<?xml version="1.0" encoding="UTF-8"?>

<leg xml:space="preserve" filenumber="2024FL0184" billnumber="HB0132" billnum="HB0132" designation="HB" otherSponsor="Evan J. Vickers" otherHouse="Senate" sess="2024GS" fileno="2024FL0184" date="03-06-24" printDate="06-19 07:32" subVer="-2" minVer="1" office="LEGISLATIVE GENERAL COUNSEL" actionDate="" impact="code" track=" " sponsor="Raymond P. Ward">
  <info>
    <nextbuid>3</nextbuid>
    <aminfo anum="0" effdate="5/1/2024" datetype="most">
      <seclist>
        <sect uid="C58-17b-S605_2024050120240501" fromuid="C58-17b-S605_2020051220200512" buid="1" src="code" mtype="section" action="A" sort="58 17b06050020240501" effdate="5/1/2024">58-17b-605</sect>
        <sect uid="EF0000" buid="2" src="uncod" untype="effdate" mtype="section" sort="UZEFF" effdate="5/1/2024"/>
      </seclist>
    </aminfo>
  </info>
  <tbox>
    <sinfo/>
    <st numlevel="1" lineno="1" slineno="0-1">PHARMACY AMENDMENTS</st>
    <sessionhead>2024 GENERAL SESSION</sessionhead>
    <statehead>STATE OF UTAH</statehead>
    <sponsorhead>Chief Sponsor: Raymond P. Ward</sponsorhead>
    <otherSponsorhead>Senate Sponsor: Evan J. Vickers</otherSponsorhead>
  </tbox>
  <lt numlevel="1" lineno="2" slineno="0-2">
    <lthead lineno="3">LONG TITLE</lthead>
    <gdhead lineno="4">General Description:</gdhead>
    <gd numlevel="1" lineno="5" slineno="0-5">This bill allows pharmacists and pharmacy interns to substitute prescribed drugs under  
      <ln numlevel="1" lineno="6" slineno="0-6"/>certain circumstances.
    </gd>
    <hphead lineno="7">Highlighted Provisions:</hphead>
    <hp numlevel="1" lineno="8" slineno="0-8">This bill:
      <hl numlevel="1" lineno="9" slineno="0-9" level="1">defines terms;</hl>
      <hl numlevel="1" lineno="10" slineno="0-10" level="1">allows pharmacists and pharmacy interns to substitute prescribed drugs under certain  
        <ln numlevel="1" lineno="11" slineno="0-11"/>circumstances;
      </hl>
      <hl numlevel="1" lineno="12" slineno="0-12" level="1">requires the Division of Professional Licensing, in consultation with certain licensing  
        <ln numlevel="1" lineno="13" slineno="0-13"/>boards, to develop a therapeutically similar drug list; and
      </hl>
      <hl numlevel="1" lineno="14" slineno="0-14" level="1">provides rulemaking authority.</hl>
    </hp>
    <moni numlevel="1" lineno="15" slineno="0-15" display="none">Money Appropriated in this Bill:</moni>
    <moniNone lineno="16">None</moniNone>
    <oc numlevel="1" lineno="17" slineno="0-17">Other Special Clauses:</oc>
    <ocNone lineno="18">None</ocNone>
    <sa numlevel="1" lineno="19" slineno="0-19">Utah Code Sections Affected:
      <saamd numlevel="1" lineno="20" slineno="0-20">
        <snhead>AMENDS:</snhead>
        <sn num="58-17b-605" src="code" uid="C58-17b-S605_2024050120240501" buid="1" sort="58 17b06050020240501" numlevel="1" lineno="21" slineno="0-21">
          <bold>58-17b-605</bold>, as last amended by Laws of Utah 2020, Chapter 372
        </sn>
      </saamd>
    </sa>
  </lt>
  <enacthead lineno="22"/>
  <enact numlevel="1" lineno="23" slineno="0-23">Be it enacted by the Legislature of the state of Utah:</enact>
  <bdy>
    <bsec buid="1" type="amend" src="code" num="58-17b-605" uid="C58-17b-S605_2024050120240501" sort="58 17b06050020240501" fromUID="C58-17b-S605_2020051220200512" numlevel="1" lineno="24" slineno="1-1" sn="1">
      <section number="58-17b-605" numlevel="1" lineno="25" slineno="1-2" type="amend">
        <secline lineno="24">Section 1, Section  
          <bold>58-17b-605</bold> is amended to read:
        </secline>
        <catline lineno="25">
          <bold>58-17b-605. Drug product equivalents and similar drug products.</bold>
        </catline>
        <subsection ssid="1-1" dnum="1-o" numlevel="1" lineno="26" slineno="1-3" placement="noreturn">
          <display>(1)</display>For the purposes of this section:
          <subsection ssid="1-2" dnum="a-o" numlevel="1" lineno="27" slineno="1-4" space="false">
            <display>(a)</display>
            <subsection ssid="1-3" dnum="i-o" placement="sameline">
              <display>(i)</display>"Drug" is as defined in Section 
              <xref depth="3" refnumber="58-17b-102">58-17b-102</xref>.
