02-24 15:57 1st Sub. (Green) S.B. 312
Evan J. Vickers proposes the following substitute bill:
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Pharmacy Practice Amendments
2025 GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Evan J. Vickers
House Sponsor:
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LONG TITLE
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General Description:
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This bill amends provisions related to pharmacists and pharmacies.
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Highlighted Provisions:
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This bill:
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▸ recognizes a pharmacist as a health care provider in limited circumstances;
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▸ addresses a prescription for a device that is necessary to ensure the appropriate delivery of
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the prescribed drug;
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▸ amends the advanced written notice requirement for an audit of pharmacy records;
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▸ modifies the definition of "eligible pharmacy" for the Charitable Prescription Drug
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Recycling Act; and
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▸ makes technical and conforming changes.
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Money Appropriated in this Bill:
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None
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Other Special Clauses:
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None
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Utah Code Sections Affected:
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AMENDS:
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58-17b-102, as last amended by Laws of Utah 2024, Chapter 507
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58-17b-610.8, as last amended by Laws of Utah 2024, Chapter 507
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58-17b-622, as last amended by Laws of Utah 2024, Chapter 210
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58-17b-902, as last amended by Laws of Utah 2023, Chapter 329
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ENACTS:
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31A-22-662, Utah Code Annotated 1953
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Be it enacted by the Legislature of the state of Utah:
1st Sub. S.B. 312 1st Sub. (Green) S.B. 312 02-24 15:57
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Section 1. Section 31A-22-662 is enacted to read:
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31A-22-662 . Pharmacist as a health care provider.
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(1) As used in this section, "pharmacist" means the same as that term is defined in Section
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58-17b-102.
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(2) An insurer that provides a health benefit plan shall consider a pharmacist as a health
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care provider for a consultation that is provided to an enrollee regarding the pharmacist:
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(a) dispensing a refill for a prescription in an emergency as described in Section
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58-17b-608;
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(b) dispensing a refill for an exhausted prescription for insulin in accordance with
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Section 58-17b-608.2;
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(c) prescribing a nebulizer, a spacer for use with a nebulizer or inhaler, or a diabetic
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supply as described in Subsection 58-17b-610.8(3);
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(d) prescribing a prescription drug or device as described in Section 58-17b-627; or
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(e) dispensing a drug as described in Section 58-17b-1004.
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(3) Subsection (2) only applies if the health benefit plan covers the prescription drug or
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device.
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(4) This section applies to a health benefit plan renewed or entered into on or after January
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1, 2026.
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Section 2. Section 58-17b-102 is amended to read:
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58-17b-102 . Definitions.
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In addition to the definitions in Section 58-1-102, as used in this chapter:
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(1) "Administering" means:
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(a) the direct application of a prescription drug or device, whether by injection,
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inhalation, ingestion, or by any other means, to the body of a human patient or
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research subject by another person; or
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(b) the placement by a veterinarian with the owner or caretaker of an animal or group of
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animals of a prescription drug for the purpose of injection, inhalation, ingestion, or
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any other means directed to the body of the animal by the owner or caretaker in
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accordance with written or verbal directions of the veterinarian.
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(2) "Adulterated drug or device" means a drug or device considered adulterated under 21
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U.S.C. Sec. 351 (2003).
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(3)(a) "Analytical laboratory" means a facility in possession of prescription drugs for the
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purpose of analysis.
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(b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
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used as standards and controls in performing drug monitoring or drug screening
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analysis if the prescription drugs are prediluted in a human or animal body fluid,
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human or animal body fluid components, organic solvents, or inorganic buffers at a
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concentration not exceeding one milligram per milliliter when labeled or otherwise
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designated as being for in vitro diagnostic use.
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(4) "Animal euthanasia agency" means an agency performing euthanasia on animals by the
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use of prescription drugs.
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(5) "Automated pharmacy systems" includes mechanical systems which perform operations
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or activities, other than compounding or administration, relative to the storage,
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packaging, dispensing, or distribution of medications, and which collect, control, and
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maintain all transaction information.
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(6) "Beyond use date" means the date determined by a pharmacist and placed on a
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prescription label at the time of dispensing that indicates to the patient or caregiver a
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time beyond which the contents of the prescription are not recommended to be used.
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(7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created in
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Section 58-17b-201.
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(8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
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underserved area, used for the storage and dispensing of prescription drugs, which is
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dependent upon, stocked by, and supervised by a pharmacist in another licensed
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pharmacy designated and approved by the division as the parent pharmacy.
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(9) "Centralized prescription processing" means the processing by a pharmacy of a request
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from another pharmacy to fill or refill a prescription drug order or to perform processing
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functions such as dispensing, drug utilization review, claims adjudication, refill
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authorizations, and therapeutic interventions.
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(10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a retail
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pharmacy to compound or dispense a drug or dispense a device to the public under a
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prescription order.
