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H.B. 13 Enrolled

             1     

DRUG LAW DEFINITIONS - AMENDMENTS

             2     
2010 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Trisha S. Beck

             5     
Senate Sponsor: Peter C. Knudson

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill modifies health care chapters in Title 58, Occupations and Professions, to
             10      provide consistency in specified definitions used in these chapters.
             11      Highlighted Provisions:
             12          This bill:
             13          .    amends the Utah Controlled Substances Act, the Utah Medical Practice Act, the
             14      Pharmacy Practice Act, the Utah Osteopathic Medical Practice Act, and the
             15      Naturopathic Physician Practice Act to provide consistency in the use of definitions,
             16      including those for "prescribe," "prescription device," and "drug."
             17      Monies Appropriated in this Bill:
             18          None
             19      Other Special Clauses:
             20          None
             21      Utah Code Sections Affected:
             22      AMENDS:
             23          58-17b-102, as last amended by Laws of Utah 2005, Chapter 160
             24          58-17b-606, as last amended by Laws of Utah 2006, Chapter 90
             25          58-17b-612, as last amended by Laws of Utah 2007, Chapter 279
             26          58-37-2, as last amended by Laws of Utah 2009, Chapter 42
             27          58-67-102, as last amended by Laws of Utah 2008, Chapter 382
             28          58-68-102, as last amended by Laws of Utah 2008, Chapter 382
             29          58-71-102, as last amended by Laws of Utah 2009, Chapter 42


             30     
             31      Be it enacted by the Legislature of the state of Utah:
             32          Section 1. Section 58-17b-102 is amended to read:
             33           58-17b-102. Definitions.
             34          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             35          (1) "Administering" means:
             36          (a) the direct application of a prescription drug or device, whether by injection,
             37      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             38      by another person; or
             39          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             40      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             41      means directed to the body of the animal by the owner or caretaker in accordance with written
             42      or verbal directions of the veterinarian.
             43          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             44      21 U.S.C.S. Sec. 351 (2003).
             45          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             46      the purpose of analysis.
             47          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             48      used as standards and controls in performing drug monitoring or drug screening analysis if the
             49      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             50      components, organic solvents, or inorganic buffers at a concentration not exceeding one
             51      milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             52      use.
             53          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             54      the use of prescription drugs.
             55          (5) "Automated pharmacy systems" includes mechanical systems which perform
             56      operations or activities, other than compounding or administration, relative to the storage,
             57      packaging, dispensing, or distribution of medications, and which collect, control, and maintain


             58      all transaction information.
             59          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
             60      prescription label at the time of dispensing that indicates to the patient or caregiver a time
             61      beyond which the contents of the prescription are not recommended to be used.
             62          (7) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
             63      underserved area, used for the storage and dispensing of prescription drugs, which is dependent
             64      upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
             65      approved by the division as the parent pharmacy.
             66          (8) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
             67      in Section 58-17b-201 .
             68          (9) "Centralized prescription processing" means the processing by a pharmacy of a
             69      request from another pharmacy to fill or refill a prescription drug order or to perform
             70      processing functions such as dispensing, drug utilization review, claims adjudication, refill
             71      authorizations, and therapeutic interventions.
             72          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             73      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             74      prescription order.
             75          (11) "Class B pharmacy":
             76          (a) means a pharmacy located in Utah:
             77          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             78      setting; and
             79          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             80      health care services; and
             81          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
             82          (ii) pharmaceutical administration and sterile product preparation facilities.
             83          (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
             84      engage in the manufacture, production, wholesale, or distribution of drugs or devices.
             85          (13) "Class D pharmacy" means a nonresident pharmacy.


             86          (14) "Class E pharmacy" means all other pharmacies.
             87          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
             88      defined and exclusive group of patients who have access to the services of the pharmacy
             89      because they are treated by or have an affiliation with a specific entity, including a health
             90      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             91      retailer of goods to the general public, or the office of a practitioner.
             92          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
             93      more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
             94      more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
             95      care functions authorized by the practitioner or practitioners under certain specified conditions
             96      or limitations.
             97          (17) "Collaborative pharmacy practice agreement" means a written and signed
             98      agreement between one or more pharmacists and one or more practitioners that provides for
             99      collaborative pharmacy practice for the purpose of drug therapy management of patients and
             100      prevention of disease of human subjects.
             101          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
             102      labeling of a limited quantity drug, sterile product, or device:
             103          (i) as the result of a practitioner's prescription order or initiative based on the
             104      practitioner, patient, or pharmacist relationship in the course of professional practice;
             105          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
             106      not for sale or dispensing; or
             107          (iii) in anticipation of prescription drug orders based on routine, regularly observed
             108      prescribing patterns.
             109          (b) "Compounding" does not include:
             110          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
             111      another pharmacist or pharmaceutical facility;
             112          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
             113      dosage form which is regularly and commonly available from a manufacturer in quantities and


             114      strengths prescribed by a practitioner; or
             115          (iii) the preparation of a prescription drug, sterile product, or device which has been
             116      withdrawn from the market for safety reasons.
             117          (19) "Confidential information" has the same meaning as "protected health
             118      information" under the Standards for Privacy of Individually Identifiable Health Information,
             119      45 C.F.R. Parts 160 and 164.
             120          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             121          [(21) "Device" means an instrument, apparatus, implement, machine, contrivance,
             122      implant, in vitro reagent, or other similar or related article, including any component part or
             123      accessory, which is required under federal or state law to be prescribed by a practitioner and
             124      dispensed by a pharmacist or pharmacy intern.]
             125          [(22)] (21) "Dietary supplement" has the same meaning as Public Law Title 103,
             126      Chapter 417, Sec. 3a(ff) which is incorporated by reference.
             127          [(23)] (22) "Dispense" means the interpretation, evaluation, and implementation of a
             128      prescription drug order or device or nonprescription drug or device under a lawful order of a
             129      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             130      by a patient, research subject, or an animal.
             131          [(24)] (23) "Distribute" means to deliver a drug or device other than by administering
             132      or dispensing.
             133          [(25)] (24) (a) "Drug" means:
             134          [(a) a substance recognized as a drug in any official compendium, or supplement
             135      thereto, designated from time to time by the division in collaboration with the board for use in
             136      the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals,
             137      excluding nonprescription drugs or dietary supplements;]
             138          [(b) a drug or device that is required by any applicable federal or state law or rule to be
             139      dispensed on prescription only or is restricted to use by practitioners only;]
             140          [(c) substances other than food intended to affect the structure or any function of the
             141      body of humans or other animals, excluding nonprescription dietary supplements; and]


