Rep. Norm Thurston — Voting Record

Bill

Number

H.B. 132 Third Substitute (2024GS)

Sponsor

Rep. Ward, R.

Final action

Governor Signed 3/13/2024

Outcome

Became law — signed by Gov. Spencer J. Cox

Summary

What it does

• This bill:
• defines terms;
• allows pharmacists and pharmacy interns to substitute prescribed drugs under certain circumstances;
• requires the Division of Professional Licensing, in consultation with certain licensing boards, to develop a therapeutically similar drug list; and
• provides rulemaking authority.

Every vote on this bill

Bill text

PHARMACY AMENDMENTS
GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Raymond P. Ward
Senate Sponsor: 
____________
LONG TITLE
General Description:
This bill allows pharmacists and pharmacy interns to substitute prescribed drugs under
certain circumstances.
Highlighted Provisions:
This bill:
▸ defines terms;
▸ allows pharmacists and pharmacy interns to substitute prescribed drugs under
certain circumstances;
▸ requires the Division of Professional Licensing, in consultation with certain
licensing boards, to develop a therapeutically similar drug list; and
▸ provides rulemaking authority.
Money Appropriated in this Bill:
None
Other Special Clauses:
None
Utah Code Sections Affected:
AMENDS:
58-17b-605
, as last amended by Laws of Utah 2020, Chapter 372
Be it enacted by the Legislature of the state of Utah:
Section 1. Section 
58-17b-605
 is amended to read:
58-17b-605.
Drug product equivalents.
(1) For the purposes of this section:
(a) (i) "Drug" is as defined in Section 
58-17b-102
.
(ii) "Drug" does not mean a "biological product" as defined in Section 
58-17b-605.5
.
(b) "[
Drug product equivalent
] 
Therapeutically equivalent drug product
" means[
: (i)
] a
drug product that is designated as the therapeutic equivalent of another drug product in the
Approved Drug Products with Therapeutic Equivalence Evaluations prepared by the Center for
Drug Evaluation and Research of the United States Food and Drug Administration[
; and
]
.
[
(ii) notwithstanding Subsection (1)(b)(i), an appropriate substitute for albuterol
designated by division rule made under Subsection (9).
]
(c) "Therapeutically similar drug product" means a drug product that:
(i) provides the same level of therapeutic benefit and risk to a patient as another drug
product; and
(ii) is on the list of therapeutically similar drugs created by the division in accordance
with Subsection (8).
(2) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
by brand or proprietary name may substitute [
a drug product equivalent for the prescribed drug
only
] 
the prescribed drug with:
(a) a therapeutically equivalent drug product
 if:
[
(a)
] 
(i)
 the purchaser specifically requests or consents to the substitution of a [
drug
product equivalent
] 
therapeutically equivalent drug product
;
[
(b)
] 
(ii)
 the [
drug product equivalent
] 
therapeutically equivalent drug product
 is of the
same generic type and is designated the therapeutic equivalent in the approved drug products
with therapeutic equivalence evaluations prepared by the Center for Drug Evaluation and
Research of the Federal Food and Drug Administration;
[
(c)
] 
(iii)
 the [
drug product equivalent
] 
therapeutically equivalent drug product
 is
permitted to move in interstate commerce;
[
(d)
] 
(iv)
 the pharmacist or pharmacy intern counsels the patient on the use and the
expected response to the prescribed drug, whether a substitute or not[
, and
]
;
(v)
 the substitution is not otherwise prohibited by [
this chapter;
] 
law; and
[
(e)
] 
(vi)
 the prescribing practitioner has not indicated that a [
drug product equivalent
]
therapeutically equivalent drug product
 may not be substituted for the drug, as provided in
Subsection [
(6)
] 
(5)
; [
and
] 
or
[
(f) the substitution is not otherwise prohibited by law.
]
(b) a therapeutically similar drug product if:
(i) the therapeutically similar drug product is listed on the therapeutically similar drug
list as a drug that can be substituted for the prescribed drug;
(ii) the purchaser specifically requests or consents to the substitution of the
therapeutically similar drug;
(iii) the dispensed therapeutically similar drug product is permitted to move in
interstate commerce;
(iv) the pharmacist or pharmacy intern counsels the patient on the use and the expected
response to the therapeutically similar drug product;
(v) the substitution is not otherwise prohibited by law;
(vi) the prescribing practitioner has indicated that a therapeutically similar drug product
may be substituted for the prescribed drug; and
(vii) the substitution:
(A) results in a decreased cost to the patient;
(B) is the preferred drug on the patient's health benefit plan formulary;
(C) is necessary because the pharmacist does not have the originally prescribed
medication available to dispense to the patient; or
