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First Substitute S.B. 194

This document includes Senate 2nd Reading Floor Amendments incorporated into the bill on Tue, Mar 5, 2013 at 11:38 AM by lpoole. -->

Senator Evan J. Vickers proposes the following substitute bill:


             1     
PHARMACY PRACTICE ACT AMENDMENTS

             2     
2013 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Evan J. Vickers

             5     
House Sponsor: Dean Sanpei

             6     

             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act.
             10      Highlighted Provisions:
             11          This bill:
             12          .    deletes "extern" from Pharmacy Practice Act definitions;
             13          .    amends the definition of "pharmaceutical wholesaler or distributor";
             14          .    amends the definition of "practice as a licensed pharmacy technician";
             15          .    amends pharmacy intern licensure qualifications;
             16          .    amends pharmacy technician licensure qualifications;
             17          .    authorizes, under certain circumstances, the dispensing of one or more refills at the
             18      time a legend drug prescription is dispensed;
             19          .    clarifies that funds paid for certain refills dispensed at the time a prescription is
             20      dispensed may not be recouped as the result of a pharmacy audit;
             21          .    makes conforming amendments; and
             22          .    makes technical changes.
             23      Money Appropriated in this Bill:
             24          None
             25      Other Special Clauses:



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             26
         None
             27      Utah Code Sections Affected:
             28      AMENDS:
             29          58-17b-102, as last amended by Laws of Utah 2012, Chapters 265 and 320
             30          58-17b-304, as last amended by Laws of Utah 2012, Chapter 93
             31          58-17b-305, as last amended by Laws of Utah 2012, Chapter 93
             32          58-17b-612, as last amended by Laws of Utah 2010, Chapter 101
             33          58-17b-622, as enacted by Laws of Utah 2012, Chapter 265
             34      ENACTS:
             35          58-17b-608.1, Utah Code Annotated 1953
             36     

             37      Be it enacted by the Legislature of the state of Utah:
             38          Section 1. Section 58-17b-102 is amended to read:
             39           58-17b-102. Definitions.
             40          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             41          (1) "Administering" means:
             42          (a) the direct application of a prescription drug or device, whether by injection,
             43      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             44      by another person; or
             45          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             46      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             47      means directed to the body of the animal by the owner or caretaker in accordance with written
             48      or verbal directions of the veterinarian.
             49          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             50      21 U.S.C.S. Sec. 351 (2003).
             51          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             52      the purpose of analysis.
             53          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             54      used as standards and controls in performing drug monitoring or drug screening analysis if the
             55      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             56      components, organic solvents, or inorganic buffers at a concentration not exceeding one



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             57
     milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             58      use.
             59          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             60      the use of prescription drugs.
             61          (5) "Automated pharmacy systems" includes mechanical systems which perform
             62      operations or activities, other than compounding or administration, relative to the storage,
             63      packaging, dispensing, or distribution of medications, and which collect, control, and maintain
             64      all transaction information.
             65          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
             66      prescription label at the time of dispensing that indicates to the patient or caregiver a time
             67      beyond which the contents of the prescription are not recommended to be used.
             68          (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
             69      in Section 58-17b-201 .
             70          (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
             71      underserved area, used for the storage and dispensing of prescription drugs, which is dependent
             72      upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
             73      approved by the division as the parent pharmacy.
             74          (9) "Centralized prescription processing" means the processing by a pharmacy of a
             75      request from another pharmacy to fill or refill a prescription drug order or to perform
             76      processing functions such as dispensing, drug utilization review, claims adjudication, refill
             77      authorizations, and therapeutic interventions.
             78          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             79      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             80      prescription order.
             81          (11) "Class B pharmacy":
             82          (a) means a pharmacy located in Utah:
             83          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             84      setting; and
             85          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             86      health care services; and
             87          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and



