LEGISLATIVE GENERAL COUNSEL H.B. 132
6 Approved for Filing: C. Williams 6 2nd Sub. (Gray)
6 01-22-24 10:15 AM 6
Representative Raymond P. Ward proposes the following substitute bill:
1 PHARMACY AMENDMENTS
2 2024 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor: Raymond P. Ward
5 Senate Sponsor: ____________
6
7 LONG TITLE
8 General Description:
9 This bill allows pharmacists and pharmacy interns to substitute prescribed drugs under
10 certain circumstances.
11 Highlighted Provisions:
12 This bill:
13 < defines terms;
14 < allows pharmacists and pharmacy interns to substitute prescribed drugs under
15 certain circumstances;
16 < requires the Division of Professional Licensing, in consultation with certain
17 licensing boards, to develop a therapeutically equivalent drug list and a
18 therapeutically similar drug list; and
19 < provides rulemaking authority.
20 Money Appropriated in this Bill: 2nd Sub. H.B. 132
21 None
22 Other Special Clauses:
23 None
24 Utah Code Sections Affected:
25 AMENDS:
*HB0132S02*
 2nd Sub. (Gray) H.B. 132 01-22-24 10:15 AM
26 58-17b-605, as last amended by Laws of Utah 2020, Chapter 372
27 REPEALS:
28 58-17b-605.5, as last amended by Laws of Utah 2015, Chapter 266
29
30 Be it enacted by the Legislature of the state of Utah:
31 Section 1. Section 58-17b-605 is amended to read:
32 58-17b-605. Therapeutically equivalent and similar drug products.
33 (1) For the purposes of this section:
34 (a) "Biological product" means the same as that term is defined in 42 U.S.C. Sec. 262.
35 (b) (i) "Drug" is as defined in Section 58-17b-102.
36 (ii) "Drug" [does not mean a "biological product" as defined in Section 58-17b-605.5]
37 includes a biological product.
38 [(b) "Drug product equivalent" means:]
39 [(i) a drug product that is designated as the therapeutic equivalent of another drug
40 product in the Approved Drug Products with Therapeutic Equivalence Evaluations prepared by
41 the Center for Drug Evaluation and Research of the United States Food and Drug
42 Administration; and]
43 [(ii) notwithstanding Subsection (1)(b)(i), an appropriate substitute for albuterol
44 designated by division rule made under Subsection (9).]
45 (c) "Orange book" means the Approved Drug Products with Therapeutic Equivalence
46 Evaluations prepared by the Center for Drug Evaluation and Research of the United States
47 Food and Drug Administration or its successor publication as determined by the division.
48 (d) "Osteopathic Physician and Surgeon's Licensing Board" means the board created in
49 Section 58-68-201.
50 (e) "Physicians Licensing Board" means the board created in Section 58-67-201.
51 (f) "Purple book" means the database of biological products prepared by the Center for
52 Drug Evaluation and Research of the United States Food and Drug Administration or its
53 successor database as determined by the division.
54 (g) "Therapeutically equivalent drug product" means a drug product that:
55 (i) is designated as the therapeutic equivalent of another drug product in the orange
56 book;
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57 (ii) is designated as a biosimilar or interchangeable product in the purple book; or
58 (iii) (A) has the same amount of the same active ingredient as another drug product;
59 and
60 (B) is on the list of therapeutically equivalent drug products created by the division in
61 accordance with Subsection (9).
62 (h) "Therapeutically similar drug product" means a drug product that:
63 (i) provides the same level of therapeutic benefit and risk to a patient as another drug
64 product; and
65 (ii) is on the list of therapeutically similar drugs created by the division in accordance
66 with Subsection (9).