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(11) "Class B pharmacy":
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(a) means a pharmacy located in Utah:
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(i) that is authorized to provide pharmaceutical care for patients in an institutional
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setting; and
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(ii) whose primary purpose is to provide a physical environment for patients to obtain
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health care services; and
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(b)(i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
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(ii) pharmaceutical administration and sterile product preparation facilities.
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(12) "Class C pharmacy" means a pharmacy that engages in the manufacture, production,
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wholesale, or distribution of drugs or devices in Utah.
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(13) "Class D pharmacy" means a nonresident pharmacy.
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(14) "Class E pharmacy" means all other pharmacies.
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(15)(a) "Closed-door pharmacy" means a pharmacy that:
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(i) provides pharmaceutical care to a defined and exclusive group of patients who
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have access to the services of the pharmacy because they are treated by or have an
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affiliation with a specific entity, including a health maintenance organization or an
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infusion company; or
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(ii) engages exclusively in the practice of telepharmacy and does not serve walk-in
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retail customers.
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(b) "Closed-door pharmacy" does not include a hospital pharmacy, a retailer of goods to
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the general public, or the office of a practitioner.
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(16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or more
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pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
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more practitioners under protocol whereby the pharmacist may perform certain
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pharmaceutical care functions authorized by the practitioner or practitioners under
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certain specified conditions or limitations.
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(17) "Collaborative pharmacy practice agreement" means a written and signed agreement
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between one or more pharmacists and one or more practitioners that provides for
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collaborative pharmacy practice for the purpose of drug therapy management of patients
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and prevention of disease of human subjects.
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(18)(a) "Compounding" means the preparation, mixing, assembling, packaging, or
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labeling of a limited quantity drug, sterile product, or device:
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(i) as the result of a practitioner's prescription order or initiative based on the
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practitioner, patient, or pharmacist relationship in the course of professional
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practice;
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(ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis
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and not for sale or dispensing; or
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(iii) in anticipation of prescription drug orders based on routine, regularly observed
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prescribing patterns.
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(b) "Compounding" does not include:
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(i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale
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to another pharmacist or pharmaceutical facility;
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(ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
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dosage form which is regularly and commonly available from a manufacturer in
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quantities and strengths prescribed by a practitioner; or
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(iii) the preparation of a prescription drug, sterile product, or device which has been
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withdrawn from the market for safety reasons.
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(19) "Confidential information" has the same meaning as "protected health information"
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under the Standards for Privacy of Individually Identifiable Health Information, 45
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C.F.R. Parts 160 and 164.
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(20) "Controlled substance" means the same as that term is defined in Section 58-37-2.
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(21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter 417, Sec.
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3a(ff) which is incorporated by reference.
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(22) "Dispense" means the interpretation, evaluation, and implementation of a prescription
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drug order or device or nonprescription drug or device under a lawful order of a
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practitioner in a suitable container appropriately labeled for subsequent administration to
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or use by a patient, research subject, or an animal.
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(23) "Dispensing medical practitioner" means an individual who is:
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(a) currently licensed as:
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(i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
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(ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic
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Medical Practice Act;
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(iii) a physician assistant under Chapter 70a, Utah Physician Assistant Act;
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(iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
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(v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the
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optometrist is acting within the scope of practice for an optometrist; and
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(b) licensed by the division under the Pharmacy Practice Act to engage in the practice of
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a dispensing medical practitioner.
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(24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
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located within a licensed dispensing medical practitioner's place of practice.
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(25) "Distribute" means to deliver a drug or device other than by administering or
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dispensing.
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(26)(a) "Drug" means:
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(i) a substance recognized in the official United States Pharmacopoeia, official
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Homeopathic Pharmacopoeia of the United States, or official National Formulary,
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or any supplement to any of them, intended for use in the diagnosis, cure,
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mitigation, treatment, or prevention of disease in humans or animals;
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(ii) a substance that is required by any applicable federal or state law or rule to be
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dispensed by prescription only or is restricted to administration by practitioners
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only;
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(iii) a substance other than food intended to affect the structure or any function of the
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body of humans or other animals; and
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(iv) substances intended for use as a component of any substance specified in
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Subsections (26)(a)(i) through [(iv)] (iii).
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(b) "Drug" does not include dietary supplements.
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(27) "Drug regimen review" includes the following activities:
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(a) evaluation of the prescription drug order and patient record for:
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(i) known allergies;
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(ii) rational therapy-contraindications;
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(iii) reasonable dose and route of administration; and
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(iv) reasonable directions for use;
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(b) evaluation of the prescription drug order and patient record for duplication of therapy;
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(c) evaluation of the prescription drug order and patient record for the following
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interactions:
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(i) drug-drug;
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(ii) drug-food;
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(iii) drug-disease; and
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(iv) adverse drug reactions; and
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(d) evaluation of the prescription drug order and patient record for proper utilization,
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including over- or under-utilization, and optimum therapeutic outcomes.
