H.B. 114 Enrolled





Chief Sponsor: Stewart Barlow

Senate Sponsor: Evan J. Vickers

             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act.
             10      Highlighted Provisions:
             11          This bill:
             12          .    amends the definition of a class C pharmacy subject to regulation under the
             13      Pharmacy Practice Act.
             14      Money Appropriated in this Bill:
             15          None
             16      Other Special Clauses:
             17          This bill takes effect on July 1, 2014.
             18      Utah Code Sections Affected:
             19      AMENDS:
             20           58-17b-102 , as last amended by Laws of Utah 2013, Chapters 52, 166, and 423
             22      Be it enacted by the Legislature of the state of Utah:
             23          Section 1. Section 58-17b-102 is amended to read:
             24           58-17b-102. Definitions.
             25          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             26          (1) "Administering" means:
             27          (a) the direct application of a prescription drug or device, whether by injection,
             28      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             29      by another person; or

             30          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             31      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             32      means directed to the body of the animal by the owner or caretaker in accordance with written
             33      or verbal directions of the veterinarian.
             34          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             35      21 U.S.C.S. Sec. 351 (2003).
             36          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             37      the purpose of analysis.
             38          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             39      used as standards and controls in performing drug monitoring or drug screening analysis if the
             40      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             41      components, organic solvents, or inorganic buffers at a concentration not exceeding one
             42      milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             43      use.
             44          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             45      the use of prescription drugs.
             46          (5) "Automated pharmacy systems" includes mechanical systems which perform
             47      operations or activities, other than compounding or administration, relative to the storage,
             48      packaging, dispensing, or distribution of medications, and which collect, control, and maintain
             49      all transaction information.
             50          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
             51      prescription label at the time of dispensing that indicates to the patient or caregiver a time
             52      beyond which the contents of the prescription are not recommended to be used.
             53          (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
             54      in Section 58-17b-201 .
             55          (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
             56      underserved area, used for the storage and dispensing of prescription drugs, which is dependent
             57      upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and

             58      approved by the division as the parent pharmacy.
             59          (9) "Centralized prescription processing" means the processing by a pharmacy of a
             60      request from another pharmacy to fill or refill a prescription drug order or to perform
             61      processing functions such as dispensing, drug utilization review, claims adjudication, refill
             62      authorizations, and therapeutic interventions.
             63          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             64      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             65      prescription order.
             66          (11) "Class B pharmacy":
             67          (a) means a pharmacy located in Utah:
             68          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             69      setting; and
             70          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             71      health care services; and
             72          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
             73          (ii) pharmaceutical administration and sterile product preparation facilities.
             74          (12) "Class C pharmacy" means a pharmacy [located in Utah that is authorized to
             75      engage] that engages in the manufacture, production, wholesale, or distribution of drugs or
             76      devices in Utah.
             77          (13) "Class D pharmacy" means a nonresident pharmacy.
             78          (14) "Class E pharmacy" means all other pharmacies.
             79          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
             80      defined and exclusive group of patients who have access to the services of the pharmacy
             81      because they are treated by or have an affiliation with a specific entity, including a health
             82      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             83      retailer of goods to the general public, or the office of a practitioner.
             84          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
             85      more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or

             86      more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
             87      care functions authorized by the practitioner or practitioners under certain specified conditions
             88      or limitations.
             89          (17) "Collaborative pharmacy practice agreement" means a written and signed
             90      agreement between one or more pharmacists and one or more practitioners that provides for
             91      collaborative pharmacy practice for the purpose of drug therapy management of patients and
             92      prevention of disease of human subjects.
             93          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
             94      labeling of a limited quantity drug, sterile product, or device:
             95          (i) as the result of a practitioner's prescription order or initiative based on the
             96      practitioner, patient, or pharmacist relationship in the course of professional practice;
             97          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
             98      not for sale or dispensing; or
             99          (iii) in anticipation of prescription drug orders based on routine, regularly observed
             100      prescribing patterns.
             101          (b) "Compounding" does not include:
             102          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
             103      another pharmacist or pharmaceutical facility;
             104          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
             105      dosage form which is regularly and commonly available from a manufacturer in quantities and
             106      strengths prescribed by a practitioner; or
             107          (iii) the preparation of a prescription drug, sterile product, or device which has been
             108      withdrawn from the market for safety reasons.
             109          (19) "Confidential information" has the same meaning as "protected health
             110      information" under the Standards for Privacy of Individually Identifiable Health Information,
             111      45 C.F.R. Parts 160 and 164.
             112          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             113          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter

