1     
PHARMACY LICENSURE EXEMPTIONS

2     
2015 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: John R. Westwood

5     
Senate Sponsor: Evan J. Vickers

6     

7     LONG TITLE
8     General Description:
9          This bill amends the Pharmacy Practice Act.
10     Highlighted Provisions:
11          This bill:
12          ▸     makes technical amendments to the exemptions from the Pharmacy Practice Act to
13     coordinate the language from three different bills that passed in the 2014 General
14     Session, which:
15               •     deletes language from the exemptions from licensing for providers who are
16     required to obtain a license as a dispensing medical practitioner; and
17               •     removes obsolete cross references of code sections.
18     Money Appropriated in this Bill:
19          None
20     Other Special Clauses:
21          This bill provides a special effective date.
22     Utah Code Sections Affected:
23     AMENDS:
24          58-17b-309, as last amended by Laws of Utah 2014, Chapters 72, 191, 385 and last
25     amended by Coordination Clause, Laws of Utah 2014, Chapter 385
26          58-17b-803, as enacted by Laws of Utah 2014, Chapter 72
27          58-67-502, as last amended by Laws of Utah 2014, Chapter 72
28          58-68-502, as last amended by Laws of Utah 2014, Chapter 72
29     

30     Be it enacted by the Legislature of the state of Utah:
31          Section 1. Section 58-17b-309 is amended to read:
32          58-17b-309. Exemptions from licensure.
33          [(1) For purposes of this section:]
34          [(a) "Cosmetic drug":]
35          [(i) means a prescription drug that is:]
36          [(A) for the purpose of promoting attractiveness or altering the appearance of an
37     individual; and]
38          [(B) listed as a cosmetic drug subject to the exemption under this section by the
39     division by administrative rule or has been expressly approved for online dispensing, whether
40     or not it is dispensed online or through a physician's office; and]
41          [(ii) does not include a prescription drug that is:]
42          [(A) a controlled substance;]
43          [(B) compounded by the physician; or]
44          [(C) prescribed or used for the patient for the purpose of diagnosing, curing, or
45     preventing a disease.]
46          [(b) "Injectable weight loss drug":]
47          [(i) means an injectable prescription drug:]
48          [(A) prescribed to promote weight loss; and]
49          [(B) listed as an injectable prescription drug subject to exemption under this section by
50     the division by administrative rule; and]
51          [(ii) does not include a prescription drug that is a controlled substance.]
52          [(c) "Prescribing practitioner" means an individual licensed under:]
53          [(i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
54     prescriptive practice;]
55          [(ii) Chapter 67, Utah Medical Practice Act;]
56          [(iii) Chapter 68, Utah Osteopathic Medical Practice Act; or]
57          [(iv) Chapter 70a, Physician Assistant Act.]
58          [(2)] In addition to the exemptions from licensure in [Sections] Section 58-1-307 [and
59     58-17b-309.5], the following individuals may engage in the acts or practices described in this
60     section without being licensed under this chapter:
61          [(a) if the individual is described in Subsections (2)(b), (d), or (e), the individual
62     notifies the division in writing of the individual's intent to dispense a drug under this
63     subsection;]
64          [(b)] (1) a person selling or providing contact lenses in accordance with Section
65     58-16a-801; and
66          [(c) an individual engaging in the practice of pharmacy technician under the direct
67     personal supervision of a pharmacist while making satisfactory progress in an approved
68     program as defined in division rule;]
69          [(d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
70     injectable weight loss drug to the prescribing practitioner's patient in accordance with
71     Subsection (5);]
72          [(e) an optometrist, as defined in Section 58-16a-102, acting within the optometrist's
73     scope of practice as defined in Section 58-16a-601, who prescribes and dispenses a cosmetic
74     drug to the optometrist's patient in accordance with Subsection (5); and]
75          [(f)] (2) an animal shelter that:
76          [(i)] (a) under the indirect supervision of a veterinarian, stores, handles, or administers
77     a drug used for euthanising an animal; and
78          [(ii)] (b) under the indirect supervision of a veterinarian who is under contract with the
79     animal shelter, stores, handles, or administers a rabies vaccine.
80          [(3) In addition to the exemptions from licensure in Section 58-1-307, a person selling
81     or providing contact lenses in accordance with Section 58-16a-801 is exempt from the
82     licensing provisions of this chapter.]
83          [(4) In accordance with Subsection 58-1-303(1)(a), an individual exempt under
84     Subsection (2)(c) must take all examinations as required by division rule following completion
85     of an approved curriculum of education, within the required time frame. This exemption
86     expires immediately upon notification of a failing score of an examination, and the individual
87     may not continue working as a pharmacy technician even under direct supervision.]
88          [(5) A prescribing practitioner or optometrist is exempt from licensing under the
89     provisions of this part if the prescribing practitioner or optometrist:]
90          [(a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has
91     the authority to dispense under Subsection (5)(b); and]
92          [(ii) informs the patient:]
93          [(A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
94     practitioner's or optometrist's office;]
95          [(B) of the directions for appropriate use of the drug;]
96          [(C) of potential side-effects to the use of the drug; and]
97          [(D) how to contact the prescribing practitioner or optometrist if the patient has
98     questions or concerns regarding the drug;]
99          [(b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
100     practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
101     patients;]
102          [(c) follows labeling, record keeping, patient counseling, storage, purchasing and
103     distribution, operating, treatment, and quality of care requirements established by
104     administrative rule adopted by the division in consultation with the boards listed in Subsection
105     (6)(a); and]
106          [(d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to
107     patients is reconstituted or compounded.]
108          [(6) (a) The division, in consultation with the board under this chapter and the relevant
109     professional board, including the Physician Licensing Board, the Osteopathic Physician
110     Licensing Board, the Physician Assistant Licensing Board, the Board of Nursing, the
111     Optometrist Licensing Board, or the Online Prescribing, Dispensing, and Facilitation Board,
