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H.B. 434 Enrolled





Chief Sponsor: Evan J. Vickers

Senate Sponsor: Todd Weiler

             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 pharmacy preceptor; and
             13          .    amends provisions related to a prescribing practitioner providing sample drugs to a
             14      patient.
             15      Money Appropriated in this Bill:
             16          None
             17      Other Special Clauses:
             18          None
             19      Utah Code Sections Affected:
             20      AMENDS:
             21          58-17b-102, as last amended by Laws of Utah 2010, Chapter 101
             22          58-17b-610, as enacted by Laws of Utah 2004, Chapter 280
             24      Be it enacted by the Legislature of the state of Utah:
             25          Section 1. Section 58-17b-102 is amended to read:
             26           58-17b-102. Definitions.
             27          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             28          (1) "Administering" means:
             29          (a) the direct application of a prescription drug or device, whether by injection,

             30      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             31      by another person; or
             32          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             33      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             34      means directed to the body of the animal by the owner or caretaker in accordance with written
             35      or verbal directions of the veterinarian.
             36          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             37      21 U.S.C.S. Sec. 351 (2003).
             38          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             39      the purpose of analysis.
             40          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             41      used as standards and controls in performing drug monitoring or drug screening analysis if the
             42      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             43      components, organic solvents, or inorganic buffers at a concentration not exceeding one
             44      milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             45      use.
             46          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             47      the use of prescription drugs.
             48          (5) "Automated pharmacy systems" includes mechanical systems which perform
             49      operations or activities, other than compounding or administration, relative to the storage,
             50      packaging, dispensing, or distribution of medications, and which collect, control, and maintain
             51      all transaction information.
             52          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
             53      prescription label at the time of dispensing that indicates to the patient or caregiver a time
             54      beyond which the contents of the prescription are not recommended to be used.
             55          (7) "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          (8) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
             60      in Section 58-17b-201 .
             61          (9) "Centralized prescription processing" means the processing by a pharmacy of a
             62      request from another pharmacy to fill or refill a prescription drug order or to perform
             63      processing functions such as dispensing, drug utilization review, claims adjudication, refill
             64      authorizations, and therapeutic interventions.
             65          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
             66      retail pharmacy to compound or dispense a drug or dispense a device to the public under a
             67      prescription order.
             68          (11) "Class B pharmacy":
             69          (a) means a pharmacy located in Utah:
             70          (i) that is authorized to provide pharmaceutical care for patients in an institutional
             71      setting; and
             72          (ii) whose primary purpose is to provide a physical environment for patients to obtain
             73      health care services; and
             74          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
             75          (ii) pharmaceutical administration and sterile product preparation facilities.
             76          (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
             77      engage in the manufacture, production, wholesale, or distribution of drugs or devices.
             78          (13) "Class D pharmacy" means a nonresident pharmacy.
             79          (14) "Class E pharmacy" means all other pharmacies.
             80          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
             81      defined and exclusive group of patients who have access to the services of the pharmacy
             82      because they are treated by or have an affiliation with a specific entity, including a health
             83      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             84      retailer of goods to the general public, or the office of a practitioner.
             85          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or

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

             114          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             115      417, Sec. 3a(ff) which is incorporated by reference.
             116          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             117      prescription drug order or device or nonprescription drug or device under a lawful order of a
             118      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             119      by a patient, research subject, or an animal.
             120          (23) "Distribute" means to deliver a drug or device other than by administering or
             121      dispensing.
             122          (24) (a) "Drug" means:
             123          (i) a substance recognized in the official United States Pharmacopoeia, Official
             124      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             125      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             126      prevention of disease in humans or animals;
             127          (ii) a substance that is required by any applicable federal or state law or rule to be
             128      dispensed by prescription only or is restricted to administration by practitioners only;
             129          (iii) a substance other than food intended to affect the structure or any function of the
             130      body of humans or other animals; and
             131          (iv) substances intended for use as a component of any substance specified in
             132      Subsections (24)(a)(i), (ii), (iii), and (iv).
             133          (b) "Drug" does not include dietary supplements.
             134          (25) "Drug product equivalent" means a drug product that is designated as the
             135      therapeutic equivalent of another drug product in the Approved Drug Products with
             136      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             137      of the Federal Food and Drug Administration.
             138          (26) "Drug regimen review" includes the following activities:
             139          (a) evaluation of the prescription drug order and patient record for:
             140          (i) known allergies;
             141          (ii) rational therapy-contraindications;