            </subsection>
            <subsection ssid="1-4" dnum="ii-o" numlevel="1" lineno="28" slineno="1-5">
              <display>(ii)</display>"Drug" 
              <amendoutstart style="5"/>
              <amend anum="0" ea="erase" pairid="1" style="2" owner="cwilliams" level="1" deltag="both">does not mean</amend>
              <amendoutend style="5"/>
              <amend anum="0" ea="amend" pairid="2" style="1" owner="cwilliams" level="1" amendtag="both" space="true">includes</amend> a "biological product" as defined in Section 
              <xref depth="3" refnumber="58-17b-605.5">
                <ln numlevel="1" lineno="29" slineno="1-6"/>58-17b-605.5
              </xref>.
            </subsection>
          </subsection>
          <subsection ssid="1-5" dnum="b-o" numlevel="1" lineno="30" slineno="1-7">
            <display>(b)</display>"Drug product equivalent" means
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="3" style="2" owner="cwilliams" level="1" deltag="both">:</amend>
            <amendoutend style="5"/>
            <subsection ssid="1-6" dnum="i-o:_-e" ea="erase" anum="0" owner="cwilliams" style="2" numlevel="1" lineno="31" slineno="1-8">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="151" style="2" owner="o" level="1" deltag="both">(i)</amend>
                <amendoutend style="5"/>
              </display>a drug product that is designated as the therapeutic equivalent of another drug  
              <ln numlevel="1" lineno="32" slineno="1-9"/>product in the Approved Drug Products with Therapeutic Equivalence Evaluations  
              <ln numlevel="1" lineno="33" slineno="1-10"/>prepared by the Center for Drug Evaluation and Research of the United States  
              <ln numlevel="1" lineno="34" slineno="1-11"/>Food and Drug Administration
              <amendoutstart style="5"/>
              <amend anum="0" ea="erase" pairid="5" style="2" owner="cwilliams" level="1" deltag="both">; and</amend>
              <amendoutend style="5"/>
              <amend anum="0" ea="amend" pairid="6" style="1" owner="cwilliams" level="1" amendtag="both" space="true">.</amend>
            </subsection>
            <subsection ssid="1-7" dnum="ii-o:_-e" ea="erase" anum="0" owner="cwilliams" style="2" numlevel="1" lineno="35" slineno="1-12">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="152" style="2" owner="o" level="1" deltag="start">(ii)</amend>
              </display>
              <amend anum="0" ea="erase" pairid="9" style="2" owner="cwilliams" level="1" deltag="end">notwithstanding Subsection (1)(b)(i), an appropriate substitute for albuterol  
                <ln numlevel="1" lineno="36" slineno="1-13"/>designated by division rule made under Subsection (9).
              </amend>
              <amendoutend style="5"/>
            </subsection>
          </subsection>
          <subsection ssid="1-8" dnum="_-o:c-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="37" slineno="1-14">
            <display>
              <amend anum="0" ea="amend" pairid="153" style="1" owner="e" level="1" amendtag="start">(c)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="12" style="1" owner="cwilliams" level="1" amendtag="end">"Osteopathic Physician and Surgeon's Licensing Board" means the board created in  
              <ln numlevel="1" lineno="38" slineno="1-15"/>Section  
              <xref depth="3" refnumber="58-68-201">58-68-201</xref>.
            </amend>
          </subsection>
          <subsection ssid="1-9" dnum="_-o:d-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="39" slineno="1-16">
            <display>
              <amend anum="0" ea="amend" pairid="154" style="1" owner="e" level="1" amendtag="start">(d)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="15" style="1" owner="cwilliams" level="1" amendtag="end">"Physicians Licensing Board" means the board created in Section  
              <xref depth="3" refnumber="58-67-201">58-67-201</xref>.
            </amend>
          </subsection>
          <subsection ssid="1-10" dnum="_-o:e-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="40" slineno="1-17">
            <display>
              <amend anum="0" ea="amend" pairid="155" style="1" owner="e" level="1" amendtag="start">(e)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="18" style="1" owner="cwilliams" level="1" amendtag="end">"Therapeutically similar drug product" means a drug product that:</amend>
            <subsection ssid="1-11" dnum="_-o:i-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="41" slineno="1-18">
              <display>
                <amend anum="0" ea="amend" pairid="156" style="1" owner="e" level="1" amendtag="start">(i)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="20" style="1" owner="cwilliams" level="1" amendtag="end">provides a similar level of therapeutic benefit and risk to a patient as another drug  
                <ln numlevel="1" lineno="42" slineno="1-19"/>product; and
              </amend>
            </subsection>
            <subsection ssid="1-12" dnum="_-o:ii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="43" slineno="1-20">
              <display>
                <amend anum="0" ea="amend" pairid="157" style="1" owner="e" level="1" amendtag="start">(ii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="23" style="1" owner="cwilliams" level="1" amendtag="end">is on the list of therapeutically similar drugs created by the division in accordance  
                <ln numlevel="1" lineno="44" slineno="1-21"/>with Subsection (9).