67 (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
68 by brand or proprietary name may substitute [a drug product equivalent for the prescribed drug
69 only] the prescribed drug with:
70 (a) a therapeutically equivalent drug product if:
71 [(a)] (i) the purchaser specifically requests or consents to the substitution of a [drug
72 product equivalent] therapeutically equivalent drug product;
73 [(b)] (ii) the [drug product equivalent] therapeutically equivalent drug product is:
74 (A) of the same generic type and is designated the therapeutic equivalent in the
75 [approved drug products with therapeutic equivalence evaluations prepared by the Center for
76 Drug Evaluation and Research of the Federal Food and Drug Administration] orange book;
77 (B) designated as a biosimilar or interchangeable product in the purple book; or
78 (C) listed on the therapeutically equivalent drug list described in Subsection (9) as a
79 drug that can be substituted for the prescribed drug;
80 [(c)] (iii) the [drug product equivalent] therapeutically equivalent drug product is
81 permitted to move in interstate commerce;
82 [(d)] (iv) the pharmacist or pharmacy intern counsels the patient on the use and the
83 expected response to the prescribed drug, whether a substitute or not[, and];
84 (v) the substitution is not otherwise prohibited by [this chapter;] law; and
85 [(e)] (vi) the prescribing practitioner has not indicated that a [drug product equivalent]
86 therapeutically equivalent drug product may not be substituted for the drug, as provided in
87 Subsection (6); [and] or
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88 [(f) the substitution is not otherwise prohibited by law.]
89 (b) a therapeutically similar drug product if:
90 (i) the prescriber has written "therapeutically similar substitution allowed" on the
91 prescription for the prescribed drug;
92 (ii) the therapeutically similar drug product is listed on the therapeutically similar drug
93 list described in Subsection (9) as a drug that can be substituted for the prescribed drug;
94 (iii) the purchaser specifically requests or consents to the substitution of the
95 therapeutically similar drug;
96 (iv) the dispensed therapeutically similar drug product is permitted to move in
97 interstate commerce;
98 (v) the pharmacist or pharmacy intern counsels the patient on the use and the expected
99 response to the therapeutically similar drug product;
100 (vi) the substitution is not otherwise prohibited by law; and
101 (vii) the substitution:
102 (A) results in a decreased cost to the patient;
103 (B) is covered on the patient's health benefit plan formulary as a preferred drug or at
104 the same or lower payment tier;
105 (C) is necessary because the pharmacist does not have the originally prescribed
106 medication available to dispense to the patient; or
107 (D) would be beneficial to the patient for any reason if the patient and pharmacist
108 mutually agree that the substitution would benefit the patient.
109 (3) (a) Each out-of-state mail service pharmacy dispensing a [drug product equivalent]
110 therapeutically equivalent drug product or a therapeutically similar drug product as a substitute
111 for another drug into this state shall notify the patient of the substitution either by telephone or
112 in writing.
113 (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
114 chapter with respect to a [drug product equivalent] therapeutically equivalent drug product or a
115 therapeutically similar drug product substituted for another drug, including labeling and record
116 keeping.
117 (4) [Pharmacists or pharmacy interns may not substitute without the prescriber's
118 authorization on trade name drug product prescriptions unless the product is currently
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119 categorized in the approved drug products with therapeutic equivalence evaluations prepared
120 by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
121 as a drug product considered to be therapeutically equivalent to another drug product.] A
122 pharmacist or pharmacy intern that substitutes a drug for a therapeutically similar drug under
123 Subsection (2)(b), for any prescription intended to last longer than 30 days, shall notify the
124 prescriber that the pharmacist or pharmacy intern substituted the drug.
125 (5) A pharmacist or pharmacy intern who dispenses a prescription with a [drug product
126 equivalent] therapeutically equivalent drug product or a therapeutically similar drug product
127 under this section assumes no greater liability than would be incurred had the pharmacist or
128 pharmacy intern dispensed the prescription with the drug product prescribed.
129 (6) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
130 patient that a [drug product equivalent] therapeutically equivalent drug product not be
131 substituted for a prescribed drug, the practitioner may indicate a prohibition on substitution
132 either by writing "dispense as written" or signing in the appropriate space where two lines have
133 been preprinted on a prescription order and captioned "dispense as written" or "substitution
134 permitted".