             142          (iii) reasonable dose and route of administration; and
             143          (iv) reasonable directions for use;
             144          (b) evaluation of the prescription drug order and patient record for duplication of
             145      therapy;
             146          (c) evaluation of the prescription drug order and patient record for the following
             147      interactions:
             148          (i) drug-drug;
             149          (ii) drug-food;
             150          (iii) drug-disease; and
             151          (iv) adverse drug reactions; and
             152          (d) evaluation of the prescription drug order and patient record for proper utilization,
             153      including over- or under-utilization, and optimum therapeutic outcomes.
             154          (27) "Drug sample" means a prescription drug packaged in small quantities consistent
             155      with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
             156      be sold, and is intended to be provided to practitioners for the immediate needs of patients for
             157      trial purposes or to provide the drug to the patient until a prescription can be filled by the
             158      patient.
             159          (28) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
             160      symbol, or process attached to or logically associated with a record and executed or adopted by
             161      a person with the intent to sign the record.
             162          (29) "Electronic transmission" means transmission of information in electronic form or
             163      the transmission of the exact visual image of a document by way of electronic equipment.
             164          (30) "Extern" means a college of pharmacy student enrolled in a college coordinated
             165      practical experience program in a health care setting under the supervision of a preceptor, as
             166      defined in this act, and approved by a college of pharmacy.
             167          (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
             168      inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
             169      under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.

             170          (32) "Legend drug" has the same meaning as prescription drug.
             171          (33) "Licensed pharmacy technician" means an individual licensed with the division,
             172      that may, under the supervision of a pharmacist, perform the activities involved in the
             173      technician practice of pharmacy.
             174          (34) "Manufacturer" means a person or business physically located in Utah licensed to
             175      be engaged in the manufacturing of drugs or devices.
             176          (35) (a) "Manufacturing" means:
             177          (i) the production, preparation, propagation, conversion, or processing of a drug or
             178      device, either directly or indirectly, by extraction from substances of natural origin or
             179      independently by means of chemical or biological synthesis, or by a combination of extraction
             180      and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
             181      or relabeling of its container; and
             182          (ii) the promotion and marketing of such drugs or devices.
             183          (b) "Manufacturing" includes the preparation and promotion of commercially available
             184      products from bulk compounds for resale by pharmacies, practitioners, or other persons.
             185          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
             186      pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
             187      compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
             188      analysis.
             189          (36) "Medical order" means a lawful order of a practitioner which may include a
             190      prescription drug order.
             191          (37) "Medication profile" or "profile" means a record system maintained as to drugs or
             192      devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
             193      the profile to provide pharmaceutical care.
             194          (38) "Misbranded drug or device" means a drug or device considered misbranded under
             195      21 U.S.C.S. Sec. 352 (2003).
             196          (39) (a) "Nonprescription drug" means a drug which:
             197          (i) may be sold without a prescription; and