              </amend>
            </subsection>
          </subsection>
        </subsection>
        <subsection ssid="1-13" dnum="2-o" numlevel="1" lineno="45" slineno="1-22">
          <display>(2)</display>A pharmacist or pharmacy intern dispensing a prescription order for a specific drug by  
          <ln numlevel="1" lineno="46" slineno="1-23"/>brand or proprietary name may substitute
          <amendoutstart style="5"/>
          <amend anum="0" ea="erase" pairid="146" style="2" owner="cwilliams" level="1" deltag="both"> </amend>
          <amendoutend style="5"/>
          <amend anum="0" ea="amend" pairid="26" style="1" owner="cwilliams" level="1" amendtag="both" space="true">:</amend>
          <subsection ssid="1-14" dnum="_-o:a-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="47" slineno="1-24">
            <display>
              <amend anum="0" ea="amend" pairid="159" style="1" owner="e" level="1" amendtag="both">(a)</amend>
            </display>a drug product equivalent for the prescribed drug  
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="28" style="2" owner="cwilliams" level="1" deltag="both">only</amend>
            <amendoutend style="5"/> if:
            <subsection ssid="1-15" dnum="a-o:i-e" numlevel="1" lineno="48" slineno="1-25">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="160" style="2" owner="o" level="1" deltag="both">(a)</amend>
                <amendoutend style="5"/>
                <amend anum="0" ea="amend" pairid="161" style="1" owner="e" level="1" amendtag="both" space="true">(i)</amend>
              </display>the purchaser specifically requests or consents to the substitution of a drug  
              <ln numlevel="1" lineno="49" slineno="1-26"/>product equivalent;
            </subsection>
            <subsection ssid="1-16" dnum="b-o:ii-e" numlevel="1" lineno="50" slineno="1-27">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="161" style="2" owner="o" level="1" deltag="both">(b)</amend>
                <amendoutend style="5"/>
                <amend anum="0" ea="amend" pairid="162" style="1" owner="e" level="1" amendtag="both" space="true">(ii)</amend>
              </display>the drug product equivalent is of the same generic type and is designated the  
              <ln numlevel="1" lineno="51" slineno="1-28"/>therapeutic equivalent in the approved drug products with therapeutic equivalence  
              <ln numlevel="1" lineno="52" slineno="1-29"/>evaluations prepared by the Center for Drug Evaluation and Research of the  
              <ln numlevel="1" lineno="53" slineno="1-30"/>Federal Food and Drug Administration;
            </subsection>
            <subsection ssid="1-17" dnum="c-o:iii-e" numlevel="1" lineno="54" slineno="1-31">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="162" style="2" owner="o" level="1" deltag="both">(c)</amend>
                <amendoutend style="5"/>
                <amend anum="0" ea="amend" pairid="163" style="1" owner="e" level="1" amendtag="both" space="true">(iii)</amend>
              </display>the drug product equivalent is permitted to move in interstate commerce;
            </subsection>
            <subsection ssid="1-18" dnum="d-o:iv-e" numlevel="1" lineno="55" slineno="1-32">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="163" style="2" owner="o" level="1" deltag="both">(d)</amend>
                <amendoutend style="5"/>
                <amend anum="0" ea="amend" pairid="164" style="1" owner="e" level="1" amendtag="both" space="true">(iv)</amend>
              </display>the pharmacist or pharmacy intern counsels the patient on the use and the  
              <ln numlevel="1" lineno="56" slineno="1-33"/>expected response to the prescribed drug, whether a substitute or not
              <amendoutstart style="5"/>
              <amend anum="0" ea="erase" pairid="29" style="2" owner="cwilliams" level="1" deltag="both">, and </amend>
              <amendoutend style="5"/>
              <amend anum="0" ea="amend" pairid="30" style="1" owner="cwilliams" level="1" amendtag="both" space="true">;</amend>
            </subsection>
            <subsection ssid="1-19" dnum="_-o:v-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="57" slineno="1-34">
              <display>
                <amend anum="0" ea="amend" pairid="164" style="1" owner="e" level="1" amendtag="both">(v)</amend>
              </display>the substitution is not otherwise prohibited by  
              <amendoutstart style="5"/>
              <amend anum="0" ea="erase" pairid="32" style="2" owner="cwilliams" level="1" deltag="both">this chapter;</amend>
              <amendoutend style="5"/>
              <amend anum="0" ea="amend" pairid="33" style="1" owner="cwilliams" level="1" amendtag="both" space="true">law; and</amend>
            </subsection>
            <subsection ssid="1-20" dnum="e-o:vi-e" numlevel="1" lineno="58" slineno="1-35">
              <display>
                <amendoutstart style="5"/>
                <amend anum="0" ea="erase" pairid="165" style="2" owner="o" level="1" deltag="both">(e)</amend>
                <amendoutend style="5"/>
                <amend anum="0" ea="amend" pairid="166" style="1" owner="e" level="1" amendtag="both" space="true">(vi)</amend>
              </display>the prescribing practitioner has not indicated that a drug product equivalent  
              <ln numlevel="1" lineno="59" slineno="1-36"/>may not be substituted for the drug, as provided in Subsection (6);  
              <amendoutstart style="5"/>
              <amend anum="0" ea="erase" pairid="35" style="2" owner="cwilliams" level="1" deltag="both">and</amend>
              <amendoutend style="5"/>
              <amend anum="0" ea="amend" pairid="36" style="1" owner="cwilliams" level="1" amendtag="both" space="true">or</amend>
            </subsection>
          </subsection>
          <subsection ssid="1-21" dnum="f-o:_-e" ea="erase" anum="0" owner="cwilliams" style="2" numlevel="1" lineno="60" slineno="1-37">
            <display>
              <amendoutstart style="5"/>
              <amend anum="0" ea="erase" pairid="166" style="2" owner="o" level="1" deltag="start">(f)</amend>
            </display>
            <amend anum="0" ea="erase" pairid="39" style="2" owner="cwilliams" level="1" deltag="end">the substitution is not otherwise prohibited by law.</amend>
            <amendoutend style="5"/>
          </subsection>
          <subsection ssid="1-22" dnum="_-o:b-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="61" slineno="1-38">
            <display>