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



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             119
     dosage form which is regularly and commonly available from a manufacturer in quantities and
             120      strengths prescribed by a practitioner; or
             121          (iii) the preparation of a prescription drug, sterile product, or device which has been
             122      withdrawn from the market for safety reasons.
             123          (19) "Confidential information" has the same meaning as "protected health
             124      information" under the Standards for Privacy of Individually Identifiable Health Information,
             125      45 C.F.R. Parts 160 and 164.
             126          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             127          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             128      417, Sec. 3a(ff) which is incorporated by reference.
             129          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             130      prescription drug order or device or nonprescription drug or device under a lawful order of a
             131      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             132      by a patient, research subject, or an animal.
             133          (23) "Distribute" means to deliver a drug or device other than by administering or
             134      dispensing.
             135          (24) (a) "Drug" means:
             136          (i) a substance recognized in the official United States Pharmacopoeia, Official
             137      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             138      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             139      prevention of disease in humans or animals;
             140          (ii) a substance that is required by any applicable federal or state law or rule to be
             141      dispensed by prescription only or is restricted to administration by practitioners only;
             142          (iii) a substance other than food intended to affect the structure or any function of the
             143      body of humans or other animals; and
             144          (iv) substances intended for use as a component of any substance specified in
             145      Subsections (24)(a)(i), (ii), (iii), and (iv).
             146          (b) "Drug" does not include dietary supplements.
             147          (25) "Drug product equivalent" means a drug product that is designated as the
             148      therapeutic equivalent of another drug product in the Approved Drug Products with
             149      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research



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             150
     of the Federal Food and Drug Administration.
             151          (26) "Drug regimen review" includes the following activities:
             152          (a) evaluation of the prescription drug order and patient record for:
             153          (i) known allergies;
             154          (ii) rational therapy-contraindications;
             155          (iii) reasonable dose and route of administration; and
             156          (iv) reasonable directions for use;
             157          (b) evaluation of the prescription drug order and patient record for duplication of
             158      therapy;
             159          (c) evaluation of the prescription drug order and patient record for the following
             160      interactions:
             161          (i) drug-drug;
             162          (ii) drug-food;
             163          (iii) drug-disease; and
             164          (iv) adverse drug reactions; and
             165          (d) evaluation of the prescription drug order and patient record for proper utilization,
             166      including over- or under-utilization, and optimum therapeutic outcomes.
             167          (27) "Drug sample" means a prescription drug packaged in small quantities consistent
             168      with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
             169      be sold, and is intended to be provided to practitioners for the immediate needs of patients for
             170      trial purposes or to provide the drug to the patient until a prescription can be filled by the
             171      patient.
             172          (28) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
             173      symbol, or process attached to or logically associated with a record and executed or adopted by
             174      a person with the intent to sign the record.
             175          (29) "Electronic transmission" means transmission of information in electronic form or
             176      the transmission of the exact visual image of a document by way of electronic equipment.
             177          [(30) "Extern" means a college of pharmacy student enrolled in a college coordinated
             178      practical experience program in a health care setting under the supervision of a preceptor, as
             179      defined in this act, and approved by a college of pharmacy.]
             180          [(31)] (30) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to



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             181
     inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             182      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             183          [(32)] (31) "Legend drug" has the same meaning as prescription drug.
             184          [(33)] (32) "Licensed pharmacy technician" means an individual licensed with the
             185      division, that may, under the supervision of a pharmacist, perform the activities involved in the
             186      technician practice of pharmacy.
             187          [(34)] (33) "Manufacturer" means a person or business physically located in Utah
             188      licensed to be engaged in the manufacturing of drugs or devices.
             189          [(35)] (34) (a) "Manufacturing" means:
             190          (i) the production, preparation, propagation, conversion, or processing of a drug or
             191      device, either directly or indirectly, by extraction from substances of natural origin or
             192      independently by means of chemical or biological synthesis, or by a combination of extraction
             193      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             194      or relabeling of its container; and
             195          (ii) the promotion and marketing of such drugs or devices.
             196          (b) "Manufacturing" includes the preparation and promotion of commercially available
             197      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             198          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             199      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             200      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
             201      analysis.
             202          [(36)] (35) "Medical order" means a lawful order of a practitioner which may include a
             203      prescription drug order.
             204          [(37)] (36) "Medication profile" or "profile" means a record system maintained as to
             205      drugs or devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
             206      analyze the profile to provide pharmaceutical care.
             207          [(38)] (37) "Misbranded drug or device" means a drug or device considered
             208      misbranded under 21 U.S.C.S. Sec. 352 (2003).
             209          [(39)] (38) (a) "Nonprescription drug" means a drug which:
             210          (i) may be sold without a prescription; and
             211          (ii) is labeled for use by the consumer in accordance with federal law.