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(28) "Drug sample" means a prescription drug packaged in small quantities consistent with
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limited dosage therapy of the particular drug, which is marked "sample", is not intended
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to be sold, and is intended to be provided to practitioners for the immediate needs of
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patients for trial purposes or to provide the drug to the patient until a prescription can be
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filled by the patient.
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(29) "Electronic signature" means a trusted, verifiable, and secure electronic sound, symbol,
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or process attached to or logically associated with a record and executed or adopted by a
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person with the intent to sign the record.
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(30) "Electronic transmission" means transmission of information in electronic form or the
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transmission of the exact visual image of a document by way of electronic equipment.
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(31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to inpatients of
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a general acute hospital or specialty hospital licensed by the Department of Health and
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Human Services under Title 26B, Chapter 2, Part 2, Health Care Facility Licensing and
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Inspection.
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(32) "Legend drug" has the same meaning as prescription drug.
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(33) "Licensed pharmacy technician" means an individual licensed with the division, that
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may, under the supervision of a pharmacist, perform the activities involved in the
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technician practice of pharmacy.
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(34) "Manufacturer" means a person or business physically located in Utah licensed to be
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engaged in the manufacturing of drugs or devices.
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(35)(a) "Manufacturing" means:
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(i) the production, preparation, propagation, conversion, or processing of a drug or
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device, either directly or indirectly, by extraction from substances of natural origin
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or independently by means of chemical or biological synthesis, or by a
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combination of extraction and chemical synthesis, and includes any packaging or
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repackaging of the substance or labeling or relabeling of its container; and
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(ii) the promotion and marketing of such drugs or devices.
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(b) "Manufacturing" includes the preparation and promotion of commercially available
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products from bulk compounds for resale by pharmacies, practitioners, or other
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persons.
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(c) "Manufacturing" does not include the preparation or compounding of a drug by a
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pharmacist, pharmacy intern, or practitioner for that individual's own use or the
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preparation, compounding, packaging, labeling of a drug, or incident to research,
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teaching, or chemical analysis.
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(36) "Medical order" means a lawful order of a practitioner which may include a
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prescription drug order.
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(37) "Medication profile" or "profile" means a record system maintained as to drugs or
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devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to
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analyze the profile to provide pharmaceutical care.
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(38) "Misbranded drug or device" means a drug or device considered misbranded under 21
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U.S.C. Sec. 352 (2003).
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(39)(a) "Nonprescription drug" means a drug which:
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(i) may be sold without a prescription; and
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(ii) is labeled for use by the consumer in accordance with federal law.
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(b) "Nonprescription drug" includes homeopathic remedies.
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(40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
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person in Utah.
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(41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
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(42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located outside
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the state that is licensed and in good standing in another state, that:
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(a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
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this state pursuant to a lawfully issued prescription;
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(b) provides information to a patient in this state on drugs or devices which may include,
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but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
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or
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(c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
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effects of drugs.
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(43) "Patient counseling" means the written and oral communication by the pharmacist or
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pharmacy intern of information, to the patient or caregiver, in order to ensure proper use
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of drugs, devices, and dietary supplements.
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(44) "Pharmaceutical administration facility" means a facility, agency, or institution in
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which:
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(a) prescription drugs or devices are held, stored, or are otherwise under the control of
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the facility or agency for administration to patients of that facility or agency;
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(b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist or
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pharmacy intern with whom the facility has established a prescription drug
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supervising relationship under which the pharmacist or pharmacy intern provides
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counseling to the facility or agency staff as required, and oversees drug control,
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accounting, and destruction; and
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(c) prescription drugs are professionally administered in accordance with the order of a
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practitioner by an employee or agent of the facility or agency.
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(45)(a) "Pharmaceutical care" means carrying out the following in collaboration with a
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prescribing practitioner, and in accordance with division rule:
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(i) designing, implementing, and monitoring a therapeutic drug plan intended to
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achieve favorable outcomes related to a specific patient for the purpose of curing
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or preventing the patient's disease;
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(ii) eliminating or reducing a patient's symptoms; or
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(iii) arresting or slowing a disease process.
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(b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
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prescribing practitioner.
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(46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
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distributing, manufacturing, or wholesaling of prescription drugs or devices within or
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into this state.
