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Sixth Substitute S.B. 161

Representative Evan J. Vickers proposes the following substitute bill:


             1     
PHARMACY PRACTICE ACT REVISIONS

             2     
2012 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 to permit certain prescribing practitioners
             10      to dispense certain drugs without a license under the Pharmacy Practice Act, and makes
             11      conforming amendments in the Utah Optometry Practice Act, the Nurse Practice Act,
             12      the Utah Medical Practice Act, the Utah Osteopathic Medical Practice Act, and the
             13      Physician Assistant Act.
             14      Highlighted Provisions:
             15          This bill:
             16          .    requires a prescribing practitioner who will dispense a drug without being licensed
             17      under the Pharmacy Practice Act to notify the Division of Occupational and
             18      Professional Licensing of the practitioner's intent to dispense;
             19          .    requires the dispensing practitioner to follow purchasing and distribution
             20      requirements established by the division by administrative rule;
             21          .    defines cancer drug regimen;
             22          .    exempts an oncologist or medical personnel acting under the direction of an
             23      oncologist from being licensed under the Pharmacy Practice Act to dispense a
             24      cancer drug regimen to a patient who is undergoing chemotherapy in an outpatient
             25      clinic setting;


             26          .    excludes Schedule I, II, and III drugs from the drugs an oncologist may dispense;
             27          .    makes it unprofessional conduct for a prescribing practitioner who dispenses a drug,
             28      to dispense the drug in violation of the exemption in the Pharmacy Practice Act;
             29          .    directs the Division of Occupational and Professional Licensing to evaluate the
             30      prescribing practitioner exemptions from licensing for dispensing drugs and to
             31      report the findings of the evaluation to the Legislature; and
             32          .    sunsets the exemption from licensure for oncologists in July 2015.
             33      Money Appropriated in this Bill:
             34          None
             35      Other Special Clauses:
             36          None
             37      Utah Code Sections Affected:
             38      AMENDS:
             39          58-16a-502, as last amended by Laws of Utah 2000, Chapter 160
             40          58-17b-309, as last amended by Laws of Utah 2011, Chapter 76
             41          58-67-502, as last amended by Laws of Utah 2011, Chapter 206
             42          58-68-502, as enacted by Laws of Utah 1996, Chapter 248
             43          58-70a-502, as enacted by Laws of Utah 1997, Chapter 229
             44          63I-1-258, as last amended by Laws of Utah 2010, Chapter 188
             45      ENACTS:
             46          58-17b-309.5, Utah Code Annotated 1953
             47     
             48      Be it enacted by the Legislature of the state of Utah:
             49          Section 1. Section 58-16a-502 is amended to read:
             50           58-16a-502. Unprofessional conduct.
             51          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 :
             52          (1) using or employing the services of an optometric assistant to assist a licensee in any
             53      manner not in accordance with:
             54          (a) the generally recognized practices and standards of ethics of the profession; or
             55          (b) applicable state law or division rule;
             56          (2) failure to refer a patient to an appropriate licensed practitioner when:


             57          (a) the patient's condition does not respond to treatment; or
             58          (b) the treatment is not within the scope of competence or licensure of the licensee;
             59          (3) providing confidential information regarding a patient to any third party who does
             60      not have a legal and professional ground for obtaining the information;
             61          (4) knowingly prescribing, selling, giving away, or administering any prescription drug
             62      [except] unless:
             63          (a) for a legitimate medical purpose [and];
             64          (b) upon a proper diagnosis indicating the use of the drug in the amount prescribed or
             65      provided; and
             66          (c) in compliance with Section 58-17b-309 ;
             67          (5) giving or receiving directly or indirectly any fee, commission, rebate, or other
             68      compensation for professional services not actually and personally rendered, except as part of a
             69      legal relationship within a lawful professional partnership, corporation, or association;
             70          (6) failure to transfer pertinent and necessary information from a patient's medical
             71      records to another optometrist or physician when so requested by the patient or his
             72      representative, as designated in writing; or
             73          (7) failure to provide a contact lens prescription to a person who sells contact lenses in
             74      accordance with Section 58-16a-306 .
             75          Section 2. Section 58-17b-309 is amended to read:
             76           58-17b-309. Exemptions from licensure.
             77          (1) For purposes of this section:
             78          (a) "Cosmetic drug":
             79          (i) means a prescription drug that is:
             80          (A) for the purpose of promoting attractiveness or altering the appearance of an
             81      individual; and
             82          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             83      by administrative rule; and
             84          (ii) does not include a prescription drug that is:
             85          (A) a controlled substance;
             86          (B) compounded by the physician; or
             87          (C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,


