House of Representatives
State of Utah
UTAH STATE CAPITOL COMPLEX . 350 STATE CAPITOL
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P.O. BOX 145030 . SALT LAKE CITY, UTAH 84114-5030 . (801) 538-1029
Madam Speaker:
The Health and Human Services Committee has returned H.B. 165, PHARMACY PATIENT
COUNSELING AMENDMENTS, by Representative M. Poulson, to the Rules Committee without
recommendation with the following amendments:
Licensing Board, the Board of Nursing, and the Optometrist Licensing Board shall adopt
administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking
Act to designate:
Respectfully,
Paul Ray
1. Page
1, Lines 10 through 14
:
10
Highlighted Provisions:
11
This bill:
12
. amends definitions;
13
. amends patient counseling provisions;
and
}
. requires rulemaking; and
14
. makes technical changes.
2. Page
1, Line 21
:
21
58-17b-102, as last amended by Laws of Utah 2010, Chapter 101
3. Page
7, Line 212 through Page 8, Line 215
:
212
(43) "Patient counseling" means [the] written [and] or oral communication by [the] a
213
pharmacist
or
}
,
pharmacy intern [of information, to the]
, or other person
with dispensing authority
with a patient [or caregiver, in order], or
214
a patient's agent, to ensure the proper use of [drugs, devices, and dietary supplements] a
drug,
215
device, or dietary supplement.
4. Page
13, Lines 374 through 384
:
374
(2) A class D pharmacy shall provide oral patient counseling by telephone, or by
video
375
conferencing over a secure data connection, for each prescription drug it dispenses to a
patient
376
in this state.
377
(3) (a) [The provisions of Subsections (1) and (2) do not apply to] If a class A
378
pharmacy or a class D pharmacy dispenses a prescription drug for a patient who is
incarcerated
379
[patients or persons]
or otherwise under the jurisdiction of
}
by
the Utah
Department of Corrections
380
or a county detention facility[. (b) A] in this state, the pharmacy shall provide patient
381
counseling for the prescription by written
with a person
described in
382
Subsection (3)(a) shall be used by a pharmacist or pharmacy intern]
in lieu of
}
[a
face to face or
383
telephonic communication for the purpose of counseling the patient]
the oral
communication
}
384
required under Subsection (1) or (2)
}
.
5. Page
13, Line 384
:
384
required under Subsection (1) or (2).
6. Page
12, Lines 357 through 358
:
357
dispenses drugs intended for use by animals or for sale to veterinarians for the
administration
358
for animals.
58-17b-309
.
Exemptions from licensure.
(1) For purposes of this section:
(a) "Cosmetic drug":
(i) means a prescription drug that is:
(A) for the purpose of promoting attractiveness or altering the appearance of an
individual; and
(B) listed as a cosmetic drug subject to the exemption under this section by the
division by administrative rule; and
(ii) does not include a prescription drug that is:
(A) a controlled substance;
(B) compounded by the physician; or
(C) prescribed or used for the patient for the purpose of diagnosing, curing,
mitigating, treating, or preventing a disease.
(b) "Injectable weight loss drug":
(i) means an injectable prescription drug:
(A) prescribed to promote weight loss; and
(B) listed as an injectable prescription drug subject to exemption under this section
by the division by administrative rule; and
(ii) does not include a prescription drug that is a controlled substance.
(i) is as defined in Section 58-17b-102; and
(ii) is limited to in-person face-to-face oral communication or communication
by video conferencing over a secure data connection.
(c)
}
(d)
"Prescribing practitioner" means an individual licensed under:
(i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
prescriptive practice;
(ii) Chapter 67, Utah Medical Practice Act;
(iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
(iv) Chapter 70a, Physician Assistant Act.
(2) 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:
(a) a person selling or providing contact lenses in accordance with Section
58-16a-801
;
(b) an individual engaging in the practice of pharmacy technician under the direct
personal supervision of a pharmacist while making satisfactory progress in an approved
program as defined in division rule;
(c) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
injectable weight loss drug to the prescribing practitioner's patient in accordance with
Subsection (4); and
(d) an optometrist, as defined in Section
58-16a-102
, acting within the optometrist's
scope of practice as defined in Section
58-16a-601
, who prescribes and dispenses a
cosmetic drug to the optometrist's patient in accordance with Subsection (4).
(3) In accordance with Subsection
58-1-303
(1)(a), an individual exempt under
Subsection (2)(b) must take all examinations as required by division rule following
completion of an approved curriculum of education, within the required time frame. This
exemption expires immediately upon notification of a failing score of an examination, and
the individual may not continue working as a pharmacy technician even under direct
supervision.
(4) A prescribing practitioner or optometrist is exempt from licensing under the
provisions of this part if the prescribing practitioner or optometrist:
(a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has
the authority to dispense under Subsection (4)(b); and
(ii) informs the patient:
(A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
practitioner's or optometrist's office;
(B) of the directions for appropriate use of the drug;
(C) of potential side-effects to the use of the drug; and
(D) how to contact the prescribing practitioner or optometrist if the patient has
questions or concerns regarding the drug;
(b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the
optometrist's patients; and
(c) follows labeling, record keeping, patient counseling, and storage requirements
established by administrative rule adopted by the division in consultation with the boards
listed in Subsection (5)(a).
(5) (a) The division, in consultation with the board under this chapter, the Physician
Licensing Board, the Osteopathic Physician Licensing Board, the Physician Assistant
(i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss
drug under this section; and
(ii) the requirements under Subsection (4)(c).
(b) When making a determination under Subsection (1)(a), the division and boards
listed in Subsection (5)(a), may consider any federal Food and Drug Administration
indications or approval associated with a drug when adopting a rule to designate a
prescription drug that may be dispensed under this section.
(c) The division may inspect the office of a prescribing practitioner or optometrist
who is dispensing under the provisions of this section, in order to determine whether the
prescribing practitioner or optometrist is in compliance with the provisions of this section.
If a prescribing practitioner or optometrist chooses to dispense under the provisions of
this section, the prescribing practitioner or optometrist consents to the jurisdiction of the
division to inspect the prescribing practitioner's or optometrist's office and determine if
the provisions of this section are being met by the prescribing practitioner and
optometrist.
(d) If a prescribing practitioner or optometrist violates a provision of this section,
the prescribing practitioner or optometrist may be subject to discipline under:
(i) this chapter; and
(ii) (A) Chapter 16a, Utah Optometry Practice Act;
(B) Chapter 31b, Nurse Practice Act;
(C) Chapter 67, Utah Medical Practice Act;
(D) Chapter 68, Utah Osteopathic Medical Practice Act; or
(E) Chapter 70a, Physician Assistant Act.
(6) Except as provided in Subsection (2)(d), this section does not restrict or limit the
scope of practice of an optometrist or optometric physician licensed under Chapter 16a,
Utah Optometry Practice Act.
Renumber remaining sections accordingly.
Committee Chair
Voting: --
14 HB0165.HC1.wpd 3/1/12 10:35 am markandrews/MDA CJD/MDA
Bill Number
*HB0165*
HB0165