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S.B. 14





Chief Sponsor: Patricia W. Jones

House Sponsor: Ronda Rudd Menlove

             7      LONG TITLE
             8      Committee Note:
             9          The Health and Human Services Interim Committee recommended this bill.
             10      General Description:
             11          This bill amends the Pharmacy Practice Act.
             12      Highlighted Provisions:
             13          This bill:
             14          .    defines "research using pharmaceuticals";
             15          .    exempts research using pharmaceuticals from licensure to engage in the practice of
             16      pharmacy, telepharmacy, or the practice of a pharmacy technician;
             17          .    exempts research using pharmaceuticals from licensure to act as a pharmacy; and
             18          .    makes technical corrections.
             19      Money Appropriated in this Bill:
             20          None
             21      Other Special Clauses:
             22          None
             23      Utah Code Sections Affected:
             24      AMENDS:
             25          58-17b-102, as last amended by Laws of Utah 2012, Chapters 265 and 320
             26          58-17b-301, as enacted by Laws of Utah 2004, Chapter 280
             27          58-17b-302, as last amended by Laws of Utah 2007, Chapter 279

             28          58-17b-612, as last amended by Laws of Utah 2010, Chapter 101
             29      ENACTS:
             30          58-17b-309.6, Utah Code Annotated 1953
             32      Be it enacted by the Legislature of the state of Utah:
             33          Section 1. Section 58-17b-102 is amended to read:
             34           58-17b-102. Definitions.
             35          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             36          (1) "Administering" means:
             37          (a) the direct application of a prescription drug or device, whether by injection,
             38      inhalation, ingestion, or by any other means, to the body of a human patient or research subject
             39      by another person; or
             40          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
             41      of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
             42      means directed to the body of the animal by the owner or caretaker in accordance with written
             43      or verbal directions of the veterinarian.
             44          (2) "Adulterated drug or device" means a drug or device considered adulterated under
             45      21 U.S.C.S. Sec. 351 (2003).
             46          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
             47      the purpose of analysis.
             48          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
             49      used as standards and controls in performing drug monitoring or drug screening analysis if the
             50      prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
             51      components, organic solvents, or inorganic buffers at a concentration not exceeding one
             52      milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
             53      use.
             54          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
             55      the use of prescription drugs.
             56          (5) "Automated pharmacy systems" includes mechanical systems which perform
             57      operations or activities, other than compounding or administration, relative to the storage,
             58      packaging, dispensing, or distribution of medications, and which collect, control, and maintain

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

             90      because they are treated by or have an affiliation with a specific entity, including a health
             91      maintenance organization or an infusion company, but not including a hospital pharmacy, a
             92      retailer of goods to the general public, or the office of a practitioner.
             93          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
             94      more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
             95      more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
             96      care functions authorized by the practitioner or practitioners under certain specified conditions
             97      or limitations.
             98          (17) "Collaborative pharmacy practice agreement" means a written and signed
             99      agreement between one or more pharmacists and one or more practitioners that provides for
             100      collaborative pharmacy practice for the purpose of drug therapy management of patients and
             101      prevention of disease of human subjects.
             102          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
             103      labeling of a limited quantity drug, sterile product, or device:
             104          (i) as the result of a practitioner's prescription order or initiative based on the
             105      practitioner, patient, or pharmacist relationship in the course of professional practice;
             106          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
             107      not for sale or dispensing; or
             108          (iii) in anticipation of prescription drug orders based on routine, regularly observed
             109      prescribing patterns.
             110          (b) "Compounding" does not include:
             111          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
             112      another pharmacist or pharmaceutical facility;
             113          (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
             114      dosage form which is regularly and commonly available from a manufacturer in quantities and
             115      strengths prescribed by a practitioner; or
             116          (iii) the preparation of a prescription drug, sterile product, or device which has been
             117      withdrawn from the market for safety reasons.
             118          (19) "Confidential information" has the same meaning as "protected health
             119      information" under the Standards for Privacy of Individually Identifiable Health Information,
             120      45 C.F.R. Parts 160 and 164.

