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Second Substitute S.B. 77

Senator Evan J. Vickers proposes the following substitute bill:


             1     
PHARMACY PRACTICE ACT AMENDMENTS

             2     
2014 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Evan J. Vickers

             5     
House Sponsor: Stewart Barlow

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends provisions of the Pharmacy Practice Act related to pharmacies and
             10      prescription drugs.
             11      Highlighted Provisions:
             12          This bill:
             13          .    directs the Division of Occupational and Professional Licensing to issue a pharmacy
             14      technician trainee license to an individual under certain circumstances;
             15          .    allows a pharmacy to sell a prescription drug to a practitioner for use in the
             16      practitioner's office or facility under certain circumstances; and
             17          .    makes technical and conforming amendments.
             18      Money Appropriated in this Bill:
             19          None
             20      Other Special Clauses:
             21          This bill takes effect on July 1, 2014.
             22          This bill coordinates with S.B. 55, Pharmaceutical Dispensing Amendments, by
             23      providing technical and substantive amendments.
             24      Utah Code Sections Affected:
             25      AMENDS:


             26           58-17b-301 , as last amended by Laws of Utah 2013, Chapter 52
             27           58-17b-309 , as last amended by Laws of Utah 2013, Chapter 278
             28      ENACTS:
             29           58-17b-305.1 , Utah Code Annotated 1953
             30           58-17b-624 , Utah Code Annotated 1953
             31      Utah Code Sections Affected by Coordination Clause:
             32           58-17b-309 , as last amended by Laws of Utah 2013, Chapter 278
             33           58-17b-624 , Utah Code Annotated 1953
             34     
             35      Be it enacted by the Legislature of the state of Utah:
             36          Section 1. Section 58-17b-301 is amended to read:
             37           58-17b-301. License required -- License classifications for individuals.
             38          (1) A license is required to engage in the practice of pharmacy, telepharmacy, or the
             39      practice of a pharmacy technician, except as specifically provided in Section 58-1-307 ,
             40      58-17b-309 , or 58-17-309.6 .
             41          (2) The division shall issue to an individual who qualifies under this chapter a license
             42      in the classification of:
             43          (a) pharmacist;
             44          (b) pharmacy intern; [or]
             45          (c) pharmacy technician[.]; or
             46          (d) pharmacy technician trainee.
             47          Section 2. Section 58-17b-305.1 is enacted to read:
             48          58-17b-305.1. Qualifications for licensure of pharmacy technician trainee.
             49          (1) An applicant for licensure as a pharmacy technician trainee shall:
             50          (a) submit an application to the division on a form created by the division;
             51          (b) pay a fee established by the division in accordance with Section 63J-1-504 ;
             52          (c) submit satisfactory evidence, as determined by the division, of good moral character
             53      as it relates to the applicant's ability to practice pharmacy;
             54          (d) unless exempted by the division, submit a completed criminal background check;
             55          (e) demonstrate, as determined by the division, that the applicant does not have a
             56      physical or mental condition that would prevent the applicant from engaging in practice as a


             57      pharmacy technician with reasonable skill, competency, and safety to the public; and
             58          (f) submit evidence that the applicant is enrolled in a training program approved by the
             59      division.
             60          (2) A pharmacist whose license has been denied, revoked, suspended, or restricted for
             61      disciplinary purposes is not eligible to be licensed as a pharmacy technician trainee during
             62      division probation.
             63          Section 3. Section 58-17b-309 is amended to read:
             64           58-17b-309. Exemptions from licensure.
             65          (1) For purposes of this section:
             66          (a) "Cosmetic drug":
             67          (i) means a prescription drug that is:
             68          (A) for the purpose of promoting attractiveness or altering the appearance of an
             69      individual; and
             70          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             71      by administrative rule or has been expressly approved for online dispensing, whether or not it is
             72      dispensed online or through a physician's office; and
             73          (ii) does not include a prescription drug that is:
             74          (A) a controlled substance;
             75          (B) compounded by the physician; or
             76          (C) prescribed or used for the patient for the purpose of diagnosing, curing, or
             77      preventing a disease.
             78          (b) "Injectable weight loss drug":
             79          (i) means an injectable prescription drug:
             80          (A) prescribed to promote weight loss; and
             81          (B) listed as an injectable prescription drug subject to exemption under this section by
             82      the division by administrative rule; and
             83          (ii) does not include a prescription drug that is a controlled substance.
             84          (c) "Prescribing practitioner" means an individual licensed under:
             85          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             86      prescriptive practice;
             87          (ii) Chapter 67, Utah Medical Practice Act;


             88          (iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
             89          (iv) Chapter 70a, Physician Assistant Act.
             90          (2) In addition to the exemptions from licensure in Sections 58-1-307 and
             91      58-17b-309.5 , the following individuals may engage in the acts or practices described in this
             92      section without being licensed under this chapter:
             93          (a) if the individual is described in Subsections (2)(b), (d), or (e), the individual
             94      notifies the division in writing of the individual's intent to dispense a drug under this
             95      subsection;
             96          (b) a person selling or providing contact lenses in accordance with Section 58-16a-801 ;
             97          [(c) an individual engaging in the practice of pharmacy technician under the direct
             98      personal supervision of a pharmacist while making satisfactory progress in an approved
             99      program as defined in division rule;]
             100          [(d)] (c) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
             101      injectable weight loss drug to the prescribing practitioner's patient in accordance with
             102      Subsection [(4)] (3); or
             103          [(e)] (d) an optometrist, as defined in Section 58-16a-102 , acting within the
             104      optometrist's scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses
             105      a cosmetic drug to the optometrist's patient in accordance with Subsection [(4)] (3).
             106          [(3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
             107      Subsection (2)(c) must take all examinations as required by division rule following completion
             108      of an approved curriculum of education, within the required time frame. This exemption
             109      expires immediately upon notification of a failing score of an examination, and the individual
             110      may not continue working as a pharmacy technician even under direct supervision.]
             111          [(4)] (3) A prescribing practitioner or optometrist is exempt from licensing under the
             112      provisions of this part if the prescribing practitioner or optometrist:
             113          (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
             114      authority to dispense under Subsection [(4)] (3)(b); and
             115          (ii) informs the patient:
             116          (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
             117      practitioner's or optometrist's office;
             118          (B) of the directions for appropriate use of the drug;


