S.B. 77

             1     

PHARMACY PRACTICE ACT AMENDMENTS

             2     
2014 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Evan J. Vickers

             5     
House Sponsor: Stewart Barlow

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends provisions of the Pharmacy Practice Act related to pharmacies and
             10      prescription drugs.
             11      Highlighted Provisions:
             12          This bill:
             13          .    directs the Division of Occupational and Professional Licensing to issue a pharmacy
             14      technician trainee license to an individual under certain circumstances;
             15          .    modifies the definition of pharmaceutical wholesaler or distributor in the Pharmacy
             16      Practice Act to exclude a facility for which the facility's total distribution-related
             17      sales of prescription drugs does not exceed 5% of the facility's total prescription
             18      drug sales;
             19          .    allows a pharmacy to sell a prescription drug to a practitioner for use in the
             20      practitioner's office or facility under certain circumstances;
             21          .    allows a hospital pharmacy that dispenses a prescription drug in a multidose
             22      container to a hospital patient and follows labeling requirements to provide the
             23      patient the drug when the patient is discharged; and
             24          .    makes technical and conforming amendments.
             25      Money Appropriated in this Bill:
             26          None
             27      Other Special Clauses:


             28          None
             29      Utah Code Sections Affected:
             30      AMENDS:
             31           58-17b-102 , as last amended by Laws of Utah 2013, Chapters 52, 166, and 423
             32           58-17b-301 , as last amended by Laws of Utah 2013, Chapter 52
             33           58-17b-502 , as last amended by Laws of Utah 2007, Chapter 279
             34           58-17b-602 , as last amended by Laws of Utah 2013, Chapter 79
             35           58-17b-613 , as enacted by Laws of Utah 2004, Chapter 280
             36      ENACTS:
             37           58-17b-305.1 , Utah Code Annotated 1953
             38           58-17b-624 , Utah Code Annotated 1953
             39     
             40      Be it enacted by the Legislature of the state of Utah:
             41          Section 1. Section 58-17b-102 is amended to read:
             42           58-17b-102. Definitions.
             43          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             44          (1) "Administering" means:
             45          (a) the direct application of a prescription drug or device, whether by injection,
             46      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             47      by another person; or
             48          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             49      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             50      means directed to the body of the animal by the owner or caretaker in accordance with written
             51      or verbal directions of the veterinarian.
             52          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             53      21 U.S.C.S. Sec. 351 (2003).
             54          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             55      the purpose of analysis.
             56          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             57      used as standards and controls in performing drug monitoring or drug screening analysis if the
             58      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid


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


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


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


             152          (i) known allergies;
             153          (ii) rational therapy-contraindications;
             154          (iii) reasonable dose and route of administration; and
             155          (iv) reasonable directions for use;
             156          (b) evaluation of the prescription drug order and patient record for duplication of
             157      therapy;
             158          (c) evaluation of the prescription drug order and patient record for the following
             159      interactions:
             160          (i) drug-drug;
             161          (ii) drug-food;
             162          (iii) drug-disease; and
             163          (iv) adverse drug reactions; and
             164          (d) evaluation of the prescription drug order and patient record for proper utilization,
             165      including over- or under-utilization, and optimum therapeutic outcomes.
             166          (26) "Drug sample" means a prescription drug packaged in small quantities consistent
             167      with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
             168      be sold, and is intended to be provided to practitioners for the immediate needs of patients for
             169      trial purposes or to provide the drug to the patient until a prescription can be filled by the
             170      patient.
             171          (27) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
             172      symbol, or process attached to or logically associated with a record and executed or adopted by
             173      a person with the intent to sign the record.
             174          (28) "Electronic transmission" means transmission of information in electronic form or
             175      the transmission of the exact visual image of a document by way of electronic equipment.
             176          (29) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             177      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             178      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             179          (30) "Legend drug" has the same meaning as prescription drug.
             180          (31) "Licensed pharmacy technician" means an individual licensed with the division,
             181      that may, under the supervision of a pharmacist, perform the activities involved in the
             182      technician practice of pharmacy.


