S.B. 55 Enrolled

             1     

PHARMACEUTICAL DISPENSING AMENDMENTS

             2     
2014 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Evan J. Vickers

             5     
House Sponsor: Stewart Barlow

             6      Cosponsors:
             7      Curtis S. BrambleBrian E. Shiozawa              8     
             9      LONG TITLE
             10      General Description:
             11          This bill amends the Pharmacy Practice Act.
             12      Highlighted Provisions:
             13          This bill:
             14          .    defines terms;
             15          .    modifies the definition of pharmaceutical wholesaler or distributor in the Pharmacy
             16      Practice Act to exclude a facility for which the facility's total distribution-related
             17      sales of prescription drugs does not exceed 5% of the facility's total prescription
             18      drug sales;
             19          .    allows a hospital pharmacy that dispenses a prescription drug in a multidose
             20      container to a hospital patient and follows labeling requirements to provide the
             21      patient the drug when the patient is discharged;
             22          .    establishes the license classification "dispensing medical practitioner" under the
             23      Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug;
             24          .    establishes the pharmacy facility license classification "dispensing medical
             25      practitioner clinic pharmacy" under the Pharmacy Practice Act;
             26          .    creates Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
             27      Clinic Pharmacy;
             28          .    removes the exemption from the Pharmacy Practice Act for medical practitioners


             29      who prescribe and dispense a cosmetic drug, injectable weight loss drug, or a cancer drug
             30      treatment regimen;
             31          .    requires a license as a dispensing medical practitioner for a health care practitioner
             32      to dispense:
             33              .    a cosmetic drug:
             34              .    a cancer drug treatment regimen; or
             35              .    a prepackaged drug at an employer sponsored clinic;
             36          .    requires the Board of Pharmacy to work in conjunction with the affected
             37      practitioner governing boards:
             38              .    for discipline or hearings related to a dispensing medical practitioner; and
             39              .    to develop the administrative rules in the Pharmacy Practice Act related to a
             40      dispensing medical practitioner and a dispensing medical practitioner clinic
             41      pharmacy;
             42          .    establishes that practice as a dispensing medical practitioner does not include:
             43              .    the use of a vending-type dispensing device; or
             44              .    the prescription of controlled substances, except as permitted for cancer drug
             45      treatment regimens;
             46          .    amends the reporting requirements for the controlled substance database;
             47          .    amends unlawful and unprofessional conduct provisions; and
             48          .    makes technical changes.
             49      Money Appropriated in this Bill:
             50          None
             51      Other Special Clauses:
             52          This bill takes effect on July 1, 2014.
             53      Utah Code Sections Affected:
             54      AMENDS:
             55           58-17b-102 , as last amended by Laws of Utah 2013, Chapters 52, 166, and 423
             56           58-17b-301 , as last amended by Laws of Utah 2013, Chapter 52


             57           58-17b-302 , as last amended by Laws of Utah 2013, Chapter 52
             58           58-17b-309 , as last amended by Laws of Utah 2013, Chapter 278
             59           58-17b-309.6 , as enacted by Laws of Utah 2013, Chapter 52
             60           58-17b-502 , as last amended by Laws of Utah 2007, Chapter 279
             61           58-17b-602 , as last amended by Laws of Utah 2013, Chapter 79
             62           58-17b-612 , as last amended by Laws of Utah 2013, Chapters 52 and 166
             63           58-17b-613 , as enacted by Laws of Utah 2004, Chapter 280
             64           58-31b-502 , as last amended by Laws of Utah 2012, Chapter 234
             65           58-37f-203 , as enacted by Laws of Utah 2010, Chapter 287
             66           58-67-502 , as last amended by Laws of Utah 2012, Chapter 234
             67           58-68-502 , as last amended by Laws of Utah 2012, Chapter 234
             68           58-70a-502 , as last amended by Laws of Utah 2012, Chapter 234
             69           58-70a-503 , as last amended by Laws of Utah 2010, Chapter 37
             70           58-83-502 , as last amended by Laws of Utah 2012, Chapter 344
             71           63I-1-258 , as last amended by Laws of Utah 2013, Chapters 55, 87, 222, 278, and 351
             72      ENACTS:
             73           58-17b-801 , Utah Code Annotated 1953
             74           58-17b-802 , Utah Code Annotated 1953
             75           58-17b-803 , Utah Code Annotated 1953
             76           58-17b-804 , Utah Code Annotated 1953
             77           58-17b-805 , Utah Code Annotated 1953
             78           58-17b-806 , Utah Code Annotated 1953
             79      REPEALS:
             80           58-17b-309.5 , as enacted by Laws of Utah 2012, Chapter 234
             81     
             82      Be it enacted by the Legislature of the state of Utah:
             83          Section 1. Section 58-17b-102 is amended to read:
             84           58-17b-102. Definitions.


             85          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             86          (1) "Administering" means:
             87          (a) the direct application of a prescription drug or device, whether by injection,
             88      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             89      by another person; or
             90          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             91      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             92      means directed to the body of the animal by the owner or caretaker in accordance with written
             93      or verbal directions of the veterinarian.
             94          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             95      21 U.S.C.S. Sec. 351 (2003).
             96          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             97      the purpose of analysis.
             98          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             99      used as standards and controls in performing drug monitoring or drug screening analysis if the
             100      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             101      components, organic solvents, or inorganic buffers at a concentration not exceeding one
             102      milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             103      use.
             104          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             105      the use of prescription drugs.
             106          (5) "Automated pharmacy systems" includes mechanical systems which perform
             107      operations or activities, other than compounding or administration, relative to the storage,
             108      packaging, dispensing, or distribution of medications, and which collect, control, and maintain
             109      all transaction information.
             110          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
             111      prescription label at the time of dispensing that indicates to the patient or caregiver a time
             112      beyond which the contents of the prescription are not recommended to be used.


             113          (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
             114      in Section 58-17b-201 .
             115          (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
             116      underserved area, used for the storage and dispensing of prescription drugs, which is dependent
             117      upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
             118      approved by the division as the parent pharmacy.
             119          (9) "Centralized prescription processing" means the processing by a pharmacy of a
             120      request from another pharmacy to fill or refill a prescription drug order or to perform
             121      processing functions such as dispensing, drug utilization review, claims adjudication, refill
             122      authorizations, and therapeutic interventions.
             123          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             124      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             125      prescription order.
             126          (11) "Class B pharmacy":
             127          (a) means a pharmacy located in Utah:
             128          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             129      setting; and
             130          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             131      health care services; and
             132          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
             133          (ii) pharmaceutical administration and sterile product preparation facilities.
             134          (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
             135      engage in the manufacture, production, wholesale, or distribution of drugs or devices.
             136          (13) "Class D pharmacy" means a nonresident pharmacy.
             137          (14) "Class E pharmacy" means all other pharmacies.
             138          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
             139      defined and exclusive group of patients who have access to the services of the pharmacy
             140      because they are treated by or have an affiliation with a specific entity, including a health


             141      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             142      retailer of goods to the general public, or the office of a practitioner.
             143          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
             144      more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
             145      more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
             146      care functions authorized by the practitioner or practitioners under certain specified conditions
             147      or limitations.
             148          (17) "Collaborative pharmacy practice agreement" means a written and signed
             149      agreement between one or more pharmacists and one or more practitioners that provides for
             150      collaborative pharmacy practice for the purpose of drug therapy management of patients and
             151      prevention of disease of human subjects.
             152          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
             153      labeling of a limited quantity drug, sterile product, or device:
             154          (i) as the result of a practitioner's prescription order or initiative based on the
             155      practitioner, patient, or pharmacist relationship in the course of professional practice;
             156          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
             157      not for sale or dispensing; or
             158          (iii) in anticipation of prescription drug orders based on routine, regularly observed
             159      prescribing patterns.
             160          (b) "Compounding" does not include:
             161          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
             162      another pharmacist or pharmaceutical facility;
             163          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
             164      dosage form which is regularly and commonly available from a manufacturer in quantities and
             165      strengths prescribed by a practitioner; or
             166          (iii) the preparation of a prescription drug, sterile product, or device which has been
             167      withdrawn from the market for safety reasons.
             168          (19) "Confidential information" has the same meaning as "protected health