             121          (20) "Controlled substance" has the same definition as in Section 58-37-2 .
             122          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
             123      417, Sec. 3a(ff) which is incorporated by reference.
             124          (22) "Dispense" means the interpretation, evaluation, and implementation of a
             125      prescription drug order or device or nonprescription drug or device under a lawful order of a
             126      practitioner in a suitable container appropriately labeled for subsequent administration to or use
             127      by a patient, research subject, or an animal.
             128          (23) "Distribute" means to deliver a drug or device other than by administering or
             129      dispensing.
             130          (24) (a) "Drug" means:
             131          (i) a substance recognized in the official United States Pharmacopoeia, Official
             132      Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
             133      supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
             134      prevention of disease in humans or animals;
             135          (ii) a substance that is required by any applicable federal or state law or rule to be
             136      dispensed by prescription only or is restricted to administration by practitioners only;
             137          (iii) a substance other than food intended to affect the structure or any function of the
             138      body of humans or other animals; and
             139          (iv) substances intended for use as a component of any substance specified in
             140      Subsections (24)(a)(i), (ii), (iii), and (iv).
             141          (b) "Drug" does not include dietary supplements.
             142          (25) "Drug product equivalent" means a drug product that is designated as the
             143      therapeutic equivalent of another drug product in the Approved Drug Products with
             144      Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
             145      of the Federal Food and Drug Administration.
             146          (26) "Drug regimen review" includes the following activities:
             147          (a) evaluation of the prescription drug order and patient record for:
             148          (i) known allergies;
             149          (ii) rational therapy-contraindications;
             150          (iii) reasonable dose and route of administration; and
             151          (iv) reasonable directions for use;

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

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

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

             245          (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
             246      engaged in the business of wholesale vending or selling of any prescription drug or device to
             247      other than the consumer or user of the prescription drug or device, which the pharmaceutical
             248      facility has not produced, manufactured, compounded, or dispensed.
             249          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
             250      facility carrying out the following business activities:
             251          (i) intracompany sales;
             252          (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             253      purchase or trade a prescription drug or device between hospitals or other health care facilities
             254      that are under common ownership or control of the management and operation of the facilities;
             255          (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
             256      purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
             257      another pharmaceutical facility to alleviate a temporary shortage; or
             258          (iv) the distribution of a prescription drug or device as a sample by representatives of a
             259      manufacturer.
             260          (48) "Pharmacist" means an individual licensed by this state to engage in the practice
             261      of pharmacy.
             262          (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
             263      who accepts responsibility for the operation of a pharmacy in conformance with all laws and
             264      rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
             265      in full and actual charge of the pharmacy and all personnel.
             266          (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
             267      more years of licensed experience. The preceptor serves as a teacher, example of professional
             268      conduct, and supervisor of interns in the professional practice of pharmacy.
             269          (51) "Pharmacy" means any place where:
             270          (a) drugs are dispensed;
             271          (b) pharmaceutical care is provided;
             272          (c) drugs are processed or handled for eventual use by a patient; or
             273          (d) drugs are used for the purpose of analysis or research.
             274          (52) "Pharmacy benefits manager or coordinator" means a person or entity that
             275      provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a

             276      self-insured employer, insurance company, health maintenance organization, or other plan
             277      sponsor, as defined by rule.
             278          (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
             279      as a pharmacy intern.
             280          (54) "Pharmacy technician training program" means an approved technician training
             281      program providing education for pharmacy technicians.
             282          (55) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a
             283      pharmacy technician under the general supervision of a licensed pharmacist and in accordance
             284      with a scope of practice defined by division rule made in collaboration with the board.
             285          (b) "Practice as a licensed pharmacy technician" does not include:
             286          (i) performing a drug utilization review, prescription drug order clarification from a
             287      prescriber, final review of the prescription and prescribed drug prepared for dispensing,
             288      dispensing of the drug, or counseling a patient with respect to a prescription drug;
             289          (ii) counseling regarding nonprescription drugs and dietary supplements unless
             290      delegated by the supervising pharmacist; or
             291          (iii) receiving new prescription drug orders when communicating telephonically or
             292      electronically unless the original information is recorded so the pharmacist may review the
             293      prescription drug order as transmitted.
             294          (56) "Practice of pharmacy" includes the following:
             295          (a) providing pharmaceutical care;
             296          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
             297      practice agreement;
             298          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
             299      distribution of prescription drugs or devices, provided that the administration of a prescription
             300      drug or device is:
             301          (i) pursuant to a lawful order of a practitioner when one is required by law; and
             302          (ii) in accordance with written guidelines or protocols:
             303          (A) established by the licensed facility in which the prescription drug or device is to be
             304      administered on an inpatient basis; or
             305          (B) approved by the division, in collaboration with the board and the Physicians
             306      Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be