             183          (32) "Manufacturer" means a person or business physically located in Utah licensed to
             184      be engaged in the manufacturing of drugs or devices.
             185          (33) (a) "Manufacturing" means:
             186          (i) the production, preparation, propagation, conversion, or processing of a drug or
             187      device, either directly or indirectly, by extraction from substances of natural origin or
             188      independently by means of chemical or biological synthesis, or by a combination of extraction
             189      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             190      or relabeling of its container; and
             191          (ii) the promotion and marketing of such drugs or devices.
             192          (b) "Manufacturing" includes the preparation and promotion of commercially available
             193      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             194          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             195      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             196      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
             197      analysis.
             198          (34) "Medical order" means a lawful order of a practitioner which may include a
             199      prescription drug order.
             200          (35) "Medication profile" or "profile" means a record system maintained as to drugs or
             201      devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
             202      the profile to provide pharmaceutical care.
             203          (36) "Misbranded drug or device" means a drug or device considered misbranded under
             204      21 U.S.C.S. Sec. 352 (2003).
             205          (37) (a) "Nonprescription drug" means a drug which:
             206          (i) may be sold without a prescription; and
             207          (ii) is labeled for use by the consumer in accordance with federal law.
             208          (b) "Nonprescription drug" includes homeopathic remedies.
             209          (38) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
             210      person in Utah.
             211          (39) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
             212          (40) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
             213      outside the state that is licensed and in good standing in another state, that:


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


             245      state.
             246          (45) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
             247      engaged in the business of wholesale vending or selling of a prescription drug or device to
             248      other than a consumer or user of the prescription drug or device that the pharmaceutical facility
             249      has not produced, manufactured, compounded, or dispensed.
             250          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             251      facility carrying out the following business activities:
             252          (i) intracompany sales;
             253          (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             254      purchase, or trade a prescription drug or device, if the activity is carried out between one or
             255      more of the following entities under common ownership or common administrative control, as
             256      defined by division rule:
             257          (A) hospitals;
             258          (B) pharmacies;
             259          (C) chain pharmacy warehouses, as defined by division rule; or
             260          (D) other health care entities, as defined by division rule;
             261          (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             262      purchase, or trade a prescription drug or device, for emergency medical reasons, including
             263      supplying another pharmaceutical facility with a limited quantity of a drug, if:
             264          (A) the facility is unable to obtain the drug through a normal distribution channel in
             265      sufficient time to eliminate the risk of harm to a patient that would result from a delay in
             266      obtaining the drug; and
             267          (B) the quantity of the drug does not exceed an amount reasonably required for
             268      immediate dispensing to eliminate the risk of harm;
             269          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             270      manufacturer; and
             271          (v) the distribution of prescription drugs, if:
             272          [(A) the dosage units distributed during a calendar year do not exceed five percent of
             273      the sum of the dosage units distributed by the facility during the calendar year and the dosage
             274      units dispensed by the facility during the calendar year; and]
             275          (A) the facility's total distribution-related sales of prescription drugs does not exceed


             276      5% of the facility's total prescription drug sales; and
             277          (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
             278          (46) "Pharmacist" means an individual licensed by this state to engage in the practice
             279      of pharmacy.
             280          (47) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
             281      who accepts responsibility for the operation of a pharmacy in conformance with all laws and
             282      rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
             283      in full and actual charge of the pharmacy and all personnel.
             284          (48) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
             285      more years of licensed experience. The preceptor serves as a teacher, example of professional
             286      conduct, and supervisor of interns in the professional practice of pharmacy.
             287          (49) "Pharmacy" means any place where:
             288          (a) drugs are dispensed;
             289          (b) pharmaceutical care is provided;
             290          (c) drugs are processed or handled for eventual use by a patient; or
             291          (d) drugs are used for the purpose of analysis or research.
             292          (50) "Pharmacy benefits manager or coordinator" means a person or entity that
             293      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
             294      self-insured employer, insurance company, health maintenance organization, or other plan
             295      sponsor, as defined by rule.
             296          (51) "Pharmacy intern" means an individual licensed by this state to engage in practice
             297      as a pharmacy intern.
             298          (52) "Pharmacy technician training program" means an approved technician training
             299      program providing education for pharmacy technicians.
             300          (53) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a
             301      pharmacy technician under the general supervision of a licensed pharmacist and in accordance
             302      with a scope of practice defined by division rule made in collaboration with the board.
             303          (b) "Practice as a licensed pharmacy technician" does not include:
             304          (i) performing a drug utilization review, prescription drug order clarification from a
             305      prescriber, final review of the prescription, dispensing of the drug, or counseling a patient with
             306      respect to a prescription drug;