135 (b) If the prescription is communicated orally by the prescribing practitioner to the
136 pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
137 and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
138 name of the practitioner and the words "orally by" and the initials of the pharmacist or
139 pharmacy intern written after it.
140 (7) (a) A pharmacist or pharmacy intern who substitutes a [drug product equivalent]
141 therapeutically equivalent drug product or therapeutically similar drug product for a prescribed
142 drug shall communicate the substitution to the purchaser.
143 (b) The [drug product equivalent] therapeutically equivalent drug product container or
144 therapeutically similar drug product container shall be labeled with the name of the drug
145 dispensed[, and the].
146 (c) The pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file
147 copy of the prescription both the name of the prescribed drug and the name of the [drug
148 product equivalent] therapeutically equivalent drug product or the therapeutically similar drug
149 product dispensed in [its] place of the prescribed drug.
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150 (8) (a) For purposes of this Subsection (8), "substitutes" means to substitute:
151 (i) a generic drug for another generic drug;
152 (ii) a generic drug for a nongeneric drug;
153 (iii) a nongeneric drug for another nongeneric drug; or
154 (iv) a nongeneric drug for a generic drug.
155 (b) A prescribing practitioner who makes a finding under Subsection (6)(a) for a
156 patient with a seizure disorder shall indicate a prohibition on substitution of a [drug product
157 equivalent] therapeutically equivalent drug product in the manner provided in Subsection (6)(a)
158 or (b).
159 (c) Except as provided in Subsection (8)(d), a pharmacist or pharmacy intern who
160 cannot dispense the prescribed drug as written, and who needs to substitute a [drug product
161 equivalent] therapeutically equivalent drug product for the drug prescribed to the patient to
162 treat or prevent seizures shall notify the prescribing practitioner prior to the substitution.
163 (d) Notification under Subsection (8)(c) is not required if the [drug product equivalent]
164 therapeutically equivalent drug product is paid for in whole or in part by Medicaid.
165 (9) (a) [The division shall designate by rule made in] In accordance with Title 63G,
166 Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the board, the
167 Physicians Licensing Board [created in Section 58-67-201,] and the Osteopathic Physician and
168 Surgeon's Licensing Board [created in Section 58-68-201, appropriate substitutes for
169 albuterol.], the division shall create:
170 (i) a therapeutically similar drug product list that contains a list of drug products that
171 are therapeutically similar to another drug product.
172 (ii) a therapeutically equivalent drug product list that contains a list of drug products
173 that are therapeutically equivalent to another drug product
174 (b) [Subsections (2)(b) and (4) do not apply to the substitution of a drug product
175 equivalent for albuterol.] The division may not add a drug product to a list described in
176 Subsection if the addition is opposed by:
177 (i) the board;
178 (ii) the Physicians Licensing Board; or
179 (iii) the Osteopathic Physician and Surgeon's Licensing Board.
180 (c) When creating a list described in Subsection (9)(a), before considering any other
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181 types of drugs, the division shall consider:
182 (i) albuterol inhalers;
183 (ii) injectable forms of insulin; and
184 (iii) diabetic test strips.
185 (d) The division may:
186 (i) create standards in rule for considering drug products that should be added to a list
187 described in Subsection (9)(a); or
188 (ii) examine any peer-reviewed scientific literature when adding a drug to a list
189 described in Subsection (9)(a).
190 (10) Failure of a licensed medical practitioner to specify that no substitution is
191 authorized does not constitute evidence of negligence.
192 Section 2. Repealer.
193 This bill repeals:
194 Section 58-17b-605.5, Interchangeable biological products.
195 Section 3. Effective date.
196 This bill takes effect on May 1, 2024.
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Statutes affected:
H.B. 132 3rd Substitute (Not Adopted) Text:
Enrolled:
H.B. 132 1st Substitute (Not Adopted) Text:
H.B. 132 2nd Substitute (Not Adopted) Text:
Introduced: