Rep. Norm Thurston — Voting Record

Bill

Number

H.B. 301 Second Substitute (2022GS)

Sponsor

Rep. Ward, R.

Final action

Governor Signed 3/24/2022

Outcome

Became law — signed by Gov. Spencer J. Cox

Summary

What it does

• This bill:
• enacts requirements for licensure as a licensed dispensing practice;
• permits a prescriber who practices at a licensed dispensing practice to dispense certain drugs to the prescriber's patients;
• authorizes the division to perform administrative inspections of a licensed dispensing practice;
• requires the division to make certain rules regarding the operating standards of a licensed practice; and
• makes technical and conforming changes.

Every vote on this bill

Bill text

MEDICATION DISPENSER AMENDMENTS
GENERAL SESSION
STATE OF UTAH
Chief Sponsor: Raymond P. Ward
Senate Sponsor: 
Michael S. Kennedy
LONG TITLE
General Description:
This bill enacts provisions relating to the dispensing of drugs by a licensed prescriber.
Highlighted Provisions:
This bill:
▸ enacts requirements for licensure as a licensed dispensing practice;
▸ permits a prescriber who practices at a licensed dispensing practice to dispense
certain drugs to the prescriber's patients;
▸ authorizes the division to perform administrative inspections of a licensed
dispensing practice;
▸ requires the division to make certain rules regarding the operating standards of a
licensed practice; and
▸ makes technical and conforming changes.
Money Appropriated in this Bill:
None
Other Special Clauses:
None
Utah Code Sections Affected:
AMENDS:
58-17b-302
, as last amended by Laws of Utah 2019, First Special Session, Chapter 5
58-17b-309
, as last amended by Laws of Utah 2016, Chapter 207
ENACTS:
58-88-201
, Utah Code Annotated 1953
58-88-202
, Utah Code Annotated 1953
58-88-203
, Utah Code Annotated 1953
58-88-204
, Utah Code Annotated 1953
58-88-205
, Utah Code Annotated 1953
Be it enacted by the Legislature of the state of Utah:
Section 1. Section 
58-17b-302
 is amended to read:
58-17b-302.
License required -- License classifications for pharmacy facilities.
(1) A license is required to act as a pharmacy, except:
(a) as specifically exempted from licensure under Section 
58-1-307
; [
and
]
(b) for the operation of a medical cannabis pharmacy under Title 26, Chapter 61a, Utah
Medical Cannabis Act[
.
]
; and
(c) to operate a licensed dispensing practice under Chapter 88, Part 2, Dispensing
Practice.
(2) The division shall issue a pharmacy license to a facility that qualifies under this
chapter in the classification of a:
(a) class A pharmacy;
(b) class B pharmacy;
(c) class C pharmacy;
(d) class D pharmacy;
(e) class E pharmacy; or
(f) dispensing medical practitioner clinic pharmacy.
(3) (a) Each place of business shall require a separate license.
(b) If multiple pharmacies exist at the same address, a separate license shall be required
for each pharmacy.
(4) (a) The division may further define or supplement the classifications of pharmacies.
(b) The division may impose restrictions upon classifications to protect the public
health, safety, and welfare.
(5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
rule.
(6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
of the pharmacy, regardless of the form of the business organization.
Section 2. Section 
58-17b-309
 is amended to read:
58-17b-309.
Exemptions from licensure.
In addition to the exemptions from licensure in Section 
58-1-307
, the following
individuals may engage in the acts or practices described in this section without being licensed
under this chapter:
(1) a person selling or providing contact lenses in accordance with Section 
58-16a-801
;
(2) an animal shelter that:
(a) under the indirect supervision of a veterinarian, stores, handles, or administers a
drug used for euthanising an animal; and
(b) under the indirect supervision of a veterinarian who is under contract with the
animal shelter, stores, handles, or administers a rabies vaccine; [
and
]
(3) an overdose outreach provider, as defined in Section 
26-55-102
, that obtains,
stores, or furnishes an opiate antagonist in accordance with Title 26, Chapter 55, Opiate
Overdose Response Act[
.
]
; and
(4) a dispensing practitioner, as defined in Section 
58-88-201
, dispensing a drug under
Chapter 88, Part 2, Dispensing Practice.
Section 3. Section 
58-88-201
 is enacted to read:
CHAPTER 88. GENERAL HEALTH PROFESSIONS
Part 2. Dispensing Practice
 58-88-201.
Definitions.