             307          (ii) except as permitted by rules made by the division in consultation with the board,
             308      final review of a prescribed drug prepared for dispensing;
             309          (iii) counseling regarding nonprescription drugs and dietary supplements unless
             310      delegated by the supervising pharmacist; or
             311          (iv) receiving new prescription drug orders when communicating telephonically or
             312      electronically unless the original information is recorded so the pharmacist may review the
             313      prescription drug order as transmitted.
             314          (54) "Practice of pharmacy" includes the following:
             315          (a) providing pharmaceutical care;
             316          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             317      practice agreement;
             318          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             319      distribution of prescription drugs or devices, provided that the administration of a prescription
             320      drug or device is:
             321          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             322          (ii) in accordance with written guidelines or protocols:
             323          (A) established by the licensed facility in which the prescription drug or device is to be
             324      administered on an inpatient basis; or
             325          (B) approved by the division, in collaboration with the board and the Physicians
             326      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             327      administered on an outpatient basis solely by a licensed pharmacist;
             328          (d) participating in drug utilization review;
             329          (e) ensuring proper and safe storage of drugs and devices;
             330          (f) maintaining records of drugs and devices in accordance with state and federal law
             331      and the standards and ethics of the profession;
             332          (g) providing information on drugs or devices, which may include advice relating to
             333      therapeutic values, potential hazards, and uses;
             334          (h) providing drug product equivalents;
             335          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             336      technicians;
             337          (j) providing patient counseling, including adverse and therapeutic effects of drugs;


             338          (k) providing emergency refills as defined by rule;
             339          (l) telepharmacy; and
             340          (m) formulary management intervention.
             341          (55) "Practice of telepharmacy" means the practice of pharmacy through the use of
             342      telecommunications and information technologies.
             343          (56) "Practice of telepharmacy across state lines" means the practice of pharmacy
             344      through the use of telecommunications and information technologies that occurs when the
             345      patient is physically located within one jurisdiction and the pharmacist is located in another
             346      jurisdiction.
             347          (57) "Practitioner" means an individual currently licensed, registered, or otherwise
             348      authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
             349      professional practice.
             350          (58) "Prescribe" means to issue a prescription:
             351          (a) orally or in writing; or
             352          (b) by telephone, facsimile transmission, computer, or other electronic means of
             353      communication as defined by division rule.
             354          (59) "Prescription" means an order issued:
             355          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             356      by collaborative pharmacy practice agreement; and
             357          (b) for a controlled substance or other prescription drug or device for use by a patient
             358      or an animal.
             359          (60) "Prescription device" means an instrument, apparatus, implement, machine,
             360      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             361      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             362      and dispensed by or through a person or entity licensed under this chapter or exempt from
             363      licensure under this chapter.
             364          (61) "Prescription drug" means a drug that is required by federal or state law or rule to
             365      be dispensed only by prescription or is restricted to administration only by practitioners.
             366          (62) "Research using pharmaceuticals" means research:
             367          (a) conducted in a research facility, as defined by division rule, that is associated with a
             368      university or college in the state accredited by the Northwest Commission on Colleges and


             369      Universities;
             370          (b) requiring the use of a controlled substance, prescription drug, or prescription
             371      device;
             372          (c) that uses the controlled substance, prescription drug, or prescription device in
             373      accordance with standard research protocols and techniques, including, if required, those
             374      approved by an institutional review committee; and
             375          (d) that includes any documentation required for the conduct of the research and the
             376      handling of the controlled substance, prescription drug, or prescription device.
             377          (63) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
             378      and devices to the general public.
             379          (64) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
             380      with this chapter.
             381          (65) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
             382      the pharmacy during a given day or shift.
             383          (66) "Supportive personnel" means unlicensed individuals who:
             384          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             385      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             386      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             387      those duties may be further defined by division rule adopted in collaboration with the board;
             388      and
             389          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             390      collaboration with the board.
             391          (67) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             392          (68) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-17b-502 and
             393      may be further defined by rule.
             394          (69) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             395      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             396      for animals.
             397          Section 2. Section 58-17b-301 is amended to read:
             398           58-17b-301. License required -- License classifications for individuals.
             399          (1) A license is required to engage in the practice of pharmacy, telepharmacy, or the