112     shall adopt administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative
113     Rulemaking Act to designate:]
114          [(i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
115     under this section; and]
116          [(ii) the requirements under Subsection (5)(c).]
117          [(b) When making a determination under Subsection (1)(a), the division and boards
118     listed in Subsection (6)(a) may consider any federal Food and Drug Administration indications
119     or approval associated with a drug when adopting a rule to designate a prescription drug that
120     may be dispensed under this section.]
121          [(c) The division may inspect the office of a prescribing practitioner or optometrist
122     who is dispensing under the provisions of this section, in order to determine whether the
123     prescribing practitioner or optometrist is in compliance with the provisions of this section. If a
124     prescribing practitioner or optometrist chooses to dispense under the provisions of this section,
125     the prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect
126     the prescribing practitioner's or optometrist's office and determine if the provisions of this
127     section are being met by the prescribing practitioner or optometrist.]
128          [(d) If a prescribing practitioner or optometrist violates a provision of this section, the
129     prescribing practitioner or optometrist may be subject to discipline under:]
130          [(i) this chapter; and]
131          [(ii) (A) Chapter 16a, Utah Optometry Practice Act;]
132          [(B) Chapter 31b, Nurse Practice Act;]
133          [(C) Chapter 67, Utah Medical Practice Act;]
134          [(D) Chapter 68, Utah Osteopathic Medical Practice Act;]
135          [(E) Chapter 70a, Physician Assistant Act; or]
136          [(F) Chapter 83, Online Prescribing, Dispensing, and Facilitation Act.]
137          [(7) Except as provided in Subsection (2)(e), this section does not restrict or limit the
138     scope of practice of an optometrist or optometric physician licensed under Chapter 16a, Utah
139     Optometry Practice Act.]
140          Section 2. Section 58-17b-803 is amended to read:
141          58-17b-803. Qualifications for licensure as a dispensing medical practitioner --
142     Scope of practice.
143          (1) An applicant for a license as a dispensing medical practitioner shall:
144          (a) be licensed in good standing under at least one of the chapters listed in Subsection
145     58-17b-102(23)(a); and
146          (b) submit an application for a license as a dispensing medical practitioner in a form
147     prescribed by the division and pay a fee established by the division.
148          (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
149     of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
150     58-17b-307.
151          (3) A dispensing medical practitioner may dispense, in accordance with this part:
152          (a) a cosmetic drug and an injectable weight loss drug if:
153          (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
154     medical practitioner's patient; and
155          (ii) the dispensing medical practitioner complies with administrative rules adopted by
156     the division under [Subsection] Section 58-17-802[(1)];
157          (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
158     with Section 58-17b-805; and
159          (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
160     sponsored clinic if the dispensing medical practitioner:
161          (i) treats an employee, or the dependent of an employee, of one of an exclusive group
162     of employers at an employer sponsored clinic;
163          (ii) prescribes a prepackaged drug to the employee or the employee's dependent;
164          (iii) dispenses the prepackaged drug at the employer sponsored clinic; and
165          (iv) complies with administrative rules adopted by the division in consultation with the
166     Board of Pharmacy that establish labeling, record keeping, patient counseling, purchasing and
167     distribution, operating, treatment, quality of care, and storage requirements.
168          (4) A dispensing medical practitioner:
169          (a) shall inform the patient:
170          (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
171     unaffiliated with the practitioner;
172          (ii) of the directions for appropriate use of the dispensed drug;
173          (iii) of potential side effects to the use of the dispensed drug; and
174          (iv) how to contact the dispensing medical practitioner if the patient has questions or
175     concerns regarding the drug;
176          (b) shall report to the controlled substance database in the same manner as required in
177     Section 58-37f-203; and
178          (c) may delegate the dispensing of the drug if the individual to whom the dispensing
179     was delegated is:
180          (i) employed by the dispensing medical practitioner or the outpatient clinic setting in
181     which the dispensing medical practitioner works; and
182          (ii) acting under the direction of a dispensing medical practitioner who is immediately
183     available on site for any necessary consultation.
184          (5) If the chapter that governs the license of a dispensing medical practitioner, as listed
185     in Subsection 58-17b-102(23), requires physician supervision in its scope of practice
186     requirements, the dispensing medical practitioner shall only dispense a drug under the
187     supervision of an individual licensed under Chapter 67, Utah Medical Practice Act, or Chapter
188     68, Utah Osteopathic Medical Practice Act.
189          Section 3. Section 58-67-502 is amended to read:
190          58-67-502. Unprofessional conduct.
191          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501:
192          (1) using or employing the services of any individual to assist a licensee in any manner
193     not in accordance with the generally recognized practices, standards, or ethics of the
194     profession, state law, or division rule;
195          (2) making a material misrepresentation regarding the qualifications for licensure under
196     Section 58-67-302.7; or
197          (3) violating the dispensing requirements of [Section 58-17b-309 or] Chapter 17b, Part
198     8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, if
199     applicable.
200          Section 4. Section 58-68-502 is amended to read:
201          58-68-502. Unprofessional conduct.
202          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501:
203          (1) using or employing the services of any individual to assist a licensee in any manner
204     not in accordance with the generally recognized practices, standards, or ethics of the
205     profession, state law, or division rule; or
206          (2) violating the dispensing requirements of [Section 58-17b-309 or] Chapter 17b, Part
207     8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, if
208     applicable.
209          Section 5. Effective date.
210          This bill takes effect on July 1, 2015.