             142          [(d) substances intended for use as a component of any substance specified in
             143      Subsection (25)(a), (b), or (c).]
             144          (i) a substance recognized in the official United States Pharmacopoeia, Official
             145      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             146      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             147      prevention of disease in humans or animals;
             148          (ii) a substance that is required by any applicable federal or state law or rule to be
             149      dispensed by prescription only or is restricted to administration by practitioners only;
             150          (iii) a substance other than food intended to affect the structure or any function of the
             151      body of humans or other animals; and
             152          (iv) substances intended for use as a component of any substance specified in
             153      Subsections (24)(a)(i), (ii), (iii), and (iv).
             154          (b) "Drug" does not include dietary supplements.
             155          [(26)] (25) "Drug product equivalent" means a drug product that is designated as the
             156      therapeutic equivalent of another drug product in the Approved Drug Products with
             157      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             158      of the Federal Food and Drug Administration.
             159          [(27)] (26) "Drug regimen review" includes the following activities:
             160          (a) evaluation of the prescription drug order and patient record for:
             161          (i) known allergies;
             162          (ii) rational therapy-contraindications;
             163          (iii) reasonable dose and route of administration; and
             164          (iv) reasonable directions for use;
             165          (b) evaluation of the prescription drug order and patient record for duplication of
             166      therapy;
             167          (c) evaluation of the prescription drug order and patient record for the following
             168      interactions:
             169          (i) drug-drug;


             170          (ii) drug-food;
             171          (iii) drug-disease; and
             172          (iv) adverse drug reactions; and
             173          (d) evaluation of the prescription drug order and patient record for proper utilization,
             174      including over- or under-utilization, and optimum therapeutic outcomes.
             175          [(28)] (27) "Drug sample" means a prescription drug packaged in small quantities
             176      consistent with limited dosage therapy of the particular drug, which is marked "sample", is not
             177      intended to be sold, and is intended to be provided to practitioners for the immediate needs of
             178      patients for trial purposes or to provide the drug to the patient until a prescription can be filled
             179      by the patient.
             180          [(29)] (28) "Electronic signature" means a trusted, verifiable, and secure electronic
             181      sound, symbol, or process attached to or logically associated with a record and executed or
             182      adopted by a person with the intent to sign the record.
             183          [(30)] (29) "Electronic transmission" means transmission of information in electronic
             184      form or the transmission of the exact visual image of a document by way of electronic
             185      equipment.
             186          [(31)] (30) "Extern" means a college of pharmacy student enrolled in a college
             187      coordinated practical experience program in a health care setting under the supervision of a
             188      preceptor, as defined in this act, and approved by a college of pharmacy.
             189          [(32)] (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             190      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             191      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             192          (32) "Legend drug" has the same meaning as prescription drug.
             193          (33) "Licensed pharmacy technician" means an individual licensed with the division,
             194      that may, under the supervision of a pharmacist, perform the activities involved in the
             195      technician practice of pharmacy.
             196          (34) "Manufacturer" means a person or business physically located in Utah licensed to
             197      be engaged in the manufacturing of drugs or devices.


             198          (35) (a) "Manufacturing" means:
             199          (i) the production, preparation, propagation, conversion, or processing of a drug or
             200      device, either directly or indirectly, by extraction from substances of natural origin or
             201      independently by means of chemical or biological synthesis, or by a combination of extraction
             202      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             203      or relabeling of its container; and
             204          (ii) the promotion and marketing of such drugs or devices.
             205          (b) "Manufacturing" includes the preparation and promotion of commercially available
             206      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             207          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             208      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             209      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
             210      analysis.
             211          (36) "Medical order" means a lawful order of a practitioner which may include a
             212      prescription drug order.
             213          (37) "Medication profile" or "profile" means a record system maintained as to drugs or
             214      devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
             215      the profile to provide pharmaceutical care.
             216          (38) "Misbranded drug or device" means a drug or device considered misbranded under
             217      21 U.S.C.S. Sec. 352 (2003).
             218          (39) (a) "Nonprescription drug" means a drug which:
             219          (i) may be sold without a prescription; and [which]
             220          (ii) is labeled for use by the consumer in accordance with federal law [and].
             221          (b) "Nonprescription drug" includes homeopathic remedies.
             222          (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
             223      person in Utah.
             224          (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
             225          (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located


             226      outside the state that is licensed and in good standing in another state, that:
             227          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
             228      this state pursuant to a lawfully issued prescription;
             229          (b) provides information to a patient in this state on drugs or devices which may
             230      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             231      or
             232          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             233      effects of drugs.
             234          (43) "Patient counseling" means the written and oral communication by the pharmacist
             235      or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
             236      drugs, devices, and dietary supplements.
             237          (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
             238      which:
             239          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             240      the facility or agency for administration to patients of that facility or agency;
             241          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             242      or pharmacy intern with whom the facility has established a prescription drug supervising
             243      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             244      or agency staff as required, and oversees drug control, accounting, and destruction; and
             245          (c) prescription drugs are professionally administered in accordance with the order of a
             246      practitioner by an employee or agent of the facility or agency.
             247          (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
             248      prescribing practitioner, and in accordance with division rule:
             249          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             250      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             251      the patient's disease;
             252          (ii) eliminating or reducing a patient's symptoms; or
             253          (iii) arresting or slowing a disease process.


             254          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             255      prescribing practitioner.
             256          (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
             257      distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
             258      state.
             259          (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
             260      engaged in the business of wholesale vending or selling of any prescription drug or device to
             261      other than the consumer or user of the prescription drug or device, which the pharmaceutical
             262      facility has not produced, manufactured, compounded, or dispensed.
             263          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             264      facility carrying out the following business activities:
             265          (i) intracompany sales;
             266          (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             267      purchase or trade a prescription drug or device between hospitals or other health care facilities
             268      that are under common ownership or control of the management and operation of the facilities;
             269          (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             270      purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
             271      another pharmaceutical facility to alleviate a temporary shortage; or
             272          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             273      manufacturer.
             274          (48) "Pharmacist" means an individual licensed by this state to engage in the practice
             275      of pharmacy.
             276          (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
             277      who accepts responsibility for the operation of a pharmacy in conformance with all laws and
             278      rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
             279      in full and actual charge of the pharmacy and all personnel.
             280          (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with two or
             281      more years of licensed experience. The preceptor serves as a teacher, example of professional


             282      conduct, and supervisor of interns in the professional practice of pharmacy.
             283          (51) "Pharmacy" means any place where:
             284          (a) drugs are dispensed;
             285          (b) pharmaceutical care is provided;
             286          (c) drugs are processed or handled for eventual use by a patient; or
             287          (d) drugs are used for the purpose of analysis or research.
             288          (52) "Pharmacy benefits manager or coordinator" means a person or entity that
             289      administers the prescription drug or device portion of a health insurance plan on behalf of a
             290      self-insured employer, insurance company, health maintenance organization, or other plan
             291      sponsor, as defined by rule.
             292          (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
             293      as a pharmacy intern.
             294          (54) "Pharmacy technician training program" means an approved technician training
             295      program providing education for pharmacy technicians.
             296          (55) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a
             297      pharmacy technician under the general supervision of a licensed pharmacist and in accordance
             298      with a scope of practice defined by division rule made in collaboration with the board.
             299          (b) "Practice as a licensed pharmacy technician" does not include:
             300          (i) performing a drug utilization review, prescription drug order clarification from a
             301      prescriber, final review of the prescription and prescribed drug prepared for dispensing,
             302      dispensing of the drug, or counseling a patient with respect to a prescription drug;
             303          (ii) counseling regarding nonprescription drugs and dietary supplements unless
             304      delegated by the supervising pharmacist; or
             305          (iii) receiving new prescription drug orders when communicating telephonically or
             306      electronically unless the original information is recorded so the pharmacist may review the
             307      prescription drug order as transmitted.
             308          (56) "Practice of pharmacy" includes the following:
             309          (a) providing pharmaceutical care;


