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Fifth Substitute S.B. 161

Senator Curtis S. Bramble 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 exemptions from licensure in the Pharmacy Practice Act.
             10      Highlighted Provisions:
             11          This bill:
             12          .    defines a cancer drug treatment regimen;
             13          .    exempts an oncologist from the licensing requirements under the Pharmacy Practice
             14      Act when the oncologist provides a cancer drug treatment regimen to a patient who
             15      is currently undergoing chemotherapy in an outpatient clinic;
             16          .    excludes Schedule I, II, and III drugs from the drugs an oncologist may provide to a
             17      patient under the licensing exemption from the Pharmacy Practice Act; and
             18          .    includes assistants to the oncologist who are under the supervision of the oncologist
             19      in the licensing exemption from the Pharmacy Practice Act.
             20      Money Appropriated in this Bill:
             21          None
             22      Other Special Clauses:
             23          None
             24      Utah Code Sections Affected:
             25      AMENDS:


             26          58-17b-309, as last amended by Laws of Utah 2011, Chapter 76
             27     
             28      Be it enacted by the Legislature of the state of Utah:
             29          Section 1. Section 58-17b-309 is amended to read:
             30           58-17b-309. Exemptions from licensure.
             31          (1) For purposes of this section:
             32          (a) "Cancer drug treatment regimen":
             33          (i) means a prescription drug used to treat cancer, manage its symptoms, or provide
             34      continuity of care for a cancer patient;
             35          (ii) includes:
             36          (A) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
             37      methods; and
             38          (B) a drug used to support cancer treatment, including to treat, alleviate, or minimize
             39      physical and psychological symptoms or pain, or to improve patient tolerance of cancer
             40      treatments or prepare a patient for a subsequent course of therapy; and
             41          (iii) does not mean a drug listed under federal law as a Schedule I, II, or III drug.
             42          [(a)] (b) "Cosmetic drug":
             43          (i) means a prescription drug that is:
             44          (A) for the purpose of promoting attractiveness or altering the appearance of an
             45      individual; and
             46          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             47      by administrative rule; and
             48          (ii) does not include a prescription drug that is:
             49          (A) a controlled substance;
             50          (B) compounded by the physician; or
             51          (C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,
             52      treating, or preventing a disease.
             53          [(b)] (c) "Injectable weight loss drug":
             54          (i) means an injectable prescription drug:
             55          (A) prescribed to promote weight loss; and
             56          (B) listed as an injectable prescription drug subject to exemption under this section by


             57      the division by administrative rule; and
             58          (ii) does not include a prescription drug that is a controlled substance.
             59          [(c)] (d) "Prescribing practitioner" means an individual licensed under:
             60          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             61      prescriptive practice;
             62          (ii) Chapter 67, Utah Medical Practice Act;
             63          (iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
             64          (iv) Chapter 70a, Physician Assistant Act.
             65          (2) In addition to the exemptions from licensure in Section 58-1-307 , the following
             66      individuals may engage in the acts or practices described in this section without being licensed
             67      under this chapter:
             68          (a) a person selling or providing contact lenses in accordance with Section 58-16a-801 ;
             69          (b) an individual engaging in the practice of pharmacy technician under the direct
             70      personal supervision of a pharmacist while making satisfactory progress in an approved
             71      program as defined in division rule;
             72          (c) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
             73      injectable weight loss drug to the prescribing practitioner's patient in accordance with
             74      Subsection (4); [and]
             75          (d) an optometrist, as defined in Section 58-16a-102 , acting within the optometrist's
             76      scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses a cosmetic
             77      drug to the optometrist's patient in accordance with Subsection (4)[.]; and
             78          (e) (i) a prescribing practitioner who:
             79          (A) treats a patient who is currently undergoing chemotherapy in an outpatient clinic
             80      setting;
             81          (B) prescribes a cancer drug treatment regimen to the patient:
             82          (C) determines that providing the cancer drug treatment regimen to the patient in the
             83      outpatient clinic setting is in the best interest of the patient, or provides better access to care for
             84      the patient;
             85          (D) discloses to the patient that the cancer drug treatment regimen may be obtained
             86      from a pharmacy unaffiliated with the prescribing practitioner;
             87          (E) does not directly or indirectly mark up, charge a commission, or make a profit on


             88      providing the cancer drug regimen, but may obtain payment for expenses and services related
             89      to providing the cancer drug regimen;
             90          (F) provides the cancer drug treatment regimen to the patient, or directs another person
             91      under Subsection (2)(e)(ii) to provide the cancer drug treatment regimen to the patient;
             92          (G) is certified or eligible to be certified by the American Board of Internal Medicine
             93      in medical oncology;
             94          (H) reports to the Utah Controlled Substance Database in the same manner as required
             95      by Section 58-37f-203 , and follows labeling, recordkeeping, patient counseling, and storage
             96      requirements established by administrative rule adopted by the division in consultation with the
             97      board; and
             98          (I) for drugs described in Subsection (1)(a)(ii)(B) only, follows the USP-NF 979
             99      standards for sterile compounding if the drug dispensed to the patient is reconstituted or
             100      compounded; and
             101          (ii) a person who is not a prescribing practitioner who:
             102          (A) is employed as a healthcare provider by a prescribing practitioner or the outpatient
             103      clinic setting in which the prescribing practitioner works and is acting within the individual's
             104      scope of practice;
             105          (B) is acting under the direction of a prescribing practitioner who is immediately
             106      available on site for any necessary consultation, and who has complied with Subsection
             107      (2)(e)(i);
             108          (C) prepares or provides the cancer drug treatment regimen to the patient at the
             109      outpatient clinic setting; and
             110          (D) follows Subsections (2)(e)(i)(E) and (H).
             111          (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
             112      Subsection (2)(b) must take all examinations as required by division rule following completion
             113      of an approved curriculum of education, within the required time frame. This exemption
             114      expires immediately upon notification of a failing score of an examination, and the individual
             115      may not continue working as a pharmacy technician even under direct supervision.
             116          (4) A prescribing practitioner or optometrist is exempt from licensing under the
             117      provisions of this part if the prescribing practitioner or optometrist:
             118          (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the


             119      authority to dispense under Subsection (4)(b); and
             120          (ii) informs the patient:
             121          (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
             122      practitioner's or optometrist's office;
             123          (B) of the directions for appropriate use of the drug;
             124          (C) of potential side-effects to the use of the drug; and
             125          (D) how to contact the prescribing practitioner or optometrist if the patient has
             126      questions or concerns regarding the drug;
             127          (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             128      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
             129      patients; and
             130          (c) follows labeling, record keeping, patient counseling, and storage requirements
             131      established by administrative rule adopted by the division in consultation with the boards listed
             132      in Subsection (5)(a).
             133          (5) (a) The division, in consultation with the board under this chapter, the Physician
             134      Licensing Board, the Osteopathic Physician Licensing Board, the Physician Assistant Licensing
             135      Board, the Board of Nursing, and the Optometrist Licensing Board shall adopt administrative
             136      rules pursuant to Title 63G, Chapter 3, Utah Administrative 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)(c).
             140          (b) When making a determination under Subsection (1)[(a)](b), the division and boards
             141      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications
             142      or approval associated with a drug when adopting a rule to designate a prescription drug that
             143      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 and 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; or
             158          (E) Chapter 70a, Physician Assistant Act.
             159          (6) Except as provided in Subsection (2)(d), this section does not restrict or limit the
             160      scope of practice of an optometrist or optometric physician licensed under Chapter 16a, Utah
             161      Optometry Practice Act.


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