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S.B. 88





Chief Sponsor: Curtis S. Bramble

House Sponsor: Bradley M. Daw

             7      LONG TITLE
             8      General Description:
             9          This bill amends Title 58, Chapter 17b, Pharmacy Practice Act, by amending the
             10      definition of a cosmetic drug.
             11      Highlighted Provisions:
             12          This bill:
             13          .    amends the definition of a "cosmetic drug;"
             14          .    states that the Division of Occupational and Professional Licensing shall consult
             15      with the Utah State Board of Pharmacy and the Online, Prescribing, Dispensing,
             16      and Facilitation Board to adopt administrative rules to regulate:
             17              .    labeling, record keeping, patient counseling, and storage requirements; and
             18              .    which prescription drugs may be dispensed as a cosmetic drug or weight loss
             19      drug without licensure;
             20          .    states that an individual who violates a provision of the section may be subject to
             21      discipline under the Online Prescribing, Dispensing, and Facilitation Act; and
             22          .    makes technical changes.
             23      Money Appropriated in this Bill:
             24          None
             25      Other Special Clauses:
             26          None
             27      Utah Code Sections Affected:

             28      AMENDS:
             29          58-17b-309, as last amended by Laws of Utah 2011, Chapter 76
             31      Be it enacted by the Legislature of the state of Utah:
             32          Section 1. Section 58-17b-309 is amended to read:
             33           58-17b-309. Exemptions from licensure.
             34          (1) For purposes of this section:
             35          (a) "Cosmetic drug":
             36          (i) means a prescription drug that is:
             37          (A) for the purpose of promoting attractiveness or altering the appearance of an
             38      individual; and
             39          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             40      by administrative rule[; and] or has been expressly approved for online dispensing, whether or
             41      not it is dispensed online or through a physician's office; and
             42          (ii) does not include a prescription drug that is:
             43          (A) a controlled substance; or
             44          (B) compounded by the physician[; or].
             45          [(C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,
             46      treating, or preventing a disease.]
             47          (b) "Injectable weight loss drug":
             48          (i) means an injectable prescription drug:
             49          (A) prescribed to promote weight loss; and
             50          (B) listed as an injectable prescription drug subject to exemption under this section by
             51      the division by administrative rule; and
             52          (ii) does not include a prescription drug that is a controlled substance.
             53          (c) "Prescribing practitioner" means an individual licensed under:
             54          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             55      prescriptive practice;
             56          (ii) Chapter 67, Utah Medical Practice Act;
             57          (iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
             58          (iv) Chapter 70a, Physician Assistant Act.

             59          (2) In addition to the exemptions from licensure in Section 58-1-307 , the following
             60      individuals may engage in the acts or practices described in this section without being licensed
             61      under this chapter:
             62          (a) a person selling or providing contact lenses in accordance with Section 58-16a-801 ;
             63          (b) an individual engaging in the practice of pharmacy technician under the direct
             64      personal supervision of a pharmacist while making satisfactory progress in an approved
             65      program as defined in division rule;
             66          (c) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
             67      injectable weight loss drug to the prescribing practitioner's patient in accordance with
             68      Subsection (4); and
             69          (d) an optometrist, as defined in Section 58-16a-102 , acting within the optometrist's
             70      scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses a cosmetic
             71      drug to the optometrist's patient in accordance with Subsection (4).
             72          (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
             73      Subsection (2)(b) must take all examinations as required by division rule following completion
             74      of an approved curriculum of education, within the required time frame. This exemption
             75      expires immediately upon notification of a failing score of an examination, and the individual
             76      may not continue working as a pharmacy technician even under direct supervision.
             77          (4) A prescribing practitioner or optometrist is exempt from licensing under the
             78      provisions of this part if the prescribing practitioner or optometrist:
             79          (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
             80      authority to dispense under Subsection (4)(b); and
             81          (ii) informs the patient:
             82          (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
             83      practitioner's or optometrist's office;
             84          (B) of the directions for appropriate use of the drug;
             85          (C) of potential side-effects to the use of the drug; and
             86          (D) how to contact the prescribing practitioner or optometrist if the patient has
             87      questions or concerns regarding the drug;
             88          (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             89      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's

             90      patients; and
             91          (c) follows labeling, record keeping, patient counseling, and storage requirements
             92      established by administrative rule adopted by the division in consultation with the boards listed
             93      in Subsection (5)(a).
             94          (5) (a) The division, in consultation with the board under this chapter[,] and the
             95      relevant professional board, including the Physician Licensing Board, the Osteopathic
             96      Physician Licensing Board, the Physician Assistant Licensing Board, the Board of Nursing,
             97      [and] the Optometrist Licensing Board, or the Online Prescribing, Dispensing, and Facilitation
             98      Board, shall adopt administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative
             99      Rulemaking Act to designate:
             100          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             101      under this section; and
             102          (ii) the requirements under Subsection (4)(c).
             103          (b) When making a determination under Subsection (1)(a), the division and boards
             104      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications
             105      or approval associated with a drug when adopting a rule to designate a prescription drug that
             106      may be dispensed under this section.
             107          (c) The division may inspect the office of a prescribing practitioner or optometrist who
             108      is dispensing under the provisions of this section, in order to determine whether the prescribing
             109      practitioner or optometrist is in compliance with the provisions of this section. If a prescribing
             110      practitioner or optometrist chooses to dispense under the provisions of this section, the
             111      prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
             112      prescribing practitioner's or optometrist's office and determine if the provisions of this section
             113      are being met by the prescribing practitioner and optometrist.
             114          (d) If a prescribing practitioner or optometrist violates a provision of this section, the
             115      prescribing practitioner or optometrist may be subject to discipline under:
             116          (i) this chapter; and
             117          (ii) (A) Chapter 16a, Utah Optometry Practice Act;
             118          (B) Chapter 31b, Nurse Practice Act;
             119          (C) Chapter 67, Utah Medical Practice Act;
             120          (D) Chapter 68, Utah Osteopathic Medical Practice Act; [or]

             121          (E) Chapter 70a, Physician Assistant Act[.]; or
             122          (F) Chapter 83, Online Prescribing, Dispensing, and Facilitation Act.
             123          (6) Except as provided in Subsection (2)(d), this section does not restrict or limit the
             124      scope of practice of an optometrist or optometric physician licensed under Chapter 16a, Utah
             125      Optometry Practice Act.

Legislative Review Note
    as of 2-6-12 1:44 PM

Office of Legislative Research and General Counsel

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