             310          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             311      practice agreement;
             312          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             313      distribution of prescription drugs or devices, provided that the administration of a prescription
             314      drug or device is:
             315          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             316          (ii) in accordance with written guidelines or protocols:
             317          (A) established by the licensed facility in which the prescription drug or device is to be
             318      administered on an inpatient basis; or
             319          (B) approved by the division, in collaboration with the board and the Physicians
             320      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             321      administered on an outpatient basis solely by a licensed pharmacist;
             322          (d) participating in drug utilization review;
             323          (e) ensuring proper and safe storage of drugs and devices;
             324          (f) maintaining records of drugs and devices in accordance with state and federal law
             325      and the standards and ethics of the profession;
             326          (g) providing information on drugs or devices, which may include advice relating to
             327      therapeutic values, potential hazards, and uses;
             328          (h) providing drug product equivalents;
             329          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             330      technicians;
             331          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
             332          (k) providing emergency refills as defined by rule;
             333          (l) telepharmacy; and
             334          (m) formulary management intervention.
             335          (57) "Practice of telepharmacy" means the practice of pharmacy through the use of
             336      telecommunications and information technologies.
             337          (58) "Practice of telepharmacy across state lines" means the practice of pharmacy


             338      through the use of telecommunications and information technologies that occurs when the
             339      patient is physically located within one jurisdiction and the pharmacist is located in another
             340      jurisdiction.
             341          (59) "Practitioner" means an individual currently licensed, registered, or otherwise
             342      authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
             343      professional practice.
             344          (60) "Prescribe" means to issue a prescription:
             345          (a) orally or in writing; or
             346          (b) by telephone, facsimile transmission, computer, or other electronic means of
             347      communication as defined by division rule.
             348          [(60)] (61) "Prescription" means an order issued:
             349          [(a) issued by a licensed practitioner:]
             350          [(i) orally, in writing, by telephone, facsimile transmission, computer, or other
             351      electronic means of communication as defined by division rule;]
             352          [(ii) in the course of the practitioner's professional practice; or]
             353          [(iii) by collaborative pharmacy practice agreement; and]
             354          [(b) for a controlled substance, other prescription drug, or device with the intent that
             355      the controlled substance, prescription drug, or device will be used by a patient or an animal.]
             356          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             357      by collaborative pharmacy practice agreement; and
             358          (b) for a controlled substance or other prescription drug or device for use by a patient
             359      or an animal.
             360          [(61) "Prescription drug or device" means:]
             361          [(a) a legend drug or device; or]
             362          [(b) a drug or device that is required by an applicable federal or state law or rule to be
             363      dispensed on prescription only or is restricted to use by practitioners only.]
             364          (62) "Prescription device" means an instrument, apparatus, implement, machine,
             365      contrivance, implant, in vitro reagent, or other similar or related article, and any component


             366      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             367      and dispensed by or through a person or entity licensed under this chapter or exempt from
             368      licensure under this chapter.
             369          (63) "Prescription drug" means a drug that is required by federal or state law or rule to
             370      be dispensed only by prescription or is restricted to administration only by practitioners.
             371          [(62)] (64) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             372      drugs and devices to the general public.
             373          [(63)] (65) "Self-audit" means an internal evaluation of a pharmacy to determine
             374      compliance with this chapter.
             375          [(64)] (66) "Supervising pharmacist" means a pharmacist who is overseeing the
             376      operation of the pharmacy during a given day or shift.
             377          [(65)] (67) "Supportive personnel" means unlicensed individuals who:
             378          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             379      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             380      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             381      those duties may be further defined by division rule adopted in collaboration with the board;
             382      and
             383          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             384      collaboration with the board.
             385          [(66)] (68) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             386          [(67)] (69) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             387      58-17b-502 and may be further defined by rule.
             388          [(68)] (70) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             389      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             390      for animals.
             391          Section 2. Section 58-17b-606 is amended to read:
             392           58-17b-606. Restrictive drug formulary prohibited.
             393          (1) As used in this section:


             394          (a) "Generic form" means a prescription drug that is available in generic form and has
             395      an A rating in the United States Pharmacopeia and Drug Index.
             396          (b) "Legend drug" [means any drug that requires a prescription under state or federal
             397      law] has the same meaning as prescription drug.
             398          [(c)] (b) "Restrictive drug formulary" means a list of legend drugs, other than drugs for
             399      cosmetic purposes, that are prohibited by the Department of Health from dispensation, but are
             400      approved by the Federal Food and Drug Administration.
             401          (2) A practitioner may prescribe legend drugs in accordance with this chapter that, in
             402      his professional judgment and within the lawful scope of his practice, he considers appropriate
             403      for the diagnosis and treatment of his patient.
             404          (3) Except as provided in Subsection (4), the Department of Health may not maintain a
             405      restrictive drug formulary that restricts a physician's ability to treat a patient with a legend drug
             406      that has been approved and designated as safe and effective by the Federal Food and Drug
             407      Administration, except for drugs for cosmetic purposes.
             408          (4) When a multisource legend drug is available in the generic form, the Department of
             409      Health may only reimburse for the generic form of the drug unless the treating physician
             410      demonstrates to the Department of Health a medical necessity for dispensing the nongeneric,
             411      brand-name legend drug.
             412          (5) The Department of Health pharmacists may override the generic mandate
             413      provisions of Subsection (4) if a financial benefit will accrue to the state.
             414          (6) This section does not affect the state's ability to exercise the exclusion options
             415      available under the Federal Omnibus Budget Reconciliation Act of 1990.
             416          Section 3. Section 58-17b-612 is amended to read:
             417           58-17b-612. Supervision -- Pharmacist-in-charge.
             418          (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
             419      pharmacy, or class E pharmacy, shall be under the general supervision of at least one
             420      pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
             421      as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.