             169      information" under the Standards for Privacy of Individually Identifiable Health Information,
             170      45 C.F.R. Parts 160 and 164.
             171          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             172          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             173      417, Sec. 3a(ff) which is incorporated by reference.
             174          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             175      prescription drug order or device or nonprescription drug or device under a lawful order of a
             176      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             177      by a patient, research subject, or an animal.
             178          (23) "Dispensing medical practitioner" means an individual who is:
             179          (a) currently licensed as:
             180          (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
             181          (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
             182      Practice Act;
             183          (iii) a physician assistant under Chapter 70a, Physician Assistant Act;
             184          (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
             185          (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the optometrist
             186      is acting within the scope of practice for an optometrist; and
             187          (b) licensed by the division under the Pharmacy Practice Act to engage in the practice
             188      of a dispensing medical practitioner.
             189          (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
             190      located within a licensed dispensing medical practitioner's place of practice.
             191          [(23)] (25) "Distribute" means to deliver a drug or device other than by administering
             192      or dispensing.
             193          [(24)] (26) (a) "Drug" means:
             194          (i) a substance recognized in the official United States Pharmacopoeia, Official
             195      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             196      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or


             197      prevention of disease in humans or animals;
             198          (ii) a substance that is required by any applicable federal or state law or rule to be
             199      dispensed by prescription only or is restricted to administration by practitioners only;
             200          (iii) a substance other than food intended to affect the structure or any function of the
             201      body of humans or other animals; and
             202          (iv) substances intended for use as a component of any substance specified in
             203      Subsections [(24)] (26)(a)(i), (ii), (iii), and (iv).
             204          (b) "Drug" does not include dietary supplements.
             205          [(25)] (27) "Drug regimen review" includes the following activities:
             206          (a) evaluation of the prescription drug order and patient record for:
             207          (i) known allergies;
             208          (ii) rational therapy-contraindications;
             209          (iii) reasonable dose and route of administration; and
             210          (iv) reasonable directions for use;
             211          (b) evaluation of the prescription drug order and patient record for duplication of
             212      therapy;
             213          (c) evaluation of the prescription drug order and patient record for the following
             214      interactions:
             215          (i) drug-drug;
             216          (ii) drug-food;
             217          (iii) drug-disease; and
             218          (iv) adverse drug reactions; and
             219          (d) evaluation of the prescription drug order and patient record for proper utilization,
             220      including over- or under-utilization, and optimum therapeutic outcomes.
             221          [(26)] (28) "Drug sample" means a prescription drug packaged in small quantities
             222      consistent with limited dosage therapy of the particular drug, which is marked "sample", is not
             223      intended to be sold, and is intended to be provided to practitioners for the immediate needs of
             224      patients for trial purposes or to provide the drug to the patient until a prescription can be filled


             225      by the patient.
             226          [(27)] (29) "Electronic signature" means a trusted, verifiable, and secure electronic
             227      sound, symbol, or process attached to or logically associated with a record and executed or
             228      adopted by a person with the intent to sign the record.
             229          [(28)] (30) "Electronic transmission" means transmission of information in electronic
             230      form or the transmission of the exact visual image of a document by way of electronic
             231      equipment.
             232          [(29)] (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             233      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             234      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             235          [(30)] (32) "Legend drug" has the same meaning as prescription drug.
             236          [(31)] (33) "Licensed pharmacy technician" means an individual licensed with the
             237      division, that may, under the supervision of a pharmacist, perform the activities involved in the
             238      technician practice of pharmacy.
             239          [(32)] (34) "Manufacturer" means a person or business physically located in Utah
             240      licensed to be engaged in the manufacturing of drugs or devices.
             241          [(33)] (35) (a) "Manufacturing" means:
             242          (i) the production, preparation, propagation, conversion, or processing of a drug or
             243      device, either directly or indirectly, by extraction from substances of natural origin or
             244      independently by means of chemical or biological synthesis, or by a combination of extraction
             245      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             246      or relabeling of its container; and
             247          (ii) the promotion and marketing of such drugs or devices.
             248          (b) "Manufacturing" includes the preparation and promotion of commercially available
             249      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             250          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             251      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             252      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical


             253      analysis.
             254          [(34)] (36) "Medical order" means a lawful order of a practitioner which may include a
             255      prescription drug order.
             256          [(35)] (37) "Medication profile" or "profile" means a record system maintained as to
             257      drugs or devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
             258      analyze the profile to provide pharmaceutical care.
             259          [(36)] (38) "Misbranded drug or device" means a drug or device considered
             260      misbranded under 21 U.S.C.S. Sec. 352 (2003).
             261          [(37)] (39) (a) "Nonprescription drug" means a drug which:
             262          (i) may be sold without a prescription; and
             263          (ii) is labeled for use by the consumer in accordance with federal law.
             264          (b) "Nonprescription drug" includes homeopathic remedies.
             265          [(38)] (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that
             266      sells to a person in Utah.
             267          [(39)] (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical
             268      service.
             269          [(40)] (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility
             270      located outside the state that is licensed and in good standing in another state, that:
             271          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
             272      this state pursuant to a lawfully issued prescription;
             273          (b) provides information to a patient in this state on drugs or devices which may
             274      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             275      or
             276          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             277      effects of drugs.
             278          [(41)] (43) "Patient counseling" means the written and oral communication by the
             279      pharmacist or pharmacy intern of information, to the patient or caregiver, in order to ensure
             280      proper use of drugs, devices, and dietary supplements.


             281          [(42)] (44) "Pharmaceutical administration facility" means a facility, agency, or
             282      institution in which:
             283          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             284      the facility or agency for administration to patients of that facility or agency;
             285          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             286      or pharmacy intern with whom the facility has established a prescription drug supervising
             287      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             288      or agency staff as required, and oversees drug control, accounting, and destruction; and
             289          (c) prescription drugs are professionally administered in accordance with the order of a
             290      practitioner by an employee or agent of the facility or agency.
             291          [(43)] (45) (a) "Pharmaceutical care" means carrying out the following in collaboration
             292      with a prescribing practitioner, and in accordance with division rule:
             293          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             294      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             295      the patient's disease;
             296          (ii) eliminating or reducing a patient's symptoms; or
             297          (iii) arresting or slowing a disease process.
             298          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             299      prescribing practitioner.
             300          [(44)] (46) "Pharmaceutical facility" means a business engaged in the dispensing,
             301      delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within
             302      or into this state.
             303          [(45)] (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical
             304      facility engaged in the business of wholesale vending or selling of a prescription drug or device
             305      to other than a consumer or user of the prescription drug or device that the pharmaceutical
             306      facility has not produced, manufactured, compounded, or dispensed.
             307          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             308      facility carrying out the following business activities:


             309          (i) intracompany sales;
             310          (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             311      purchase, or trade a prescription drug or device, if the activity is carried out between one or
             312      more of the following entities under common ownership or common administrative control, as
             313      defined by division rule:
             314          (A) hospitals;
             315          (B) pharmacies;
             316          (C) chain pharmacy warehouses, as defined by division rule; or
             317          (D) other health care entities, as defined by division rule;
             318          (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             319      purchase, or trade a prescription drug or device, for emergency medical reasons, including
             320      supplying another pharmaceutical facility with a limited quantity of a drug, if:
             321          (A) the facility is unable to obtain the drug through a normal distribution channel in
             322      sufficient time to eliminate the risk of harm to a patient that would result from a delay in
             323      obtaining the drug; and
             324          (B) the quantity of the drug does not exceed an amount reasonably required for
             325      immediate dispensing to eliminate the risk of harm;
             326          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             327      manufacturer; and
             328          (v) the distribution of prescription drugs, if:
             329          [(A) the dosage units distributed during a calendar year do not exceed five percent of
             330      the sum of the dosage units distributed by the facility during the calendar year and the dosage
             331      units dispensed by the facility during the calendar year; and]
             332          (A) the facility's total distribution-related sales of prescription drugs does not exceed
             333      5% of the facility's total prescription drug sales; and
             334          (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
             335          [(46)] (48) "Pharmacist" means an individual licensed by this state to engage in the
             336      practice of pharmacy.