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         (b) "Nonprescription drug" includes homeopathic remedies.
             213          [(40)] (39) "Nonresident pharmacy" means a pharmacy located outside of Utah that
             214      sells to a person in Utah.
             215          [(41)] (40) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical
             216      service.
             217          [(42)] (41) "Out-of-state mail service pharmacy" means a pharmaceutical facility
             218      located outside the state that is licensed and in good standing in another state, that:
             219          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
             220      this state pursuant to a lawfully issued prescription;
             221          (b) provides information to a patient in this state on drugs or devices which may
             222      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             223      or
             224          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             225      effects of drugs.
             226          [(43)] (42) "Patient counseling" means the written and oral communication by the
             227      pharmacist or pharmacy intern of information, to the patient or caregiver, in order to ensure
             228      proper use of drugs, devices, and dietary supplements.
             229          [(44)] (43) "Pharmaceutical administration facility" means a facility, agency, or
             230      institution in which:
             231          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             232      the facility or agency for administration to patients of that facility or agency;
             233          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             234      or pharmacy intern with whom the facility has established a prescription drug supervising
             235      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             236      or agency staff as required, and oversees drug control, accounting, and destruction; and
             237          (c) prescription drugs are professionally administered in accordance with the order of a
             238      practitioner by an employee or agent of the facility or agency.
             239          [(45)] (44) (a) "Pharmaceutical care" means carrying out the following in collaboration
             240      with a prescribing practitioner, and in accordance with division rule:
             241          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             242      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing



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             243
     the patient's disease;
             244          (ii) eliminating or reducing a patient's symptoms; or
             245          (iii) arresting or slowing a disease process.
             246          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             247      prescribing practitioner.
             248          [(46)] (45) "Pharmaceutical facility" means a business engaged in the dispensing,
             249      delivering, distributing, manufacturing, or wholesaling of prescription drugs or devices within
             250      or into this state.
             251          [(47)] (46) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical
             252      facility engaged in the business of wholesale vending or selling of [any] a prescription drug or
             253      device to other than [the] a consumer or user of the prescription drug or device[, which] that
             254      the pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
             255          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             256      facility carrying out the following business activities:
             257          (i) intracompany sales;
             258          (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             259      purchase, or trade a prescription drug or device, if the activity is carried out between one or
             260      more of the following entities under common ownership or common administrative control, as
             261      defined by division rule:
             262          (A) hospitals [or other health care facilities that are under common ownership or
             263      control of the management and operation of the facilities];
             264          (B) pharmacies;
             265          (C) chain pharmacy warehouses, as defined by division rule; or
             266          (D) other health care entities, as defined by division rule;
             267          (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             268      purchase, or trade a prescription drug or device, for emergency medical reasons, [or to supply
             269      another] including supplying another pharmaceutical facility [to alleviate a temporary shortage;
             270      or] with a limited quantity of a drug, if:
             271          (A) the facility is unable to obtain the drug through a normal distribution channel S. [ or
             272      other source
] .S
in sufficient time to eliminate the risk of harm to a patient that would result from a
             273      delay in obtaining the drug; and