(D) would be beneficial to the patient for any reason if the patient and pharmacist
mutually agree that the substitution would benefit the patient.
(3) (a) Each out-of-state mail service pharmacy dispensing a [
drug product equivalent
]
therapeutically equivalent drug product
 as a substitute for another drug into this state shall
notify the patient of the substitution either by telephone or in writing.
(b) Each out-of-state mail service pharmacy shall comply with the requirements of this
chapter with respect to a [
drug product equivalent
] 
therapeutically equivalent drug product
substituted for another drug, including labeling and record keeping.
[
(4) Pharmacists or pharmacy interns may not substitute without the prescriber's
authorization on trade name drug product prescriptions unless the product is currently
categorized in the approved drug products with therapeutic equivalence evaluations prepared
by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
as a drug product considered to be therapeutically equivalent to another drug product.
]
[
(5)
] 
(4)
 A pharmacist or pharmacy intern who dispenses a prescription with a [
drug
product equivalent
] 
therapeutically equivalent drug product or a therapeutically similar drug
product
 under this section assumes no greater liability than would be incurred had the
pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
[
(6)
] 
(5)
 (a) If, in the opinion of the prescribing practitioner, it is in the best interest of
the patient that a [
drug product equivalent
] 
therapeutically equivalent drug product
 not be
substituted for a prescribed drug, the practitioner may indicate a prohibition on substitution
either by writing "dispense as written" or signing in the appropriate space where two lines have
been preprinted on a prescription order and captioned "dispense as written" or "substitution
permitted".
(b) If the prescription is communicated orally by the prescribing practitioner to the
pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
name of the practitioner and the words "orally by" and the initials of the pharmacist or
pharmacy intern written after it.
[
(7)
] 
(6) (a)
 A pharmacist or pharmacy intern who substitutes a [
drug product
equivalent
] 
therapeutically equivalent drug product or therapeutically similar drug product
 for a
prescribed drug shall communicate the substitution to the purchaser.
(b)
 The [
drug product equivalent
] 
therapeutically equivalent drug product container or
therapeutically similar drug product
 container shall be labeled with the name of the drug
dispensed[
, and the
]
.
(c) The
 pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file
copy of the prescription both the name of the prescribed drug and the name of the [
drug
product equivalent
] 
therapeutically equivalent drug product or the therapeutically similar drug
product
 dispensed in [
its
] place 
of the prescribed drug
.
[
(8)
] 
(7)
 (a) For purposes of this Subsection [
(8)
] 
(7)
, "substitutes" means to substitute:
(i) a generic drug for another generic drug;
(ii) a generic drug for a nongeneric drug;
(iii) a nongeneric drug for another nongeneric drug; or
(iv) a nongeneric drug for a generic drug.
(b) A prescribing practitioner who makes a finding under Subsection [
(6)(a)
] 
(5)(a)
 for
a patient with a seizure disorder shall indicate a prohibition on substitution of a [
drug product
equivalent
] 
therapeutically equivalent drug product
 in the manner provided in Subsection
[
(6)(a)
] 
(5)(a)
 or (b).
(c) Except as provided in Subsection [
(8)(d)
] 
(7)(d)
, a pharmacist or pharmacy intern
who cannot dispense the prescribed drug as written, and who needs to substitute a [
drug
product equivalent
] 
therapeutically equivalent drug product
 for the drug prescribed to the
patient to treat or prevent seizures shall notify the prescribing practitioner prior to the
substitution.
(d) Notification under Subsection [
(8)(c)
] 
(7)(c)
 is not required if the [
drug product
equivalent
] 
therapeutically equivalent drug product
 is paid for in whole or in part by Medicaid.
[
(9)
] 
(8)
 [
(a) The division shall designate by rule made in
] 
In
 accordance with Title
63G, Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the board, the
Physicians Licensing Board created in Section 
58-67-201
, and the Osteopathic Physician and
Surgeon's Licensing Board created in Section 
58-68-201
, [
appropriate substitutes for albuterol
]
the division shall create a therapeutically similar drug product list
.
[
(b) Subsections (2)(b) and (4) do not apply to the substitution of a drug product
equivalent for albuterol.
]
[
(10)
] 
(9)
 Failure of a licensed medical practitioner to specify that no substitution is
authorized does not constitute evidence of negligence.
Section 2. 
Effective date.
This bill takes effect on May 1, 2024.