             337          [(47)] (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good
             338      standing who accepts responsibility for the operation of a pharmacy in conformance with all
             339      laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
             340      personally in full and actual charge of the pharmacy and all personnel.
             341          [(48)] (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with
             342      one or more years of licensed experience. The preceptor serves as a teacher, example of
             343      professional conduct, and supervisor of interns in the professional practice of pharmacy.
             344          [(49)] (51) "Pharmacy" means any place where:
             345          (a) drugs are dispensed;
             346          (b) pharmaceutical care is provided;
             347          (c) drugs are processed or handled for eventual use by a patient; or
             348          (d) drugs are used for the purpose of analysis or research.
             349          [(50)] (52) "Pharmacy benefits manager or coordinator" means a person or entity that
             350      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
             351      self-insured employer, insurance company, health maintenance organization, or other plan
             352      sponsor, as defined by rule.
             353          [(51)] (53) "Pharmacy intern" means an individual licensed by this state to engage in
             354      practice as a pharmacy intern.
             355          [(52)] (54) "Pharmacy technician training program" means an approved technician
             356      training program providing education for pharmacy technicians.
             357          (55) (a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
             358      specifically relating to the dispensing of a prescription drug in accordance with Part 8,
             359      Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, and
             360      division rule adopted after consultation with the Board of Pharmacy and the governing boards
             361      of the practitioners described in Subsection (23)(a).
             362          (b) "Practice as a dispensing medical practitioner" does not include:
             363          (i) using a vending type of dispenser as defined by the division by administrative rule;
             364      or


             365          (ii) except as permitted by Section 58-17b-805 , dispensing of a controlled substance as
             366      defined in Section 58-37-2 .
             367          [(53)] (56) (a) "Practice as a licensed pharmacy technician" means engaging in practice
             368      as a pharmacy technician under the general supervision of a licensed pharmacist and in
             369      accordance with a scope of practice defined by division rule made in collaboration with the
             370      board.
             371          (b) "Practice as a licensed pharmacy technician" does not include:
             372          (i) performing a drug utilization review, prescription drug order clarification from a
             373      prescriber, final review of the prescription, dispensing of the drug, or counseling a patient with
             374      respect to a prescription drug;
             375          (ii) except as permitted by rules made by the division in consultation with the board,
             376      final review of a prescribed drug prepared for dispensing;
             377          (iii) counseling regarding nonprescription drugs and dietary supplements unless
             378      delegated by the supervising pharmacist; or
             379          (iv) receiving new prescription drug orders when communicating telephonically or
             380      electronically unless the original information is recorded so the pharmacist may review the
             381      prescription drug order as transmitted.
             382          [(54)] (57) "Practice of pharmacy" includes the following:
             383          (a) providing pharmaceutical care;
             384          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             385      practice agreement;
             386          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             387      distribution of prescription drugs or devices, provided that the administration of a prescription
             388      drug or device is:
             389          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             390          (ii) in accordance with written guidelines or protocols:
             391          (A) established by the licensed facility in which the prescription drug or device is to be
             392      administered on an inpatient basis; or


             393          (B) approved by the division, in collaboration with the board and the Physicians
             394      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             395      administered on an outpatient basis solely by a licensed pharmacist;
             396          (d) participating in drug utilization review;
             397          (e) ensuring proper and safe storage of drugs and devices;
             398          (f) maintaining records of drugs and devices in accordance with state and federal law
             399      and the standards and ethics of the profession;
             400          (g) providing information on drugs or devices, which may include advice relating to
             401      therapeutic values, potential hazards, and uses;
             402          (h) providing drug product equivalents;
             403          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             404      technicians;
             405          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
             406          (k) providing emergency refills as defined by rule;
             407          (l) telepharmacy; and
             408          (m) formulary management intervention.
             409          [(55)] (58) "Practice of telepharmacy" means the practice of pharmacy through the use
             410      of telecommunications and information technologies.
             411          [(56)] (59) "Practice of telepharmacy across state lines" means the practice of
             412      pharmacy through the use of telecommunications and information technologies that occurs
             413      when the patient is physically located within one jurisdiction and the pharmacist is located in
             414      another jurisdiction.
             415          [(57)] (60) "Practitioner" means an individual currently licensed, registered, or
             416      otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
             417      course of professional practice.
             418          [(58)] (61) "Prescribe" means to issue a prescription:
             419          (a) orally or in writing; or
             420          (b) by telephone, facsimile transmission, computer, or other electronic means of


             421      communication as defined by division rule.
             422          [(59)] (62) "Prescription" means an order issued:
             423          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             424      by collaborative pharmacy practice agreement; and
             425          (b) for a controlled substance or other prescription drug or device for use by a patient
             426      or an animal.
             427          [(60)] (63) "Prescription device" means an instrument, apparatus, implement, machine,
             428      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             429      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             430      and dispensed by or through a person or entity licensed under this chapter or exempt from
             431      licensure under this chapter.
             432          [(61)] (64) "Prescription drug" means a drug that is required by federal or state law or
             433      rule to be dispensed only by prescription or is restricted to administration only by practitioners.
             434          [(62)] (65) "Research using pharmaceuticals" means research:
             435          (a) conducted in a research facility, as defined by division rule, that is associated with a
             436      university or college in the state accredited by the Northwest Commission on Colleges and
             437      Universities;
             438          (b) requiring the use of a controlled substance, prescription drug, or prescription
             439      device;
             440          (c) that uses the controlled substance, prescription drug, or prescription device in
             441      accordance with standard research protocols and techniques, including, if required, those
             442      approved by an institutional review committee; and
             443          (d) that includes any documentation required for the conduct of the research and the
             444      handling of the controlled substance, prescription drug, or prescription device.
             445          [(63)] (66) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             446      drugs and devices to the general public.
             447          [(64)] (67) "Self-audit" means an internal evaluation of a pharmacy to determine
             448      compliance with this chapter.