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(47)(a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
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engaged in the business of wholesale vending or selling of a prescription drug or
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device to other than a consumer or user of the prescription drug or device that the
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pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
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(b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical facility
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carrying out the following business activities:
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(i) intracompany sales;
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(ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
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purchase, or trade a prescription drug or device, if the activity is carried out
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between one or more of the following entities under common ownership or
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common administrative control, as defined by division rule:
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(A) hospitals;
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(B) pharmacies;
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(C) chain pharmacy warehouses, as defined by division rule; or
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(D) other health care entities, as defined by division rule;
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(iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
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purchase, or trade a prescription drug or device, for emergency medical reasons,
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including supplying another pharmaceutical facility with a limited quantity of a
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drug, if:
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(A) the facility is unable to obtain the drug through a normal distribution channel
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in sufficient time to eliminate the risk of harm to a patient that would result
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from a delay in obtaining the drug; and
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(B) the quantity of the drug does not exceed an amount reasonably required for
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immediate dispensing to eliminate the risk of harm;
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(iv) the distribution of a prescription drug or device as a sample by representatives of
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a manufacturer; and
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(v) the distribution of prescription drugs, if:
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(A) the facility's total distribution-related sales of prescription drugs does not
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exceed 5% of the facility's total prescription drug sales; and
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(B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
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(48) "Pharmacist" means an individual licensed by this state to engage in the practice of
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pharmacy.
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(49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing who
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accepts responsibility for the operation of a pharmacy in conformance with all laws and
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rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
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personally in full and actual charge of the pharmacy and all personnel.
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(50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
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more years of licensed experience. The preceptor serves as a teacher, example of
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professional conduct, and supervisor of interns in the professional practice of pharmacy.
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(51) "Pharmacy" means any place where:
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(a) drugs are dispensed;
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(b) pharmaceutical care is provided;
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(c) drugs are processed or handled for eventual use by a patient; or
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(d) drugs are used for the purpose of analysis or research.
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(52) "Pharmacy benefits manager or coordinator" means a person or entity that provides a
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pharmacy benefits management service as defined in Section 31A-46-102 on behalf of a
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self-insured employer, insurance company, health maintenance organization, or other
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plan sponsor, as defined by rule.
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(53) "Pharmacy intern" means an individual licensed by this state to engage in practice as a
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pharmacy intern.
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(54) "Pharmacy manager" means:
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(a) a pharmacist-in-charge;
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(b) a licensed pharmacist designated by a licensed pharmacy to consult on the
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pharmacy's administration;
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(c) an individual who manages the facility in which a licensed pharmacy is located;
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(d) an individual who oversees the operations of a licensed pharmacy;
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(e) an immediate supervisor of an individual described in Subsections (54)(a) through (d);
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or
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(f) another operations or site manager of a licensed pharmacy.
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(55) "Pharmacy technician training program" means an approved technician training
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program providing education for pharmacy technicians.
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(56)(a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
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specifically relating to the dispensing of a prescription drug in accordance with Part
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8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic
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Pharmacy, and division rule adopted after consultation with the Board of pharmacy
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and the governing boards of the practitioners described in Subsection (23)(a).
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(b) "Practice as a dispensing medical practitioner" does not include:
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(i) using a vending type of dispenser as defined by the division by administrative
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rule; or
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(ii) except as permitted by Section 58-17b-805, dispensing of a controlled substance
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as defined in Section 58-37-2.
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(57) "Practice as a licensed pharmacy technician" means engaging in practice as a
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pharmacy technician under the general supervision of a licensed pharmacist and in
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accordance with a scope of practice defined by division rule made in collaboration with
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the board.
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(58) "Practice of pharmacy" includes the following:
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(a) providing pharmaceutical care;
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(b) collaborative pharmacy practice in accordance with a collaborative pharmacy
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practice agreement;
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(c) compounding, packaging, labeling, dispensing, administering, and the coincident
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distribution of prescription drugs or devices, provided that the administration of a
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prescription drug or device is:
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(i) pursuant to a lawful order of a practitioner when one is required by law; and
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(ii) in accordance with written guidelines or protocols:
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(A) established by the licensed facility in which the prescription drug or device is
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to be administered on an inpatient basis; or
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(B) approved by the division, in collaboration with the board and, when
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appropriate, the Medical Licensing Board, created in Section 58-67-201, if the
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prescription drug or device is to be administered on an outpatient basis solely
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by a licensed pharmacist;
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(d) participating in drug utilization review;
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(e) ensuring proper and safe storage of drugs and devices;
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(f) maintaining records of drugs and devices in accordance with state and federal law
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and the standards and ethics of the profession;
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(g) providing information on drugs or devices, which may include advice relating to
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therapeutic values, potential hazards, and uses;
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(h) providing drug product equivalents;
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(i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
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technicians;
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(j) providing patient counseling, including adverse and therapeutic effects of drugs;
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(k) providing emergency refills as defined by rule;
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(l) telepharmacy;
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(m) formulary management intervention;
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(n) prescribing and dispensing a self-administered hormonal contraceptive in accordance
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with Title 26B, Chapter 4, Part 5, Treatment Access; and
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(o) issuing a prescription in accordance with Section 58-17b-610.8 or 58-17b-627.
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(59) "Practice of telepharmacy" means the practice of pharmacy through the use of
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telecommunications and information technologies.