             114      417, Sec. 3a(ff) which is incorporated by reference.
             115          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             116      prescription drug order or device or nonprescription drug or device under a lawful order of a
             117      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             118      by a patient, research subject, or an animal.
             119          (23) "Distribute" means to deliver a drug or device other than by administering or
             120      dispensing.
             121          (24) (a) "Drug" means:
             122          (i) a substance recognized in the official United States Pharmacopoeia, Official
             123      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             124      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             125      prevention of disease in humans or animals;
             126          (ii) a substance that is required by any applicable federal or state law or rule to be
             127      dispensed by prescription only or is restricted to administration by practitioners only;
             128          (iii) a substance other than food intended to affect the structure or any function of the
             129      body of humans or other animals; and
             130          (iv) substances intended for use as a component of any substance specified in
             131      Subsections (24)(a)(i), (ii), (iii), and (iv).
             132          (b) "Drug" does not include dietary supplements.
             133          (25) "Drug regimen review" includes the following activities:
             134          (a) evaluation of the prescription drug order and patient record for:
             135          (i) known allergies;
             136          (ii) rational therapy-contraindications;
             137          (iii) reasonable dose and route of administration; and
             138          (iv) reasonable directions for use;
             139          (b) evaluation of the prescription drug order and patient record for duplication of
             140      therapy;
             141          (c) evaluation of the prescription drug order and patient record for the following

             142      interactions:
             143          (i) drug-drug;
             144          (ii) drug-food;
             145          (iii) drug-disease; and
             146          (iv) adverse drug reactions; and
             147          (d) evaluation of the prescription drug order and patient record for proper utilization,
             148      including over- or under-utilization, and optimum therapeutic outcomes.
             149          (26) "Drug sample" means a prescription drug packaged in small quantities consistent
             150      with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
             151      be sold, and is intended to be provided to practitioners for the immediate needs of patients for
             152      trial purposes or to provide the drug to the patient until a prescription can be filled by the
             153      patient.
             154          (27) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
             155      symbol, or process attached to or logically associated with a record and executed or adopted by
             156      a person with the intent to sign the record.
             157          (28) "Electronic transmission" means transmission of information in electronic form or
             158      the transmission of the exact visual image of a document by way of electronic equipment.
             159          (29) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             160      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             161      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
             162          (30) "Legend drug" has the same meaning as prescription drug.
             163          (31) "Licensed pharmacy technician" means an individual licensed with the division,
             164      that may, under the supervision of a pharmacist, perform the activities involved in the
             165      technician practice of pharmacy.
             166          (32) "Manufacturer" means a person or business physically located in Utah licensed to
             167      be engaged in the manufacturing of drugs or devices.
             168          (33) (a) "Manufacturing" means:
             169          (i) the production, preparation, propagation, conversion, or processing of a drug or

             170      device, either directly or indirectly, by extraction from substances of natural origin or
             171      independently by means of chemical or biological synthesis, or by a combination of extraction
             172      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             173      or relabeling of its container; and
             174          (ii) the promotion and marketing of such drugs or devices.
             175          (b) "Manufacturing" includes the preparation and promotion of commercially available
             176      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             177          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             178      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             179      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
             180      analysis.
             181          (34) "Medical order" means a lawful order of a practitioner which may include a
             182      prescription drug order.
             183          (35) "Medication profile" or "profile" means a record system maintained as to drugs or
             184      devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
             185      the profile to provide pharmaceutical care.
             186          (36) "Misbranded drug or device" means a drug or device considered misbranded under
             187      21 U.S.C.S. Sec. 352 (2003).
             188          (37) (a) "Nonprescription drug" means a drug which:
             189          (i) may be sold without a prescription; and
             190          (ii) is labeled for use by the consumer in accordance with federal law.
             191          (b) "Nonprescription drug" includes homeopathic remedies.
             192          (38) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
             193      person in Utah.
             194          (39) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
             195          (40) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
             196      outside the state that is licensed and in good standing in another state, that:
             197          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in