             449          [(65)] (68) "Supervising pharmacist" means a pharmacist who is overseeing the
             450      operation of the pharmacy during a given day or shift.
             451          [(66)] (69) "Supportive personnel" means unlicensed individuals who:
             452          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             453      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             454      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             455      those duties may be further defined by division rule adopted in collaboration with the board;
             456      and
             457          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             458      collaboration with the board.
             459          [(67)] (70) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             460          [(68)] (71) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             461      58-17b-502 and may be further defined by rule.
             462          [(69)] (72) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             463      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             464      for animals.
             465          Section 2. Section 58-17b-301 is amended to read:
             466           58-17b-301. License required -- License classifications for individuals.
             467          (1) A license is required to engage in the practice of pharmacy, telepharmacy, [or the
             468      practice of a] pharmacy technician, or dispensing medical practitioner except as specifically
             469      provided in Section 58-1-307 [,] or 58-17b-309 [, or 58-17-309.6 ].
             470          (2) The division shall issue to an individual who qualifies under this chapter a license
             471      in the classification of:
             472          (a) pharmacist;
             473          (b) pharmacy intern; [or]
             474          (c) pharmacy technician[.]; or
             475          (d) dispensing medical practitioner.
             476          Section 3. Section 58-17b-302 is amended to read:


             477           58-17b-302. License required -- License classifications for pharmacy facilities.
             478          (1) A license is required to act as a pharmacy, except as specifically exempted from
             479      licensure under Section 58-1-307 [or 58-17-309.6 ].
             480          (2) The division shall issue a pharmacy license to a facility that qualifies under this
             481      chapter in the classification of a:
             482          (a) class A pharmacy;
             483          (b) class B pharmacy;
             484          (c) class C pharmacy;
             485          (d) class D pharmacy; [or]
             486          (e) class E pharmacy[.]; or
             487          (f) dispensing medical practitioner clinic pharmacy.
             488          (3) Each place of business shall require a separate license. If multiple pharmacies exist
             489      at the same address, a separate license shall be required for each pharmacy.
             490          (4) The division may further define or supplement the classifications of pharmacies.
             491      The division may impose restrictions upon classifications to protect the public health, safety,
             492      and welfare.
             493          (5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
             494      rule.
             495          (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
             496      the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
             497      of the pharmacy, regardless of the form of the business organization.
             498          Section 4. Section 58-17b-309 is amended to read:
             499           58-17b-309. Exemptions from licensure.
             500          [(1) For purposes of this section:]
             501          [(a) "Cosmetic drug":]
             502          [(i) means a prescription drug that is:]
             503          [(A) for the purpose of promoting attractiveness or altering the appearance of an
             504      individual; and]


             505          [(B) listed as a cosmetic drug subject to the exemption under this section by the
             506      division by administrative rule or has been expressly approved for online dispensing, whether
             507      or not it is dispensed online or through a physician's office; and]
             508          [(ii) does not include a prescription drug that is:]
             509          [(A) a controlled substance;]
             510          [(B) compounded by the physician; or]
             511          [(C) prescribed or used for the patient for the purpose of diagnosing, curing, or
             512      preventing a disease.]
             513          [(b) "Injectable weight loss drug":]
             514          [(i) means an injectable prescription drug:]
             515          [(A) prescribed to promote weight loss; and]
             516          [(B) listed as an injectable prescription drug subject to exemption under this section by
             517      the division by administrative rule; and]
             518          [(ii) does not include a prescription drug that is a controlled substance.]
             519          [(c) "Prescribing practitioner" means an individual licensed under:]
             520          [(i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             521      prescriptive practice;]
             522          [(ii) Chapter 67, Utah Medical Practice Act;]
             523          [(iii) Chapter 68, Utah Osteopathic Medical Practice Act; or]
             524          [(iv) Chapter 70a, Physician Assistant Act.]
             525          [(2)] (1) In addition to the exemptions from licensure in [Sections] Section 58-1-307
             526      [and 58-17b-309.5 ], the following individuals may engage in the acts or practices described in
             527      this section without being licensed under this chapter:
             528          [(a) if the individual is described in Subsections (2)(b), (d), or (e), the individual
             529      notifies the division in writing of the individual's intent to dispense a drug under this
             530      subsection;]
             531          [(b)] (a) a person selling or providing contact lenses in accordance with Section
             532      58-16a-801 ; or


             533          [(c)] (b) an individual engaging in the practice of pharmacy technician under the direct
             534      personal supervision of a pharmacist while making satisfactory progress in an approved
             535      program as defined in division rule[;].
             536          [(d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
             537      injectable weight loss drug to the prescribing practitioner's patient in accordance with
             538      Subsection (4); or]
             539          [(e) an optometrist, as defined in Section 58-16a-102 , acting within the optometrist's
             540      scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses a cosmetic
             541      drug to the optometrist's patient in accordance with Subsection (4).]
             542          [(3)] (2) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
             543      Subsection [(2)(c)] (1)(b) must take all examinations as required by division rule following
             544      completion of an approved curriculum of education, within the required time frame. This
             545      exemption expires immediately upon notification of a failing score of an examination, and the
             546      individual may not continue working as a pharmacy technician even under direct supervision.
             547          [(4) A prescribing practitioner or optometrist is exempt from licensing under the
             548      provisions of this part if the prescribing practitioner or optometrist:]
             549          [(a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has
             550      the authority to dispense under Subsection (4)(b); and]
             551          [(ii) informs the patient:]
             552          [(A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
             553      practitioner's or optometrist's office;]
             554          [(B) of the directions for appropriate use of the drug;]
             555          [(C) of potential side-effects to the use of the drug; and]
             556          [(D) how to contact the prescribing practitioner or optometrist if the patient has
             557      questions or concerns regarding the drug;]
             558          [(b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             559      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
             560      patients;]


             561          [(c) follows labeling, record keeping, patient counseling, storage, purchasing and
             562      distribution, operating, treatment, and quality of care requirements established by
             563      administrative rule adopted by the division in consultation with the boards listed in Subsection
             564      (5)(a); and]
             565          [(d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to
             566      patients is reconstituted or compounded.]
             567          [(5) (a) The division, in consultation with the board under this chapter and the relevant
             568      professional board, including the Physician Licensing Board, the Osteopathic Physician
             569      Licensing Board, the Physician Assistant Licensing Board, the Board of Nursing, the
             570      Optometrist Licensing Board, or the Online Prescribing, Dispensing, and Facilitation Board,
             571      shall adopt administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative
             572      Rulemaking Act to designate:]
             573          [(i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             574      under this section; and]
             575          [(ii) the requirements under Subsection (4)(c).]
             576          [(b) When making a determination under Subsection (1)(a), the division and boards
             577      listed in Subsection (5)(a) may consider any federal Food and Drug Administration indications
             578      or approval associated with a drug when adopting a rule to designate a prescription drug that
             579      may be dispensed under this section.]
             580          [(c) The division may inspect the office of a prescribing practitioner or optometrist
             581      who is dispensing under the provisions of this section, in order to determine whether the
             582      prescribing practitioner or optometrist is in compliance with the provisions of this section. If a
             583      prescribing practitioner or optometrist chooses to dispense under the provisions of this section,
             584      the prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect
             585      the prescribing practitioner's or optometrist's office and determine if the provisions of this
             586      section are being met by the prescribing practitioner or optometrist.]
             587          [(d) If a prescribing practitioner or optometrist violates a provision of this section, the
             588      prescribing practitioner or optometrist may be subject to discipline under:]