             400      practice of a pharmacy technician, except as specifically provided in Section 58-1-307 ,
             401      58-17b-309 , or 58-17-309.6 .
             402          (2) The division shall issue to an individual who qualifies under this chapter a license
             403      in the classification of:
             404          (a) pharmacist;
             405          (b) pharmacy intern; [or]
             406          (c) pharmacy technician[.]; or
             407          (d) pharmacy technician trainee.
             408          Section 3. Section 58-17b-305.1 is enacted to read:
             409          58-17b-305.1. Qualifications for licensure of pharmacy technician trainee.
             410          (1) An applicant for licensure as a pharmacy technician trainee shall:
             411          (a) submit an application to the division on a form created by the division;
             412          (b) pay a fee established by the department in accordance with Section 63J-1-504 ;
             413          (c) submit satisfactory evidence, as determined by the department, of good moral
             414      character as it relates to the applicant's ability to practice pharmacy;
             415          (d) submit a completed criminal background check;
             416          (e) submit evidence that the applicant has not engaged in conduct that is considered
             417      unlawful conduct or unprofessional conduct under Section 58-1-501 , 58-17b-501 , or
             418      58-17b-502 ;
             419          (f) demonstrate, as determined by the department, that the applicant does not have a
             420      physical or mental condition that would prevent the applicant from engaging in practice as a
             421      pharmacy technician with reasonable skill, competency, and safety to the public;
             422          (g) have completed training that meets the standards established by the division in
             423      collaboration with the board; and
             424          (h) pass an examination designated by the division in collaboration with the board.
             425          (2) A pharmacist whose license has been denied, revoked, suspended, or restricted for
             426      disciplinary purposes is not eligible to be licensed as a pharmacy technician trainee during
             427      division probation.
             428          Section 4. Section 58-17b-502 is amended to read:
             429           58-17b-502. Unprofessional conduct.
             430          "Unprofessional conduct" includes:


             431          (1) willfully deceiving or attempting to deceive the division, the board, or their agents
             432      as to any relevant matter regarding compliance under this chapter;
             433          (2) (a) except as provided in Subsection (2)(b):
             434          (i) paying or offering rebates to practitioners or any other health care providers, or
             435      receiving or soliciting rebates from practitioners or any other health care provider; or
             436          (ii) paying, offering, receiving, or soliciting compensation in the form of a commission,
             437      bonus, rebate, kickback, or split fee arrangement with practitioners or any other health care
             438      provider, for the purpose of obtaining referrals.
             439          (b) Subsection (2)(a) does not apply to:
             440          (i) giving or receiving price discounts based on purchase volume;
             441          (ii) passing along pharmaceutical manufacturer's rebates; or
             442          (iii) providing compensation for services to a veterinarian.
             443          (3) misbranding or adulteration of any drug or device or the sale, distribution, or
             444      dispensing of any outdated, misbranded, or adulterated drug or device;
             445          (4) engaging in the sale or purchase of drugs or devices that are samples or packages
             446      bearing the inscription "sample" or "not for resale" or similar words or phrases;
             447          (5) except as provided in Section 58-17b-503 , accepting back and redistributing of any
             448      unused drug, or a part of it, after it has left the premises of any pharmacy, unless the drug is in
             449      a unit pack, as defined in Section 58-17b-503 , or the manufacturer's sealed container, as
             450      defined in rule;
             451          (6) an act in violation of this chapter committed by a person for any form of
             452      compensation if the act is incidental to the person's professional activities, including the
             453      activities of a pharmacist, pharmacy intern, or pharmacy technician;
             454          (7) violating Federal Title II, P.L. 91, Controlled Substances Act, Title 58, Chapter 37,
             455      Utah Controlled Substances Act, or rules or regulations adopted under either act;
             456          (8) requiring or permitting pharmacy interns or technicians to engage in activities
             457      outside the scope of practice for their respective license classifications, as defined in this
             458      chapter and division rules made in collaboration with the board, or beyond their scope of
             459      training and ability;
             460          (9) administering:
             461          (a) without appropriate training, as defined by rule;


