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S.B. 142

This document includes Senate Committee Amendments incorporated into the bill on Tue, Feb 1, 2005 at 2:18 PM by rday. --> This document includes Senate 2nd Reading Floor Amendments incorporated into the bill on Thu, Feb 10, 2005 at 4:26 PM by rday. --> This document includes Senate 2nd Reading Floor Amendments (CORRECTED) incorporated into the bill on Fri, Feb 11, 2005 at 8:57 AM by rday. --> This document includes Senate 2nd Reading Floor Amendments (CORRECTED) incorporated into the bill on Tue, Feb 15, 2005 at 3:21 PM by rday. --> This document includes Senate 2nd Reading Floor Amendments (CORRECTED) incorporated into the bill on Tue, Feb 15, 2005 at 3:52 PM by rday. -->             


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Senate Committee Amendments 2-1-2005 rd/cjd
1
    
PHARMACY PRACTICE ACT AMENDMENTS

             2     
2005 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Sponsor: Peter C. Knudson

             5     

             6      LONG TITLE
             7      General Description:
             8          This bill makes technical and clarifying changes to the Pharmacy Practice Act.
             9      Highlighted Provisions:
             10          This bill:
             11          .    clarifies and modifies definitions;
             12          .    updates an organization name;
             13          .    amends the definition of "unprofessional conduct"; and
             14          .    makes technical and clarifying changes.
             15      Monies Appropriated in this Bill:
             16          None
             17      Other Special Clauses:
             18          None
             19      Utah Code Sections Affected:
             20      AMENDS:
             21          58-17b-102, as enacted by Chapter 280, Laws of Utah 2004
             22          58-17b-303, as enacted by Chapter 280, Laws of Utah 2004
             23          58-17b-304, as enacted by Chapter 280, Laws of Utah 2004
             24          58-17b-502, as enacted by Chapter 280, Laws of Utah 2004
             25          58-17b-503, as enacted by Chapter 280, Laws of Utah 2004
             25a      S. 58-17b-609, as enacted by Chapter 280, Laws of Utah 2004 .S
             26          58-17b-612, as enacted by Chapter 280, Laws of Utah 2004


             27      REPEALS:



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             28
         58-17a-303, as last amended by Chapter 28, Laws of Utah 1998
             29          58-17a-605.1, as last amended by Chapter 18, Laws of Utah 2002, Fifth Special Session
             30     

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




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



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



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             121
         (19) "Confidential information" has the same meaning as "protected health
             122      information" under the Standards for Privacy of Individually Identifiable Health Information,
             123      45 C.F.R. Parts 160 and 164.
             124          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             125          (21) "Device" means an instrument, apparatus, implement, machine, contrivance,
             126      implant, in vitro reagent, or other similar or related article, including any component part or
             127      accessory, which is required under federal or state law to be prescribed by a practitioner and
             128      dispensed by a pharmacist or pharmacy intern.
             129          (22) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             130      417, Sec. 3a(ff) which is incorporated by reference.
             131          (23) "Dispense" means the interpretation, evaluation, and implementation of a
             132      prescription drug order or device or nonprescription drug or device under a lawful order of a
             133      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             134      by a patient, research subject, or an animal.
             135          (24) "Distribute" means to deliver a drug or device other than by administering or
             136      dispensing.
             137          (25) "Drug" means:
             138          (a) a substance recognized as a drug in any official compendium, or supplement
             139      thereto, designated from time to time by the division in collaboration with the board for use in
             140      the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals,
             141      excluding nonprescription drugs or dietary supplements;
             142          (b) a drug or device that is required by any applicable federal or state law or rule to be
             143      dispensed on prescription only or is restricted to use by practitioners only;
             144          (c) substances other than food intended to affect the structure or any function of the
             145      body of humans or other animals, excluding nonprescription dietary supplements; and
             146          (d) substances intended for use as a component of any substance specified in
             147      Subsection (25)(a), (b), or (c).
             148          (26) "Drug product equivalent" means a drug product that is designated as the
             149      therapeutic equivalent of another drug product in the Approved Drug Products with
             150      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             151      of the Federal Food and Drug Administration.