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(60) "Practice of telepharmacy across state lines" means the practice of pharmacy through
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the use of telecommunications and information technologies that occurs when the
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patient is physically located within one jurisdiction and the pharmacist is located in
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another jurisdiction.
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(61) "Practitioner" means an individual currently licensed, registered, or otherwise
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authorized by the appropriate jurisdiction to prescribe and administer drugs in the course
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of professional practice.
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(62) "Prescribe" means to issue a prescription:
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(a) orally or in writing; or
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(b) by telephone, facsimile transmission, computer, or other electronic means of
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communication as defined by division rule.
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(63) "Prescription" means an order issued:
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(a) by a licensed practitioner in the course of that practitioner's professional practice or
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by collaborative pharmacy practice agreement; and
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(b) for a controlled substance or other prescription drug or device for use by a patient or
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an animal.
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(64) "Prescription device" means an instrument, apparatus, implement, machine,
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contrivance, implant, in vitro reagent, or other similar or related article, and any
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component part or accessory, which is required under federal or state law to be
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prescribed by a practitioner and dispensed by or through a person or entity licensed
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under this chapter or exempt from licensure under this chapter.
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(65) "Prescription drug" means a drug that is required by federal or state law or rule to be
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dispensed only by prescription or is restricted to administration only by practitioners.
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(66) "Repackage":
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(a) means changing the container, wrapper, or labeling to further the distribution of a
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prescription drug; and
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(b) does not include:
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(i) Subsection (66)(a) when completed by the pharmacist responsible for dispensing
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the product to a patient; or
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(ii) changing or altering a label as necessary for a dispensing practitioner under Part
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8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic
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Pharmacy, for dispensing a product to a patient.
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(67) "Research using pharmaceuticals" means research:
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(a) conducted in a research facility, as defined by division rule, that is associated with a
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university or college in the state accredited by the Northwest Commission on
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Colleges and Universities;
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(b) requiring the use of a controlled substance, prescription drug, or prescription device;
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(c) that uses the controlled substance, prescription drug, or prescription device in
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accordance with standard research protocols and techniques, including, if required,
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those approved by an institutional review committee; and
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(d) that includes any documentation required for the conduct of the research and the
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handling of the controlled substance, prescription drug, or prescription device.
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(68) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs and
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devices to the general public.
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(69)(a) "Self-administered hormonal contraceptive" means a self-administered hormonal
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contraceptive that is approved by the United States Food and Drug Administration to
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prevent pregnancy.
428
(b) "Self-administered hormonal contraceptive" includes an oral hormonal contraceptive,
429
a hormonal vaginal ring, and a hormonal contraceptive patch.
430
(c) "Self-administered hormonal contraceptive" does not include any drug intended to
431
induce an abortion, as that term is defined in Section 76-7-301.
432
(70) "Self-audit" means an internal evaluation of a pharmacy to determine compliance with
433
this chapter.
434
(71) "Supervising pharmacist" means a pharmacist who is overseeing the operation of the
435
pharmacy during a given day or shift.
436
(72) "Supportive personnel" means unlicensed individuals who:
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437
(a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
438
pharmacy technician in nonjudgmental duties not included in the definition of the
439
practice of pharmacy, practice of a pharmacy intern, or practice of a licensed
440
pharmacy technician, and as those duties may be further defined by division rule
441
adopted in collaboration with the board; and
442
(b) are supervised by a pharmacist in accordance with rules adopted by the division in
443
collaboration with the board.
444
(73) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501 and
445
58-17b-501.
446
(74) "Unprofessional conduct" means the same as that term is defined in Sections 58-1-501
447
and 58-17b-502 and may be further defined by rule.
448
(75) "Veterinary pharmaceutical facility" means a pharmaceutical facility that dispenses
449
drugs intended for use by animals or for sale to veterinarians for the administration for
450
animals.
451
(76) "Written communication" means a physical document, or an electronic
452
communication, by or from which the recipient may read or access the information
453
intended to be communicated, including:
454
(a) email;
455
(b) text message; and
456
(c) quick response (QR) code.
457
Section 3. Section 58-17b-610.8 is amended to read:
458
58-17b-610.8 . Prescription devices.
459
(1) The following documents from a prescribing practitioner [shall be] are considered a
460
prescription for purposes of dispensing of and payment for a device described in
461
Subsection [(3)] (4), if the device is prescribed or indicated by the document and the
462
document is on file with a pharmacy:
463
(a) a written prescription; or
464
(b) a written record of a patient's:
465
(i) current diagnosis; or
466
(ii) treatment protocol.
467
(2) A pharmacist or pharmacy intern at a pharmacy at which a document that is considered
468
a prescription under Subsection (1) is on file may dispense under prescription a device
469
described in Subsection [(3)] (4) to the patient in accordance with:
470
(a) the document that is considered a prescription under Subsection (1); and
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471
(b) rules made by the division under Subsection [(4)] (5).