             119          (C) of potential side-effects to the use of the drug; and
             120          (D) how to contact the prescribing practitioner or optometrist if the patient has
             121      questions or concerns regarding the drug;
             122          (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             123      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
             124      patients;
             125          (c) follows labeling, record keeping, patient counseling, storage, purchasing and
             126      distribution, operating, treatment, and quality of care requirements established by
             127      administrative rule adopted by the division in consultation with the boards listed in Subsection
             128      [(5)] (4)(a); and
             129          (d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to
             130      patients is reconstituted or compounded.
             131          [(5)] (4) (a) The division, in consultation with the board under this chapter and the
             132      relevant professional board, including the Physician Licensing Board, the Osteopathic
             133      Physician Licensing Board, the Physician Assistant Licensing Board, the Board of Nursing, the
             134      Optometrist Licensing Board, or the Online Prescribing, Dispensing, and Facilitation Board,
             135      shall adopt administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative
             136      Rulemaking Act to designate:
             137          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             138      under this section; and
             139          (ii) the requirements under Subsection [(4)] (3)(c).
             140          (b) When making a determination under Subsection (1)(a), the division and boards
             141      listed in Subsection [(5)] (4)(a) may consider any federal Food and Drug Administration
             142      indications or approval associated with a drug when adopting a rule to designate a prescription
             143      drug that may be dispensed under this section.
             144          (c) The division may inspect the office of a prescribing practitioner or optometrist who
             145      is dispensing under the provisions of this section, in order to determine whether the prescribing
             146      practitioner or optometrist is in compliance with the provisions of this section. If a prescribing
             147      practitioner or optometrist chooses to dispense under the provisions of this section, the
             148      prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
             149      prescribing practitioner's or optometrist's office and determine if the provisions of this section


             150      are being met by the prescribing practitioner or optometrist.
             151          (d) If a prescribing practitioner or optometrist violates a provision of this section, the
             152      prescribing practitioner or optometrist may be subject to discipline under:
             153          (i) this chapter; and
             154          (ii) (A) Chapter 16a, Utah Optometry Practice Act;
             155          (B) Chapter 31b, Nurse Practice Act;
             156          (C) Chapter 67, Utah Medical Practice Act;
             157          (D) Chapter 68, Utah Osteopathic Medical Practice Act;
             158          (E) Chapter 70a, Physician Assistant Act; or
             159          (F) Chapter 83, Online Prescribing, Dispensing, and Facilitation Act.
             160          [(6)] (5) Except as provided in Subsection (2)(e), this section does not restrict or limit
             161      the scope of practice of an optometrist or optometric physician licensed under Chapter 16a,
             162      Utah Optometry Practice Act.
             163          Section 4. Section 58-17b-624 is enacted to read:
             164          58-17b-624. Prescription drugs -- Sale to a practitioner for office use.
             165          (1) A pharmacy licensed under this chapter may, subject to rules established by the
             166      division, repackage or compound a prescription drug for sale to a practitioner if:
             167          (a) the prescription drug:
             168          (i) does not include a compounded drug; or
             169          (ii) (A) includes a compounded drug; and
             170          (B) is not a controlled substance;
             171          (b) the pharmacy labels the prescription drug "for office use only";
             172          (c) the practitioner administers the drug to a patient in the practitioner's office or
             173      facility; and
             174          (d) the practitioner does not dispense the drug to the patient.
             175          (2) The division shall establish, in accordance with Title 63G, Chapter 3, Utah
             176      Administrative Rulemaking Act, prescription drug labeling and control standards for a
             177      prescription drug that a pharmacy provides to a practitioner under this section.
             178          Section 5. Effective date.
             179          This bill takes effect on July 1, 2014.
             180          Section 6. Coordinating S.B. 77 with S.B. 55 -- Technical and substantive


             181      amendments.
             182          If this S.B. 77 and S.B. 55, Pharmaceutical Dispensing Amendments both pass and
             183      become law, it is the intent of the Legislature that the Office of Legislative Research and
             184      General Counsel shall prepare the Utah Code database for publication by:
             185          (1) modifying Section 58-17b-309 to read:
             186          "58-17b-309. Exemption from licensure -- Contact lenses.
             187          In addition to the exemptions from licensure in Section 58-1-307 , a person selling or
             188      providing contact lenses in accordance with Section 58-16a-801 is exempt from the licensing
             189      provisions of this chapter."; and
             190          (2) modifying Subsection 58-17b-624 (1)(d) to read:
             191          "(d) except in accordance with Title 58, Chapter 17b, Part 8, Dispensing Medical
             192      Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, the practitioner does not
             193      dispense the drug to the patient.".


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