             589          [(i) this chapter; and]
             590          [(ii) (A) Chapter 16a, Utah Optometry Practice Act;]
             591          [(B) Chapter 31b, Nurse Practice Act;]
             592          [(C) Chapter 67, Utah Medical Practice Act;]
             593          [(D) Chapter 68, Utah Osteopathic Medical Practice Act;]
             594          [(E) Chapter 70a, Physician Assistant Act; or]
             595          [(F) Chapter 83, Online Prescribing, Dispensing, and Facilitation Act.]
             596          [(6) Except as provided in Subsection (2)(e), this section does not restrict or limit the
             597      scope of practice of an optometrist or optometric physician licensed under Chapter 16a, Utah
             598      Optometry Practice Act.]
             599          Section 5. Section 58-17b-309.6 is amended to read:
             600           58-17b-309.6. Exemptions from licensure for research using pharmaceuticals.
             601          Research using pharmaceuticals, as defined in Subsection 58-17b-102 [(64)](65), is
             602      exempt from licensure under Sections 58-17b-301 and 58-17b-302 .
             603          Section 6. Section 58-17b-502 is amended to read:
             604           58-17b-502. Unprofessional conduct.
             605          "Unprofessional conduct" includes:
             606          (1) willfully deceiving or attempting to deceive the division, the board, or their agents
             607      as to any relevant matter regarding compliance under this chapter;
             608          (2) (a) except as provided in Subsection (2)(b):
             609          (i) paying or offering rebates to practitioners or any other health care providers, or
             610      receiving or soliciting rebates from practitioners or any other health care provider; or
             611          (ii) paying, offering, receiving, or soliciting compensation in the form of a commission,
             612      bonus, rebate, kickback, or split fee arrangement with practitioners or any other health care
             613      provider, for the purpose of obtaining referrals.
             614          (b) Subsection (2)(a) does not apply to:
             615          (i) giving or receiving price discounts based on purchase volume;
             616          (ii) passing along pharmaceutical manufacturer's rebates; or


             617          (iii) providing compensation for services to a veterinarian.
             618          (3) misbranding or adulteration of any drug or device or the sale, distribution, or
             619      dispensing of any outdated, misbranded, or adulterated drug or device;
             620          (4) engaging in the sale or purchase of drugs or devices that are samples or packages
             621      bearing the inscription "sample" or "not for resale" or similar words or phrases;
             622          (5) except as provided in Section 58-17b-503 , accepting back and redistributing of any
             623      unused drug, or a part of it, after it has left the premises of any pharmacy, unless the drug is in
             624      a unit pack, as defined in Section 58-17b-503 , or the manufacturer's sealed container, as
             625      defined in rule;
             626          (6) an act in violation of this chapter committed by a person for any form of
             627      compensation if the act is incidental to the person's professional activities, including the
             628      activities of a pharmacist, pharmacy intern, or pharmacy technician;
             629          (7) violating Federal Title II, P.L. 91, Controlled Substances Act, Title 58, Chapter 37,
             630      Utah Controlled Substances Act, or rules or regulations adopted under either act;
             631          (8) requiring or permitting pharmacy interns or technicians to engage in activities
             632      outside the scope of practice for their respective license classifications, as defined in this
             633      chapter and division rules made in collaboration with the board, or beyond their scope of
             634      training and ability;
             635          (9) administering:
             636          (a) without appropriate training, as defined by rule;
             637          (b) without a physician's order, when one is required by law; and
             638          (c) in conflict with a practitioner's written guidelines or written protocol for
             639      administering;
             640          (10) disclosing confidential patient information in violation of the provisions of the
             641      Health Insurance Portability and Accountability Act of 1996 or other applicable law;
             642          (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
             643      the pharmacist-in-charge;
             644          (12) failing to report to the division any adverse action taken by another licensing


             645      jurisdiction, government agency, law enforcement agency, or court for conduct that in
             646      substance would be considered unprofessional conduct under this section; and
             647          [(13) as a pharmacist or pharmacy intern, preparing a prescription drug for sale to
             648      another pharmacist or pharmaceutical facility; and]
             649          [(14)] (13) as a pharmacist or pharmacy intern, preparing a prescription drug in a
             650      dosage form which is regularly and commonly available from a manufacturer in quantities and
             651      strengths prescribed by a practitioner.
             652          Section 7. Section 58-17b-602 is amended to read:
             653           58-17b-602. Prescription orders -- Information required -- Alteration -- Labels --
             654      Signatures -- Dispensing in pharmacies.
             655          (1) Except as provided in Section 58-1-501.3 , the minimum information that shall be
             656      included in a prescription order, and that may be defined by rule, is:
             657          (a) the prescriber's name, address, and telephone number, and, if the order is for a
             658      controlled substance, the patient's age and the prescriber's DEA number;
             659          (b) the patient's name and address or, in the case of an animal, the name of the owner
             660      and species of the animal;
             661          (c) the date of issuance;
             662          (d) the name of the medication or device prescribed and dispensing instructions, if
             663      necessary;
             664          (e) the directions, if appropriate, for the use of the prescription by the patient or animal
             665      and any refill, special labeling, or other instructions;
             666          (f) the prescriber's signature if the prescription order is written;
             667          (g) if the order is an electronically transmitted prescription order, the prescribing
             668      practitioner's electronic signature; and
             669          (h) if the order is a hard copy prescription order generated from electronic media, the
             670      prescribing practitioner's electronic or manual signature.
             671          (2) The requirement of Subsection (1)(a) does not apply to prescription orders
             672      dispensed for inpatients by hospital pharmacies if the prescriber is a current member of the


             673      hospital staff and the prescription order is on file in the patient's medical record.
             674          (3) Unless it is for a Schedule II controlled substance, a prescription order may be
             675      dispensed by a pharmacist or pharmacy intern upon an oral prescription of a practitioner only if
             676      the oral prescription is promptly reduced to writing.
             677          (4) (a) Except as provided under Subsection (4)(b), a pharmacist or pharmacy intern
             678      may not dispense or compound any prescription of a practitioner if the prescription shows
             679      evidence of alteration, erasure, or addition by any person other than the person writing the
             680      prescription.
             681          (b) A pharmacist or pharmacy intern dispensing or compounding a prescription may
             682      alter or make additions to the prescription after receiving permission of the prescriber and may
             683      make entries or additions on the prescription required by law or necessitated in the
             684      compounding and dispensing procedures.
             685          (5) Each drug dispensed shall have a label securely affixed to the container indicating
             686      the following minimum information:
             687          (a) the name, address, and telephone number of the pharmacy;
             688          (b) the serial number of the prescription as assigned by the dispensing pharmacy;
             689          (c) the filling date of the prescription or its last dispensing date;
             690          (d) the name of the patient, or in the case of an animal, the name of the owner and
             691      species of the animal;
             692          (e) the name of the prescriber;
             693          (f) the directions for use and cautionary statements, if any, which are contained in the
             694      prescription order or are needed;
             695          (g) except as provided in Subsection [(6)] (7), the trade, generic, or chemical name,
             696      amount dispensed and the strength of dosage form, but if multiple ingredient products with
             697      established proprietary or nonproprietary names are prescribed, those products' names may be
             698      used; and
             699          (h) the beyond use date.
             700          (6) A hospital pharmacy that dispenses a prescription drug that is packaged in a


             701      multidose container to a hospital patient may provide the drug in the multidose container to the
             702      patient when the patient is discharged from the hospital if:
             703          (a) the pharmacy receives a discharge order for the patient; and
             704          (b) the pharmacy labels the drug with the:
             705          (i) patient's name;
             706          (ii) drug's name and strength;
             707          (iii) directions for use of the drug, if applicable; and
             708          (iv) pharmacy's name and phone number.
             709          [(6)] (7) If the prescriber specifically indicates the name of the prescription product
             710      should not appear on the label, then any of the trade, generic, chemical, established proprietary,
             711      and established nonproprietary names and the strength of dosage form may not be included.
             712          [(7)] (8) Prescribers are encouraged to include on prescription labels the information
             713      described in Section 58-17b-602.5 in accordance with the provisions of that section.
             714          [(8) Except when it is delivered to the ultimate user via the United States Postal
             715      Service, licensed common carrier, or supportive personnel, a prescription drug may be
             716      dispensed to the ultimate user or his agent only at a licensed pharmacy.]
             717          (9) A pharmacy may only deliver a prescription drug to a patient or a patient's agent:
             718          (a) in person at the pharmacy; or
             719          (b) via the United States Postal Service, a licensed common carrier, or supportive
             720      personnel, if the pharmacy takes reasonable precautions to ensure the prescription drug is:
             721          (i) delivered to the patient or patient's agent; or
             722          (ii) returned to the pharmacy.
             723          Section 8. Section 58-17b-612 is amended to read:
             724           58-17b-612. Supervision -- Pharmacist-in-charge.
             725          (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
             726      pharmacy, or class E pharmacy, shall be under the general supervision of at least one
             727      pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
             728      as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.