             88      treating, or preventing a disease.
             89          (b) "Injectable weight loss drug":
             90          (i) means an injectable prescription drug:
             91          (A) prescribed to promote weight loss; and
             92          (B) listed as an injectable prescription drug subject to exemption under this section by
             93      the division by administrative rule; and
             94          (ii) does not include a prescription drug that is a controlled substance.
             95          (c) "Prescribing practitioner" means an individual licensed under:
             96          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             97      prescriptive practice;
             98          (ii) Chapter 67, Utah Medical Practice Act;
             99          (iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
             100          (iv) Chapter 70a, Physician Assistant Act.
             101          (2) In addition to the exemptions from licensure in [Section] Sections 58-1-307 and
             102      58-17b-309.5 , the following individuals may engage in the acts or practices described in this
             103      section without being licensed under this chapter:
             104          (a) if the individual is described in Subsections (2)(b), (d), and (e), the individual
             105      notifies the division in writing of the individual's intent to dispense a drug under this
             106      subsection;
             107          [(a)] (b) a person selling or providing contact lenses in accordance with Section
             108      58-16a-801 ;
             109          [(b)] (c) an individual engaging in the practice of pharmacy technician under the direct
             110      personal supervision of a pharmacist while making satisfactory progress in an approved
             111      program as defined in division rule;
             112          [(c)] (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
             113      injectable weight loss drug to the prescribing practitioner's patient in accordance with
             114      Subsection (4); [and] or
             115          [(d)] (e) an optometrist, as defined in Section 58-16a-102 , acting within the
             116      optometrist's scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses
             117      a cosmetic drug to the optometrist's patient in accordance with Subsection (4).
             118          (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under


             119      Subsection (2)[(b)](c) must take all examinations as required by division rule following
             120      completion of an approved curriculum of education, within the required time frame. This
             121      exemption expires immediately upon notification of a failing score of an examination, and the
             122      individual may not continue working as a pharmacy technician even under direct supervision.
             123          (4) A prescribing practitioner or optometrist is exempt from licensing under the
             124      provisions of this part if the prescribing practitioner or optometrist:
             125          (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
             126      authority to dispense under Subsection (4)(b); and
             127          (ii) informs the patient:
             128          (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
             129      practitioner's or optometrist's office;
             130          (B) of the directions for appropriate use of the drug;
             131          (C) of potential side-effects to the use of the drug; and
             132          (D) how to contact the prescribing practitioner or optometrist if the patient has
             133      questions or concerns regarding the drug;
             134          (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             135      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
             136      patients; [and]
             137          (c) follows labeling, record keeping, patient counseling, [and] storage, purchasing and
             138      distribution, operating, treatment, and quality of care requirements established by
             139      administrative rule adopted by the division in consultation with the boards listed in Subsection
             140      (5)(a)[.]; and
             141          (d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to
             142      patients is reconstituted or compounded.
             143          (5) (a) The division, in consultation with the board under this chapter, the Physician
             144      Licensing Board, the Osteopathic Physician Licensing Board, the Physician Assistant Licensing
             145      Board, the Board of Nursing, and the Optometrist Licensing Board shall adopt administrative
             146      rules pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act to designate:
             147          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             148      under this section; and
             149          (ii) the requirements under Subsection (4)(c).