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



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Senate 2nd Reading Amendments 2-10-2005 rd/cjd
             183
     under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             184          (33) "Licensed pharmacy technician" means an individual licensed with the division,
             185      that may, under the supervision of a pharmacist, perform the activities involved in the
             186      technician practice of pharmacy.
             187          (34) "Manufacturer" means a person or business physically located in Utah licensed to
             188      be engaged in the manufacturing of drugs or devices.
             189          (35) (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) "Medical order" means a lawful order of a practitioner which may include a
             203      prescription drug order.
             204          (37) "Medication profile" or "profile" means a record system maintained as to drugs or
             205      devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
             206      the profile to provide pharmaceutical care.
             207          (38) "Misbranded drug or device" means a drug or device considered misbranded under
             208      21 U.S.C.S. Sec. 352 (2003).
             209          (39) "Nonprescription drug" means a drug which may be sold without a prescription
             210      and which is labeled for use by the consumer in accordance with federal law and includes
             211      homeopathic remedies.
             212          (40) "Nonresident pharmacy" means [any] a pharmacy [that sells to anyone in Utah, but
             213      is not physically] located [in] outside of Utah that sells to a S. [ patient ] person .S in Utah.



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             214
         (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
             215          (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
             216      outside the state that is licensed and in good standing in another state, that:
             217          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a [resident]
             218      patient in this state pursuant to a [legally] lawfully issued prescription;
             219          (b) provides information to a [resident of] patient in this state on drugs or devices
             220      which may include, but is not limited to, advice relating to therapeutic values, potential
             221      hazards, and uses; or
             222          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             223      effects of drugs.
             224          (43) "Patient counseling" means the written and oral communication by the
             225      pharmacist[, pharmacy preceptor,] or pharmacy intern of information, to the patient or
             226      caregiver, in order to ensure proper use of drugs, devices, and dietary supplements.
             227          (44) "Pharmaceutical administration facility" means a [health care] facility [or],
             228      agency, or institution in which:
             229          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             230      the facility or agency for administration to patients of that facility or agency;
             231          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             232      or pharmacy intern with whom the facility has established a prescription drug supervising
             233      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             234      or agency staff as required, and oversees drug control, accounting, and destruction; and
             235          (c) prescription drugs are professionally administered in accordance with the order of a
             236      practitioner by an employee or agent of the facility or agency.
             237          (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
             238      prescribing practitioner, and in accordance with division rule:
             239          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             240      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             241      the patient's disease;
             242          (ii) eliminating or reducing a patient's symptoms; or
             243          (iii) arresting or slowing a disease process.
             244          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a



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             245
     prescribing practitioner.
             246          (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
             247      distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
             248      state.
             249          [(47) (a) "Pharmaceutical research facility" means a facility engaged in conducting
             250      scientific research regarding drugs and their use in accordance with standard research protocols
             251      and techniques, who maintains competent documentation with respect to the research, and
             252      who uses prescription drugs in the conduct of the research.]
             253          [(b) "Pharmaceutical research facility" does not include any licensed facility or clinic
             254      whose primary researchers are licensed practitioners.]
             255          [(48)] (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical
             256      facility engaged in the business of wholesale vending or selling of any prescription drug or
             257      device to other than the consumer or user of the prescription drug or device, which the
             258      pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
             259          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             260      facility carrying out the following business activities:
             261          (i) intracompany sales;
             262          (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             263      purchase or trade a prescription drug or device between hospitals or other health care facilities
             264      that are under common ownership or control of the management and operation of the facilities;
             265          (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             266      purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
             267      another pharmaceutical facility to alleviate a temporary shortage; or
             268          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             269      manufacturer.
             270          [(49)] (48) "Pharmacist" means an individual licensed by this state to engage in the
             271      practice of pharmacy.
             272          [(50)] (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good
             273      standing who accepts responsibility for the operation of a pharmacy in conformance with all
             274      laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
             275      personally in full and actual charge of the pharmacy and all personnel.