             422          (b) Notwithstanding Subsection 58-17b-102 [(64)](66), a supervising pharmacist does
             423      not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
             424      for immediate contact with the supervised pharmacy technician or pharmacy intern if:
             425          (i) the pharmacy is located in:
             426          (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
             427          (B) a clinic located in a remote rural county with less than 20 people per square mile;
             428          (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
             429          (iii) the telepharmacy system maintains records and files quarterly reports as required
             430      by division rule to assure that patient safety is not compromised.
             431          (2) Each out-of-state mail service pharmacy shall designate and identify to the division
             432      a pharmacist holding a current license in good standing issued by the state in which the
             433      pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
             434      chapter.
             435          Section 4. Section 58-37-2 is amended to read:
             436           58-37-2. Definitions.
             437          (1) As used in this chapter:
             438          (a) "Administer" means the direct application of a controlled substance, whether by
             439      injection, inhalation, ingestion, or any other means, to the body of a patient or research subject
             440      by:
             441          (i) a practitioner or, in the practitioner's presence, by the practitioner's authorized agent;
             442      or
             443          (ii) the patient or research subject at the direction and in the presence of the
             444      practitioner.
             445          (b) "Agent" means an authorized person who acts on behalf of or at the direction of a
             446      manufacturer, distributor, or practitioner but does not include a motor carrier, public
             447      warehouseman, or employee of any of them.
             448          (c) "Consumption" means ingesting or having any measurable amount of a controlled
             449      substance in a person's body, but this Subsection (1)(c) does not include the metabolite of a


             450      controlled substance.
             451          (d) "Continuing criminal enterprise" means any individual, sole proprietorship,
             452      partnership, corporation, business trust, association, or other legal entity, and any union or
             453      groups of individuals associated in fact although not a legal entity, and includes illicit as well
             454      as licit entities created or maintained for the purpose of engaging in conduct which constitutes
             455      the commission of episodes of activity made unlawful by Title 58, Chapters 37, 37a, 37b, 37c,
             456      or 37d, which episodes are not isolated, but have the same or similar purposes, results,
             457      participants, victims, methods of commission, or otherwise are interrelated by distinguishing
             458      characteristics. Taken together, the episodes shall demonstrate continuing unlawful conduct
             459      and be related either to each other or to the enterprise.
             460          (e) "Control" means to add, remove, or change the placement of a drug, substance, or
             461      immediate precursor under Section 58-37-3 .
             462          (f) (i) "Controlled substance" means a drug or substance:
             463          (A) included in Schedules I, II, III, IV, or V of Section 58-37-4 [, and also includes a
             464      drug or substance];
             465          (B) included in Schedules I, II, III, IV, or V of the federal Controlled Substances Act,
             466      Title II, P.L. 91-513[,]; or [any]
             467          (C) that is a controlled substance analog.
             468          (ii) "Controlled substance" does not include:
             469          (A) distilled spirits, wine, or malt beverages, as those terms are defined [or used] in
             470      Title 32A, Alcoholic Beverage Control Act[, regarding tobacco or food];
             471          (B) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
             472      prevention of disease in [man] human or other animals, which contains ephedrine,
             473      pseudoephedrine, norpseudoephedrine, or phenylpropanolamine if the drug is lawfully
             474      purchased, sold, transferred, or furnished as an over-the-counter medication without
             475      prescription; or
             476          (C) dietary supplements, vitamins, minerals, herbs, or other similar substances
             477      including concentrates or extracts, which:


             478          (I) are not otherwise regulated by law[, which]; and
             479          (II) may contain naturally occurring amounts of chemical or substances listed in this
             480      chapter, or in rules adopted pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking
             481      Act.
             482          (g) (i) "Controlled substance analog" means a substance the chemical structure of
             483      which is substantially similar to the chemical structure of a controlled substance listed in
             484      Schedules I and II of Section 58-37-4 , or in Schedules I and II of the federal Controlled
             485      Substances Act, Title II, P.L. 91-513:
             486          (A) which has a stimulant, depressant, or hallucinogenic effect on the central nervous
             487      system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central
             488      nervous system of controlled substances in the schedules set forth in Subsection (1)(f); or
             489          (B) which, with respect to a particular individual, is represented or intended to have a
             490      stimulant, depressant, or hallucinogenic effect on the central nervous system substantially
             491      similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of
             492      controlled substances in the schedules set forth in this Subsection (1).
             493          (ii) "Controlled substance analog" does not include:
             494          (A) a controlled substance currently scheduled in Schedules I through V of Section
             495      58-37-4 ;
             496          (B) a substance for which there is an approved new drug application;
             497          (C) a substance with respect to which an exemption is in effect for investigational use
             498      by a particular person under Section 505 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 355,
             499      to the extent the conduct with respect to the substance is permitted by the exemption;
             500          (D) any substance to the extent not intended for human consumption before an
             501      exemption takes effect with respect to the substance;
             502          (E) any drug intended for lawful use in the diagnosis, cure, mitigation, treatment, or
             503      prevention of disease in man or other animals, which contains ephedrine, pseudoephedrine,
             504      norpseudoephedrine, or phenylpropanolamine if the drug is lawfully purchased, sold,
             505      transferred, or furnished as an over-the-counter medication without prescription; or


             506          (F) dietary supplements, vitamins, minerals, herbs, or other similar substances
             507      including concentrates or extracts, which are not otherwise regulated by law, which may
             508      contain naturally occurring amounts of chemical or substances listed in this chapter, or in rules
             509      adopted pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             510          (h) "Conviction" means a determination of guilt by verdict, whether jury or bench, or
             511      plea, whether guilty or no contest, for any offense proscribed by Title 58, Chapters 37, 37a,
             512      37b, 37c, or 37d, or for any offense under the laws of the United States and any other state
             513      which, if committed in this state, would be an offense under Title 58, Chapters 37, 37a, 37b,
             514      37c, or 37d.
             515          (i) "Counterfeit substance" means:
             516          (i) any substance or container or labeling of any substance that without authorization
             517      bears the trademark, trade name, or other identifying mark, imprint, number, device, or any
             518      likeness of them, of a manufacturer, distributor, or dispenser other than the person or persons
             519      who in fact manufactured, distributed, or dispensed the substance which falsely purports to be a
             520      controlled substance distributed by, any other manufacturer, distributor, or dispenser; or
             521          (ii) any substance that is represented to be a controlled substance.
             522          (j) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a
             523      controlled substance or a listed chemical, whether or not an agency relationship exists.
             524          (k) "Department" means the Department of Commerce.
             525          (l) "Depressant or stimulant substance" means:
             526          (i) a drug which contains any quantity of barbituric acid or any of the salts of barbituric
             527      acid;
             528          (ii) a drug which contains any quantity of:
             529          (A) amphetamine or any of its optical isomers;
             530          (B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or
             531          (C) any substance which the Secretary of Health and Human Services or the Attorney
             532      General of the United States after investigation has found and by regulation designated
             533      habit-forming because of its stimulant effect on the central nervous system;


