a
             509      false name, address, or other personal information for the purpose of securing the controlled
             510      substance.
             511          (k) A person who is licensed under this chapter to manufacture, distribute, or dispense
             512      a controlled substance may not manufacture, distribute, or dispense a controlled substance to
             513      another licensee or any other authorized person not authorized by this license.
             514          (l) A person licensed under this chapter may not omit, remove, alter, or obliterate a
             515      symbol required by this chapter or by a rule issued under this chapter.
             516          (m) A person licensed under this chapter may not refuse or fail to make, keep, or
             517      furnish any record notification, order form, statement, invoice, or information required under
             518      this chapter.
             519          (n) A person licensed under this chapter may not refuse entry into any premises for
             520      inspection as authorized by this chapter.
             521          (o) A person licensed under this chapter may not furnish false or fraudulent material
             522      information in any application, report, or other document required to be kept by this chapter or
             523      willfully make any false statement in any prescription, order, report, or record required by this
             524      chapter.
             525          (8) (a) (i) Any person licensed under this chapter who is found by the division to have
             526      violated any of the provisions of Subsections (7)(k) through (7)(o) is subject to a penalty not to
             527      exceed $5,000. The division shall determine the procedure for adjudication of any violations
             528      in accordance with Sections 58-1-106 and 58-1-108 .
             529          (ii) The division shall deposit all penalties collected under Subsection (8)(a)(i) in the
             530      General Fund as a dedicated credit to be used by the division under Subsection 58-37-7.7 (1).
             531          (b) Any person who knowingly and intentionally violates Subsections (7)(h) through
             532      (7)(j) is:
             533          (i) upon first conviction, guilty of a class B misdemeanor;


             534          (ii) upon second conviction, guilty of a class A misdemeanor; and
             535          (iii) on third or subsequent conviction, guilty of a third degree felony.
             536          (c) Any person who knowingly and intentionally violates Subsections (7)(k) through
             537      (7)(o) shall upon conviction be guilty of a third degree felony.
             538          (9) Any information communicated to any licensed practitioner in an attempt to
             539      unlawfully procure, or to procure the administration of, a controlled substance is not
             540      considered to be a privileged communication.
             541          Section 3. Section 58-71-102 is amended to read:
             542           58-71-102. Definitions.
             543          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             544          (1) "Administrative penalty" means a monetary fine imposed by the division for acts
             545      or omissions determined to constitute unprofessional or unlawful conduct, as a result of an
             546      adjudicative proceeding conducted in accordance with Title 63G, Chapter 4, Administrative
             547      Procedures Act.
             548          (2) "Acupuncture" has the same definition as in Section 58-72-102 .
             549          (3) "Board" means the Naturopathic Physicians Licensing Board created in Section
             550      58-71-201 .
             551          (4) "Diagnose" means:
             552          (a) to examine in any manner another person, parts of a person's body, substances,
             553      fluids, or materials excreted, taken, or removed from a person's body, or produced by a
             554      person's body, to determine the source, nature, kind, or extent of a disease or other physical or
             555      mental condition;
             556          (b) to attempt to conduct an examination or determination described under Subsection
             557      (4)(a);
             558          (c) to hold oneself out as making or to represent that one is making an examination or
             559      determination as described in Subsection (4)(a); or
             560          (d) to make an examination or determination as described in Subsection (4)(a) upon or
             561      from information supplied directly or indirectly by another person, whether or not in the


             562      presence of the person making or attempting the diagnosis or examination.
             563          (5) "Local anesthesia" means an agent, whether a natural medicine or prescription
             564      drug, which:
             565          (a) is applied topically or by injection in superficial tissues associated with the
             566      performance of minor office procedures;
             567          (b) has the ability to produce loss of sensation at the site of minor office procedures;
             568      and
             569          (c) does not cause loss of consciousness or produce general sedation.
             570          (6) "Medical naturopathic assistant" means an unlicensed individual working under
             571      the direct and immediate supervision of a licensed naturopathic physician and engaged in
             572      specific tasks assigned by the licensed naturopathic physician in accordance with the
             573      standards and ethics of the profession.
             574          (7) (a) "Minor office procedures" means:
             575          (i) the use of operative, electrical, or other methods for repair and care of superficial
             576      lacerations, abrasions, and benign lesions;
             577          (ii) removal of foreign bodies located in the superficial tissues, excluding the eye or
             578      ear; and
             579          (iii) the use of antiseptics and local anesthetics in connection with minor office
             580      surgical procedures[; and].
             581          (b) "Minor office procedures" does not include:
             582          (i) general or spinal anesthesia;
             583          (ii) office procedures more complicated or extensive than those set forth in Subsection
             584      (7)(a);
             585          (iii) procedures involving the eye; or
             586          (iv) any office procedure involving tendons, nerves, veins, or arteries.
             587          (8) "Natural medicine" means:
             588          (a) food, food extracts, dietary supplements as defined by the federal Food, Drug, and
             589      Cosmetics Act, all homeopathic remedies, and plant substances that are not designated as


             590      prescription drugs or controlled substances;
             591          (b) over-the-counter medications;
             592          (c) other nonprescription substances, the prescription or administration of which is not
             593      otherwise prohibited or restricted under federal or state law; [and]
             594          (d) prescription drugs:
             595          (i) that, except as provided in Subsection (8)(e), are not controlled substances as
             596      defined in Section 58-37-2 ;
             597          (ii) the prescription of which is consistent with the competent practice of naturopathic
             598      medicine; and
             599          (iii) the prescription of which is approved by the division in collaboration with the
             600      naturopathic formulary advisory peer committee[.]; and
             601          (e) testosterone, if the testosterone is:
             602          (i) bio-identical;
             603          (ii) designed to be:
             604          (A) administered topically, for transdermal absorption; or
             605          (B) absorbed across the mucosal membranes of the mouth; and
             606          (iii) prescribed or administered, in accordance with the requirements of federal and
             607      state law, solely for the purpose of treating a patient with a low testosterone level in order to
             608      restore the patient to a normal testosterone level.
             609          (9) (a) "Naturopathic childbirth" means uncomplicated natural childbirth assisted by a
             610      naturopathic physician, and includes the use of:
             611          (i) natural medicines; and
             612          (ii) uncomplicated episiotomy.
             613          (b) "Naturopathic childbirth" does not include the use of:
             614          (i) forceps delivery;
             615          (ii) general or spinal anesthesia;
             616          (iii) caesarean section delivery; or
             617          (iv) induced labor or abortion.