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             274
         (B) the quantity of the drug does not exceed an amount reasonably required for
             275      immediate dispensing to eliminate the risk of harm;
             276          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             277      manufacturer[.]; and
             278          (v) the distribution of prescription drugs, if:
             279          (A) the dosage units distributed during a calendar year do not exceed five percent of
             280      the sum of the dosage units distributed by the facility during the calendar year and the dosage
             281      units dispensed by the facility during the calendar year; and
             282          (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
             283          [(48)] (47) "Pharmacist" means an individual licensed by this state to engage in the
             284      practice of pharmacy.
             285          [(49)] (48) "Pharmacist-in-charge" means a pharmacist currently licensed in good
             286      standing who accepts responsibility for the operation of a pharmacy in conformance with all
             287      laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
             288      personally in full and actual charge of the pharmacy and all personnel.
             289          [(50)] (49) "Pharmacist preceptor" means a licensed pharmacist in good standing with
             290      one or more years of licensed experience. The preceptor serves as a teacher, example of
             291      professional conduct, and supervisor of interns in the professional practice of pharmacy.
             292          [(51)] (50) "Pharmacy" means any place where:
             293          (a) drugs are dispensed;
             294          (b) pharmaceutical care is provided;
             295          (c) drugs are processed or handled for eventual use by a patient; or
             296          (d) drugs are used for the purpose of analysis or research.
             297          [(52)] (51) "Pharmacy benefits manager or coordinator" means a person or entity that
             298      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
             299      self-insured employer, insurance company, health maintenance organization, or other plan
             300      sponsor, as defined by rule.
             301          [(53)] (52) "Pharmacy intern" means an individual licensed by this state to engage in
             302      practice as a pharmacy intern.
             303          [(54)] (53) "Pharmacy technician training program" means an approved technician
             304      training program providing education for pharmacy technicians.



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         [(55)] (54) (a) "Practice as a licensed pharmacy technician" means engaging in practice
             306      as a pharmacy technician under the general supervision of a licensed pharmacist and in
             307      accordance with a scope of practice defined by division rule made in collaboration with the
             308      board.
             309          (b) "Practice as a licensed pharmacy technician" does not include:
             310          (i) performing a drug utilization review, prescription drug order clarification from a
             311      prescriber, final review of the prescription [and prescribed drug prepared for dispensing],
             312      dispensing of the drug, or counseling a patient with respect to a prescription drug;
             313          (ii) except as permitted by rules made by the division in consultation with the board,
             314      final review of a prescribed drug prepared for dispensing;
             315          [(ii)] (iii) counseling regarding nonprescription drugs and dietary supplements unless
             316      delegated by the supervising pharmacist; or
             317          [(iii)] (iv) receiving new prescription drug orders when communicating telephonically
             318      or electronically unless the original information is recorded so the pharmacist may review the
             319      prescription drug order as transmitted.
             320          [(56)] (55) "Practice of pharmacy" includes the following:
             321          (a) providing pharmaceutical care;
             322          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             323      practice agreement;
             324          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             325      distribution of prescription drugs or devices, provided that the administration of a prescription
             326      drug or device is:
             327          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             328          (ii) in accordance with written guidelines or protocols:
             329          (A) established by the licensed facility in which the prescription drug or device is to be
             330      administered on an inpatient basis; or
             331          (B) approved by the division, in collaboration with the board and the Physicians
             332      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             333      administered on an outpatient basis solely by a licensed pharmacist;
             334          (d) participating in drug utilization review;
             335          (e) ensuring proper and safe storage of drugs and devices;



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         (f) maintaining records of drugs and devices in accordance with state and federal law
             337      and the standards and ethics of the profession;
             338          (g) providing information on drugs or devices, which may include advice relating to
             339      therapeutic values, potential hazards, and uses;
             340          (h) providing drug product equivalents;
             341          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             342      technicians;
             343          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
             344          (k) providing emergency refills as defined by rule;
             345          (l) telepharmacy; and
             346          (m) formulary management intervention.
             347          [(57)] (56) "Practice of telepharmacy" means the practice of pharmacy through the use
             348      of telecommunications and information technologies.
             349          [(58)] (57) "Practice of telepharmacy across state lines" means the practice of
             350      pharmacy through the use of telecommunications and information technologies that occurs
             351      when the patient is physically located within one jurisdiction and the pharmacist is located in
             352      another jurisdiction.
             353          [(59)] (58) "Practitioner" means an individual currently licensed, registered, or
             354      otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
             355      course of professional practice.
             356          [(60)] (59) "Prescribe" means to issue a prescription:
             357          (a) orally or in writing; or
             358          (b) by telephone, facsimile transmission, computer, or other electronic means of
             359      communication as defined by division rule.
             360          [(61)] (60) "Prescription" means an order issued:
             361          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             362      by collaborative pharmacy practice agreement; and
             363          (b) for a controlled substance or other prescription drug or device for use by a patient
             364      or an animal.
             365          [(62)] (61) "Prescription device" means an instrument, apparatus, implement, machine,
             366      contrivance, implant, in vitro reagent, or other similar or related article, and any component