             534          (iii) lysergic acid diethylamide; or
             535          (iv) any drug which contains any quantity of a substance which the Secretary of Health
             536      and Human Services or the Attorney General of the United States after investigation has found
             537      to have, and by regulation designated as having, a potential for abuse because of its depressant
             538      or stimulant effect on the central nervous system or its hallucinogenic effect.
             539          (m) "Dispense" means the delivery of a controlled substance by a pharmacist to an
             540      ultimate user pursuant to the lawful order or prescription of a practitioner, and includes
             541      distributing to, leaving with, giving away, or disposing of that substance as well as the
             542      packaging, labeling, or compounding necessary to prepare the substance for delivery.
             543          (n) "Dispenser" means a pharmacist who dispenses a controlled substance.
             544          (o) "Distribute" means to deliver other than by administering or dispensing a controlled
             545      substance or a listed chemical.
             546          (p) "Distributor" means a person who distributes controlled substances.
             547          (q) "Division" means the Division of Occupational and Professional Licensing created
             548      in Section 58-1-103 .
             549          (r) (i) "Drug" means:
             550          [(i) articles recognized in the official United States Pharmacopoeia, Official
             551      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             552      supplement to any of them;]
             553          [(ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
             554      of disease in man or other animals;]
             555          [(iii) articles, other than food, intended to affect the structure or function of man or
             556      other animals; and]
             557          [(iv) articles intended for use as a component of any articles specified in Subsection
             558      (1)(r)(i), (ii), or (iii); but does not include devices or their components, parts, or accessories.]
             559          (A) a substance recognized in the official United States Pharmacopoeia, Official
             560      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             561      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or


             562      prevention of disease in humans or animals;
             563          (B) a substance that is required by any applicable federal or state law or rule to be
             564      dispensed by prescription only or is restricted to administration by practitioners only;
             565          (C) a substance other than food intended to affect the structure or any function of the
             566      body of humans or other animals; and
             567          (D) substances intended for use as a component of any substance specified in
             568      Subsections (1)(r)(i)(A), (B), (C), and (D).
             569          (ii) "Drug" does not include dietary supplements.
             570          (s) "Drug dependent person" means any individual who unlawfully and habitually uses
             571      any controlled substance to endanger the public morals, health, safety, or welfare, or who is so
             572      dependent upon the use of controlled substances as to have lost the power of self-control with
             573      reference to the individual's dependency.
             574          (t) "Food" means:
             575          (i) any nutrient or substance of plant, mineral, or animal origin other than a drug as
             576      specified in this chapter, and normally ingested by human beings; and
             577          (ii) foods for special dietary uses as exist by reason of a physical, physiological,
             578      pathological, or other condition including but not limited to the conditions of disease,
             579      convalescence, pregnancy, lactation, allergy, hypersensitivity to food, underweight, and
             580      overweight; uses for supplying a particular dietary need which exist by reason of age including
             581      but not limited to the ages of infancy and childbirth, and also uses for supplementing and for
             582      fortifying the ordinary or unusual diet with any vitamin, mineral, or other dietary property for
             583      use of a food. Any particular use of a food is a special dietary use regardless of the nutritional
             584      purposes.
             585          (u) "Immediate precursor" means a substance which the Attorney General of the United
             586      States has found to be, and by regulation designated as being, the principal compound used or
             587      produced primarily for use in the manufacture of a controlled substance, or which is an
             588      immediate chemical intermediary used or likely to be used in the manufacture of a controlled
             589      substance, the control of which is necessary to prevent, curtail, or limit the manufacture of the


             590      controlled substance.
             591          (v) "Indian" means a member of an Indian tribe.
             592          (w) "Indian religion" means any religion:
             593          (i) the origin and interpretation of which is from within a traditional Indian culture or
             594      community; and
             595          (ii) which is practiced by Indians.
             596          (x) "Indian tribe" means any tribe, band, nation, pueblo, or other organized group or
             597      community of Indians, including any Alaska Native village, which is legally recognized as
             598      eligible for and is consistent with the special programs, services, and entitlements provided by
             599      the United States to Indians because of their status as Indians.
             600          (y) "Manufacture" means the production, preparation, propagation, compounding, or
             601      processing of a controlled substance, either directly or indirectly by extraction from substances
             602      of natural origin, or independently by means of chemical synthesis or by a combination of
             603      extraction and chemical synthesis.
             604          (z) "Manufacturer" includes any person who packages, repackages, or labels any
             605      container of any controlled substance, except pharmacists who dispense or compound
             606      prescription orders for delivery to the ultimate consumer.
             607          (aa) "Marijuana" means all species of the genus cannabis and all parts of the genus,
             608      whether growing or not; the seeds of it; the resin extracted from any part of the plant; and every
             609      compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or
             610      resin. The term does not include the mature stalks of the plant, fiber produced from the stalks,
             611      oil or cake made from the seeds of the plant, any other compound, manufacture, salt,
             612      derivative, mixture, or preparation of the mature stalks, except the resin extracted from them,
             613      fiber, oil or cake, or the sterilized seed of the plant which is incapable of germination. Any
             614      synthetic equivalents of the substances contained in the plant cannabis sativa or any other
             615      species of the genus cannabis which are chemically indistinguishable and pharmacologically
             616      active are also included.
             617          (bb) "Money" means officially issued coin and currency of the United States or any


             618      foreign country.
             619          (cc) "Narcotic drug" means any of the following, whether produced directly or
             620      indirectly by extraction from substances of vegetable origin, or independently by means of
             621      chemical synthesis, or by a combination of extraction and chemical synthesis:
             622          (i) opium, coca leaves, and opiates;
             623          (ii) a compound, manufacture, salt, derivative, or preparation of opium, coca leaves, or
             624      opiates;
             625          (iii) opium poppy and poppy straw; or
             626          (iv) a substance, and any compound, manufacture, salt, derivative, or preparation of the
             627      substance, which is chemically identical with any of the substances referred to in Subsection
             628      (1)(cc)(i), (ii), or (iii), except narcotic drug does not include decocainized coca leaves or
             629      extracts of coca leaves which do not contain cocaine or ecgonine.
             630          (dd) "Negotiable instrument" means documents, containing an unconditional promise
             631      to pay a sum of money, which are legally transferable to another party by endorsement or
             632      delivery.
             633          (ee) "Opiate" means any drug or other substance having an addiction-forming or
             634      addiction-sustaining liability similar to morphine or being capable of conversion into a drug
             635      having addiction-forming or addiction-sustaining liability.
             636          (ff) "Opium poppy" means the plant of the species papaver somniferum L., except the
             637      seeds of the plant.
             638          (gg) "Person" means any corporation, association, partnership, trust, other institution or
             639      entity or one or more individuals.
             640          (hh) "Poppy straw" means all parts, except the seeds, of the opium poppy, after
             641      mowing.
             642          (ii) "Possession" or "use" means the joint or individual ownership, control, occupancy,
             643      holding, retaining, belonging, maintaining, or the application, inhalation, swallowing, injection,
             644      or consumption, as distinguished from distribution, of controlled substances and includes
             645      individual, joint, or group possession or use of controlled substances. For a person to be a


