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S.B. 88 Enrolled





Chief Sponsor: Curtis S. Bramble

House Sponsor: Bradley M. Daw

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

             29      AMENDS:
             30          58-17b-309, as last amended by Laws of Utah 2011, Chapter 76
             31          58-83-502, as enacted by Laws of Utah 2010, Chapter 180
             33      Be it enacted by the Legislature of the state of Utah:
             34          Section 1. Section 58-17b-309 is amended to read:
             35           58-17b-309. Exemptions from licensure.
             36          (1) For purposes of this section:
             37          (a) "Cosmetic drug":
             38          (i) means a prescription drug that is:
             39          (A) for the purpose of promoting attractiveness or altering the appearance of an
             40      individual; and
             41          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             42      by administrative rule[; and] or has been expressly approved for online dispensing, whether or
             43      not it is dispensed online or through a physician's office; and
             44          (ii) does not include a prescription drug that is:
             45          (A) a controlled substance;
             46          (B) compounded by the physician; or
             47          (C) prescribed or used for the patient for the purpose of diagnosing, curing, [mitigating,
             48      treating,] or preventing a disease.
             49          (b) "Injectable weight loss drug":
             50          (i) means an injectable prescription drug:
             51          (A) prescribed to promote weight loss; and
             52          (B) listed as an injectable prescription drug subject to exemption under this section by
             53      the division by administrative rule; and
             54          (ii) does not include a prescription drug that is a controlled substance.
             55          (c) "Prescribing practitioner" means an individual licensed under:
             56          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with

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

             85      practitioner's or optometrist's office;
             86          (B) of the directions for appropriate use of the drug;
             87          (C) of potential side-effects to the use of the drug; and
             88          (D) how to contact the prescribing practitioner or optometrist if the patient has
             89      questions or concerns regarding the drug;
             90          (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             91      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
             92      patients; and
             93          (c) follows labeling, record keeping, patient counseling, and storage requirements
             94      established by administrative rule adopted by the division in consultation with the boards listed
             95      in Subsection (5)(a).
             96          (5) (a) The division, in consultation with the board under this chapter[,] and the
             97      relevant professional board, including the Physician Licensing Board, the Osteopathic
             98      Physician Licensing Board, the Physician Assistant Licensing Board, the Board of Nursing,
             99      [and] the Optometrist Licensing Board, or the Online Prescribing, Dispensing, and Facilitation
             100      Board, shall adopt administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative
             101      Rulemaking Act to designate:
             102          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             103      under this section; and
             104          (ii) the requirements under Subsection (4)(c).
             105          (b) When making a determination under Subsection (1)(a), the division and boards
             106      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications
             107      or approval associated with a drug when adopting a rule to designate a prescription drug that
             108      may be dispensed under this section.
             109          (c) The division may inspect the office of a prescribing practitioner or optometrist who
             110      is dispensing under the provisions of this section, in order to determine whether the prescribing
             111      practitioner or optometrist is in compliance with the provisions of this section. If a prescribing
             112      practitioner or optometrist chooses to dispense under the provisions of this section, the

             113      prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
             114      prescribing practitioner's or optometrist's office and determine if the provisions of this section
             115      are being met by the prescribing practitioner and optometrist.
             116          (d) If a prescribing practitioner or optometrist violates a provision of this section, the
             117      prescribing practitioner or optometrist may be subject to discipline under:
             118          (i) this chapter; and
             119          (ii) (A) Chapter 16a, Utah Optometry Practice Act;
             120          (B) Chapter 31b, Nurse Practice Act;
             121          (C) Chapter 67, Utah Medical Practice Act;
             122          (D) Chapter 68, Utah Osteopathic Medical Practice Act; [or]
             123          (E) Chapter 70a, Physician Assistant Act[.]; or
             124          (F) Chapter 83, Online Prescribing, Dispensing, and Facilitation Act.
             125          (6) Except as provided in Subsection (2)(d), this section does not restrict or limit the
             126      scope of practice of an optometrist or optometric physician licensed under Chapter 16a, Utah
             127      Optometry Practice Act.
             128          Section 2. Section 58-83-502 is amended to read:
             129           58-83-502. Unprofessional conduct.
             130          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
             131      as may be further defined by administrative rule:
             132          (1) online prescribing, dispensing, or facilitation with respect to a person under the age
             133      of 18 years;
             134          (2) using the name or official seal of the state, the Utah Department of Commerce, or
             135      the Utah Division of Occupational and Professional Licensing, or their boards, in an
             136      unauthorized manner;
             137          (3) failing to respond promptly to a request by the division for information including:
             138          (a) an audit of the website; or
             139          (b) records of the online prescriber, the Internet facilitator, or the online contract
             140      pharmacy;

             141          (4) using an online prescriber, online contract pharmacy, or Internet facilitator without
             142      approval of the division;
             143          (5) failing to inform a patient of the patient's freedom of choice in selecting who will
             144      dispense a prescription in accordance with Subsection 58-83-305 (1)(n); [and]
             145          (6) failing to keep the division informed of the name and contact information of the
             146      Internet facilitator or online contract pharmacy[.]; and
             147          (7) violating the dispensing and labeling requirements of Section 58-17b-309 .

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