             198          (ii) is labeled for use by the consumer in accordance with federal law.
             199          (b) "Nonprescription drug" includes homeopathic remedies.
             200          (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
             201      person in Utah.
             202          (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
             203          (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
             204      outside the state that is licensed and in good standing in another state, that:
             205          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
             206      this state pursuant to a lawfully issued prescription;
             207          (b) provides information to a patient in this state on drugs or devices which may
             208      include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
             209      or
             210          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
             211      effects of drugs.
             212          (43) "Patient counseling" means the written and oral communication by the pharmacist
             213      or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
             214      drugs, devices, and dietary supplements.
             215          (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
             216      which:
             217          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
             218      the facility or agency for administration to patients of that facility or agency;
             219          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
             220      or pharmacy intern with whom the facility has established a prescription drug supervising
             221      relationship under which the pharmacist or pharmacy intern provides counseling to the facility
             222      or agency staff as required, and oversees drug control, accounting, and destruction; and
             223          (c) prescription drugs are professionally administered in accordance with the order of a
             224      practitioner by an employee or agent of the facility or agency.
             225          (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a

             226      prescribing practitioner, and in accordance with division rule:
             227          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
             228      achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
             229      the patient's disease;
             230          (ii) eliminating or reducing a patient's symptoms; or
             231          (iii) arresting or slowing a disease process.
             232          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
             233      prescribing practitioner.
             234          (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
             235      distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
             236      state.
             237          (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
             238      engaged in the business of wholesale vending or selling of any prescription drug or device to
             239      other than the consumer or user of the prescription drug or device, which the pharmaceutical
             240      facility has not produced, manufactured, compounded, or dispensed.
             241          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             242      facility carrying out the following business activities:
             243          (i) intracompany sales;
             244          (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             245      purchase or trade a prescription drug or device between hospitals or other health care facilities
             246      that are under common ownership or control of the management and operation of the facilities;
             247          (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             248      purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
             249      another pharmaceutical facility to alleviate a temporary shortage; or
             250          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             251      manufacturer.
             252          (48) "Pharmacist" means an individual licensed by this state to engage in the practice
             253      of pharmacy.

             254          (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
             255      who accepts responsibility for the operation of a pharmacy in conformance with all laws and
             256      rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
             257      in full and actual charge of the pharmacy and all personnel.
             258          (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with [two]
             259      one or more years of licensed experience. The preceptor serves as a teacher, example of
             260      professional conduct, and supervisor of interns in the professional practice of pharmacy.
             261          (51) "Pharmacy" means any place where:
             262          (a) drugs are dispensed;
             263          (b) pharmaceutical care is provided;
             264          (c) drugs are processed or handled for eventual use by a patient; or
             265          (d) drugs are used for the purpose of analysis or research.
             266          (52) "Pharmacy benefits manager or coordinator" means a person or entity that
             267      administers the prescription drug or device portion of a health insurance plan on behalf of a
             268      self-insured employer, insurance company, health maintenance organization, or other plan
             269      sponsor, as defined by rule.
             270          (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
             271      as a pharmacy intern.
             272          (54) "Pharmacy technician training program" means an approved technician training
             273      program providing education for pharmacy technicians.
             274          (55) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a
             275      pharmacy technician under the general supervision of a licensed pharmacist and in accordance
             276      with a scope of practice defined by division rule made in collaboration with the board.
             277          (b) "Practice as a licensed pharmacy technician" does not include:
             278          (i) performing a drug utilization review, prescription drug order clarification from a
             279      prescriber, final review of the prescription and prescribed drug prepared for dispensing,
             280      dispensing of the drug, or counseling a patient with respect to a prescription drug;
             281          (ii) counseling regarding nonprescription drugs and dietary supplements unless

             282      delegated by the supervising pharmacist; or
             283          (iii) receiving new prescription drug orders when communicating telephonically or
             284      electronically unless the original information is recorded so the pharmacist may review the
             285      prescription drug order as transmitted.
             286          (56) "Practice of pharmacy" includes the following:
             287          (a) providing pharmaceutical care;
             288          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             289      practice agreement;
             290          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             291      distribution of prescription drugs or devices, provided that the administration of a prescription
             292      drug or device is:
             293          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             294          (ii) in accordance with written guidelines or protocols:
             295          (A) established by the licensed facility in which the prescription drug or device is to be
             296      administered on an inpatient basis; or
             297          (B) approved by the division, in collaboration with the board and the Physicians
             298      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
             299      administered on an outpatient basis solely by a licensed pharmacist;
             300          (d) participating in drug utilization review;
             301          (e) ensuring proper and safe storage of drugs and devices;
             302          (f) maintaining records of drugs and devices in accordance with state and federal law
             303      and the standards and ethics of the profession;
             304          (g) providing information on drugs or devices, which may include advice relating to
             305      therapeutic values, potential hazards, and uses;
             306          (h) providing drug product equivalents;
             307          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
             308      technicians;
             309          (j) providing patient counseling, including adverse and therapeutic effects of drugs;