As used in this part:
(1) (a) "Dispense" means the delivery by a prescriber of a prescription drug or device to
a patient, including the packaging, labeling, and security necessary to prepare and safeguard the
drug or device for supplying to a patient.
(b) "Dispense" does not include:
(i) prescribing or administering a drug or device; or
(ii) delivering to a patient a sample packaged for individual use by a licensed
manufacturer or re-packager of a drug or device.
(2) "Dispensing practitioner" means an individual who:
(a) is currently licensed as:
(i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
(ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
Practice Act;
(iii) an advanced practice registered nurse under Subsection 
58-31b-301
(2)(d); or
(iv) a physician assistant under Chapter 70a, Utah Physician Assistant Act;
(b) is authorized by state law to prescribe and administer drugs in the course of
professional practice; and
(c) practices at a licensed dispensing practice.
(3) "Drug" means the same as that term is defined in Section 
58-17b-102
.
(4) "Health care practice" means:
(a) a health care facility as defined in Section 
26-21-2
; or
(b) the offices of one or more private prescribers, whether for individual or group
practice.
(5) "Licensed dispensing practice" means a health care practice that is licensed as a
dispensing practice under Section 
58-88-202
.
Section 4. Section 
58-88-202
 is enacted to read:
 58-88-202.
Dispensing practice -- Drugs that may be dispensed -- Limitations and
exceptions.
(1) Notwithstanding Section 
58-17b-302
, a dispensing practitioner may dispense a drug
at a licensed dispensing practice if the drug is:
(a) packaged in a fixed quantity per package by:
(i) the drug manufacturer;
(ii) a pharmaceutical wholesaler or distributor; or
(iii) a pharmacy licensed under Chapter 17b, Pharmacy Practice Act;
(b) dispensed:
(i) at a licensed dispensing practice at which the dispensing practitioner regularly
practices; and
(ii) under a prescription issued by the dispensing practitioner to the dispensing
practitioner's patient;
(c) for a condition that is not expected to last longer than 30 days; and
(d) for a condition for which the patient has been evaluated by the dispensing
practitioner on the same day on which the dispensing practitioner dispenses the drug.
(2) A dispensing practitioner may not dispense:
(a) a controlled substance as defined in Section 
58-37-2
;
(b) a drug or class of drugs that is designated by the division under Subsection
58-88-205
(2);
(c) gabapentin; or
(d) a supply of a drug under this part that exceeds a 30-day supply.
(3) A dispensing practitioner may not make a claim against workers' compensation or
automobile insurance for a drug dispensed under this part for outpatient use unless the
dispensing practitioner is contracted with a pharmacy network established by the claim payor.
(4) When a dispensing practitioner dispenses a drug to the patient under this part, a
dispensing practitioner shall:
(a) disclose to the patient verbally and in writing that the patient is not required to fill
the prescription through the licensed dispensing practice and that the patient has a right to fill
the prescription through a pharmacy; and
(b) if the patient will be responsible to pay cash for the drug, disclose:
(i) that the patient will be responsible to pay cash for the drug; and
(ii) the amount that the patient will be charged by the licensed dispensing practice for
the drug.
(5) This part does not:
(a) require a dispensing practitioner to dispense a drug under this part;
(b) limit a health care prescriber from dispensing under Chapter 17b, Part 8,
Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy; or
(c) apply to a physician who dispenses:
(i) a drug sample, as defined in Section 
58-17b-102
, to a patient in accordance with
Section 
58-1-501.3
 or Section 
58-17b-610
;
(ii) a prescription drug or device to a patient for a patient's immediate need in an
emergency department in accordance with Section 
58-17b-610.5
; or
(iii) a drug in an emergency situation as defined by the division in rule under Chapter
17b, Pharmacy Practice Act.
Section 5. Section 
58-88-203
 is enacted to read:
 58-88-203.
Application for licensure as a licensed dispensing practice --
Requirements -- Notification -- Dispensing.
(1) An applicant for licensure as a dispensing practice shall:
(a) submit a written application in the form prescribed by the division;