             618          (10) "Naturopathic mobilization therapy":
             619          (a) means manually administering mechanical treatment of body structures or tissues
             620      for the purpose of restoring normal physiological function to the body by normalizing and
             621      balancing the musculoskeletal system of the body;
             622          (b) does not mean manipulation or adjustment of the joints of the human body beyond
             623      the elastic barrier; and
             624          (c) does not include manipulation as defined in Title 58, Chapter 73, Chiropractic
             625      Physician Practice Act.
             626          (11) "Naturopathic physical medicine" means the use of the physical agents of air,
             627      water, heat, cold, sound, light, and electromagnetic nonionizing radiation, and the physical
             628      modalities of electrotherapy, biofeedback, acupuncture, diathermy, ultraviolet light,
             629      ultrasound, hydrotherapy, naturopathic mobilization therapy, and exercise. Naturopathic
             630      medicine does not include the practice of physical therapy or physical rehabilitation.
             631          (12) "Practice of naturopathic medicine" means:
             632          (a) a system of primary health care for the prevention, diagnosis, and treatment of
             633      human health conditions, injuries, and diseases that uses education, natural medicines, and
             634      natural therapies, to support and stimulate the patient's intrinsic self-healing processes:
             635          (i) using naturopathic childbirth, but only if:
             636          (A) the licensee meets standards of the American College of Naturopathic
             637      Obstetricians (ACNO) or its successor as determined by the division in collaboration with the
             638      board; and
             639          (B) the licensee follows a written plan for naturopathic physicians practicing
             640      naturopathic childbirth approved by the division in collaboration with the board, which
             641      includes entering into an agreement with a consulting physician and surgeon or osteopathic
             642      physician, in cases where the scope of practice of naturopathic childbirth may be exceeded and
             643      specialty care and delivery is indicated, detailing the guidelines by which the naturopathic
             644      physician will:
             645          (I) refer patients to the consulting physician; and


             646          (II) consult with the consulting physician;
             647          (ii) using naturopathic mobilization therapy;
             648          (iii) using naturopathic physical medicine;
             649          (iv) using minor office procedures;
             650          (v) prescribing or administering natural medicine;
             651          (vi) prescribing medical equipment and devices, diagnosing by the use of medical
             652      equipment and devices, and administering therapy or treatment by the use of medical devices
             653      necessary and consistent with the competent practice of naturopathic medicine;
             654          (vii) prescribing barrier devices for contraception;
             655          (viii) using dietary therapy;
             656          (ix) taking and using diagnostic x-rays, electrocardiograms, ultrasound, and
             657      physiological function tests;
             658          (x) taking of body fluids for clinical laboratory tests and using the results of the tests
             659      in diagnosis;
             660          (xi) taking of a history from and conducting of a physical examination upon a human
             661      patient; and
             662          (xii) prescribing and administering natural medicines and medical devices, except a
             663      naturopathic physician may only administer:
             664          (A) a prescription drug, as defined in Section 58-17b-102 , in accordance with
             665      Subsection (8)(d); and
             666          (B) local anesthesia that is not a controlled substance, and only in the performance of
             667      minor office procedures;
             668          (b) to maintain an office or place of business for the purpose of doing any of the acts
             669      described in Subsection (12)(a), whether or not for compensation; or
             670          (c) to use, in the conduct of any occupation or profession pertaining to the diagnosis
             671      or treatment of human diseases or conditions, in any printed material, stationery, letterhead,
             672      envelopes, signs, or advertisements, the designation "naturopathic physician," "naturopathic
             673      doctor," "naturopath," "doctor of naturopathic medicine," "doctor of naturopathy,"


             674      "naturopathic medical doctor," "naturopathic medicine," "naturopathic health care,"
             675      "naturopathy," "N.D.," "N.M.D.," or any combination of these designations in any manner that
             676      might cause a reasonable person to believe the individual using the designation is a licensed
             677      naturopathic physician.
             678          (13) "Prescription drug or device" means:
             679          (a) a drug or device which, under federal law, is required to be labeled with either of
             680      the following statements or their equivalent:
             681          (i) "CAUTION: Federal law prohibits dispensing without prescription"; or
             682          (ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
             683      veterinarian"; or
             684          (b) a drug or device that is required by any applicable federal or state law or rule to be
             685      dispensed on prescription only or is restricted to use by practitioners only.
             686          (14) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-71-501 .
             687          (15) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-71-502 , and
             688      as may be further defined by division rule.
             689          Section 4. Section 58-71-804 is amended to read:
             690           58-71-804. Insurance coverage not mandated.
             691          (1) This chapter does not mandate health insurance coverage for naturopathic medical
             692      services.
             693          (2) This chapter does not establish a class of health care providers for the purposes of
             694      Section 31A-22-618 .
             695          (3) This chapter does not mandate health insurance coverage for the prescription or
             696      administration of testosterone, as described in Subsection 58-71-102 (8)(e), by a naturopathic
             697      physician.


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