             646      possessor or user of a controlled substance, it is not required that the person be shown to have
             647      individually possessed, used, or controlled the substance, but it is sufficient if it is shown that
             648      the person jointly participated with one or more persons in the use, possession, or control of
             649      any substances with knowledge that the activity was occurring, or the controlled substance is
             650      found in a place or under circumstances indicating that the person had the ability and the intent
             651      to exercise dominion and control over it.
             652          (jj) "Practitioner" means a physician, dentist, naturopathic physician, veterinarian,
             653      pharmacist, scientific investigator, pharmacy, hospital, or other person licensed, registered, or
             654      otherwise permitted to distribute, dispense, conduct research with respect to, administer, or use
             655      in teaching or chemical analysis a controlled substance in the course of professional practice or
             656      research in this state.
             657          (kk) "Prescribe" means to issue a prescription:
             658          (i) orally or in writing[.]; or
             659          (ii) by telephone, facsimile transmission, computer, or other electronic means of
             660      communication as defined by division rule.
             661          (ll) "Prescription" means an order issued:
             662          (i) by a licensed practitioner, in the course of that practitioner's professional practice[,]
             663      or by collaborative pharmacy practice agreement; and
             664          (ii) for a controlled substance[,] or other prescription drug[,] or device [which it
             665      dispenses or administers] for use by a patient or an animal. [The order may be issued by word
             666      of mouth, written document, telephone, facsimile transmission, computer, or other electronic
             667      means of communication as defined by rule.]
             668          (mm) "Production" means the manufacture, planting, cultivation, growing, or
             669      harvesting of a controlled substance.
             670          (nn) "Securities" means any stocks, bonds, notes, or other evidences of debt or of
             671      property.
             672          (oo) "State" means the state of Utah.
             673          (pp) "Ultimate user" means any person who lawfully possesses a controlled substance


             674      for the person's own use, for the use of a member of the person's household, or for
             675      administration to an animal owned by the person or a member of the person's household.
             676          (2) If a term used in this chapter is not defined, the definition and terms of Title 76,
             677      Utah Criminal Code, shall apply.
             678          Section 5. Section 58-67-102 is amended to read:
             679           58-67-102. Definitions.
             680          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             681          (1) "ACGME" means the Accreditation Council for Graduate Medical Education of the
             682      American Medical Association.
             683          (2) "Administrative penalty" means a monetary fine imposed by the division for acts or
             684      omissions determined to constitute unprofessional or unlawful conduct, as a result of an
             685      adjudicative proceeding conducted in accordance with Title 63G, Chapter 4, Administrative
             686      Procedures Act.
             687          (3) "Board" means the Physicians Licensing Board created in Section 58-67-201 .
             688          (4) "Diagnose" means:
             689          (a) to examine in any manner another person, parts of a person's body, substances,
             690      fluids, or materials excreted, taken, or removed from a person's body, or produced by a person's
             691      body, to determine the source, nature, kind, or extent of a disease or other physical or mental
             692      condition;
             693          (b) to attempt to conduct an examination or determination described under Subsection
             694      (4)(a);
             695          (c) to hold oneself out as making or to represent that one is making an examination or
             696      determination as described in Subsection (4)(a); or
             697          (d) to make an examination or determination as described in Subsection (4)(a) upon or
             698      from information supplied directly or indirectly by another person, whether or not in the
             699      presence of the person making or attempting the diagnosis or examination.
             700          (5) "LCME" means the Liaison Committee on Medical Education of the American
             701      Medical Association.


             702          (6) "Medical assistant" means an unlicensed individual working under the direct and
             703      immediate supervision of a licensed physician and surgeon and engaged in specific tasks
             704      assigned by the licensed physician and surgeon in accordance with the standards and ethics of
             705      the profession.
             706          (7) "Physician" means both physicians and surgeons licensed under Section 58-67-301 ,
             707      Utah Medical Practice Act, and osteopathic physicians and surgeons licensed under Section
             708      58-68-301 , Utah Osteopathic Medical Practice Act.
             709          (8) "Practice of medicine" means:
             710          (a) to diagnose, treat, correct, administer anesthesia, or prescribe for any human
             711      disease, ailment, injury, infirmity, deformity, pain or other condition, physical or mental, real
             712      or imaginary, or to attempt to do so, by any means or instrumentality, and by an individual in
             713      Utah or outside the state upon or for any human within the state, except that conduct described
             714      in this Subsection (8)(a) that is performed by a person legally and in accordance with a license
             715      issued under another chapter of this title does not constitute the practice of medicine;
             716          (b) when a person not licensed as a physician directs a licensee under this chapter to
             717      withhold or alter the health care services that the licensee has ordered, but practice of medicine
             718      does not include any conduct under Subsection 58-67-501 (2);
             719          (c) to maintain an office or place of business for the purpose of doing any of the acts
             720      described in Subsection (8)(a) whether or not for compensation; or
             721          (d) to use, in the conduct of any occupation or profession pertaining to the diagnosis or
             722      treatment of human diseases or conditions in any printed material, stationery, letterhead,
             723      envelopes, signs, or advertisements, the designation "doctor," "doctor of medicine,"
             724      "physician," "surgeon," "physician and surgeon," "Dr.," "M.D.," or any combination of these
             725      designations in any manner which might cause a reasonable person to believe the individual
             726      using the designation is a licensed physician and surgeon, and if the party using the designation
             727      is not a licensed physician and surgeon, the designation must additionally contain the
             728      description of the branch of the healing arts for which the person has a license.
             729          (9) "Prescription [drug or] device" means[:] an instrument, apparatus, implement,


             730      machine, contrivance, implant, in vitro reagent, or other similar or related article, and any
             731      component part or accessory, which is required under federal or state law to be prescribed by a
             732      practitioner and dispensed by or through a person or entity licensed under this chapter or
             733      exempt from licensure under this chapter.
             734          [(a) a drug or device which, under federal law, is required to be labeled with either of
             735      the following statements or their equivalent:]
             736          [(i) "CAUTION: Federal law prohibits dispensing without prescription"; or]
             737          [(ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
             738      veterinarian"; or]
             739          [(b) a drug or device that is required by any applicable federal or state law or rule to be
             740      dispensed on prescription only or is restricted to use by practitioners only.]
             741          (10) "Prescription drug" means a drug that is required by federal or state law or rule to
             742      be dispensed only by prescription or is restricted to administration only by practitioners.
             743          [(10)] (11) "SPEX" means the Special Purpose Examination of the Federation of State
             744      Medical Boards.
             745          [(11)] (12) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-67-501 .
             746          [(12)] (13) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             747      58-67-502 , and as may be further defined by division rule.
             748          Section 6. Section 58-68-102 is amended to read:
             749           58-68-102. Definitions.
             750          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             751          (1) "ACGME" means the Accreditation Council for Graduate Medical Education of the
             752      American Medical Association.
             753          (2) "Administrative penalty" means a monetary fine imposed by the division for acts or
             754      omissions determined to constitute unprofessional or unlawful conduct, as a result of an
             755      adjudicative proceeding conducted in accordance with Title 63G, Chapter 4, Administrative
             756      Procedures Act.
             757          (3) "AOA" means the American Osteopathic Association.