              <amend anum="0" ea="amend" pairid="167" style="1" owner="e" level="1" amendtag="start">(b)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="42" style="1" owner="cwilliams" level="1" amendtag="end">a therapeutically similar drug product if:</amend>
            <subsection ssid="1-23" dnum="_-o:i-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="62" slineno="1-39">
              <display>
                <amend anum="0" ea="amend" pairid="168" style="1" owner="e" level="1" amendtag="start">(i)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="44" style="1" owner="cwilliams" level="1" amendtag="end">the prescriber has written "similar substitution authorized" on the prescription for  
                <ln numlevel="1" lineno="63" slineno="1-40"/>the prescribed drug;
              </amend>
            </subsection>
            <subsection ssid="1-24" dnum="_-o:ii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="64" slineno="1-41">
              <display>
                <amend anum="0" ea="amend" pairid="169" style="1" owner="e" level="1" amendtag="start">(ii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="47" style="1" owner="cwilliams" level="1" amendtag="end">the therapeutically similar drug product is listed on the therapeutically similar  
                <ln numlevel="1" lineno="65" slineno="1-42"/>drug list described in Subsection (9) as a drug that can be substituted for the  
                <ln numlevel="1" lineno="66" slineno="1-43"/>prescribed drug;
              </amend>
            </subsection>
            <subsection ssid="1-25" dnum="_-o:iii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="67" slineno="1-44">
              <display>
                <amend anum="0" ea="amend" pairid="170" style="1" owner="e" level="1" amendtag="start">(iii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="50" style="1" owner="cwilliams" level="1" amendtag="end">the purchaser specifically requests or consents to the substitution of the  
                <ln numlevel="1" lineno="68" slineno="1-45"/>therapeutically similar drug;
              </amend>
            </subsection>
            <subsection ssid="1-26" dnum="_-o:iv-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="69" slineno="1-46">
              <display>
                <amend anum="0" ea="amend" pairid="171" style="1" owner="e" level="1" amendtag="start">(iv)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="53" style="1" owner="cwilliams" level="1" amendtag="end">the dispensed therapeutically similar drug product is permitted to move in  
                <ln numlevel="1" lineno="70" slineno="1-47"/>interstate commerce;
              </amend>
            </subsection>
            <subsection ssid="1-27" dnum="_-o:v-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="71" slineno="1-48">
              <display>
                <amend anum="0" ea="amend" pairid="172" style="1" owner="e" level="1" amendtag="start">(v)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="56" style="1" owner="cwilliams" level="1" amendtag="end">the pharmacist or pharmacy intern counsels the patient on the use and the  
                <ln numlevel="1" lineno="72" slineno="1-49"/>expected response to the therapeutically similar drug product;
              </amend>
            </subsection>
            <subsection ssid="1-28" dnum="_-o:vi-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="73" slineno="1-50">
              <display>
                <amend anum="0" ea="amend" pairid="173" style="1" owner="e" level="1" amendtag="start">(vi)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="59" style="1" owner="cwilliams" level="1" amendtag="end">the substitution is not otherwise prohibited by law; and</amend>
            </subsection>
            <subsection ssid="1-29" dnum="_-o:vii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="74" slineno="1-51">
              <display>
                <amend anum="0" ea="amend" pairid="174" style="1" owner="e" level="1" amendtag="start">(vii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="62" style="1" owner="cwilliams" level="1" amendtag="end">the substitution:</amend>
              <subsection ssid="1-30" dnum="_-o:A-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="75" slineno="1-52">
                <display>
                  <amend anum="0" ea="amend" pairid="175" style="1" owner="e" level="1" amendtag="start">(A)</amend>
                </display>
                <amend anum="0" ea="amend" pairid="64" style="1" owner="cwilliams" level="1" amendtag="end">results in a decreased cost to the patient;</amend>
              </subsection>
              <subsection ssid="1-31" dnum="_-o:B-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="76" slineno="1-53">
                <display>
                  <amend anum="0" ea="amend" pairid="176" style="1" owner="e" level="1" amendtag="start">(B)</amend>
                </display>
                <amend anum="0" ea="amend" pairid="67" style="1" owner="cwilliams" level="1" amendtag="end">is covered on the patient's health benefit plan formulary as a preferred drug or  
                  <ln numlevel="1" lineno="77" slineno="1-54"/>at the same or lower payment tier;
                </amend>
              </subsection>
              <subsection ssid="1-32" dnum="_-o:C-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="78" slineno="1-55">
                <display>
                  <amend anum="0" ea="amend" pairid="177" style="1" owner="e" level="1" amendtag="start">(C)</amend>
                </display>
                <amend anum="0" ea="amend" pairid="70" style="1" owner="cwilliams" level="1" amendtag="end">is necessary because the pharmacist does not have the originally prescribed  
                  <ln numlevel="1" lineno="79" slineno="1-56"/>medication available to dispense to the patient; or
                </amend>
              </subsection>
              <subsection ssid="1-33" dnum="_-o:D-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="80" slineno="1-57">
                <display>
                  <amend anum="0" ea="amend" pairid="178" style="1" owner="e" level="1" amendtag="start">(D)</amend>
                </display>
                <amend anum="0" ea="amend" pairid="73" style="1" owner="cwilliams" level="1" amendtag="end">would be beneficial to the patient for any reason if the patient and pharmacist  
                  <ln numlevel="1" lineno="81" slineno="1-58"/>mutually agree that the substitution would benefit the patient.