(b) pay a fee as determined by the department under Section 
63J-1-504
; and
(c) provide any additional information required by the division by rule.
(2) (a) A dispensing practice shall designate at least one responsible dispensing
practitioner who is responsible for all activities of the licensed dispensing practice related to
the dispensing of drugs under this part.
(b) A responsible dispensing practitioner for the licensed dispensing practice shall:
(i) be currently licensed to prescribe and administer drugs in the course of professional
practice;
(ii) practice at the licensed dispensing practice;
(iii) accept responsibility for the operation of the licensed dispensing practice related to
the dispensing of drugs under this part and in accordance with all laws and rules relating to the
dispensing of drugs at the licensed dispensing practice; and
(iv) be personally in full and actual charge of the operation of the licensed dispensing
practice related to the dispensing of drugs under this part.
(c) Whenever an applicable statute or rule requires or prohibits action by a licensed
dispensing practice, the responsible dispensing practitioner or practitioners and the owner of
the licensed dispensing practice shall be responsible for all activities of the licensed dispensing
practice, regardless of the form of the business or entity.
(3) (a) Each license issued under this section shall be issued for a single, specific
address, and is not transferable or assignable.
(b) Each license issued under this section shall be issued in accordance with a two-year
renewal cycle established by the division by rule.
(c) The division may extend or shorten a renewal period for a period of up to one year
to maintain established renewal cycles or to change an established renewal cycle.
(d) Each license automatically expires on the expiration date shown on the license
unless the license is renewed by the licensee in accordance with Section 
58-1-308
.
(4) (a) A licensed dispensing practice shall report in writing to the division not later
than 10 business days before the date of:
(i) a permanent closure of the licensed dispensing practice;
(ii) a change of name or ownership of the licensed dispensing practice;
(iii) a change of location of the licensed dispensing practice; and
(iv) any matter or occurrence that the division requires by rule to be reported.
(b) As defined by the division by rule, a licensed dispensing practice shall report in
writing to the division:
(i) theft of a drug, immediately after the licensed dispensing practice is aware that theft
has occurred; and
(ii) a disaster, accident, or emergency that may affect the purity or labeling of a drug,
medication, device, or other material used in the diagnosis or treatment of injury, illness, or
disease immediately upon the occurrence of the disaster, accident, or emergency.
(c) A reporting licensed dispensing practice shall maintain a copy of any notification
required by this Subsection (4) for two years and make a copy of the notification available to
the division for inspection at the division's request.
Section 6. Section 
58-88-204
 is enacted to read:
 58-88-204.
Administrative inspections of a dispensing practice -- Penalties.
(1) The division shall conduct audits and inspections of licensed dispensing practices
in accordance with standards established by the division by rule.
(2) Penalties for a violation of this part, including fines and citations, shall be issued by
the division under:
(a) Section 
58-1-502
; and
(b) the dispensing practitioner's respective licensing chapter.
Section 7. Section 
58-88-205
 is enacted to read:
 58-88-205.
Operating standards -- Rulemaking.
(1) The division shall make rules in accordance with Title 63G, Chapter 3, Utah
Administrative Rulemaking Act, regarding the operating standards for a licensed dispensing
practice licensed under this part which shall include, but is not limited to, standards for:
(a) security;
(b) labeling;
(c) storage;
(d) supervision;
(e) inventory control; and
(f) patient counseling.
(2) The division may designate individual medications and classes of medications that
may not be dispensed at a licensed dispensing practice under this chapter.
(3) When making rules under this part, the division shall consult with a group
consisting of:
(a) two members of the Physicians Licensing Board created in Section 
58-67-201
; and
(b) two members of the Utah State Board of Pharmacy created in Section 
58-17b-201
.