             758          (4) "Board" means the Osteopathic Physicians Licensing Board created in Section
             759      58-68-201 .
             760          (5) "Diagnose" means:
             761          (a) to examine in any manner another person, parts of a person's body, substances,
             762      fluids, or materials excreted, taken, or removed from a person's body, or produced by a person's
             763      body, to determine the source, nature, kind, or extent of a disease or other physical or mental
             764      condition;
             765          (b) to attempt to conduct an examination or determination described under Subsection
             766      (5)(a);
             767          (c) to hold oneself out as making or to represent that one is making an examination or
             768      determination as described in Subsection (5)(a); or
             769          (d) to make an examination or determination as described in Subsection (5)(a) upon or
             770      from information supplied directly or indirectly by another person, whether or not in the
             771      presence of the person making or attempting the diagnosis or examination.
             772          (6) "Medical assistant" means an unlicensed individual working under the direct and
             773      immediate supervision of a licensed osteopathic physician and surgeon and engaged in specific
             774      tasks assigned by the licensed osteopathic physician and surgeon in accordance with the
             775      standards and ethics of the profession.
             776          (7) "Physician" means both physicians and surgeons licensed under Section 58-67-301 ,
             777      Utah Medical Practice Act, and osteopathic physicians and surgeons licensed under Section
             778      58-68-301 , Utah Osteopathic Medical Practice Act.
             779          (8) "Practice of osteopathic medicine" means:
             780          (a) to diagnose, treat, correct, administer anesthesia, or prescribe for any human
             781      disease, ailment, injury, infirmity, deformity, pain, or other condition, physical or mental, real
             782      or imaginary, or to attempt to do so, by any means or instrumentality, which in whole or in part
             783      is based upon emphasis of the importance of the musculoskeletal system and manipulative
             784      therapy in the maintenance and restoration of health, by an individual in Utah or outside of the
             785      state upon or for any human within the state, except that conduct described in this Subsection


             786      (8)(a) that is performed by a person legally and in accordance with a license issued under
             787      another chapter of this title does not constitute the practice of medicine;
             788          (b) when a person not licensed as a physician directs a licensee under this chapter to
             789      withhold or alter the health care services that the licensee has ordered, but practice of medicine
             790      does not include any conduct under Subsection 58-68-501 (2);
             791          (c) to maintain an office or place of business for the purpose of doing any of the acts
             792      described in Subsection (8)(a) whether or not for compensation; or
             793          (d) to use, in the conduct of any occupation or profession pertaining to the diagnosis or
             794      treatment of human diseases or conditions, in any printed material, stationery, letterhead,
             795      envelopes, signs, or advertisements, the designation "doctor," "doctor of osteopathic medicine,"
             796      "osteopathic physician," "osteopathic surgeon," "osteopathic physician and surgeon," "Dr.,"
             797      "D.O.," or any combination of these designations in any manner which might cause a
             798      reasonable person to believe the individual using the designation is a licensed osteopathic
             799      physician, and if the party using the designation is not a licensed osteopathic physician, the
             800      designation must additionally contain the description of the branch of the healing arts for which
             801      the person has a license.
             802          (9) "Prescription [drug or] device" means[:] an instrument, apparatus, implement,
             803      machine, contrivance, implant, in vitro reagent, or other similar or related article, and any
             804      component part or accessory, which is required under federal or state law to be prescribed by a
             805      practitioner and dispensed by or through a person or entity licensed under this chapter or
             806      exempt from licensure under this chapter.
             807          [(a) a drug or device which, under federal law, is required to be labeled with either]
             808          [of the following statements or their equivalent:]
             809          [(i) "CAUTION: Federal law prohibits dispensing without prescription"; or]
             810          [(ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
             811      veterinarian"; or]
             812          [(b) a drug or device that is required by any applicable federal or state law or rule to be
             813      dispensed on prescription only or is restricted to use by practitioners only.]


             814          (10) "Prescription drug" means a drug that is required by federal or state law or rule to
             815      be dispensed only by prescription or is restricted to administration only by practitioners.
             816          [(10)] (11) "SPEX" means the Special Purpose Examination of the Federation of State
             817      Medical Boards.
             818          [(11)] (12) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-68-501 .
             819          [(12)] (13) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-68-502
             820      and as may be further defined by division rule.
             821          Section 7. Section 58-71-102 is amended to read:
             822           58-71-102. Definitions.
             823          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             824          (1) "Administrative penalty" means a monetary fine imposed by the division for acts or
             825      omissions determined to constitute unprofessional or unlawful conduct, as a result of an
             826      adjudicative proceeding conducted in accordance with Title 63G, Chapter 4, Administrative
             827      Procedures Act.
             828          (2) "Acupuncture" has the same definition as in Section 58-72-102 .
             829          (3) "Board" means the Naturopathic Physicians Licensing Board created in Section
             830      58-71-201 .
             831          (4) "Diagnose" means:
             832          (a) to examine in any manner another person, parts of a person's body, substances,
             833      fluids, or materials excreted, taken, or removed from a person's body, or produced by a person's
             834      body, to determine the source, nature, kind, or extent of a disease or other physical or mental
             835      condition;
             836          (b) to attempt to conduct an examination or determination described under Subsection
             837      (4)(a);
             838          (c) to hold oneself out as making or to represent that one is making an examination or
             839      determination as described in Subsection (4)(a); or
             840          (d) to make an examination or determination as described in Subsection (4)(a) upon or
             841      from information supplied directly or indirectly by another person, whether or not in the


             842      presence of the person making or attempting the diagnosis or examination.
             843          (5) "Local anesthesia" means an agent, whether a natural medicine or prescription drug,
             844      which:
             845          (a) is applied topically or by injection in superficial tissues associated with the
             846      performance of minor office procedures;
             847          (b) has the ability to produce loss of sensation at the site of minor office procedures;
             848      and
             849          (c) does not cause loss of consciousness or produce general sedation.
             850          (6) "Medical naturopathic assistant" means an unlicensed individual working under the
             851      direct and immediate supervision of a licensed naturopathic physician and engaged in specific
             852      tasks assigned by the licensed naturopathic physician in accordance with the standards and
             853      ethics of the profession.
             854          (7) (a) "Minor office procedures" means:
             855          (i) the use of operative, electrical, or other methods for repair and care of superficial
             856      lacerations, abrasions, and benign lesions;
             857          (ii) removal of foreign bodies located in the superficial tissues, excluding the eye or
             858      ear; and
             859          (iii) the use of antiseptics and local anesthetics in connection with minor office surgical
             860      procedures.
             861          (b) "Minor office procedures" does not include:
             862          (i) general or spinal anesthesia;
             863          (ii) office procedures more complicated or extensive than those set forth in Subsection
             864      (7)(a);
             865          (iii) procedures involving the eye; or
             866          (iv) any office procedure involving tendons, nerves, veins, or arteries.
             867          (8) "Natural medicine" means:
             868          (a) food, food extracts, dietary supplements as defined by the federal Food, Drug, and
             869      Cosmetics Act, all homeopathic remedies, and plant substances that are not designated as