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             367
     part or accessory, which is required under federal or state law to be prescribed by a practitioner
             368      and dispensed by or through a person or entity licensed under this chapter or exempt from
             369      licensure under this chapter.
             370          [(63)] (62) "Prescription drug" means a drug that is required by federal or state law or
             371      rule to be dispensed only by prescription or is restricted to administration only by practitioners.
             372          [(64)] (63) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             373      drugs and devices to the general public.
             374          [(65)] (64) "Self-audit" means an internal evaluation of a pharmacy to determine
             375      compliance with this chapter.
             376          [(66)] (65) "Supervising pharmacist" means a pharmacist who is overseeing the
             377      operation of the pharmacy during a given day or shift.
             378          [(67)] (66) "Supportive personnel" means unlicensed individuals who:
             379          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             380      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             381      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             382      those duties may be further defined by division rule adopted in collaboration with the board;
             383      and
             384          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             385      collaboration with the board.
             386          [(68)] (67) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             387          [(69)] (68) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             388      58-17b-502 and may be further defined by rule.
             389          [(70)] (69) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             390      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             391      for animals.
             392          Section 2. Section 58-17b-304 is amended to read:
             393           58-17b-304. Qualifications for licensure of pharmacy intern.
             394          An applicant for licensure as a pharmacy intern shall:
             395          (1) submit an application in a form prescribed by the division;
             396          (2) pay a fee determined by the department under Section 63J-1-504 ;
             397          (3) produce satisfactory evidence of good moral character as it relates to the applicant's



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             398
     ability to practice pharmacy;
             399          (4) complete a criminal background check and be free from criminal convictions as
             400      described in Section 58-1-501 ;
             401          (5) have no physical or mental condition of a nature which prevents the applicant from
             402      engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
             403      public;
             404          (6) meet the preliminary educational qualifications required by division rule made in
             405      collaboration with the board; and
             406          (7) meet one of the following educational criteria:
             407          (a) be a current pharmacy student, a resident, or fellow in a program approved by
             408      division rule made in collaboration with the board; or
             409          [(b) have graduated and received a pharmacy degree from a school or college of
             410      pharmacy which is accredited by the Accreditation Council on Pharmacy Education but not
             411      completed the internship hours required by division rule for licensure as a pharmacist; or]
             412          [(c)] (b) have graduated from a foreign pharmacy school and received certification of
             413      equivalency from a credentialing agency approved by division rule made in collaboration with
             414      the board.
             415          Section 3. Section 58-17b-305 is amended to read:
             416           58-17b-305. Qualifications for licensure of pharmacy technician.
             417          (1) An applicant for licensure as a pharmacy technician shall:
             418          (a) submit an application in a form prescribed by the division;
             419          (b) pay a fee determined by the department under Section 63J-1-504 ;
             420          (c) produce satisfactory evidence of good moral character as it relates to the applicant's
             421      ability to practice pharmacy;
             422          (d) complete a criminal background check and be free from criminal convictions as
             423      described in Section 58-1-501 ;
             424          (e) have no physical or mental condition of a nature which prevents the applicant from
             425      engaging in practice as a pharmacy technician with reasonable skill, competency, and safety to
             426      the public;
             427          (f) have completed a [board approved] program and curriculum of education and
             428      training, meeting standards established by division rule made in collaboration with the board;