             198      this state pursuant to a lawfully issued prescription;
             199          (b) provides information to a patient in this state on drugs or devices which may
             200      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             201      or
             202          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             203      effects of drugs.
             204          (41) "Patient counseling" means the written and oral communication by the pharmacist
             205      or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
             206      drugs, devices, and dietary supplements.
             207          (42) "Pharmaceutical administration facility" means a facility, agency, or institution in
             208      which:
             209          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             210      the facility or agency for administration to patients of that facility or agency;
             211          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             212      or pharmacy intern with whom the facility has established a prescription drug supervising
             213      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             214      or agency staff as required, and oversees drug control, accounting, and destruction; and
             215          (c) prescription drugs are professionally administered in accordance with the order of a
             216      practitioner by an employee or agent of the facility or agency.
             217          (43) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
             218      prescribing practitioner, and in accordance with division rule:
             219          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             220      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             221      the patient's disease;
             222          (ii) eliminating or reducing a patient's symptoms; or
             223          (iii) arresting or slowing a disease process.
             224          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             225      prescribing practitioner.

             226          (44) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
             227      distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
             228      state.
             229          (45) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
             230      engaged in the business of wholesale vending or selling of a prescription drug or device to
             231      other than a consumer or user of the prescription drug or device that the pharmaceutical facility
             232      has not produced, manufactured, compounded, or dispensed.
             233          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             234      facility carrying out the following business activities:
             235          (i) intracompany sales;
             236          (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             237      purchase, or trade a prescription drug or device, if the activity is carried out between one or
             238      more of the following entities under common ownership or common administrative control, as
             239      defined by division rule:
             240          (A) hospitals;
             241          (B) pharmacies;
             242          (C) chain pharmacy warehouses, as defined by division rule; or
             243          (D) other health care entities, as defined by division rule;
             244          (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
             245      purchase, or trade a prescription drug or device, for emergency medical reasons, including
             246      supplying another pharmaceutical facility with a limited quantity of a drug, if:
             247          (A) the facility is unable to obtain the drug through a normal distribution channel in
             248      sufficient time to eliminate the risk of harm to a patient that would result from a delay in
             249      obtaining the drug; and
             250          (B) the quantity of the drug does not exceed an amount reasonably required for
             251      immediate dispensing to eliminate the risk of harm;
             252          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             253      manufacturer; and

             254          (v) the distribution of prescription drugs, if:
             255          (A) the dosage units distributed during a calendar year do not exceed five percent of
             256      the sum of the dosage units distributed by the facility during the calendar year and the dosage
             257      units dispensed by the facility during the calendar year; and
             258          (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
             259          (46) "Pharmacist" means an individual licensed by this state to engage in the practice
             260      of pharmacy.
             261          (47) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
             262      who accepts responsibility for the operation of a pharmacy in conformance with all laws and
             263      rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
             264      in full and actual charge of the pharmacy and all personnel.
             265          (48) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
             266      more years of licensed experience. The preceptor serves as a teacher, example of professional
             267      conduct, and supervisor of interns in the professional practice of pharmacy.
             268          (49) "Pharmacy" means any place where:
             269          (a) drugs are dispensed;
             270          (b) pharmaceutical care is provided;
             271          (c) drugs are processed or handled for eventual use by a patient; or
             272          (d) drugs are used for the purpose of analysis or research.
             273          (50) "Pharmacy benefits manager or coordinator" means a person or entity that
             274      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
             275      self-insured employer, insurance company, health maintenance organization, or other plan
             276      sponsor, as defined by rule.
             277          (51) "Pharmacy intern" means an individual licensed by this state to engage in practice
             278      as a pharmacy intern.
             279          (52) "Pharmacy technician training program" means an approved technician training
             280      program providing education for pharmacy technicians.
             281          (53) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a