             310          (k) providing emergency refills as defined by rule;
             311          (l) telepharmacy; and
             312          (m) formulary management intervention.
             313          (57) "Practice of telepharmacy" means the practice of pharmacy through the use of
             314      telecommunications and information technologies.
             315          (58) "Practice of telepharmacy across state lines" means the practice of pharmacy
             316      through the use of telecommunications and information technologies that occurs when the
             317      patient is physically located within one jurisdiction and the pharmacist is located in another
             318      jurisdiction.
             319          (59) "Practitioner" means an individual currently licensed, registered, or otherwise
             320      authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
             321      professional practice.
             322          (60) "Prescribe" means to issue a prescription:
             323          (a) orally or in writing; or
             324          (b) by telephone, facsimile transmission, computer, or other electronic means of
             325      communication as defined by division rule.
             326          (61) "Prescription" means an order issued:
             327          (a) by a licensed practitioner in the course of that practitioner's professional practice or
             328      by collaborative pharmacy practice agreement; and
             329          (b) for a controlled substance or other prescription drug or device for use by a patient
             330      or an animal.
             331          (62) "Prescription device" means an instrument, apparatus, implement, machine,
             332      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             333      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             334      and dispensed by or through a person or entity licensed under this chapter or exempt from
             335      licensure under this chapter.
             336          (63) "Prescription drug" means a drug that is required by federal or state law or rule to
             337      be dispensed only by prescription or is restricted to administration only by practitioners.

             338          (64) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
             339      and devices to the general public.
             340          (65) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
             341      with this chapter.
             342          (66) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
             343      the pharmacy during a given day or shift.
             344          (67) "Supportive personnel" means unlicensed individuals who:
             345          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             346      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             347      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             348      those duties may be further defined by division rule adopted in collaboration with the board;
             349      and
             350          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             351      collaboration with the board.
             352          (68) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             353          (69) "Unprofessional conduct" is as defined in Sections 58-1-501 and 58-17b-502 and
             354      may be further defined by rule.
             355          (70) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             356      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             357      for animals.
             358          Section 2. Section 58-17b-610 is amended to read:
             359           58-17b-610. Patients' immediate needs -- Dispensing drug samples.
             360          (1) This chapter may not be construed to prevent the personal administration of drugs
             361      or medicines by practitioners licensed to prescribe in order to supply the immediate needs of
             362      [their] the practitioner's patients.
             363          (2) Immediate need for a patient includes giving out drug samples [for up to a
             364      three-day supply or the amount necessary to determine the best pharmaceutical agent for that
             365      specific patient.] that:

             366          (a) are not Schedule II drugs, opiods, or Benzodiazepines;
             367          (b) are prepackaged by the original manufacturer;
             368          (c) are provided to the prescribing practitioner free of charge and provided to the
             369      patient free of any direct or indirect charge;
             370          (d) do not exceed a 30-day supply for:
             371          (i) controlled substances; or
             372          (ii) non-controlled substances, unless a prescribing practitioner documents that
             373      providing more than a 30-day supply is medically necessary; and
             374          (e) (i) are marked on the immediate container to indicate that the drug is a sample; or
             375          (ii) are recorded in the patient's chart with the name and number of samples provided.
             376          (3) A prescribing practitioner who provides samples for a patient shall comply with
             377      Subsection (2).

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