             150          (b) When making a determination under Subsection (1)(a), the division and boards
             151      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications
             152      or approval associated with a drug when adopting a rule to designate a prescription drug that
             153      may be dispensed under this section.
             154          (c) The division may inspect the office of a prescribing practitioner or optometrist who
             155      is dispensing under the provisions of this section, in order to determine whether the prescribing
             156      practitioner or optometrist is in compliance with the provisions of this section. If a prescribing
             157      practitioner or optometrist chooses to dispense under the provisions of this section, the
             158      prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
             159      prescribing practitioner's or optometrist's office and determine if the provisions of this section
             160      are being met by the prescribing practitioner and optometrist.
             161          (d) If a prescribing practitioner or optometrist violates a provision of this section, the
             162      prescribing practitioner or optometrist may be subject to discipline under:
             163          (i) this chapter; and
             164          (ii) (A) Chapter 16a, Utah Optometry Practice Act;
             165          (B) Chapter 31b, Nurse Practice Act;
             166          (C) Chapter 67, Utah Medical Practice Act;
             167          (D) Chapter 68, Utah Osteopathic Medical Practice Act; or
             168          (E) Chapter 70a, Physician Assistant Act.
             169          (6) Except as provided in Subsection (2)[(d)](e), this section does not restrict or limit
             170      the scope of practice of an optometrist or optometric physician licensed under Chapter 16a,
             171      Utah Optometry Practice Act.
             172          Section 3. Section 58-17b-309.5 is enacted to read:
             173          58-17b-309.5. Exemption for prescribing practitioner of cancer drug regimen --
             174      Division study of dispensing practitioners.
             175          (1) For purposes of this section, "cancer drug treatment regimen":
             176          (a) means a prescription drug used to treat cancer, manage its symptoms, or provide
             177      continuity of care for a cancer patient;
             178          (b) includes:
             179          (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
             180      methods; and


             181          (ii) a drug used to support cancer treatment, including to treat, alleviate, or minimize
             182      physical and psychological symptoms or pain, or to improve patient tolerance of cancer
             183      treatments or prepare a patient for a subsequent course of therapy; and
             184          (c) does not mean a drug listed under federal law as a Schedule I, II, or III drug.
             185          (2) In addition to the exemption from licensure under Section 58-1-307 , the following
             186      individuals are exempt from licensure under this chapter:
             187          (a) an individual who:
             188          (i) meets the requirements of Subsection (2)(b) or (c); and
             189          (ii) notifies the division that the individual intends to dispense a cancer drug regimen
             190      under this section;
             191          (b) a prescribing practitioner who:
             192          (i) treats a patient who is currently undergoing chemotherapy in an outpatient clinic
             193      setting;
             194          (ii) prescribes a cancer drug treatment regimen to the patient;
             195          (iii) determines that providing the cancer drug treatment regimen to the patient in the
             196      outpatient clinic setting is in the best interest of the patient, or provides better access to care for
             197      the patient;
             198          (iv) discloses to the patient that the cancer drug treatment regimen may be obtained
             199      from a pharmacy unaffiliated with the prescribing practitioner and offers to the patient the
             200      opportunity to consult with a pharmacist if the patient desires patient counseling;
             201          (v) does not directly or indirectly mark up, charge a commission, or make a profit on
             202      providing the cancer drug regimen, but may obtain payment for expenses and services related
             203      to providing the cancer drug regimen;
             204          (vi) provides the cancer drug treatment regimen to the patient, or directs another person
             205      under Subsection (2)(c) to provide the cancer drug treatment regimen to the patient;
             206          (vii) is certified or eligible to be certified by the American Board of Internal Medicine
             207      in medical oncology;
             208          (viii) reports to the Utah Controlled Substance Database in the same manner as
             209      required by Section 58-37f-203 , and follows labeling, recordkeeping, patient counseling,
             210      purchasing and distribution, operating, treatment, quality of care, and storage requirements
             211      established by administrative rule adopted by the division in consultation with the board; and