472
(3)(a) A pharmacist may prescribe a device described in Subsection (4) if:
473
(i) the device is not prescribed or indicated by the document described in Subsection
474
(1) that is on file with the pharmacy; and
475
(ii) the pharmacist determines that the device is necessary to ensure the appropriate
476
delivery of the prescribed drug.
477
[(3)] (4) This section applies to:
478
(a) nebulizers;
479
(b) spacers for use with nebulizers or inhalers; and
480
(c) diabetic supplies.
481
[(4)] (5) The division shall make rules in accordance with Title 63G, Chapter 3, Utah
482
Administrative Rulemaking Act, and in consultation with the board and the Medical
483
Licensing Board created in Section 58-67-201 to implement this section.
484
Section 4. Section 58-17b-622 is amended to read:
485
58-17b-622 . Pharmacy benefit management services -- Auditing of pharmacy
486
records -- Appeals.
487
(1) [For purposes of] As used in this section:
488
(a) "Audit" means a review of the records of a pharmacy by or on behalf of an entity that
489
finances or reimburses the cost of health care services or pharmaceutical products.
490
(b) "Audit completion date" means:
491
(i) for an audit that does not require an on-site visit at the pharmacy, the date on
492
which the pharmacy, in response to the initial audit request, submits records or
493
other documents to the entity conducting the audit, as determined by:
494
(A) postmark or other evidence of the date of mailing; or
495
(B) the date of transmission if the records or other documents are transmitted
496
electronically; and
497
(ii) for an audit that requires an on-site visit at a pharmacy, the date on which the
498
auditing entity completes the on-site visit, including any follow-up visits or
499
analysis which shall be completed within 60 days after the day on which the
500
on-site visit begins.
501
(c) "Entity" includes:
502
(i) a pharmacy benefits manager or coordinator;
503
(ii) a health benefit plan;
504
(iii) a third party administrator as defined in Section 31A-1-301;
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505
(iv) a state agency; or
506
(v) a company, group, or agent that represents, or is engaged by, one of the entities
507
described in Subsections (1)(c)(i) through (iv).
508
(d) "Extrapolation" means a method of using a mathematical formula that uses the audit
509
results from a small sample of insurance claims and projects the results over a larger
510
group of insurance claims.
511
(e) "Fraud" means an intentional act of deception, misrepresentation, or concealment in
512
order to gain something of value.
513
(f) "Health benefit plan" means:
514
(i) a health benefit plan as defined in Section 31A-1-301; or
515
(ii) a health, dental, medical, Medicare supplement, or conversion program offered
516
under Title 49, Chapter 20, Public Employees' Benefit and Insurance Program Act.
517
(2)(a) Except as provided in Subsection (2)(b), this section applies to:
518
(i) a contract for the audit of a pharmacy entered into, amended, or renewed on or
519
after July 1, 2012; and
520
(ii) an entity that conducts an audit of the pharmacy records of a pharmacy licensed
521
under this chapter.
522
(b) This section does not apply to an audit of pharmacy records:
523
(i) for a federally funded prescription drug program, including:
524
(A) the state Medicaid program;
525
(B) the Medicare Part D program;
526
(C) a Department of Defense prescription drug program; and
527
(D) a Veterans Affairs prescription drug program; or
528
(ii) when fraud or other intentional and willful misrepresentation is alleged and the
529
pharmacy audit entity has evidence that the pharmacy's actions reasonably
530
indicate fraud or intentional and willful misrepresentation.
531
(3)(a) An audit that involves clinical or professional judgment shall be conducted by or
532
in consultation with a pharmacist who is employed by or working with the auditing
533
entity and who is licensed in the state or another state.
534
(b) If an audit is conducted on site at a pharmacy, the entity conducting the audit:
535
(i) shall give the pharmacy 10 days advanced written notice of:
536
(A) the audit; and
537
(B) the range of prescription numbers [or] and a date range for the prescription
538
numbers included in the audit; and
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539
(ii) may not audit a pharmacy during the first five business days of the month, unless
540
the pharmacy agrees to the timing of the audit.
541
(c) An entity may not audit claims:
542
(i) submitted more than 18 months prior to the audit, unless:
543
(A) required by federal law; or
544
(B) the originating prescription is dated in the preceding six months; or
545
(ii) that exceed 200 selected prescription claims annually.
546
(d) Subsection (3)(c)(ii) does not apply to any investigative audit that involves fraud,
547
waste, abuse, or willful misrepresentation.