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             276
         [(51)] (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with
             277      two or more years of licensed experience [whose name appears on a division list of approved
             278      preceptors]. The preceptor serves as a teacher, example of professional conduct, and
             279      supervisor of interns in the professional practice of pharmacy.
             280          [(52)] (51) "Pharmacy" means any place [within Utah] where:
             281          (a) drugs are dispensed [and];
             282          (b) pharmaceutical care is provided [and any place outside of Utah where drugs are
             283      dispensed and pharmaceutical care is provided to residents of Utah.];
             284          (c) drugs are processed or handled for eventual use by a patient; or
             285          (d) drugs are used for the purpose of analysis or research.
             286          [(53)] (52) "Pharmacy benefits manager or coordinator" means a person or entity that
             287      administers the prescription drug or device portion of a health insurance [plans] plan on behalf
             288      of [plan sponsors, such as] a self-insured [employers] employer, insurance [companies]
             289      company, [and] health maintenance [organizations, and may be further] organization, or other
             290      plan sponsor, as defined by rule.
             291          [(54)] (53) "Pharmacy intern" means an individual licensed by this state to engage in
             292      practice as a pharmacy intern.
             293          [(55)] (54) "Pharmacy technician training program" means an approved technician
             294      training program providing education for pharmacy technicians.
             295          [(56)] (55) (a) "Practice as a licensed pharmacy technician" means engaging in practice
             296      as a pharmacy technician under the general supervision of a licensed pharmacist and in
             297      accordance with a scope of practice [as] defined by division rule made in collaboration with the
             298      board.
             299          (b) "Practice as a licensed pharmacy technician" does not include:
             300          (i) performing a drug utilization review, prescription drug order clarification from a
             301      prescriber, final review of the prescription and prescribed drug prepared for dispensing,
             302      dispensing of the drug, or counseling a patient with respect to a prescription drug;
             303          (ii) counseling regarding nonprescription drugs and dietary supplements unless
             304      delegated by the supervising pharmacist; or
             305          (iii) receiving new prescription drug orders when communicating telephonically or
             306      electronically unless the original information is recorded so the pharmacist may review the



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             307
     prescription drug order as transmitted.
             308          [(57)] (56) "Practice of pharmacy" includes the following:
             309          (a) providing pharmaceutical care;
             310          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             311      practice agreement;
             312          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             313      distribution of prescription drugs or devices, provided that the administration of a prescription
             314      drug or device is:
             315          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             316          (ii) in accordance with written guidelines or protocols:
             317          (A) established by the licensed facility in which the prescription drug or device is to be
             318      administered on an inpatient basis; or
             319          (B) approved by the division, in collaboration with the board and the Physicians
             320      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             321      administered on an outpatient basis solely by a licensed pharmacist;
             322          (d) participating in drug utilization review;
             323          (e) ensuring proper and safe storage of drugs and devices;
             324          (f) maintaining records of drugs and devices in accordance with state and federal law
             325      and the standards and ethics of the profession;
             326          (g) providing information on drugs or devices, which may include advice relating to
             327      therapeutic values, potential hazards, and uses;
             328          (h) providing drug product equivalents;
             329          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             330      technicians;
             331          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
             332          (k) providing emergency refills as defined by rule;
             333          (l) telepharmacy; and
             334          (m) formulary management intervention.
             335          [(58)] (57) "Practice of telepharmacy" means the practice of pharmacy through the use
             336      of telecommunications and information technologies.
             337          [(59)] (58) "Practice of telepharmacy across state lines" means the practice of



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             338
     pharmacy through the use of telecommunications and information technologies that occurs
             339      when the patient is physically located within one jurisdiction and the pharmacist is located in
             340      another jurisdiction.
             341          [(60)] (59) "Practitioner" means an individual currently licensed, registered, or
             342      otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
             343      course of professional practice.
             344          [(61)] (60) "Prescription" means an order:
             345          (a) issued by a licensed practitioner:
             346          (i) orally, in writing, by telephone, facsimile transmission, computer, or other
             347      electronic means of communication as defined by division rule;
             348          (ii) in the course of the practitioner's professional practice; or
             349          (iii) by collaborative pharmacy practice agreement; and
             350          (b) for a controlled substance, other prescription drug, or device with the intent that the
             351      controlled substance, prescription drug, or device will be used by a patient or an animal.
             352          [(62)] (61) "Prescription drug or device" means:
             353          (a) a legend drug or device; or
             354          (b) a drug or device that is required by an applicable federal or state law or rule to be
             355      dispensed on prescription only or is restricted to use by practitioners only.
             356          [(63)] (62) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             357      drugs and devices to the general public.
             358          [(64)] (63) "Self-audit" means an internal evaluation of a pharmacy to determine
             359      compliance with this chapter.
             360          [(65)] (64) "Supervising pharmacist" means a pharmacist who is overseeing the
             361      operation of the pharmacy during a given day or shift.
             362          [(66)] (65) "Supportive personnel" means unlicensed individuals who:
             363          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             364      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             365      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             366      those duties may be further defined by division rule adopted in collaboration with the board;
             367      and
             368          (b) are supervised by a pharmacist in accordance with rules adopted by the division in