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             429
     and
             430          (g) successfully complete the examinations requirement within the time periods
             431      established by division rule made in collaboration with the board.
             432          (2) A pharmacist whose license has been denied, revoked, suspended, or restricted for
             433      disciplinary purposes is not eligible to be a licensed pharmacy technician while on probation
             434      with the division.
             435          Section 4. Section 58-17b-608.1 is enacted to read:
             436          58-17b-608.1. Refills of legend drug prescriptions.
             437          If a prescription for a legend drug includes authorization for one or more refills, a
             438      pharmacist or pharmacy intern may dispense one or more of the refills at the time the drug is
             439      dispensed, if:
             440          (1) the drug is not a controlled substance;
             441          (2) the prescription does not include "Dispense quantity written," or some other
             442      notation having similar meaning;
             443          (3) the total dosage units dispensed, including the units for both the prescription and
             444      any refills, do not exceed a 100-day supply; and
             445          (4) in the professional judgment of the pharmacist or pharmacy intern the refill, or
             446      refills, should be dispensed at the time the prescription is dispensed.
             447          Section 5. Section 58-17b-612 is amended to read:
             448           58-17b-612. Supervision -- Pharmacist-in-charge.
             449          (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
             450      pharmacy, or class E pharmacy, shall be under the general supervision of at least one
             451      pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
             452      as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
             453          (b) Notwithstanding Subsection [ 58-17b-102 (66)] 58-17b-102 (65), a supervising
             454      pharmacist does not have to be in the pharmacy or care facility but shall be available via a
             455      telepharmacy system for immediate contact with the supervised pharmacy technician or
             456      pharmacy intern if:
             457          (i) the pharmacy is located in:
             458          (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
             459          (B) a clinic located in a remote rural county with less than 20 people per square mile;



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             460
         (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
             461          (iii) the telepharmacy system maintains records and files quarterly reports as required
             462      by division rule to assure that patient safety is not compromised.
             463          (2) Each out-of-state mail service pharmacy shall designate and identify to the division
             464      a pharmacist holding a current license in good standing issued by the state in which the
             465      pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
             466      chapter.
             467          Section 6. Section 58-17b-622 is amended to read:
             468           58-17b-622. Pharmacy benefit management services -- Auditing of pharmacy
             469      records -- Appeals.
             470          (1) For purposes of this section:
             471          (a) "Audit" means a review of the records of a pharmacy by or on behalf of an entity
             472      that finances or reimburses the cost of health care services or pharmaceutical products.
             473          (b) "Entity" includes:
             474          (i) a pharmacy benefits manager or coordinator;
             475          (ii) a health benefit plan;
             476          (iii) a third party administrator as defined in Section 31A-1-301 ;
             477          (iv) a state agency; or
             478          (v) a company, group, or agent that represents, or is engaged by, one of the entities
             479      described in Subsections (1)(b)(i) through (iv).
             480          (c) "Fraud" means an intentional act of deception, misrepresentation, or concealment in
             481      order to gain something of value.
             482          (d) "Health benefit plan" means:
             483          (i) a health benefit plan as defined in Section 31A-1-301 ; or
             484          (ii) a health, dental, medical, Medicare supplement, or conversion program offered
             485      under Title 49, Chapter 20, Public Employees' Benefit and Insurance Program Act.
             486          (2) (a) Except as provided in Subsection (2)(b), this section applies to:
             487          (i) a contract for the audit of a pharmacy entered into, amended, or renewed on or after
             488      July 1, 2012; and
             489          (ii) an entity that conducts an audit of the pharmacy records of a pharmacy licensed
             490      under this chapter.