                </amend>
              </subsection>
            </subsection>
          </subsection>
        </subsection>
        <subsection ssid="1-34" dnum="3-o" numlevel="1" lineno="82" slineno="1-59" space="false">
          <display>(3)</display>
          <subsection ssid="1-35" dnum="a-o" placement="sameline">
            <display>(a)</display>Each out-of-state mail service pharmacy dispensing a drug product equivalent
            <amend anum="0" ea="amend" pairid="77" style="1" owner="cwilliams" level="1" amendtag="both">or 
              <ln numlevel="1" lineno="83" slineno="1-60"/>a therapeutically similar drug product
            </amend> as a substitute for another drug into this state 
            <ln numlevel="1" lineno="84" slineno="1-61"/>shall notify the patient of the substitution either by telephone or in writing.
          </subsection>
          <subsection ssid="1-36" dnum="b-o" numlevel="1" lineno="85" slineno="1-62">
            <display>(b)</display>Each out-of-state mail service pharmacy shall comply with the requirements of this 
            <ln numlevel="1" lineno="86" slineno="1-63"/>chapter with respect to a drug product equivalent
            <amend anum="0" ea="amend" pairid="78" style="1" owner="cwilliams" level="1" amendtag="both">or a therapeutically similar drug 
              <ln numlevel="1" lineno="87" slineno="1-64"/>product
            </amend> substituted for another drug, including labeling and record keeping.
          </subsection>
        </subsection>
        <subsection ssid="1-37" dnum="4-o" numlevel="1" lineno="88" slineno="1-65" space="false">
          <display>(4)</display>
          <subsection ssid="1-38" dnum="_-o:a-e" ea="amend" anum="0" owner="cwilliams" style="1" placement="sameline">
            <display>
              <amend anum="0" ea="amend" pairid="183" style="1" owner="e" level="1" amendtag="both">(a)</amend>
            </display>Pharmacists or pharmacy interns may not substitute without the prescriber's 
            <ln numlevel="1" lineno="89" slineno="1-66"/>authorization on trade name drug product prescriptions unless the product is currently 
            <ln numlevel="1" lineno="90" slineno="1-67"/>categorized in the approved drug products with therapeutic equivalence evaluations 
            <ln numlevel="1" lineno="91" slineno="1-68"/>prepared by the Center for Drug Evaluation and Research of the Federal Food and 
            <ln numlevel="1" lineno="92" slineno="1-69"/>Drug Administration as a drug product considered to be therapeutically equivalent to 
            <ln numlevel="1" lineno="93" slineno="1-70"/>another drug product.
          </subsection>
          <subsection ssid="1-39" dnum="_-o:b-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="94" slineno="1-71">
            <display>
              <amend anum="0" ea="amend" pairid="184" style="1" owner="e" level="1" amendtag="start">(b)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="82" style="1" owner="cwilliams" level="1" amendtag="end">A pharmacist or pharmacy intern that substitutes a drug product for a therapeutically 
              <ln numlevel="1" lineno="95" slineno="1-72"/>similar drug product under Subsection (2)(b), for any prescription intended to last 
              <ln numlevel="1" lineno="96" slineno="1-73"/>longer than 30 days, shall notify the prescriber that the pharmacist or pharmacy intern 
              <ln numlevel="1" lineno="97" slineno="1-74"/>substituted the drug.
            </amend>
          </subsection>
        </subsection>
        <subsection ssid="1-40" dnum="5-o" numlevel="1" lineno="98" slineno="1-75">
          <display>(5)</display>A pharmacist or pharmacy intern who dispenses a prescription with a drug product  
          <ln numlevel="1" lineno="99" slineno="1-76"/>equivalent
          <amend anum="0" ea="amend" pairid="84" style="1" owner="cwilliams" level="1" amendtag="both"> or a therapeutically similar drug product</amend> under this section assumes no  
          <ln numlevel="1" lineno="100" slineno="1-77"/>greater liability than would be incurred had the pharmacist or pharmacy intern dispensed  
          <ln numlevel="1" lineno="101" slineno="1-78"/>the prescription with the drug product prescribed.