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             369
     collaboration with the board.
             370          [(67)] (66) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             371          [(68)] (67) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             372      58-17b-502 and may be further defined by rule.
             373          [(69)] (68) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             374      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             375      for animals.
             376          Section 2. Section 58-17b-303 is amended to read:
             377           58-17b-303. Qualifications for licensure as a pharmacist.
             378          (1) Each applicant for licensure as a pharmacist shall:
             379          (a) submit an application in a form prescribed by the division;
             380          (b) pay a fee as determined by the department under Section 63-38-3.2 ;
             381          (c) produce satisfactory evidence of good moral character as it relates to the applicant's
             382      ability to practice pharmacy;
             383          (d) complete a criminal background check and be free from criminal convictions as
             384      required by Section 58-17b-307 , or as described in Section 58-1-501 ;
             385          (e) have no physical or mental condition of a nature which prevents the applicant from
             386      engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
             387      public;
             388          (f) have graduated and received a professional entry degree from a school or college of
             389      pharmacy which is accredited by the [American Council on Pharmaceutical Education]
             390      Accreditation Council on Pharmacy Education;
             391          (g) have completed an internship meeting standards established by division rule made
             392      in collaboration with the board; and
             393          (h) have successfully passed examinations required by division rule made in
             394      collaboration with the board.
             395          (2) Each applicant for licensure as a pharmacist whose pharmacy education was
             396      completed at a foreign pharmacy school shall, in addition to the requirements under
             397      Subsections (1)(a) through (e), (g), and (h), obtain a certification of equivalency from a
             398      credentialing agency required by division rule made in collaboration with the board.
             399          (3) Each applicant for a license by endorsement as a pharmacist under this section



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             400
     shall:
             401          (a) submit a written application in the form prescribed by the division;
             402          (b) pay the fee determined by the department under Section 63-38-3.2 ;
             403          (c) be of good moral character as required of applicants for licensure as pharmacists
             404      under Subsection (1);
             405          (d) complete a criminal background check and be free from criminal convictions as
             406      required by Section 58-17b-307 , or as otherwise described in Section 58-1-501 ;
             407          (e) have no physical or mental condition of a nature which prevents the applicant from
             408      engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
             409      public;
             410          (f) have lawfully practiced as a licensed pharmacist a minimum of 2,000 hours in the
             411      four years immediately preceding the date of application;
             412          (g) produce satisfactory evidence of completing the professional education required
             413      under Subsection (1);
             414          (h) be currently licensed in good standing as a pharmacist in another state, territory, or
             415      possession of the United States;
             416          (i) produce satisfactory evidence that the examination requirements are or were at the
             417      time the license was issued, equal to those of this state; and
             418          (j) pass the jurisprudence examination prescribed by division rule made in
             419      collaboration with the board.
             420          Section 3. Section 58-17b-304 is amended to read:
             421           58-17b-304. Qualifications for licensure of pharmacy intern.
             422          Each applicant for licensure as a pharmacy intern shall:
             423          (1) submit an application in a form prescribed by the division;
             424          (2) pay a fee determined by the department under Section 63-38-3.2 ;
             425          (3) produce satisfactory evidence of good moral character as it relates to the applicant's
             426      ability to practice pharmacy;
             427          (4) complete a criminal background check and be free from criminal convictions as
             428      required by Section 58-17b-307 , or as otherwise described in Section 58-1-501 ;
             429          (5) have no physical or mental condition of a nature which prevents the applicant from
             430      engaging in the practice of pharmacy with reasonable skill, competency, and safety to the