             870      prescription drugs or controlled substances;
             871          (b) over-the-counter medications;
             872          (c) other nonprescription substances, the prescription or administration of which is not
             873      otherwise prohibited or restricted under federal or state law;
             874          (d) prescription drugs:
             875          (i) that, except as provided in Subsection (8)(e), are not controlled substances as
             876      defined in Section 58-37-2 ;
             877          (ii) the prescription of which is consistent with the competent practice of naturopathic
             878      medicine; and
             879          (iii) the prescription of which is approved by the division in collaboration with the
             880      naturopathic formulary advisory peer committee; and
             881          (e) testosterone, if the testosterone is:
             882          (i) bio-identical;
             883          (ii) designed to be:
             884          (A) administered topically, for transdermal absorption; or
             885          (B) absorbed across the mucosal membranes of the mouth; and
             886          (iii) prescribed or administered, in accordance with the requirements of federal and
             887      state law, solely for the purpose of treating a patient with a low testosterone level in order to
             888      restore the patient to a normal testosterone level.
             889          (9) (a) "Naturopathic childbirth" means uncomplicated natural childbirth assisted by a
             890      naturopathic physician, and includes the use of:
             891          (i) natural medicines; and
             892          (ii) uncomplicated episiotomy.
             893          (b) "Naturopathic childbirth" does not include the use of:
             894          (i) forceps delivery;
             895          (ii) general or spinal anesthesia;
             896          (iii) caesarean section delivery; or
             897          (iv) induced labor or abortion.


             898          (10) "Naturopathic mobilization therapy":
             899          (a) means manually administering mechanical treatment of body structures or tissues
             900      for the purpose of restoring normal physiological function to the body by normalizing and
             901      balancing the musculoskeletal system of the body;
             902          (b) does not mean manipulation or adjustment of the joints of the human body beyond
             903      the elastic barrier; and
             904          (c) does not include manipulation as defined in Title 58, Chapter 73, Chiropractic
             905      Physician Practice Act.
             906          (11) "Naturopathic physical medicine" means the use of the physical agents of air,
             907      water, heat, cold, sound, light, and electromagnetic nonionizing radiation, and the physical
             908      modalities of electrotherapy, biofeedback, acupuncture, diathermy, ultraviolet light, ultrasound,
             909      hydrotherapy, naturopathic mobilization therapy, and exercise. Naturopathic medicine does not
             910      include the practice of physical therapy or physical rehabilitation.
             911          (12) "Practice of naturopathic medicine" means:
             912          (a) a system of primary health care for the prevention, diagnosis, and treatment of
             913      human health conditions, injuries, and diseases that uses education, natural medicines, and
             914      natural therapies, to support and stimulate the patient's intrinsic self-healing processes:
             915          (i) using naturopathic childbirth, but only if:
             916          (A) the licensee meets standards of the American College of Naturopathic
             917      Obstetricians (ACNO) or its successor as determined by the division in collaboration with the
             918      board; and
             919          (B) the licensee follows a written plan for naturopathic physicians practicing
             920      naturopathic childbirth approved by the division in collaboration with the board, which
             921      includes entering into an agreement with a consulting physician and surgeon or osteopathic
             922      physician, in cases where the scope of practice of naturopathic childbirth may be exceeded and
             923      specialty care and delivery is indicated, detailing the guidelines by which the naturopathic
             924      physician will:
             925          (I) refer patients to the consulting physician; and


             926          (II) consult with the consulting physician;
             927          (ii) using naturopathic mobilization therapy;
             928          (iii) using naturopathic physical medicine;
             929          (iv) using minor office procedures;
             930          (v) prescribing or administering natural medicine;
             931          (vi) prescribing medical equipment and devices, diagnosing by the use of medical
             932      equipment and devices, and administering therapy or treatment by the use of medical devices
             933      necessary and consistent with the competent practice of naturopathic medicine;
             934          (vii) prescribing barrier devices for contraception;
             935          (viii) using dietary therapy;
             936          (ix) taking and using diagnostic x-rays, electrocardiograms, ultrasound, and
             937      physiological function tests;
             938          (x) taking of body fluids for clinical laboratory tests and using the results of the tests in
             939      diagnosis;
             940          (xi) taking of a history from and conducting of a physical examination upon a human
             941      patient; and
             942          (xii) prescribing and administering natural medicines and medical devices, except a
             943      naturopathic physician may only administer:
             944          (A) a prescription drug, as defined in Section 58-17b-102 , in accordance with
             945      Subsection (8)(d); and
             946          (B) local anesthesia that is not a controlled substance, and only in the performance of
             947      minor office procedures;
             948          (b) to maintain an office or place of business for the purpose of doing any of the acts
             949      described in Subsection (12)(a), whether or not for compensation; or
             950          (c) to use, in the conduct of any occupation or profession pertaining to the diagnosis or
             951      treatment of human diseases or conditions, in any printed material, stationery, letterhead,
             952      envelopes, signs, or advertisements, the designation "naturopathic physician," "naturopathic
             953      doctor," "naturopath," "doctor of naturopathic medicine," "doctor of naturopathy,"


             954      "naturopathic medical doctor," "naturopathic medicine," "naturopathic health care,"
             955      "naturopathy," "N.D.," "N.M.D.," or any combination of these designations in any manner that
             956      might cause a reasonable person to believe the individual using the designation is a licensed
             957      naturopathic physician.
             958          (13) "Prescribe" means to issue a prescription:
             959          (a) orally or in writing; or
             960          (b) by telephone, facsimile transmission, computer, or other electronic means of
             961      communication as defined by division rule.
             962          [(13)] (14) "Prescription [drug or] device" means[:] an instrument, apparatus,
             963      implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,
             964      and any component part or accessory, which is required under federal or state law to be
             965      prescribed by a practitioner and dispensed by or through a person or entity licensed under this
             966      chapter or exempt from licensure under this chapter.
             967          [(a) a drug or device which, under federal law, is required to be labeled with either of
             968      the following statements or their equivalent:]
             969          [(i) "CAUTION: Federal law prohibits dispensing without prescription"; or]
             970          [(ii) "CAUTION: Federal law restricts this drug to use by or on the order of a licensed
             971      veterinarian"; or]
             972          [(b) a drug or device that is required by any applicable federal or state law or rule to be
             973      dispensed on prescription only or is restricted to use by practitioners only.]
             974          (15) "Prescription drug" means a drug that is required by federal or state law or rule to
             975      be dispensed only by prescription or is restricted to administration only by practitioners.
             976          [(14)] (16) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-71-501 .
             977          [(15)] (17) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             978      58-71-502 , and as may be further defined by division rule.


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