        </subsection>
        <subsection ssid="1-41" dnum="6-o" numlevel="1" lineno="102" slineno="1-79" space="false">
          <display>(6)</display>
          <subsection ssid="1-42" dnum="a-o" placement="sameline">
            <display>(a)</display>If, in the opinion of the prescribing practitioner, it is in the best interest of the 
            <ln numlevel="1" lineno="103" slineno="1-80"/>patient that a drug product equivalent not be substituted for a prescribed drug, the 
            <ln numlevel="1" lineno="104" slineno="1-81"/>practitioner may indicate a prohibition on substitution either by writing "dispense as 
            <ln numlevel="1" lineno="105" slineno="1-82"/>written" or signing in the appropriate space where two lines have been preprinted on 
            <ln numlevel="1" lineno="106" slineno="1-83"/>a prescription order and captioned "dispense as written" or "substitution permitted".
          </subsection>
          <subsection ssid="1-43" dnum="b-o" numlevel="1" lineno="107" slineno="1-84">
            <display>(b)</display>If the prescription is communicated orally by the prescribing practitioner to the 
            <ln numlevel="1" lineno="108" slineno="1-85"/>pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on 
            <ln numlevel="1" lineno="109" slineno="1-86"/>substitution and that indication shall be noted in writing by the pharmacist or 
            <ln numlevel="1" lineno="110" slineno="1-87"/>pharmacy intern with the name of the practitioner and the words "orally by" and the 
            <ln numlevel="1" lineno="111" slineno="1-88"/>initials of the pharmacist or pharmacy intern written after it.
          </subsection>
        </subsection>
        <subsection ssid="1-44" dnum="7-o" numlevel="1" lineno="112" slineno="1-89" space="false">
          <display>(7)</display>
          <subsection ssid="1-45" dnum="_-o:a-e" ea="amend" anum="0" owner="cwilliams" style="1" placement="sameline">
            <display>
              <amend anum="0" ea="amend" pairid="190" style="1" owner="e" level="1" amendtag="both">(a)</amend>
            </display>A pharmacist or pharmacy intern who substitutes a drug product equivalent
            <amend anum="0" ea="amend" pairid="86" style="1" owner="cwilliams" level="1" amendtag="both">or 
              <ln numlevel="1" lineno="113" slineno="1-90"/>therapeutically similar drug product
            </amend> for a prescribed drug shall communicate the 
            <ln numlevel="1" lineno="114" slineno="1-91"/>substitution to the purchaser.
          </subsection>
          <subsection ssid="1-46" dnum="_-o:b-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="115" slineno="1-92">
            <display>
              <amend anum="0" ea="amend" pairid="191" style="1" owner="e" level="1" amendtag="both">(b)</amend>
            </display> The drug product equivalent
            <amend anum="0" ea="amend" pairid="89" style="1" owner="cwilliams" level="1" amendtag="both">or therapeutically similar drug product</amend> container shall 
            <ln numlevel="1" lineno="116" slineno="1-93"/>be labeled with the name of the drug dispensed
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="90" style="2" owner="cwilliams" level="1" deltag="both">, and the</amend>
            <amendoutend style="5"/>
            <amend anum="0" ea="amend" pairid="91" style="1" owner="cwilliams" level="1" amendtag="both" space="true">.</amend>
          </subsection>
          <subsection ssid="1-47" dnum="_-o:c-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="117" slineno="1-94">
            <display>
              <amend anum="0" ea="amend" pairid="192" style="1" owner="e" level="1" amendtag="start">(c)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="94" style="1" owner="cwilliams" level="1" amendtag="end">The</amend> pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file 
            <ln numlevel="1" lineno="118" slineno="1-95"/>copy of the prescription both the name of the prescribed drug and the name of the 
            <ln numlevel="1" lineno="119" slineno="1-96"/>drug product equivalent
            <amend anum="0" ea="amend" pairid="95" style="1" owner="cwilliams" level="1" amendtag="both">or the therapeutically similar drug product</amend> dispensed in 
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="96" style="2" owner="cwilliams" level="1" deltag="both">its</amend>
            <amendoutend style="5"/>
            <ln numlevel="1" lineno="120" slineno="1-97"/> place
            <amend anum="0" ea="amend" pairid="97" style="1" owner="cwilliams" level="1" amendtag="both">of the prescribed drug</amend>.
          </subsection>
        </subsection>
        <subsection ssid="1-48" dnum="8-o" numlevel="1" lineno="121" slineno="1-98" space="false">
          <display>(8)</display>
          <subsection ssid="1-49" dnum="a-o" placement="sameline">
            <display>(a)</display>For purposes of this Subsection (8), "substitutes" means to substitute:
            <subsection ssid="1-50" dnum="i-o" numlevel="1" lineno="122" slineno="1-99" tab="1">
              <display>(i)</display>a generic drug for another generic drug;
            </subsection>
            <subsection ssid="1-51" dnum="ii-o" numlevel="1" lineno="123" slineno="1-100" tab="1">
              <display>(ii)</display>a generic drug for a nongeneric drug;
            </subsection>
            <subsection ssid="1-52" dnum="iii-o" numlevel="1" lineno="124" slineno="1-101" tab="1">
              <display>(iii)</display>a nongeneric drug for another nongeneric drug; or
            </subsection>
            <subsection ssid="1-53" dnum="iv-o" numlevel="1" lineno="125" slineno="1-102" tab="1">
              <display>(iv)</display>a nongeneric drug for a generic drug.