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

             338      or an animal.
             339          (62) "Prescription device" means an instrument, apparatus, implement, machine,
             340      contrivance, implant, in vitro reagent, or other similar or related article, and any component
             341      part or accessory, which is required under federal or state law to be prescribed by a practitioner
             342      and dispensed by or through a person or entity licensed under this chapter or exempt from
             343      licensure under this chapter.
             344          (63) "Prescription drug" means a drug that is required by federal or state law or rule to
             345      be dispensed only by prescription or is restricted to administration only by practitioners.
             346          (64) "Research using pharmaceuticals" means research:
             347          (a) conducted in a research facility, as defined by division rule, that is associated with a
             348      university or college in the state accredited by the Northwest Commission on Colleges and
             349      Universities;
             350          (b) requiring the use of a controlled substance, prescription drug, or prescription
             351      device;
             352          (c) that uses the controlled substance, prescription drug, or prescription device in
             353      accordance with standard research protocols and techniques, including, if required, those
             354      approved by an institutional review committee; and
             355          (d) that includes any documentation required for the conduct of the research and the
             356      handling of the controlled substance, prescription drug, or prescription device.
             357          [(64)] (65) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
             358      drugs and devices to the general public.
             359          [(65)] (66) "Self-audit" means an internal evaluation of a pharmacy to determine
             360      compliance with this chapter.
             361          [(66)] (67) "Supervising pharmacist" means a pharmacist who is overseeing the
             362      operation of the pharmacy during a given day or shift.
             363          [(67)] (68) "Supportive personnel" means unlicensed individuals who:
             364          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
             365      pharmacy technician in nonjudgmental duties not included in the definition of the practice of
             366      pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
             367      those duties may be further defined by division rule adopted in collaboration with the board;
             368      and

             369          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
             370      collaboration with the board.
             371          [(68)] (69) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
             372          [(69)] (70) "Unprofessional conduct" is as defined in Sections 58-1-501 and
             373      58-17b-502 and may be further defined by rule.
             374          [(70)] (71) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
             375      dispenses drugs intended for use by animals or for sale to veterinarians for the administration
             376      for animals.
             377          Section 2. Section 58-17b-301 is amended to read:
             378           58-17b-301. License required -- License classifications for individuals.
             379          (1) A license is required to engage in the practice of pharmacy, telepharmacy, or the
             380      practice of a pharmacy technician, except as specifically provided in Section 58-1-307 [or],
             381      58-17b-309 , or 58-17-309.6 .
             382          (2) The division shall issue to an individual who qualifies under this chapter a license
             383      in the classification of:
             384          (a) pharmacist;
             385          (b) pharmacy intern; or
             386          (c) pharmacy technician.
             387          Section 3. Section 58-17b-302 is amended to read:
             388           58-17b-302. License required -- License classifications for pharmacy facilities.
             389          (1) A license is required to act as a pharmacy, except as specifically exempted from
             390      licensure under Section 58-1-307 or 58-17-309.6 .
             391          (2) The division shall issue a pharmacy license to a facility that qualifies under this
             392      chapter in the classification of a:
             393          (a) class A pharmacy;
             394          (b) class B pharmacy;
             395          (c) class C pharmacy;
             396          (d) class D pharmacy; or
             397          (e) class E pharmacy.
             398          (3) Each place of business shall require a separate license. If multiple pharmacies exist
             399      at the same address, a separate license shall be required for each pharmacy.

             400          (4) The division may further define or supplement the classifications of pharmacies.
             401      The division may impose restrictions upon classifications to protect the public health, safety,
             402      and welfare.
             403          (5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
             404      rule.
             405          (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
             406      the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
             407      of the pharmacy, regardless of the form of the business organization.
             408          Section 4. Section 58-17b-309.6 is enacted to read:
             409          58-17b-309.6. Exemptions from licensure for research using pharmaceuticals.
             410          Research using pharmaceuticals, as defined in Subsection 58-17b-102 (64), is exempt
             411      from licensure under Sections 58-17b-301 and 58-17b-302 .
             412          Section 5. Section 58-17b-612 is amended to read:
             413           58-17b-612. Supervision -- Pharmacist-in-charge.
             414          (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
             415      pharmacy, or class E pharmacy, shall be under the general supervision of at least one
             416      pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
             417      as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
             418          (b) Notwithstanding Subsection 58-17b-102 [(66)](67), a supervising pharmacist does
             419      not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
             420      for immediate contact with the supervised pharmacy technician or pharmacy intern if:
             421          (i) the pharmacy is located in:
             422          (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
             423          (B) a clinic located in a remote rural county with less than 20 people per square mile;
             424          (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
             425          (iii) the telepharmacy system maintains records and files quarterly reports as required
             426      by division rule to assure that patient safety is not compromised.
             427          (2) Each out-of-state mail service pharmacy shall designate and identify to the division
             428      a pharmacist holding a current license in good standing issued by the state in which the
             429      pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
             430      chapter.

Legislative Review Note
    as of 10-23-12 2:25 PM

Office of Legislative Research and General Counsel

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