             282      pharmacy technician under the general supervision of a licensed pharmacist and in accordance
             283      with a scope of practice defined by division rule made in collaboration with the board.
             284          (b) "Practice as a licensed pharmacy technician" does not include:
             285          (i) performing a drug utilization review, prescription drug order clarification from a
             286      prescriber, final review of the prescription, dispensing of the drug, or counseling a patient with
             287      respect to a prescription drug;
             288          (ii) except as permitted by rules made by the division in consultation with the board,
             289      final review of a prescribed drug prepared for dispensing;
             290          (iii) counseling regarding nonprescription drugs and dietary supplements unless
             291      delegated by the supervising pharmacist; or
             292          (iv) receiving new prescription drug orders when communicating telephonically or
             293      electronically unless the original information is recorded so the pharmacist may review the
             294      prescription drug order as transmitted.
             295          (54) "Practice of pharmacy" includes the following:
             296          (a) providing pharmaceutical care;
             297          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             298      practice agreement;
             299          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             300      distribution of prescription drugs or devices, provided that the administration of a prescription
             301      drug or device is:
             302          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             303          (ii) in accordance with written guidelines or protocols:
             304          (A) established by the licensed facility in which the prescription drug or device is to be
             305      administered on an inpatient basis; or
             306          (B) approved by the division, in collaboration with the board and the Physicians
             307      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             308      administered on an outpatient basis solely by a licensed pharmacist;
             309          (d) participating in drug utilization review;

             310          (e) ensuring proper and safe storage of drugs and devices;
             311          (f) maintaining records of drugs and devices in accordance with state and federal law
             312      and the standards and ethics of the profession;
             313          (g) providing information on drugs or devices, which may include advice relating to
             314      therapeutic values, potential hazards, and uses;
             315          (h) providing drug product equivalents;
             316          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             317      technicians;
             318          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
             319          (k) providing emergency refills as defined by rule;
             320          (l) telepharmacy; and
             321          (m) formulary management intervention.
             322          (55) "Practice of telepharmacy" means the practice of pharmacy through the use of
             323      telecommunications and information technologies.
             324          (56) "Practice of telepharmacy across state lines" means the practice of pharmacy
             325      through the use of telecommunications and information technologies that occurs when the
             326      patient is physically located within one jurisdiction and the pharmacist is located in another
             327      jurisdiction.
             328          (57) "Practitioner" means an individual currently licensed, registered, or otherwise
             329      authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
             330      professional practice.
             331          (58) "Prescribe" means to issue a prescription:
             332          (a) orally or in writing; or
             333          (b) by telephone, facsimile transmission, computer, or other electronic means of
             334      communication as defined by division rule.
             335          (59) "Prescription" means an order issued:
             336          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             337      by collaborative pharmacy practice agreement; and

             338          (b) for a controlled substance or other prescription drug or device for use by a patient
             339      or an animal.
             340          (60) "Prescription device" means an instrument, apparatus, implement, machine,
             341      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             342      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             343      and dispensed by or through a person or entity licensed under this chapter or exempt from
             344      licensure under this chapter.
             345          (61) "Prescription drug" means a drug that is required by federal or state law or rule to
             346      be dispensed only by prescription or is restricted to administration only by practitioners.
             347          (62) "Research using pharmaceuticals" means research:
             348          (a) conducted in a research facility, as defined by division rule, that is associated with a
             349      university or college in the state accredited by the Northwest Commission on Colleges and
             350      Universities;
             351          (b) requiring the use of a controlled substance, prescription drug, or prescription
             352      device;
             353          (c) that uses the controlled substance, prescription drug, or prescription device in
             354      accordance with standard research protocols and techniques, including, if required, those
             355      approved by an institutional review committee; and
             356          (d) that includes any documentation required for the conduct of the research and the
             357      handling of the controlled substance, prescription drug, or prescription device.
             358          (63) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
             359      and devices to the general public.
             360          (64) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
             361      with this chapter.
             362          (65) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
             363      the pharmacy during a given day or shift.
             364          (66) "Supportive personnel" means unlicensed individuals who:
             365          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed

             366      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             367      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             368      those duties may be further defined by division rule adopted in collaboration with the board;
             369      and
             370          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             371      collaboration with the board.
             372          (67) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             373          (68) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-17b-502 and
             374      may be further defined by rule.
             375          (69) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             376      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             377      for animals.
             378          Section 2. Effective date.
             379          This bill takes effect on July 1, 2014.

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