(1) The division may for the purpose of ascertaining compliance with the provisions of this chapter, require a self-audit or enter and inspect the business premises of a person:

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Terms Used In Utah Code 58-17b-103

  • Adjudicative proceeding: means :
         (2)(a) an action by a board, commission, department, officer, or other administrative unit of the state that determines the legal rights, duties, privileges, immunities, or other legal interests of one or more identifiable persons, including an action to grant, deny, revoke, suspend, modify, annul, withdraw, or amend an authority, right, or license; and
         (2)(b) judicial review of an action described in Subsection (2)(a). See Utah Code 68-3-12.5
  • Director: means the director of the Division of Professional Licensing. See Utah Code 58-1-102
  • Division: means the Division of Professional Licensing created in Section 58-1-103. See Utah Code 58-1-102
  • Drug: means :
              (26)(a)(i) a substance recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
              (26)(a)(ii) a substance that is required by any applicable federal or state law or rule to be dispensed by prescription only or is restricted to administration by practitioners only;
              (26)(a)(iii) a substance other than food intended to affect the structure or any function of the body of humans or other animals; and
              (26)(a)(iv) substances intended for use as a component of any substance specified in Subsections (26)(a)(i) through (iv). See Utah Code 58-17b-102
  • Licensee: includes any holder of a license, certificate, registration, permit, student card, or apprentice card authorized under this title. See Utah Code 58-1-102
  • Person: means :
         (24)(a) an individual;
         (24)(b) an association;
         (24)(c) an institution;
         (24)(d) a corporation;
         (24)(e) a company;
         (24)(f) a trust;
         (24)(g) a limited liability company;
         (24)(h) a partnership;
         (24)(i) a political subdivision;
         (24)(j) a government office, department, division, bureau, or other body of government; and
         (24)(k) any other organization or entity. See Utah Code 68-3-12.5
  • Prescription: means an order issued:
         (63)(a) by a licensed practitioner in the course of that practitioner's professional practice or by collaborative pharmacy practice agreement; and
         (63)(b) for a controlled substance or other prescription drug or device for use by a patient or an animal. See Utah Code 58-17b-102
  • Self-audit: means an internal evaluation of a pharmacy to determine compliance with this chapter. See Utah Code 58-17b-102
     (1)(a) licensed under Part 3, Licensing; or
     (1)(b) who is engaged in activities that require a license under Part 3, Licensing.
(2) Before conducting an inspection under Subsection (1), the division shall, after identifying the person in charge:

     (2)(a) give proper identification;
     (2)(b) request to see the applicable license or licenses;
     (2)(c) describe the nature and purpose of the inspection; and
     (2)(d) provide upon request, the authority of the division to conduct the inspection and the penalty for refusing to permit the inspection as provided in Section 58-17b-504.
(3) In conducting an inspection under Subsection (1), the division may, after meeting the requirements of Subsection (2):

     (3)(a) examine any record, prescription, order, drug, device, equipment, machine, electronic device or media, or area related to activities for which a license has been issued or is required by Part 3, Licensing, for the purpose of ascertaining compliance with the applicable provisions of this chapter;
     (3)(b) reproduce any record or media at the division’s own cost;
     (3)(c) take a drug or device for further analysis if considered necessary;
     (3)(d) temporarily seize a drug or device that is suspected to be adulterated, misbranded, outdated, or otherwise in violation of this chapter, pending an adjudicative proceeding on the matter;
     (3)(e) box and seal drugs suspected to be adulterated, outdated, misbranded, or otherwise in violation of this chapter; and
     (3)(f) dispose of or return a drug or device obtained under this Subsection (3) in accordance with procedures established by division rule.
(4) An inspection described in Subsection (1) shall be conducted during regular business hours.
(5) If, upon inspection, the division concludes that a person has violated the provisions of this chapter or Chapter 37, Utah Controlled Substances Act, or a rule or order issued with respect to those chapters, and that disciplinary action is appropriate, the director or the director’s designee shall promptly issue a fine or citation to the licensee in accordance with Section 58-17b-504.

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