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 similar drug list; and
18          ▸     provides rulemaking authority.
19     Money Appropriated in this Bill:
20          None
21     Other Special Clauses:
22          None
23     Utah Code Sections Affected:
24     AMENDS:
25          58-17b-605, as last amended by Laws of Utah 2020, Chapter 372
26     

27     Be it enacted by the Legislature of the state of Utah:
28          Section 1. Section 58-17b-605 is amended to read:
29          58-17b-605. Drug product equivalents.
30          (1) For the purposes of this section:
31          (a) (i) "Drug" is as defined in Section 58-17b-102.
32          (ii) "Drug" does not mean a "biological product" as defined in Section 58-17b-605.5.
33          (b) "[Drug product equivalent] Therapeutically equivalent drug product" means[: (i)] a
34     drug product that is designated as the therapeutic equivalent of another drug product in the
35     Approved Drug Products with Therapeutic Equivalence Evaluations prepared by the Center for
36     Drug Evaluation and Research of the United States Food and Drug Administration[; and].
37          [(ii) notwithstanding Subsection (1)(b)(i), an appropriate substitute for albuterol
38     designated by division rule made under Subsection (9).]
39          (c) "Therapeutically similar drug product" means a drug product that:
40          (i) provides the same level of therapeutic benefit and risk to a patient as another drug
41     product; and
42          (ii) is on the list of therapeutically similar drugs created by the division in accordance
43     with Subsection (8).
44          (2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
45     by brand or proprietary name may substitute [a drug product equivalent for the prescribed drug
46     only] the prescribed drug with:
47          (a) a therapeutically equivalent drug product if:
48          [(a)] (i) the purchaser specifically requests or consents to the substitution of a [drug
49     product equivalent] therapeutically equivalent drug product;
50          [(b)] (ii) the [drug product equivalent] therapeutically equivalent drug product is of the
51     same generic type and is designated the therapeutic equivalent in the approved drug products
52     with therapeutic equivalence evaluations prepared by the Center for Drug Evaluation and
53     Research of the Federal Food and Drug Administration;
54          [(c)] (iii) the [drug product equivalent] therapeutically equivalent drug product is
55     permitted to move in interstate commerce;
56          [(d)] (iv) the pharmacist or pharmacy intern counsels the patient on the use and the
57     expected response to the prescribed drug, whether a substitute or not[, and];
58          (v) the substitution is not otherwise prohibited by [this chapter;] law; and
59          [(e)] (vi) the prescribing practitioner has not indicated that a [drug product equivalent]
60     therapeutically equivalent drug product may not be substituted for the drug, as provided in
61     Subsection [(6)] (5); [and] or
62          [(f) the substitution is not otherwise prohibited by law.]
63          (b) a therapeutically similar drug product if:
64          (i) the therapeutically similar drug product is listed on the therapeutically similar drug
65     list as a drug that can be substituted for the prescribed drug;
66          (ii) the purchaser specifically requests or consents to the substitution of the
67     therapeutically similar drug;
68          (iii) the dispensed therapeutically similar drug product is permitted to move in
69     interstate commerce;
70          (iv) the pharmacist or pharmacy intern counsels the patient on the use and the expected
71     response to the therapeutically similar drug product;
72          (v) the substitution is not otherwise prohibited by law;
73          (vi) the prescribing practitioner has indicated that a therapeutically similar drug product
74     may be substituted for the prescribed drug; and
75          (vii) the substitution:
76          (A) results in a decreased cost to the patient;
77          (B) is the preferred drug on the patient's health benefit plan formulary;
78          (C) is necessary because the pharmacist does not have the originally prescribed
79     medication available to dispense to the patient; or
80          (D) would be beneficial to the patient for any reason if the patient and pharmacist
81     mutually agree that the substitution would benefit the patient.
82          (3) (a) Each out-of-state mail service pharmacy dispensing a [drug product equivalent]
83     therapeutically equivalent drug product as a substitute for another drug into this state shall
84     notify the patient of the substitution either by telephone or in writing.