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             431
     public;
             432          (6) meet the preliminary educational qualifications required by division rule made in
             433      collaboration with the board; and
             434          (7) meet one of the following educational criteria:
             435          (a) be a current pharmacy student, a resident, or fellow in a program approved by
             436      division rule in collaboration with the board;
             437          (b) have graduated and received a pharmacy degree from a school or college of
             438      pharmacy which is accredited by the [American Council on Pharmaceutical Education]
             439      Accreditation Council on Pharmacy Education; or
             440          (c) have graduated from a foreign pharmacy school and received certification of
             441      equivalency from a credentialing agency approved by the division rule in collaboration with the
             442      board.
             443          Section 4. Section 58-17b-502 is amended to read:
             444           58-17b-502. Unprofessional conduct.
             445          "Unprofessional conduct" includes:
             446          (1) willfully deceiving or attempting to deceive the division, the board, or their agents
             447      as to any relevant matter regarding compliance under this chapter;
             448          (2) [(a)] except for price discounts conditional upon volume purchases:
             449          (a) paying rebates to practitioners or any other health care providers[, or]; and
             450          (b) entering into any agreement with a medical practitioner or any other person for the
             451      payment or acceptance of compensation or its economic equivalent for recommending the
             452      professional services of either party[, except as allowed under Subsection (2)(b); and];
             453          [(b) price discounts conditional upon volume purchases are not prohibited under
             454      Subsection (2)(a);]
             455          (3) misbranding or adulteration of any drug or device or the sale, distribution, or
             456      dispensing of any outdated, misbranded, or adulterated drug or device;
             457          (4) engaging in the sale or purchase of drugs or devices that are samples or packages
             458      bearing the inscription "sample" or "not for resale" or similar words or phrases;
             459          (5) except as provided in Section 58-17b-503 , accepting back and redistributing of any
             460      unused drug, or a part of it, after it has left the premises of any pharmacy, unless the drug is in
             461      [the original sealed unit dose package] a unit pack, as defined in Section 58-17b-503 , or the



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             462
     manufacturer's sealed container, as defined in rule[, except as provided in Section 58-17b-503 ];
             463          (6) being employed as a pharmacist, pharmacy intern, or pharmacy technician, or
             464      sharing or receiving compensation in any form arising out of an act incidental to professional
             465      activities in the course of which any person requires him to engage in any aspect of the practice
             466      of pharmacy in violation of this chapter;
             467          (7) violating Federal Title II, P.L. 91, Controlled Substances Act, or Title 58, Chapter
             468      37, Utah Controlled Substances Act, or rules and regulations adopted under either act;
             469          (8) requiring or permitting pharmacy interns or technicians to engage in activities
             470      outside the scope of practice for their respective license classifications as defined in this
             471      chapter and division rules made in collaboration with the board, or beyond an individual's
             472      scope of training and ability;
             473          (9) administering:
             474          (a) without appropriate training, as defined by rule[:];
             475          [(a) written guidelines or protocols of a practitioner or in conflict with such guidelines
             476      or protocols; or]
             477          (b) without a [lawful] physician's order, when one is required by law; and
             478          (c) in conflict with a practitioner's written guidelines or written protocol for
             479      administering;
             480          (10) disclosing confidential patient information in violation of the provisions of the
             481      Health Insurance Portability and Accountability Act of 1996 or other applicable law;
             482          (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
             483      the pharmacist-in-charge;
             484          (12) failing to report to the division any adverse action taken by another licensing
             485      jurisdiction, government agency, law enforcement agency, or court for conduct that would
             486      constitute grounds for action, as defined in this section;
             487          (13) preparing as a pharmacist or pharmacy intern, a prescription drug for sale to
             488      another pharmacist or pharmaceutical facility; and
             489          (14) preparing as a pharmacist or pharmacy intern, a prescription drug in a dosage form
             490      which is regularly and commonly available from a manufacturer in quantities and strengths
             491      prescribed by a practitioner.
             492          Section 5. Section 58-17b-503 is amended to read:



