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S.B. 128

             1     

REGULATORY AMENDMENTS

             2     
2011 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Curtis S. Bramble

             5     
House Sponsor: Evan J. Vickers

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act.
             10      Highlighted Provisions:
             11          This bill:
             12          .    defines terms;
             13          .    amends provisions related to exemptions from licensure;
             14          .    exempts advanced practice registered nurses and physician assistants from licensure
             15      under the Pharmacy Practice Act to dispense a cosmetic drug or injectable weight
             16      loss drug to a patient; and
             17          .    exempts optometrists from licensure under the Pharmacy Practice Act to dispense a
             18      cosmetic drug to a patient.
             19      Money 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 2010, Chapter 213
             26     
             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 an injectable prescription drug:
             44          (A) 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"] "Prescribing practitioner" means an individual licensed under [either]:
             49          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             50      prescriptive practice;
             51          (ii) Chapter 67, Utah Medical Practice Act[, or];
             52          (iii) Chapter 68, Utah Osteopathic Medical Practice Act[.]; or
             53          (iv) Chapter 70a, Physician Assistant Act.
             54          (2) In addition to the exemptions from licensure in Section 58-1-307 , the following
             55      individuals may engage in the acts or practices described in this [Subsection (2)] section
             56      without being licensed under this chapter:
             57          (a) a person selling or providing contact lenses in accordance with Section 58-16a-801 ;
             58          (b) an individual engaging in the practice of pharmacy technician under the direct


             59      personal supervision of a pharmacist while making satisfactory progress in an approved
             60      program as defined in division rule; [and]
             61          (c) a [physician] prescribing practitioner who prescribes and dispenses a cosmetic drug
             62      or an injectable weight loss drug to the [physician's] prescribing practitioner's patient in
             63      accordance with Subsection (4)[.]; and
             64          (d) an optometrist, as defined in Section 58-16a-102 , acting within the optometrist's
             65      scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses a cosmetic
             66      drug to the optometrist's patient in accordance with Subsection (4).
             67          (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
             68      Subsection (2)(b) must take all examinations as required by division rule following completion
             69      of an approved curriculum of education, within the required time frame. This exemption
             70      expires immediately upon notification of a failing score of an examination, and the individual
             71      may not continue working as a pharmacy technician even under direct supervision.
             72          (4) A [physician] prescribing practitioner or optometrist is exempt from licensing
             73      under the provisions of [Subsection (2)(c)] this part if the [physician] prescribing practitioner
             74      or optometrist:
             75          (a) (i) writes a prescription for a cosmetic drug or injectable weight loss drug; and
             76          (ii) informs the patient:
             77          (A) that the prescription may be filled at a pharmacy or dispensed in the [physician's]
             78      prescribing practitioner's or optometrist's office;
             79          (B) of the directions for appropriate use of the drug;
             80          (C) of potential side-effects to the use of the drug; and
             81          (D) how to contact the [physician] prescribing practitioner or optometrist if the patient
             82      has questions or concerns regarding the drug;
             83          (b) dispenses a cosmetic drug or injectable weight loss drug only to the [physician's]
             84      prescribing practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the
             85      optometrist's patients; and
             86          (c) follows labeling, record keeping, patient counseling, and storage requirements
             87      established by administrative rule adopted by the division in consultation with the boards listed
             88      in Subsection (5)(a).
             89          (5) (a) The division, in consultation with the board under this chapter, the Physician


             90      Licensing Board, [and] the Osteopathic Physician Licensing Board, the Physician Assistant
             91      Licensing Board, the Board of Nursing, and the Optometrist Licensing Board shall adopt
             92      administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act to
             93      designate:
             94          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             95      under this section; and
             96          (ii) the requirements under Subsection (4)(c).
             97          (b) When making a determination under Subsection (1)(a), the division and boards
             98      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications
             99      or approval associated with a drug when adopting a rule to designate a prescription drug that
             100      may be dispensed under this section.
             101          (c) The division may inspect the office of a [physician] prescribing practitioner or
             102      optometrist who is dispensing under the provisions of this section, in order to determine
             103      whether the [physician] prescribing practitioner or optometrist is in compliance with the
             104      provisions of this section. If a [physician] prescribing practitioner or optometrist chooses to
             105      dispense under the provisions of this section, the [physician] prescribing practitioner or
             106      optometrist consents to the jurisdiction of the division to inspect the [physician's] prescribing
             107      practitioner's or optometrist's office and determine if the provisions of this section are being
             108      met by the [physician] prescribing practitioner and optometrist.
             109          (d) If a [physician] prescribing practitioner or optometrist violates a provision of this
             110      section, the [physician] prescribing practitioner or optometrist may be subject to discipline
             111      under:
             112          (i) this chapter; and
             113          (ii) (A) Chapter 16a, Utah Optometry Practice Act;
             114          (B) Chapter 31b, Nurse Practice Act;
             115          [(ii) (A)] (C) Chapter 67, Utah Medical Practice Act; [or]
             116          [(B)] (D) Chapter 68, Utah Osteopathic Medical Practice Act[.]; or
             117          (E) Chapter 70a, Physician Assistant Act.
             118          (6) [This] Except as provided in Subsection (2)(d), this section does not restrict or limit
             119      the scope of practice of an optometrist or optometric physician licensed under Chapter 16a,
             120      Utah Optometry Practice Act.






Legislative Review Note
    as of 1-25-11 1:35 PM


Office of Legislative Research and General Counsel


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