            </subsection>
          </subsection>
          <subsection ssid="1-54" dnum="b-o" numlevel="1" lineno="126" slineno="1-103">
            <display>(b)</display>A prescribing practitioner who makes a finding under Subsection (6)(a) for a patient 
            <ln numlevel="1" lineno="127" slineno="1-104"/>with a seizure disorder shall indicate a prohibition on substitution of a drug product 
            <ln numlevel="1" lineno="128" slineno="1-105"/>equivalent in the manner provided in Subsection (6)(a) or (b).
          </subsection>
          <subsection ssid="1-55" dnum="c-o" numlevel="1" lineno="129" slineno="1-106">
            <display>(c)</display>Except as provided in Subsection (8)(d), a pharmacist or pharmacy intern who cannot 
            <ln numlevel="1" lineno="130" slineno="1-107"/>dispense the prescribed drug as written, and who needs to substitute a drug product 
            <ln numlevel="1" lineno="131" slineno="1-108"/>equivalent for the drug prescribed to the patient to treat or prevent seizures shall 
            <ln numlevel="1" lineno="132" slineno="1-109"/>notify the prescribing practitioner prior to the substitution.
          </subsection>
          <subsection ssid="1-56" dnum="d-o" numlevel="1" lineno="133" slineno="1-110">
            <display>(d)</display>Notification under Subsection (8)(c) is not required if the drug product equivalent is 
            <ln numlevel="1" lineno="134" slineno="1-111"/>paid for in whole or in part by Medicaid.
          </subsection>
        </subsection>
        <subsection ssid="1-57" dnum="9-o" numlevel="1" lineno="135" slineno="1-112" space="false">
          <display>(9)</display>
          <subsection ssid="1-58" dnum="a-o" placement="sameline">
            <display>(a)</display>
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="99" style="2" owner="cwilliams" level="1" deltag="both">The division shall designate by rule made in</amend>
            <amendoutend style="5"/>
            <amend anum="0" ea="amend" pairid="100" style="1" owner="cwilliams" level="1" amendtag="both" space="true">In</amend> accordance with Title 63G, 
            <ln numlevel="1" lineno="136" slineno="1-113"/>Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the board, 
            <ln numlevel="1" lineno="137" slineno="1-114"/>the Physicians Licensing Board 
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="101" style="2" owner="cwilliams" level="1" deltag="both">created in Section 
              <xref depth="3" refnumber="58-67-201">58-67-201</xref>
            </amend>
            <amendoutend style="5"/>, and the Osteopathic 
            <ln numlevel="1" lineno="138" slineno="1-115"/>Physician and Surgeon's Licensing Board 
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="102" style="2" owner="cwilliams" level="1" deltag="both">created in Section 
              <xref depth="3" refnumber="58-68-201">58-68-201</xref>, appropriate 
              <ln numlevel="1" lineno="139" slineno="1-116"/>substitutes for albuterol.
            </amend>
            <amendoutend style="5"/>
            <amend anum="0" ea="amend" pairid="103" style="1" owner="cwilliams" level="1" amendtag="both" space="true">, the division shall create a therapeutically similar drug 
              <ln numlevel="1" lineno="140" slineno="1-117"/>product list that contains lists of drug products that are therapeutically similar to each 
              <ln numlevel="1" lineno="141" slineno="1-118"/>other.
            </amend>
          </subsection>
          <subsection ssid="1-59" dnum="b-o" numlevel="1" lineno="142" slineno="1-119">
            <display>(b)</display>
            <amendoutstart style="5"/>
            <amend anum="0" ea="erase" pairid="104" style="2" owner="cwilliams" level="1" deltag="both">Subsections (2)(b) and (4) do not apply to the substitution of a drug product 
              <ln numlevel="1" lineno="143" slineno="1-120"/>equivalent for albuterol.
            </amend>
            <amendoutend style="5"/>
            <amend anum="0" ea="amend" pairid="105" style="1" owner="cwilliams" level="1" amendtag="both" space="true">The division may not add a drug product to the 
              <ln numlevel="1" lineno="144" slineno="1-121"/>therapeutically similar drug product list if the addition is opposed by:
            </amend>
            <subsection ssid="1-60" dnum="_-o:i-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="145" slineno="1-122">
              <display>
                <amend anum="0" ea="amend" pairid="205" style="1" owner="e" level="1" amendtag="start">(i)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="107" style="1" owner="cwilliams" level="1" amendtag="end">the board;</amend>
            </subsection>
            <subsection ssid="1-61" dnum="_-o:ii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="146" slineno="1-123">
              <display>
                <amend anum="0" ea="amend" pairid="206" style="1" owner="e" level="1" amendtag="start">(ii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="110" style="1" owner="cwilliams" level="1" amendtag="end">the Physicians Licensing Board; or</amend>
            </subsection>
            <subsection ssid="1-62" dnum="_-o:iii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="147" slineno="1-124">
              <display>
                <amend anum="0" ea="amend" pairid="207" style="1" owner="e" level="1" amendtag="start">(iii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="113" style="1" owner="cwilliams" level="1" amendtag="end">the Osteopathic Physician and Surgeon's Licensing Board.</amend>
            </subsection>
          </subsection>
          <subsection ssid="1-63" dnum="_-o:c-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="148" slineno="1-125">
            <display>
              <amend anum="0" ea="amend" pairid="208" style="1" owner="e" level="1" amendtag="start">(c)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="116" style="1" owner="cwilliams" level="1" amendtag="end">When considering a drug to be added to the therapeutically similar drug product list, 
              <ln numlevel="1" lineno="149" slineno="1-126"/>the division shall consult with each board described in Subsection (9)(b).