548
(4)(a) An entity may not:
549
(i) include dispensing fees in the calculations of overpayments unless the prescription
550
is considered a misfill;
551
(ii) recoup funds for prescription clerical or recordkeeping errors, including
552
typographical errors, scrivener's errors, and computer errors on a required
553
document or record unless the audit entity is alleging fraud or other intentional or
554
willful misrepresentation and the audit entity has evidence that the pharmacy's
555
actions reasonably indicate fraud or intentional and willful misrepresentation;
556
(iii) recoup funds for refills dispensed in accordance with Section 58-17b-608.1,
557
unless the health benefit plan does not cover the prescription drug dispensed by
558
the pharmacy;
559
(iv) collect any funds, charge-backs, or penalties until the audit and all appeals are
560
final, unless the audit entity is alleging fraud or other intentional or willful
561
misrepresentation and the audit entity has evidence that the pharmacy's actions
562
reasonably indicate fraud or intentional and willful misrepresentation; or
563
(v) recoup funds or collect any funds, charge-backs, or penalties from a pharmacy in
564
response to a request for audit unless the pharmacy confirms to the entity the date
565
on which the pharmacy received the request for audit.
566
(b) Auditors shall only have access to previous audit reports on a particular pharmacy if
567
the previous audit was conducted by the same entity except as required for
568
compliance with state or federal law.
569
(5) A pharmacy subject to an audit:
570
(a) may use one or more of the following to validate a claim for a prescription, refill, or
571
change in a prescription:
572
(i) electronic or physical copies of records of a health care facility, or a health care
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573
provider with prescribing authority;
574
(ii) any prescription that complies with state law;
575
(iii) the pharmacy's own physical or electronic records; or
576
(iv) the physical or electronic records, or valid copies of the physical or electronic
577
records, of a practitioner or health care facility as defined in Section 26B-2-201;
578
and
579
(b) may not be required to provide the following records to validate a claim for a
580
prescription, refill, or change in a prescription:
581
(i) if the prescription was handwritten, the physical handwritten version of the
582
prescription; or
583
(ii) a note from the practitioner regarding the patient or the prescription that is not
584
otherwise required for a prescription under state or federal law.
585
(6)(a)(i) An entity that audits a pharmacy shall establish:
586
(A) a maximum time for the pharmacy to submit records or other documents to
587
the entity following receipt of an audit request for records or documents; and
588
(B) a maximum time for the entity to provide the pharmacy with a preliminary
589
audit report following submission of records under Subsection (6)(a)(i)(A).
590
(ii) The time limits established under Subsections (6)(a)(i)(A) and (B):
591
(A) shall be identical; and
592
(B) may not be less than seven days or more than 60 days.
593
(iii) An entity that audits a pharmacy may not, after the audit completion date,
594
request additional records or other documents from the pharmacy to complete the
595
preliminary audit report described in Subsection (6)(b).
596
(b) An entity that audits a pharmacy shall provide the pharmacy with a preliminary audit
597
report:
598
(i) delivered to the pharmacy or its corporate office of record, within the time limit
599
established under Subsection (6)(a)(i)(B); and
600
(ii) that includes a notation and detailed explanation for each suspected error.
601
(c)(i) Except as provided in Subsection (6)(c)(ii), a pharmacy has 30 days following
602
receipt of the preliminary audit report to respond to questions, provide additional
603
documentation, and comment on and clarify findings of the audit.
604
(ii) An entity may grant a reasonable extension under Subsection (6)(c)(i) upon
605
request by the pharmacy.
606
(iii) Receipt of the report under Subsection (6)(c)(i) shall be determined by:
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607
(A) postmark or other evidence of the date of mailing; or
608
(B) the date of transmission if the report is transmitted electronically.
609
(iv) If a dispute exists between the records of the auditing entity and the pharmacy,
610
the records maintained by the pharmacy shall be presumed valid for the purpose
611
of the audit.
612
(7) If an audit results in the dispute or denial of a claim, the entity conducting the audit shall
613
allow any of the following:
614
(a) the pharmacy to resubmit a claim using any commercially reasonable method,
615
including fax, mail, or electronic claims submission within 30 days from the day on
616
which the audit report is received by the pharmacy; or
617
(b) the health benefit plan or other entity that finances or reimburses the cost of health
618
care services or pharmaceutical products to rerun the claim if the health benefit plan
619
or other entity chooses to rerun the claim at no cost to the pharmacy.
620
(8)(a) Within 60 days after the completion of the appeals process under Subsection (9), a
621
final audit report shall be delivered to the pharmacy or its corporate office of record.
622
(b) The final audit report shall include:
623
(i) a disclosure of any money recovered by the entity that conducted the audit; and
624
(ii) legal or contractual information supporting any money recovered, recoupments,
625
or penalties included in the report.
626
(9)(a) An entity that audits a pharmacy shall establish a written appeals process for
627
appealing a preliminary audit report and a final audit report, and shall provide the
628
pharmacy with notice of the written appeals process.
629
(b) If the pharmacy benefit manager's contract or provider manual contains the
630
information required by this Subsection (9), the requirement for notice is met.