             212          (ix) follows the USP-NF 797 standards for sterile compounding if the drug dispensed
             213      to the patient is reconstituted or compounded; and
             214          (c) a person who is not a prescribing practitioner who:
             215          (i) is employed as a health care provider by a prescribing practitioner or the outpatient
             216      clinic setting in which the prescribing practitioner works and is acting within the individual's
             217      scope of practice;
             218          (ii) is acting under the direction of a prescribing practitioner who is immediately
             219      available on site for any necessary consultation, and who has complied with Subsection
             220      (2)(b)(i);
             221          (iii) prepares or provides the cancer drug treatment regimen to the patient at the
             222      outpatient clinic setting; and
             223          (iv) follows Subsections (2)(b)(iv), (v), and (viii).
             224          (3) (a) The division shall work with stakeholders to evaluate the exemptions to
             225      licensure under this title in Subsections 58-17b-309 (2)(a), (c), and (d) and this section.
             226          (b) The evaluation under this Subsection (3) shall include:
             227          (i) practitioner compliance with the requirements of this section and Section
             228      58-17b-309 ;
             229          (ii) current research on dispensing and patient safety;
             230          (iii) survey of other state dispensing laws; and
             231          (iv) recommendations for future action concerning practitioner dispensing.
             232          (c) The division shall report to the Legislature's Health and Human Services Interim
             233      Committee by November 30, 2012, and by November 30, 2013, with the results and
             234      recommendations from the evaluation required by this Subsection (3).
             235          (4) This section sunsets in accordance with Section 63I-1-258 .
             236          Section 4. Section 58-67-502 is amended to read:
             237           58-67-502. Unprofessional conduct.
             238          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 [,]:
             239          (1) using or employing the services of any individual to assist a licensee in any manner
             240      not in accordance with the generally recognized practices, standards, or ethics of the
             241      profession, state law, or division rule[, or];
             242          (2) making a material misrepresentation regarding the qualifications for licensure under


             243      Section 58-67-302.7 [.]; or
             244          (3) violating the dispensing requirements of Section 58-17b-309 or 58-17b-309.5 if
             245      applicable.
             246          Section 5. Section 58-68-502 is amended to read:
             247           58-68-502. Unprofessional conduct.
             248          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 [,]:
             249          (1) using or employing the services of any individual to assist a licensee in any manner
             250      not in accordance with the generally recognized practices, standards, or ethics of the
             251      profession, state law, or division rule[.]; or
             252          (2) violating the dispensing requirements of Section 58-17b-309 or 58-17b-309.5 if
             253      applicable.
             254          Section 6. Section 58-70a-502 is amended to read:
             255           58-70a-502. Unlawful conduct.
             256          "Unlawful conduct" includes:
             257          (1) engaging in practice as a licensed physician assistant while not under the
             258      supervision of a supervising physician or substitute supervising physician[.]; or
             259          (2) violating the drug dispensing requirements of Section 58-17b-309 or 58-17b-309.5 ,
             260      if applicable.
             261          Section 7. Section 63I-1-258 is amended to read:
             262           63I-1-258. Repeal dates, Title 58.
             263          (1) Title 58, Chapter 9, Funeral Services Licensing Act, is repealed July 1, 2018.
             264          (2) Title 58, Chapter 13, Health Care Providers Immunity from Liability Act, is
             265      repealed July 1, 2016.
             266          (3) Title 58, Chapter 15, Health Facility Administrator Act, is repealed July 1, 2015.
             267          (4) Section 58-17b-309.5 is repealed July 1, 2015.
             268          [(4)] (5) Title 58, Chapter 20a, Environmental Health Scientist Act, is repealed July 1,
             269      2013.
             270          [(5)] (6) Title 58, Chapter 40, Recreational Therapy Practice Act, is repealed July 1,
             271      2013.
             272          [(6)] (7) Title 58, Chapter 41, Speech-language Pathology and Audiology Licensing
             273      Act, is repealed July 1, 2019.


             274          [(7)] (8) Title 58, Chapter 42a, Occupational Therapy Practice Act, is repealed July 1,
             275      2015.
             276          [(8)] (9) Title 58, Chapter 46a, Hearing Instrument Specialist Licensing Act, is
             277      repealed July 1, 2013.
             278          [(9)] (10) Title 58, Chapter 47b, Massage Therapy Practice Act, is repealed July 1,
             279      2014.
             280          [(10)] (11) Title 58, Chapter 72, Acupuncture Licensing Act, is repealed July 1, 2017.
             281          [(11)] (12) Section 58-13-2.5 is repealed July 1, 2013.


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