            </amend>
          </subsection>
          <subsection ssid="1-64" dnum="_-o:d-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="150" slineno="1-127">
            <display>
              <amend anum="0" ea="amend" pairid="209" style="1" owner="e" level="1" amendtag="start">(d)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="119" style="1" owner="cwilliams" level="1" amendtag="end">When consulting with the division under Subsection (9)(c), a board described in 
              <ln numlevel="1" lineno="151" slineno="1-128"/>Subsection (9)(b) may:
            </amend>
            <subsection ssid="1-65" dnum="_-o:i-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="152" slineno="1-129">
              <display>
                <amend anum="0" ea="amend" pairid="210" style="1" owner="e" level="1" amendtag="start">(i)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="121" style="1" owner="cwilliams" level="1" amendtag="end">review clinical practice guidelines;</amend>
            </subsection>
            <subsection ssid="1-66" dnum="_-o:ii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="153" slineno="1-130">
              <display>
                <amend anum="0" ea="amend" pairid="211" style="1" owner="e" level="1" amendtag="start">(ii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="124" style="1" owner="cwilliams" level="1" amendtag="end">review peer-reviewed studies; and</amend>
            </subsection>
            <subsection ssid="1-67" dnum="_-o:iii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="154" slineno="1-131">
              <display>
                <amend anum="0" ea="amend" pairid="212" style="1" owner="e" level="1" amendtag="start">(iii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="127" style="1" owner="cwilliams" level="1" amendtag="end">consult with medical specialists who are familiar with the drug under 
                <ln numlevel="1" lineno="155" slineno="1-132"/>consideration.
              </amend>
            </subsection>
          </subsection>
          <subsection ssid="1-68" dnum="_-o:e-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="156" slineno="1-133">
            <display>
              <amend anum="0" ea="amend" pairid="213" style="1" owner="e" level="1" amendtag="start">(e)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="131" style="1" owner="cwilliams" level="1" amendtag="end">When creating the therapeutically similar drug product list, before considering any 
              <ln numlevel="1" lineno="157" slineno="1-134"/>other types of drugs, the division shall consider:
            </amend>
            <subsection ssid="1-69" dnum="_-o:i-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="158" slineno="1-135">
              <display>
                <amend anum="0" ea="amend" pairid="214" style="1" owner="e" level="1" amendtag="start">(i)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="133" style="1" owner="cwilliams" level="1" amendtag="end">albuterol inhalers;</amend>
            </subsection>
            <subsection ssid="1-70" dnum="_-o:ii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="159" slineno="1-136">
              <display>
                <amend anum="0" ea="amend" pairid="215" style="1" owner="e" level="1" amendtag="start">(ii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="136" style="1" owner="cwilliams" level="1" amendtag="end">injectable forms of insulin; and</amend>
            </subsection>
            <subsection ssid="1-71" dnum="_-o:iii-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="160" slineno="1-137">
              <display>
                <amend anum="0" ea="amend" pairid="216" style="1" owner="e" level="1" amendtag="start">(iii)</amend>
              </display>
              <amend anum="0" ea="amend" pairid="139" style="1" owner="cwilliams" level="1" amendtag="end">diabetic test strips.</amend>
            </subsection>
          </subsection>
          <subsection ssid="1-72" dnum="_-o:f-e" ea="amend" anum="0" owner="cwilliams" style="1" numlevel="1" lineno="161" slineno="1-138">
            <display>
              <amend anum="0" ea="amend" pairid="217" style="1" owner="e" level="1" amendtag="start">(f)</amend>
            </display>
            <amend anum="0" ea="amend" pairid="143" style="1" owner="cwilliams" level="1" amendtag="end">The division may, in consultation with each board described in Subsection (9)(b), 
              <ln numlevel="1" lineno="162" slineno="1-139"/>create standards in rule for considering drug products that should be added to the 
              <ln numlevel="1" lineno="163" slineno="1-140"/>therapeutically similar drug product list.
            </amend>
          </subsection>
        </subsection>
        <subsection ssid="1-73" dnum="10-o" numlevel="1" lineno="164" slineno="1-141">
          <display>(10)</display>Failure of a licensed medical practitioner to specify that no substitution is authorized  
          <ln numlevel="1" lineno="165" slineno="1-142"/>does not constitute evidence of negligence.
        </subsection>
      </section>
    </bsec>
    <bsec buid="2" type="uncod" untype="effdate" src="uncod" uid="EF0000" sort="UZEFF" numlevel="1" lineno="166" slineno="2-1" sn="2">
      <section type="uncod" untype="effdate" display="false" src="uncod">
        <secline lineno="166">Section 2.   
          <bold>Effective date.</bold>
        </secline>
        <sectionText lineno="167">
          <amend anum="0" ea="amend" pairid="1" style="1" owner="cwilliams" level="1" amendtag="both">
            <tab/>This bill takes effect on May 1, 2024.
          </amend>
        </sectionText>
      </section>
    </bsec>
  </bdy>
  <foot>
    <rev/>
  </foot>
</leg>