             729          (b) Notwithstanding Subsection 58-17b-102 [(65)](68), a supervising pharmacist does
             730      not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
             731      for immediate contact with the supervised pharmacy technician or pharmacy intern if:
             732          (i) the pharmacy is located in:
             733          (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
             734          (B) a clinic located in a remote rural county with less than 20 people per square mile;
             735          (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
             736          (iii) the telepharmacy system maintains records and files quarterly reports as required
             737      by division rule to assure that patient safety is not compromised.
             738          (2) Each out-of-state mail service pharmacy shall designate and identify to the division
             739      a pharmacist holding a current license in good standing issued by the state in which the
             740      pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
             741      chapter.
             742          Section 9. Section 58-17b-613 is amended to read:
             743           58-17b-613. Patient counseling.
             744          (1) [Every] A retail pharmacy [facility shall orally] shall verbally offer to counsel a
             745      patient or a patient's agent in a personal face-to-face discussion [with respect to] regarding each
             746      prescription drug dispensed, if the patient or patient's agent:
             747          (a) delivers the prescription in person to the pharmacist or pharmacy intern; or
             748          (b) receives the drug in person at the time it is dispensed at the pharmacy facility.
             749          [(2) A pharmacist or pharmacy intern shall provide counseling to each patient, and
             750      shall provide the patient with a toll-free telephone number by which the patient may contact a
             751      pharmacist at the dispensing pharmacy during normal business hours and receive oral
             752      counseling, with respect to each prescription drug dispensed if the patient provides or the
             753      prescription is otherwise provided to the pharmacy facility by a means other than personal
             754      delivery, and the dispensed prescription drug is mailed or otherwise delivered to the patient
             755      outside of the pharmacy facility.]
             756          [(3) (a) The provisions of Subsections (1) and (2) do not apply to incarcerated patients


             757      or persons otherwise under the jurisdiction of the Utah Department of Corrections or a county
             758      detention facility.]
             759          [(b) A written communication with a person described in Subsection (3)(a) shall be
             760      used by a pharmacist or pharmacy intern in lieu of a face to face or telephonic communication
             761      for the purpose of counseling the patient.]
             762          (2) A pharmacist or pharmacy intern at a pharmacy that receives a prescription from a
             763      patient by means other than personal delivery, and that dispenses prescription drugs to the
             764      patient by means other than personal delivery, shall:
             765          (a) provide patient counseling to a patient regarding each prescription drug the
             766      pharmacy dispenses; and
             767          (b) provide each patient with a toll-free telephone number by which the patient can
             768      contact a pharmacist or pharmacy intern at the pharmacy for counseling.
             769          (3) Notwithstanding the provisions of Subsections (1) and (2), a pharmacist or a
             770      pharmacy intern may provide patient counseling to an individual under the jurisdiction of the
             771      Utah Department of Corrections or a county detention facility via a written, telephone, or
             772      electronic communication.
             773          Section 10. Section 58-17b-801 is enacted to read:
             774     
Part 8. Dispensing Medical Practitioner and Dispensing Medical

             775     
Practitioner Clinic Pharmacy

             776          58-17b-801. Title.
             777          This part is known as "Dispensing Medical Practitioner and Dispensing Medical
             778      Practitioner Clinic Pharmacy."
             779          Section 11. Section 58-17b-802 is enacted to read:
             780          58-17b-802. Definitions.
             781          As used in this part:
             782          (1) (a) "Cosmetic drug" means a prescription drug that:
             783          (i) is for the purpose of promoting attractiveness or altering the appearance of an
             784      individual; and


             785          (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
             786      division by administrative rule; or
             787          (B) has been expressly approved for online dispensing, whether or not it is dispensed
             788      online or through a physician's office.
             789          (b) "Cosmetic drug" does not include a prescription drug that is:
             790          (i) a controlled substance;
             791          (ii) compounded by the physician; or
             792          (iii) prescribed for or used by the patient for the purpose of diagnosing, curing, or
             793      preventing a disease.
             794          (2) "Employer sponsored clinic" means an entity that has a medical director who is
             795      licensed as a physician as defined in Section 58-67-102 and offers health care only to the
             796      employees of an exclusive group of employers and the employees' dependents.
             797          (3) "Health care" is as defined in Section 31A-1-301 .
             798          (4) (a) "Injectable weight loss drug" means an injectable prescription drug:
             799          (i) prescribed to promote weight loss; and
             800          (ii) listed as an injectable prescription drug subject to exemption under this section by
             801      the division by administrative rule.
             802          (b) "Injectable weight loss drug" does not include a prescription drug that is a
             803      controlled substance.
             804          (5) "Prepackaged drug" means a prescription drug that:
             805          (a) is not listed under federal or state law as a Schedule I, II, III, IV, or V drug; and
             806          (b) is packaged in a fixed quantity per package by:
             807          (i) the drug manufacturer;
             808          (ii) a pharmaceutical wholesaler or distributor; or
             809          (iii) a pharmacy licensed under this title.
             810          Section 12. Section 58-17b-803 is enacted to read:
             811          58-17b-803. Qualifications for licensure as a dispensing medical practitioner --
             812      Scope of practice.


             813          (1) An applicant for a license as a dispensing medical practitioner shall:
             814          (a) be licensed in good standing under at least one of the chapters listed in Subsection
             815      58-17b-102 (23)(a); and
             816          (b) submit an application for a license as a dispensing medical practitioner in a form
             817      prescribed by the division and pay a fee established by the division.
             818          (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
             819      of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
             820      58-17b-307 .
             821          (3) A dispensing medical practitioner may dispense, in accordance with this part:
             822          (a) a cosmetic drug and an injectable weight loss drug if:
             823          (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
             824      medical practitioner's patient; and
             825          (ii) the dispensing medical practitioner complies with administrative rules adopted by
             826      the division under Subsection 58-17-802 (1);
             827          (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
             828      with Section 58-17b-805 ; and
             829          (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
             830      sponsored clinic if the dispensing medical practitioner:
             831          (i) treats an employee, or the dependent of an employee, of one of an exclusive group
             832      of employers at an employer sponsored clinic;
             833          (ii) prescribes a prepackaged drug to the employee or the employee's dependent;
             834          (iii) dispenses the prepackaged drug at the employer sponsored clinic; and
             835          (iv) complies with administrative rules adopted by the division in consultation with the
             836      Board of Pharmacy that establish labeling, record keeping, patient counseling, purchasing and
             837      distribution, operating, treatment, quality of care, and storage requirements.
             838          (4) A dispensing medical practitioner:
             839          (a) shall inform the patient:
             840          (i) that the drug dispensed by the practitioner may be obtained from a pharmacy


