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Fifth Substitute S.B. 88

Representative Rebecca D. Lockhart proposes the following substitute bill:




Chief Sponsor: Curtis S. Bramble

House Sponsor: Rebecca D. Lockhart

             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act.
             10      Highlighted Provisions:
             11          This bill:
             12          .    amends provisions related to exemptions from licensure;
             13          .    defines terms;
             14          .    exempts prescribing physicians from licensure under the Pharmacy Practice Act
             15      when a physician dispenses a cosmetic drug or injectable weight loss drug to the
             16      physician's patient; and
             17          .    requires certain drug labeling and record keeping standards for the dispensing
             18      physician.
             19      Monies Appropriated in this Bill:
             20          None
             21      Other Special Clauses:
             22          None
             23      Utah Code Sections Affected:
             24      AMENDS:
             25          58-17b-309, as last amended by Laws of Utah 2005, Chapter 71

             27      Be it enacted by the Legislature of the state of Utah:
             28          Section 1. Section 58-17b-309 is amended to read:
             29           58-17b-309. Exemptions from licensure.
             30          (1) For purposes of this section:
             31          (a) "Cosmetic drug":
             32          (i) means a prescription drug that is:
             33          (A) for the purpose of promoting attractiveness or altering the appearance of an
             34      individual; and
             35          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             36      by administrative rule; and
             37          (ii) does not include a prescription drug that is:
             38          (A) a controlled substance;
             39          (B) compounded by the physician; or
             40          (C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,
             41      treating, or preventing a disease.
             42          (b) "Injectable weight loss drug":
             43          (i) means:
             44          (A) an injectable prescription drug prescribed to promote weight loss; and
             45          (B) listed as an injectable prescription drug subject to exemption under this section by
             46      the division by administrative rule; and
             47          (ii) does not include a prescription drug that is a controlled substance.
             48          (c) "Physician" means an individual licensed under either Chapter 67, Utah Medical
             49      Practice Act, or Chapter 68, Utah Osteopathic Medical Practice Act.
             50          [(1)] (2) In addition to the exemptions from licensure in Section 58-1-307 , the
             51      following individuals may engage in the acts or practices described in this Subsection [(1)] (2)
             52      without being licensed under this chapter:
             53          (a) a person selling or providing contact lenses in accordance with Section 58-16a-801 ;
             54      [and]
             55          (b) an individual engaging in the practice of pharmacy technician under the direct
             56      personal supervision of a pharmacist while making satisfactory progress in an approved

             57      program as defined in division rule[.]; and
             58          (c) a physician who prescribes and dispenses a cosmetic drug or an injectable weight
             59      loss drug to the physician's patient in accordance with Subsection (4).
             60          [(2)] (3) In accordance with Subsection 58-1-303 [(1)] (2)(a), an individual exempt
             61      under Subsection [(1)] (2)(b) must take all examinations as required by division rule following
             62      completion of an approved curriculum of education, within the required time frame. This
             63      exemption expires immediately upon notification of a failing score of an examination, and the
             64      individual may not continue working as a pharmacy technician even under direct supervision.
             65          (4) A physician is exempt from licensing under the provisions of Subsection (2)(c) if
             66      the physician:
             67          (a) (i) writes a prescription for a cosmetic drug or injectable weight loss drug; and
             68          (ii) informs the patient:
             69          (A) that the prescription may be filled at a pharmacy or dispensed in the physician's
             70      office;
             71          (B) of the directions for appropriate use of the drug;
             72          (C) of potential side-effects to the use of the drug; and
             73          (D) how to contact the physician if the patient has questions or concerns regarding the
             74      drug;
             75          (b) dispenses a cosmetic drug or injectable weight loss drug only to the physician's
             76      patients; and
             77          (c) follows labeling, record keeping, patient counseling, and storage requirements
             78      established by administrative rule adopted by the division in consultation with the boards listed
             79      in Subsection (5)(a).
             80          (5) (a) The division, in consultation with the board under this chapter, the Physician
             81      Licensing Board, and the Osteopathic Physician Licensing Board, shall adopt administrative
             82      rules pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act to designate:
             83          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             84      under this section; and
             85          (ii) the requirements under Subsection (4)(c).
             86          (b) When making a determination under Subsection (1)(a), the division and boards
             87      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications

             88      or approval associated with a drug when adopting a rule to designate a prescription drug that
             89      may be dispensed under this section.
             90          (c) The division may inspect the office of a physician who is dispensing under the
             91      provisions of this section, in order to determine whether the physician is in compliance with the
             92      provisions of this section. If a physician chooses to dispense under the provisions of this
             93      section, the physician consents to the jurisdiction of the division to inspect the physician's
             94      office and determine if the provisions of this section are being met by the physician.
             95          (d) If a physician violates a provision of this section the physician may be subject to
             96      discipline under:
             97          (i) this chapter; and
             98          (ii) (A) Chapter 67, Utah Medical Practice Act; or
             99          (B) Chapter 68, Utah Osteopathic Medical Practice Act.
             100          (6) This section does not restrict or limit the scope of practice of an optometrist or
             101      optometric physician licensed under Chapter 16a, Utah Optometry Practice Act.

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