85          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
86     chapter with respect to a [drug product equivalent] therapeutically equivalent drug product
87     substituted for another drug, including labeling and record keeping.
88          [(4) Pharmacists or pharmacy interns may not substitute without the prescriber's
89     authorization on trade name drug product prescriptions unless the product is currently
90     categorized in the approved drug products with therapeutic equivalence evaluations prepared
91     by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
92     as a drug product considered to be therapeutically equivalent to another drug product.]
93          [(5)] (4) A pharmacist or pharmacy intern who dispenses a prescription with a [drug
94     product equivalent] therapeutically equivalent drug product or a therapeutically similar drug
95     product under this section assumes no greater liability than would be incurred had the
96     pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
97          [(6)] (5) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of
98     the patient that a [drug product equivalent] therapeutically equivalent drug product not be
99     substituted for a prescribed drug, the practitioner may indicate a prohibition on substitution
100     either by writing "dispense as written" or signing in the appropriate space where two lines have
101     been preprinted on a prescription order and captioned "dispense as written" or "substitution
102     permitted".
103          (b) If the prescription is communicated orally by the prescribing practitioner to the
104     pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
105     and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
106     name of the practitioner and the words "orally by" and the initials of the pharmacist or
107     pharmacy intern written after it.
108          [(7)] (6) (a) A pharmacist or pharmacy intern who substitutes a [drug product
109     equivalent] therapeutically equivalent drug product or therapeutically similar drug product for a
110     prescribed drug shall communicate the substitution to the purchaser.
111          (b) The [drug product equivalent] therapeutically equivalent drug product container or
112     therapeutically similar drug product container shall be labeled with the name of the drug
113     dispensed[, and the].
114          (c) The pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file
115     copy of the prescription both the name of the prescribed drug and the name of the [drug
116     product equivalent] therapeutically equivalent drug product or the therapeutically similar drug
117     product dispensed in [its] place of the prescribed drug.
118          [(8)] (7) (a) For purposes of this Subsection [(8)] (7), "substitutes" means to substitute:
119          (i) a generic drug for another generic drug;
120          (ii) a generic drug for a nongeneric drug;
121          (iii) a nongeneric drug for another nongeneric drug; or
122          (iv) a nongeneric drug for a generic drug.
123          (b) A prescribing practitioner who makes a finding under Subsection [(6)(a)] (5)(a) for
124     a patient with a seizure disorder shall indicate a prohibition on substitution of a [drug product
125     equivalent] therapeutically equivalent drug product in the manner provided in Subsection
126     [(6)(a)] (5)(a) or (b).
127          (c) Except as provided in Subsection [(8)(d)] (7)(d), a pharmacist or pharmacy intern
128     who cannot dispense the prescribed drug as written, and who needs to substitute a [drug
129     product equivalent] therapeutically equivalent drug product for the drug prescribed to the
130     patient to treat or prevent seizures shall notify the prescribing practitioner prior to the
131     substitution.
132          (d) Notification under Subsection [(8)(c)] (7)(c) is not required if the [drug product
133     equivalent] therapeutically equivalent drug product is paid for in whole or in part by Medicaid.
134          [(9)] (8) [(a) The division shall designate by rule made in] In accordance with Title
135     63G, Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the board, the
136     Physicians Licensing Board created in Section 58-67-201, and the Osteopathic Physician and
137     Surgeon's Licensing Board created in Section 58-68-201, [appropriate substitutes for albuterol]
138     the division shall create a therapeutically similar drug product list.
139          [(b) Subsections (2)(b) and (4) do not apply to the substitution of a drug product
140     equivalent for albuterol.]
141          [(10)] (9) Failure of a licensed medical practitioner to specify that no substitution is
142     authorized does not constitute evidence of negligence.
143          Section 2. Effective date.
144          This bill takes effect on May 1, 2024.