             841      unaffiliated with the practitioner;
             842          (ii) of the directions for appropriate use of the dispensed drug;
             843          (iii) of potential side effects to the use of the dispensed drug; and
             844          (iv) how to contact the dispensing medical practitioner if the patient has questions or
             845      concerns regarding the drug;
             846          (b) shall report to the controlled substance database in the same manner as required in
             847      Section 58-37f-203 ; and
             848          (c) may delegate the dispensing of the drug if the individual to whom the dispensing
             849      was delegated is:
             850          (i) employed by the dispensing medical practitioner or the outpatient clinic setting in
             851      which the dispensing medical practitioner works; and
             852          (ii) acting under the direction of a dispensing medical practitioner who is immediately
             853      available on site for any necessary consultation.
             854          (5) If the chapter that governs the license of a dispensing medical practitioner, as listed
             855      in Subsection 58-17b-102 (23), requires physician supervision in its scope of practice
             856      requirements, the dispensing medical practitioner shall only dispense a drug under the
             857      supervision of an individual licensed under Chapter 67, Utah Medical Practice Act, or Chapter
             858      68, Utah Osteopathic Medical Practice Act.
             859          Section 13. Section 58-17b-804 is enacted to read:
             860          58-17b-804. Qualifications for licensure as a dispensing medical practitioner clinic
             861      pharmacy.
             862          (1) An applicant for a license as a dispensing medical practitioner clinic pharmacy shall
             863      comply with Section 58-17b-306 .
             864          (2) (a) Notwithstanding Section 58-17b-302 , a pharmacy licensed under this part is not
             865      required to have a pharmacist-in-charge if:
             866          (i) the pharmacy has designated a dispensing medical practitioner as responsible for all
             867      activities of the pharmacy; and
             868          (ii) the pharmacy complies with administrative rules adopted by the division in


             869      consultation with the Board of Pharmacy and the governing bodies of the practitioners
             870      described in Subsection 58-17b-102 (23)(a).
             871          (b) Notwithstanding Subsection 58-17b-306 (1)(e), the division, in consultation with
             872      the Board of Pharmacy and the governing boards of the practitioners described in Subsection
             873      58-17b-102 (23)(a), may modify the operating standards for a dispensing medical practitioner
             874      clinic pharmacy.
             875          Section 14. Section 58-17b-805 is enacted to read:
             876          58-17b-805. Dispensing medical practitioner -- Cancer drug treatment regimen.
             877          (1) For purposes of this section:
             878          (a) "Cancer drug treatment regimen" means a prescription drug used to treat cancer,
             879      manage its symptoms, or provide continuity of care for a cancer patient.
             880          (b) "Cancer drug treatment regimen" includes:
             881          (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
             882      methods; and
             883          (ii) a drug used to support cancer treatment, including a drug used to treat, alleviate, or
             884      minimize physical and psychological symptoms or pain, to improve patient tolerance of cancer
             885      treatments, or to prepare a patient for a subsequent course of therapy.
             886          (c) "Cancer drug treatment regimen" does not mean a drug listed under federal law as a
             887      Schedule I, II, or III drug.
             888          (2) An individual may be licensed as a dispensing medical practitioner with a scope of
             889      practice that permits the dispensing medical practitioner to prescribe and dispense a cancer
             890      drug treatment regimen if the individual:
             891          (a) is licensed as described in Subsections 58-17b-102 (23)(a)(i) and (ii); and
             892          (b) is certified or eligible to be certified by the American Board of Internal Medicine in
             893      medical oncology.
             894          (3) A dispensing medical practitioner authorized to prescribe and dispense a cancer
             895      drug treatment regimen under this section may prescribe and dispense a cancer drug treatment
             896      regimen:


             897          (a) to the practitioner's patient who is currently undergoing chemotherapy in an
             898      outpatient clinic setting; and
             899          (b) if the practitioner determines that providing the cancer drug treatment regimen to
             900      the patient in the outpatient clinic setting is in the best interest of the patient or provides better
             901      access to care for the patient.
             902          Section 15. Section 58-17b-806 is enacted to read:
             903          58-17b-806. Enforcement of dispensing medical practitioner and dispensing
             904      medical practitioner clinic pharmacy compliance with Pharmacy Practice Act.
             905          (1) (a) The division shall consult with the dispensing medical practitioner's appropriate
             906      licensing board as designated in Subsection 58-17b-102 (23)(a) regarding a violation of this
             907      chapter; and
             908          (b) the Pharmacy Board shall, if requested by the licensing board of the dispensing
             909      medical practitioner, assist the licensing board for the dispensing medical practitioner with
             910      reviewing the violations of the provisions of this chapter.
             911          (2) The division may take appropriate action against a dispensing medical practitioner,
             912      in accordance with this chapter, if the licensing board designated in Subsection
             913      58-17b-102 (23)(a) recommends to the division that action be taken under this chapter.
             914          (3) The division, in consultation with the board is the primary enforcer under this
             915      chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
             916      58-17b-804 .
             917          Section 16. Section 58-31b-502 is amended to read:
             918           58-31b-502. Unprofessional conduct.
             919          "Unprofessional conduct" includes:
             920          (1) failure to safeguard a patient's right to privacy as to the patient's person, condition,
             921      diagnosis, personal effects, or any other matter about which the licensee is privileged to know
             922      because of the licensee's or person with a certification's position or practice as a nurse or
             923      practice as a medication aide certified;
             924          (2) failure to provide nursing service or service as a medication aide certified in a


             925      manner that demonstrates respect for the patient's human dignity and unique personal character
             926      and needs without regard to the patient's race, religion, ethnic background, socioeconomic
             927      status, age, sex, or the nature of the patient's health problem;
             928          (3) engaging in sexual relations with a patient during any:
             929          (a) period when a generally recognized professional relationship exists between the
             930      person licensed or certified under this chapter and patient; or
             931          (b) extended period when a patient has reasonable cause to believe a professional
             932      relationship exists between the person licensed or certified under the provisions of this chapter
             933      and the patient;
             934          (4) (a) as a result of any circumstance under Subsection (3), exploiting or using
             935      information about a patient or exploiting the licensee's or the person with a certification's
             936      professional relationship between the licensee or holder of a certification under this chapter and
             937      the patient; or
             938          (b) exploiting the patient by use of the licensee's or person with a certification's
             939      knowledge of the patient obtained while acting as a nurse or a medication aide certified;
             940          (5) unlawfully obtaining, possessing, or using any prescription drug or illicit drug;
             941          (6) unauthorized taking or personal use of nursing supplies from an employer;
             942          (7) unauthorized taking or personal use of a patient's personal property;
             943          (8) knowingly entering into any medical record any false or misleading information or
             944      altering a medical record in any way for the purpose of concealing an act, omission, or record
             945      of events, medical condition, or any other circumstance related to the patient and the medical or
             946      nursing care provided;
             947          (9) unlawful or inappropriate delegation of nursing care;
             948          (10) failure to exercise appropriate supervision of persons providing patient care
             949      services under supervision of the licensed nurse;
             950          (11) employing or aiding and abetting the employment of an unqualified or unlicensed
             951      person to practice as a nurse;
             952          (12) failure to file or record any medical report as required by law, impeding or


             953      obstructing the filing or recording of such a report, or inducing another to fail to file or record
             954      such a report;
             955          (13) breach of a statutory, common law, regulatory, or ethical requirement of
             956      confidentiality with respect to a person who is a patient, unless ordered by a court;
             957          (14) failure to pay a penalty imposed by the division;
             958          (15) prescribing a schedule II-III controlled substance without a consulting physician or
             959      outside of a consultation and referral plan;
             960          (16) violating Section 58-31b-801 ; and
             961          (17) violating the dispensing requirements of Section 58-17b-309 or [ 58-17b-309.5 ]
             962      Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
             963      Clinic Pharmacy, if applicable.
             964          Section 17. Section 58-37f-203 is amended to read:
             965           58-37f-203. Submission, collection, and maintenance of data.
             966          (1) (a) The pharmacist in charge of the drug outlet where a controlled substance is
             967      dispensed shall submit the data described in this section to the division:
             968          [(a)] (i) in accordance with the requirements of this section;
             969          [(b)] (ii) in accordance with the procedures established by the division; and
             970          [(c)] (iii) in the format established by the division.
             971          (b) A dispensing medical practitioner licensed under Chapter 17b, Part 8, Dispensing
             972      Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, shall comply with
             973      the provisions of this section and the dispensing medical practitioner shall assume the duties of
             974      the pharmacist under this chapter.
             975          (2) The pharmacist described in Subsection (1) shall, for each controlled substance
             976      dispensed by a pharmacist under the pharmacist's supervision other than those dispensed for an
             977      inpatient at a health care facility, submit to the division the following information:
             978          (a) the name of the prescribing practitioner;
             979          (b) the date of the prescription;
             980          (c) the date the prescription was filled;