631
(10) An auditing entity conducting a pharmacy audit may not:
632
(a) use extrapolation when conducting an audit, including calculating recoupments or
633
penalties for audits, unless otherwise required by federal law or a self-funded
634
insurance plan; or
635
(b) compensate an employee or contractor participating in the audit in a manner that is
636
based on the amount claimed or the actual amount recouped from the pharmacy being
637
audited.
638
Section 5. Section 58-17b-902 is amended to read:
639
58-17b-902 . Definitions.
640
As used in this part:
- 19 - 1st Sub. (Green) S.B. 312 02-24 15:57
641
(1) "Assisted living facility" means the same as that term is defined in Section 26B-2-201.
642
(2) "Cancer drug" means a drug that controls or kills neoplastic cells and includes a drug
643
used in chemotherapy to destroy cancer cells.
644
(3) "Charitable clinic" means a charitable nonprofit corporation that:
645
(a) holds a valid exemption from federal income taxation issued under Section 501(a),
646
Internal Revenue Code;
647
(b) is exempt from federal income taxation under Section 501(c)(3), Internal Revenue
648
Code;
649
(c) provides, on an outpatient basis, for a period of less than 24 consecutive hours, to an
650
individual not residing or confined at a facility owned or operated by the charitable
651
nonprofit corporation:
652
(i) advice;
653
(ii) counseling;
654
(iii) diagnosis;
655
(iv) treatment;
656
(v) surgery; or
657
(vi) care or services relating to the preservation or maintenance of health; and
658
(d) has a licensed outpatient pharmacy.
659
(4) "Charitable pharmacy" means an eligible pharmacy that is operated by a charitable
660
clinic.
661
(5) "County health department" means the same as that term is defined in Section
662
26A-1-102.
663
(6) "Donated prescription drug" means a prescription drug that an eligible donor or
664
individual donates to an eligible pharmacy under the program.
665
(7) "Eligible donor" means a donor that donates a prescription drug from within the state
666
and is:
667
(a) a nursing care facility;
668
(b) an assisted living facility;
669
(c) a licensed intermediate care facility for people with an intellectual disability;
670
(d) a manufacturer;
671
(e) a pharmaceutical wholesale distributor;
672
(f) an eligible pharmacy; or
673
(g) a physician's office.
674
(8) "Eligible pharmacy" means a pharmacy that:
- 20 - 02-24 15:57 1st Sub. (Green) S.B. 312
675
(a) is registered by the division as eligible to participate in the program; and
676
(b)(i) is licensed in the state as a [Class A retail pharmacy] Class A pharmacy or a
677
Class B pharmacy; or
678
(ii) is operated by:
679
(A) a county;
680
(B) a county health department;
681
(C) a pharmacy under contract with a county health department;
682
(D) the Department of Health and Human Services created in Section 26B-1-201;
683
or
684
(E) a charitable clinic.
685
(9)(a) "Eligible prescription drug" means a prescription drug, described in Section
686
58-17b-904, that is not:
687
(i) except as provided in Subsection (9)(b), a controlled substance; or
688
(ii) a drug that can only be dispensed to a patient registered with the drug's
689
manufacturer in accordance with federal Food and Drug Administration
690
requirements.
691
(b) "Eligible prescription drug" includes a medication-assisted treatment drug that may
692
be accepted, transferred, and dispensed under the program in accordance with federal
693
law.
694
(10) "Licensed intermediate care facility for people with an intellectual disability" means
695
the same as that term is defined in Section 58-17b-503.
696
(11) "Medically indigent individual" means an individual who:
697
(a)(i) does not have health insurance; and
698
(ii) lacks reasonable means to purchase prescribed medications; or
699
(b)(i) has health insurance; and
700
(ii) lacks reasonable means to pay the insured's portion of the cost of the prescribed
701
medications.
702
(12) "Medication-assisted treatment drug" means buprenorphine prescribed to treat
703
substance use withdrawal symptoms or an opiate use disorder.
704
(13) "Nursing care facility" means the same as that term is defined in Section 26B-2-201.
705
(14) "Physician's office" means a fixed medical facility that:
706
(a) is staffed by a physician, physician's assistant, nurse practitioner, or registered nurse,
707
licensed under this title; and
708
(b) treats an individual who presents at, or is transported to, the facility.
- 21 - 1st Sub. (Green) S.B. 312 02-24 15:57
709
(15) "Program" means the Charitable Prescription Drug Recycling Program created in
710
Section 58-17b-903.
711
(16) "Unit pack" means the same as that term is defined in Section 58-17b-503.
712
(17) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501 and
713
58-17b-501.
714
(18) "Unprofessional conduct" means the same as that term is defined in Sections 58-1-501
715
and 58-17b-502.
716
Section 6. Effective Date.
717
This bill takes effect on May 7, 2025.
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