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             491
         (b) This section does not apply to an audit of pharmacy records:
             492          (i) for a federally funded prescription drug program, including:
             493          (A) the state Medicaid program;
             494          (B) the Medicare Part D program;
             495          (C) a Department of Defense prescription drug program;
             496          (D) a Veteran's Affairs prescription drug program; or
             497          (ii) when fraud or other intentional and willful misrepresentation is alleged and the
             498      pharmacy audit entity has evidence that the pharmacy's actions reasonably indicate fraud or
             499      intentional and willful misrepresentation.
             500          (3) (a) An audit that involves clinical or professional judgment shall be conducted by
             501      or in consultation with a licensed pharmacist who is employed by or working with the auditing
             502      entity.
             503          (b) If an audit is conducted on site at a pharmacy, the entity conducting the audit:
             504          (i) shall give the pharmacy 10 days advanced written notice of:
             505          (A) the audit; and
             506          (B) the range of prescription numbers or a date range included in the audit; and
             507          (ii) may not audit a pharmacy during the first five business days of the month, unless
             508      the pharmacy agrees to the timing of the audit.
             509          (c) An entity may not audit claims:
             510          (i) submitted more than 18 months prior to the audit, unless:
             511          (A) required by federal law; or
             512          (B) the originating prescription is dated in the preceding six months; or
             513          (ii) that exceed 200 selected prescription claims.
             514          (4) (a) An entity may not:
             515          (i) include dispensing fees in the calculations of overpayments unless the prescription
             516      is considered a misfill;
             517          (ii) recoup funds for prescription clerical or recordkeeping errors, including
             518      typographical errors, scrivener's errors, and computer errors on a required document or record
             519      unless the audit entity is alleging fraud or other intentional or willful misrepresentation and the
             520      audit entity has evidence that the pharmacy's actions reasonably indicate fraud or intentional
             521      and willful misrepresentation; [or]



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Senate 2nd Reading Amendments 3-5-2013 lp/cjd
             522
         (iii) recoup funds for refills dispensed in accordance with Section 58-17b-608.1 S. [ at the
             523      time a prescription is dispensed;
] , unless the health benefit plan does not cover the prescription

             523a      drug dispensed by the pharmacy; .S or
             524          [(iii)] (iv) collect any funds, charge-backs, or penalties until the audit and all appeals
             525      are final, unless the audit entity is alleging fraud or other intentional or willful
             526      misrepresentation and the audit entity has evidence that the pharmacy's actions reasonably
             527      indicate fraud or intentional and willful misrepresentation.
             528          (b) Auditors shall only have access to previous audit reports on a particular pharmacy
             529      if the previous audit was conducted by the same entity except as required for compliance with
             530      state or federal law.
             531          (5) A pharmacy subject to an audit may use the following records to validate a claim
             532      for a prescription, refill, or change in a prescription:
             533          (a) electronic or physical copies of records of a health care facility, or a health care
             534      provider with prescribing authority; and
             535          (b) any prescription that complies with state law.
             536          (6) (a) An entity that audits a pharmacy shall provide the pharmacy with a preliminary
             537      audit report, delivered to the pharmacy or its corporate office of record within 60 days after
             538      completion of the audit.
             539          (b) A pharmacy has 30 days following receipt of the preliminary audit report to
             540      respond to questions, provide additional documentation, and comment on and clarify findings
             541      of the audit. Receipt of the report shall be based on the postmark date or the date of a
             542      computer transmission if transferred electronically.
             543          (7) If an audit results in the dispute or denial of a claim, the entity conducting the audit
             544      shall allow the pharmacy to resubmit a claim using any commercially reasonable method,
             545      including fax, mail, or electronic claims submission provided that the period of time when a
             546      claim may be resubmitted has not expired under the rules of the plan sponsor.
             547          (8) (a) Within 120 days after the completion of the appeals process under Subsection
             548      (9), a final audit report shall be delivered to the pharmacy or its corporate office of record.
             549          (b) The final audit report shall include a disclosure of any money recovered by the
             550      entity that conducted the audit.
             551          (9) An entity that audits a pharmacy shall establish a written appeals process for
             552      appealing a preliminary audit report and a final audit report, and shall provide the pharmacy



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             553
     with notice of the written appeals process. If the pharmacy benefit manager's contract or
             554      provider manual contains the information required by this Subsection (9), the requirement for
             555      notice is met.


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