             981          (d) the name of the individual for whom the prescription was written;
             982          (e) positive identification of the individual receiving the prescription, including the
             983      type of identification and any identifying numbers on the identification;
             984          (f) the name of the controlled substance;
             985          (g) the quantity of the controlled substance prescribed;
             986          (h) the strength of the controlled substance;
             987          (i) the quantity of the controlled substance dispensed;
             988          (j) the dosage quantity and frequency as prescribed;
             989          (k) the name of the drug outlet dispensing the controlled substance;
             990          (l) the name of the pharmacist dispensing the controlled substance; and
             991          (m) other relevant information as required by division rule.
             992          (3) (a) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
             993      Administrative Rulemaking Act, to establish the electronic format in which the information
             994      required under this section shall be submitted to the division.
             995          (b) The division shall ensure that the database system records and maintains for
             996      reference:
             997          (i) the identification of each individual who requests or receives information from the
             998      database;
             999          (ii) the information provided to each individual; and
             1000          (iii) the date and time that the information is requested or provided.
             1001          Section 18. Section 58-67-502 is amended to read:
             1002           58-67-502. Unprofessional conduct.
             1003          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 :
             1004          (1) using or employing the services of any individual to assist a licensee in any manner
             1005      not in accordance with the generally recognized practices, standards, or ethics of the
             1006      profession, state law, or division rule;
             1007          (2) making a material misrepresentation regarding the qualifications for licensure under
             1008      Section 58-67-302.7 ; or


             1009          (3) violating the dispensing requirements of Section 58-17b-309 or [ 58-17b-309.5 ]
             1010      Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
             1011      Clinic Pharmacy, if applicable.
             1012          Section 19. Section 58-68-502 is amended to read:
             1013           58-68-502. Unprofessional conduct.
             1014          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 :
             1015          (1) using or employing the services of any individual to assist a licensee in any manner
             1016      not in accordance with the generally recognized practices, standards, or ethics of the
             1017      profession, state law, or division rule; or
             1018          (2) violating the dispensing requirements of Section 58-17b-309 or [ 58-17b-309.5 ]
             1019      Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner
             1020      Clinic Pharmacy, if applicable.
             1021          Section 20. Section 58-70a-502 is amended to read:
             1022           58-70a-502. Unlawful conduct.
             1023          "Unlawful conduct" includes[: (1)] engaging in practice as a licensed physician assistant
             1024      while not under the supervision of a supervising physician or substitute supervising physician[;
             1025      or].
             1026          [(2) violating the drug dispensing requirements of Section 58-17b-309 or
             1027      58-17b-309.5 , if applicable.]
             1028          Section 21. Section 58-70a-503 is amended to read:
             1029           58-70a-503. Unprofessional conduct.
             1030          "Unprofessional conduct" includes:
             1031          (1) violation of a patient confidence to any person who does not have a legal right and
             1032      a professional need to know the information concerning the patient;
             1033          (2) knowingly prescribing, selling, giving away, or directly or indirectly administering,
             1034      or offering to prescribe, sell, furnish, give away, or administer any prescription drug except for
             1035      a legitimate medical purpose upon a proper diagnosis indicating use of that drug in the amounts
             1036      prescribed or provided;


             1037          (3) prescribing prescription drugs for himself or administering prescription drugs to
             1038      himself, except those that have been legally prescribed for him by a licensed practitioner and
             1039      that are used in accordance with the prescription order for the condition diagnosed;
             1040          (4) failure to maintain at the practice site a delegation of services agreement that
             1041      accurately reflects current practices;
             1042          (5) failure to make the delegation of services agreement available to the division for
             1043      review upon request; [and]
             1044          (6) in a practice that has physician assistant ownership interests, failure to allow the
             1045      supervising physician the independent final decision making authority on patient treatment
             1046      decisions, as set forth in the delegation of services agreement or as defined by rule[.]; and
             1047          (7) violating the dispensing requirements of Chapter 17b, Part 8, Dispensing Medical
             1048      Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, if applicable.
             1049          Section 22. Section 58-83-502 is amended to read:
             1050           58-83-502. Unprofessional conduct.
             1051          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
             1052      as may be further defined by administrative rule:
             1053          (1) online prescribing, dispensing, or facilitation with respect to a person under the age
             1054      of 18 years;
             1055          (2) using the name or official seal of the state, the Utah Department of Commerce, or
             1056      the Utah Division of Occupational and Professional Licensing, or their boards, in an
             1057      unauthorized manner;
             1058          (3) failing to respond promptly to a request by the division for information including:
             1059          (a) an audit of the website; or
             1060          (b) records of the online prescriber, the Internet facilitator, or the online contract
             1061      pharmacy;
             1062          (4) using an online prescriber, online contract pharmacy, or Internet facilitator without
             1063      approval of the division;
             1064          (5) failing to inform a patient of the patient's freedom of choice in selecting who will


             1065      dispense a prescription in accordance with Subsection 58-83-305 (1)(n);
             1066          (6) failing to keep the division informed of the name and contact information of the
             1067      Internet facilitator or online contract pharmacy; and
             1068          (7) violating the dispensing and labeling requirements of [Section 58-17b-309 ] Chapter
             1069      17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic
             1070      Pharmacy.
             1071          Section 23. Section 63I-1-258 is amended to read:
             1072           63I-1-258. Repeal dates, Title 58.
             1073          (1) Title 58, Chapter 13, Health Care Providers Immunity from Liability Act, is
             1074      repealed July 1, 2016.
             1075          (2) Title 58, Chapter 15, Health Facility Administrator Act, is repealed July 1, 2015.
             1076          (3) [Section 58-17b-309.5 is repealed July 1, 2015. (4)] Title 58, Chapter 20a,
             1077      Environmental Health Scientist Act, is repealed July 1, 2018.
             1078          [(5)] (4) Title 58, Chapter 40, Recreational Therapy Practice Act, is repealed July 1,
             1079      2023.
             1080          [(6)] (5) Title 58, Chapter 41, Speech-Language Pathology and Audiology Licensing
             1081      Act, is repealed July 1, 2019.
             1082          [(7)] (6) Title 58, Chapter 42a, Occupational Therapy Practice Act, is repealed July 1,
             1083      2015.
             1084          [(8)] (7) Title 58, Chapter 46a, Hearing Instrument Specialist Licensing Act, is
             1085      repealed July 1, 2023.
             1086          [(9)] (8) Title 58, Chapter 47b, Massage Therapy Practice Act, is repealed July 1, 2014.
             1087          [(10)] (9) Section 58-69-302.5 is repealed on July 1, 2015.
             1088          [(11)] (10) Title 58, Chapter 72, Acupuncture Licensing Act, is repealed July 1, 2017.
             1089          Section 24. Repealer.
             1090          This bill repeals:
             1091          Section 58-17b-309.5 , Exemption for prescribing practitioner of cancer drug
             1092      regimen -- Division study of dispensing practitioners.


             1093          Section 25. Effective date.
             1094          This bill takes effect on July 1, 2014.


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