             462          (b) without a physician's order, when one is required by law; and
             463          (c) in conflict with a practitioner's written guidelines or written protocol for
             464      administering;
             465          (10) disclosing confidential patient information in violation of the provisions of the
             466      Health Insurance Portability and Accountability Act of 1996 or other applicable law;
             467          (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
             468      the pharmacist-in-charge;
             469          (12) failing to report to the division any adverse action taken by another licensing
             470      jurisdiction, government agency, law enforcement agency, or court for conduct that in
             471      substance would be considered unprofessional conduct under this section; and
             472          [(13) as a pharmacist or pharmacy intern, preparing a prescription drug for sale to
             473      another pharmacist or pharmaceutical facility; and]
             474          [(14)] (13) as a pharmacist or pharmacy intern, preparing a prescription drug in a
             475      dosage form which is regularly and commonly available from a manufacturer in quantities and
             476      strengths prescribed by a practitioner.
             477          Section 5. Section 58-17b-602 is amended to read:
             478           58-17b-602. Prescription orders -- Information required -- Alteration -- Labels --
             479      Signatures -- Dispensing in pharmacies.
             480          (1) Except as provided in Section 58-1-501.3 , the minimum information that shall be
             481      included in a prescription order, and that may be defined by rule, is:
             482          (a) the prescriber's name, address, and telephone number, and, if the order is for a
             483      controlled substance, the patient's age and the prescriber's DEA number;
             484          (b) the patient's name and address or, in the case of an animal, the name of the owner
             485      and species of the animal;
             486          (c) the date of issuance;
             487          (d) the name of the medication or device prescribed and dispensing instructions, if
             488      necessary;
             489          (e) the directions, if appropriate, for the use of the prescription by the patient or animal
             490      and any refill, special labeling, or other instructions;
             491          (f) the prescriber's signature if the prescription order is written;
             492          (g) if the order is an electronically transmitted prescription order, the prescribing


             493      practitioner's electronic signature; and
             494          (h) if the order is a hard copy prescription order generated from electronic media, the
             495      prescribing practitioner's electronic or manual signature.
             496          (2) The requirement of Subsection (1)(a) does not apply to prescription orders
             497      dispensed for inpatients by hospital pharmacies if the prescriber is a current member of the
             498      hospital staff and the prescription order is on file in the patient's medical record.
             499          (3) Unless it is for a Schedule II controlled substance, a prescription order may be
             500      dispensed by a pharmacist or pharmacy intern upon an oral prescription of a practitioner only if
             501      the oral prescription is promptly reduced to writing.
             502          (4) (a) Except as provided under Subsection (4)(b), a pharmacist or pharmacy intern
             503      may not dispense or compound any prescription of a practitioner if the prescription shows
             504      evidence of alteration, erasure, or addition by any person other than the person writing the
             505      prescription.
             506          (b) A pharmacist or pharmacy intern dispensing or compounding a prescription may
             507      alter or make additions to the prescription after receiving permission of the prescriber and may
             508      make entries or additions on the prescription required by law or necessitated in the
             509      compounding and dispensing procedures.
             510          (5) Each drug dispensed shall have a label securely affixed to the container indicating
             511      the following minimum information:
             512          (a) the name, address, and telephone number of the pharmacy;
             513          (b) the serial number of the prescription as assigned by the dispensing pharmacy;
             514          (c) the filling date of the prescription or its last dispensing date;
             515          (d) the name of the patient, or in the case of an animal, the name of the owner and
             516      species of the animal;
             517          (e) the name of the prescriber;
             518          (f) the directions for use and cautionary statements, if any, which are contained in the
             519      prescription order or are needed;
             520          (g) except as provided in Subsection [(6)] (7), the trade, generic, or chemical name,
             521      amount dispensed and the strength of dosage form, but if multiple ingredient products with
             522      established proprietary or nonproprietary names are prescribed, those products' names may be
             523      used; and