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             493
          58-17b-503. Exception to unprofessional conduct.
             494          (1) For purposes of this section:
             495          (a) "ICFMR" means an intermediate care facility for the mentally retarded licensed as a
             496      nursing care facility or a small health care facility under Title 26, Chapter 21, Health Care
             497      Facility Licensing and Inspection Act.
             498          (b) "Nursing care facility" has the same definition as in Section 26-21-2 .
             499          (c) "Unit pack" means a tamper-resistant nonreusable single-dose single-drug package
             500      [which] with identification that indicates the lot number and expiration date for the drug.
             501          (2) Notwithstanding the provisions of Subsection 58-17b-502 (5), a pharmacist may
             502      accept back and redistribute any unused drug, or a part of it, after it has left the premises of the
             503      pharmacy if:
             504          (a) the drug was prescribed to a patient in a nursing care facility, an ICFMR, or state
             505      prison facility, county jail, or state hospital;
             506          (b) the drug was stored under the supervision of a licensed health care provider
             507      according to manufacturer recommendations;
             508          (c) the drug is in a unit pack or in the manufacturer's sealed container;
             509          (d) the drug was returned to the original dispensing pharmacy;
             510          (e) the drug was initially dispensed by a licensed pharmacist or licensed pharmacy
             511      intern; and
             512          (f) accepting back and redistribution of the drug complies with Federal Food and Drug
             513      Administration and Drug Enforcement Administration regulations.
             513a      S. Section 6. Section 58-17B-609 is amended to read:
             513b              58-17b-609.   Limitation on prescriptions and refills -- Controlled Substances Act
             513c      not affected -- Legend drugs.
             513d              (1) [A] Except as provided in Subsection 58-16a-102, a prescription for any
             513e1      prescription drug or device may not be dispensed
             513e      after one year from the date it was initiated except as otherwise provided in Chapter 37, Utah
             513f      Controlled Substances Act.
             513g              (2) A prescription authorized to be refilled may not be refilled after one year
             513h      from the original issue date.
             513i          (3) A practitioner may not be prohibited from issuing a new prescription for the same
             513j      drug orally, in writing, or by electronic transmission.
             513k          (4) Nothing in this chapter affects Chapter 37, Utah Controlled Substances Act.
             513l          (5) [Prescriptions] A prescription for a legend drug written by a licensed
             513m      prescribing practitioner in another state may be filled or refilled by a pharmacist or .S


            
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513n
     S. pharmacy intern in this state [, and] if the pharmacist or pharmacy intern [knows
             513o      the prescribing practitioner holds a current license] verifies that the prescription is valid..S
             514          Section S. [ 6 ] 7 .S . Section 58-17b-612 is amended to read:
             515           58-17b-612. Supervision -- Pharmacist-in-charge.
             516          (1) (a) Any pharmacy, except a wholesaler, distributor, or out-of-state mail service
             517      pharmacy, shall be under the general supervision of at least one pharmacist licensed to practice
             518      in Utah. One pharmacist licensed in Utah shall be designated as the pharmacist-in-charge,
             519      whose responsibility it is to oversee the operation of the pharmacy.
             520          (b) Notwithstanding the provisions of Subsection 58-17b-102 [(63)](64), a supervising
             521      pharmacist does not have to be in the pharmacy or care facility but shall be available via a
             522      telepharmacy system for immediate contact with the supervised pharmacy technician or
             523      pharmacy intern if:



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             524
         (i) the pharmacy is located in:
             525          (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
             526          (B) a clinic located in a remote rural county with less than 20 people per square mile;
             527          (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
             528          (iii) the telepharmacy system maintains records and files quarterly reports as required
             529      by division rule to assure that patient safety is not compromised.
             530          (2) Each out-of-state mail service pharmacy shall designate and identify to the division
             531      a pharmacist holding a current license in good standing issued by the state in which the
             532      pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
             533      chapter.
             534          Section 7. Repealer.
             535          This bill repeals:
             536          Section 58-17a-303, License classifications of drug outlets and other facilities --
             537      Qualifications for licensure.
             538          Section 58-17a-605.1, Restrictive drug formulary prohibited.





Legislative Review Note
    as of 1-24-05 5:33 PM


Based on a limited legal review, this legislation has not been determined to have a high
probability of being held unconstitutional.

Office of Legislative Research and General Counsel


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