             524          (h) the beyond use date.
             525          (6) A hospital pharmacy that dispenses a prescription drug that is packaged in a
             526      multidose container to a hospital patient may provide the drug in the multidose container to the
             527      patient when the patient is discharged from the hospital if:
             528          (a) the pharmacy receives a discharge order for the patient; and
             529          (b) the pharmacy labels the drug with the:
             530          (i) patient's name;
             531          (ii) drug's name and strength;
             532          (iii) directions for use of the drug, if applicable; and
             533          (iv) pharmacy's name and phone number.
             534          [(6)] (7) If the prescriber specifically indicates the name of the prescription product
             535      should not appear on the label, then any of the trade, generic, chemical, established proprietary,
             536      and established nonproprietary names and the strength of dosage form may not be included.
             537          [(7)] (8) Prescribers are encouraged to include on prescription labels the information
             538      described in Section 58-17b-602.5 in accordance with the provisions of that section.
             539          [(8) Except when it is delivered to the ultimate user via the United States Postal
             540      Service, licensed common carrier, or supportive personnel, a prescription drug may be
             541      dispensed to the ultimate user or his agent only at a licensed pharmacy.]
             542          (9) A pharmacy may only deliver a prescription drug to a patient or a patient's agent:
             543          (a) in person at the pharmacy; or
             544          (b) via the United States Postal Service, a licensed common carrier, or supportive
             545      personnel, if the pharmacy takes reasonable precautions to ensure the prescription drug is:
             546          (i) delivered to the patient or patient's agent; or
             547          (ii) returned to the pharmacy.
             548          Section 6. Section 58-17b-613 is amended to read:
             549           58-17b-613. Patient counseling.
             550          (1) [Every] A retail pharmacy [facility shall orally] shall verbally offer to counsel a
             551      patient or a patient's agent in a personal face-to-face discussion [with respect to] regarding each
             552      prescription drug dispensed, if the patient or patient's agent:
             553          (a) delivers the prescription in person to the pharmacist or pharmacy intern; or
             554          (b) receives the drug in person at the time it is dispensed at the pharmacy facility.


             555          [(2) A pharmacist or pharmacy intern shall provide counseling to each patient, and
             556      shall provide the patient with a toll-free telephone number by which the patient may contact a
             557      pharmacist at the dispensing pharmacy during normal business hours and receive oral
             558      counseling, with respect to each prescription drug dispensed if the patient provides or the
             559      prescription is otherwise provided to the pharmacy facility by a means other than personal
             560      delivery, and the dispensed prescription drug is mailed or otherwise delivered to the patient
             561      outside of the pharmacy facility.]
             562          [(3) (a) The provisions of Subsections (1) and (2) do not apply to incarcerated patients
             563      or persons otherwise under the jurisdiction of the Utah Department of Corrections or a county
             564      detention facility.]
             565          [(b) A written communication with a person described in Subsection (3)(a) shall be
             566      used by a pharmacist or pharmacy intern in lieu of a face to face or telephonic communication
             567      for the purpose of counseling the patient.]
             568          (2) A pharmacist or pharmacy intern at a pharmacy that receives a prescription from a
             569      patient by means other than personal delivery, and that dispenses prescription drugs to the
             570      patient by means other than personal delivery, shall:
             571          (a) provide patient counseling to a patient regarding each prescription drug the
             572      pharmacy dispenses; and
             573          (b) provide each patient with a toll-free telephone number by which the patient can
             574      contact a pharmacist or pharmacy intern at the pharmacy for counseling.
             575          (3) Notwithstanding the provisions of Subsections (1) and (2), a pharmacist or a
             576      pharmacy intern may provide patient counseling to an individual under the jurisdiction of the
             577      Utah Department of Corrections or a county detention facility via a written, telephone, or
             578      electronic communication.
             579          Section 7. Section 58-17b-624 is enacted to read:
             580          58-17b-624. Prescription drugs -- Sale to a practitioner for office use.
             581          (1) A pharmacy licensed under this chapter may, subject to rules established by the
             582      division, repackage or compound a prescription drug for sale to a practitioner if:
             583          (a) the prescription drug is not a controlled substance;
             584          (b) the pharmacy labels the prescription drug "for office use only";
             585          (c) the practitioner administers the drug to a patient in the practitioner's office or


             586      facility; and
             587          (d) the practitioner does not dispense the drug to the patient.
             588          (2) The division shall establish, in accordance with Title 63G, Chapter 3, Utah
             589      Administrative Rulemaking Act, prescription drug labeling and control standards for a
             590      prescription drug a pharmacy provides to a practitioner under this section.




Legislative Review Note
    as of 2-27-14 3:55 PM


Office of Legislative Research and General Counsel


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