H.B. 106

1

EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor: Stewart Barlow
6 Senate Sponsor: ____________
7
8 LONG TITLE
9 General Description:
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances.
12 Highlighted Provisions:
13 This bill:
14 . exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements;
17 . repeals, subject to sunset review, the provisions of this bill relating to the exemption
18 described above; and
19 . makes technical and conforming changes.
20 Money Appropriated in this Bill:
21 None
22 Other Special Clauses:
23 None
24 Utah Code Sections Affected:
25 AMENDS:
26 58-17b-301 , as last amended by Laws of Utah 2013, Chapter 52
27 58-17b-302 , as last amended by Laws of Utah 2013, Chapter 52

28 58-17b-309 , as last amended by Laws of Utah 2013, Chapter 278
29 58-17b-309.5 , as enacted by Laws of Utah 2012, Chapter 234
30 63I-1-258 , as last amended by Laws of Utah 2013, Chapters 55, 87, 222, 278, and 351
31 ENACTS:
32 58-17b-309.7 , Utah Code Annotated 1953
33
34 Be it enacted by the Legislature of the state of Utah:
35 Section 1. Section 58-17b-301 is amended to read:
36 58-17b-301. License required -- License classifications for individuals.
37 (1) A license is required to engage in the practice of pharmacy, telepharmacy, or the
38 practice of a pharmacy technician, except as specifically provided in Section 58-1-307 ,
39 58-17b-309 , [or] 58-17b-309.5 , 58-17-309.6 , or 58-17b-309.7 .
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of:
42 (a) pharmacist;
43 (b) pharmacy intern; or
44 (c) pharmacy technician.
45 Section 2. Section 58-17b-302 is amended to read:
46 58-17b-302. License required -- License classifications for pharmacy facilities.
47 (1) A license is required to act as a pharmacy, except as specifically exempted from
48 licensure under Section 58-1-307 [or], 58-17b-309 , 58-17b-309.5 , 58-17-309.6 , or
49 58-17b-309.7 .
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a:
52 (a) class A pharmacy;
53 (b) class B pharmacy;
54 (c) class C pharmacy;
55 (d) class D pharmacy; or
56 (e) class E pharmacy.
57 (3) Each place of business shall require a separate license. If multiple pharmacies exist
58 at the same address, a separate license shall be required for each pharmacy.

59 (4) The division may further define or supplement the classifications of pharmacies.
60 The division may impose restrictions upon classifications to protect the public health, safety,
61 and welfare.
62 (5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
63 rule.
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy, regardless of the form of the business organization.
67 Section 3. Section 58-17b-309 is amended to read:
68 58-17b-309. Exemptions from licensure.
69 (1) [For purposes of] As used in this section:
70 (a) "Cosmetic drug":
71 (i) means a prescription drug that is:
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual; and
74 (B) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing, whether or not it is
76 dispensed online or through a physician's office; and
77 (ii) does not include a prescription drug that is:
78 (A) a controlled substance;
79 (B) compounded by the physician; or
80 (C) prescribed or used for the patient for the purpose of diagnosing, curing, or
81 preventing a disease.
82 (b) "Injectable weight loss drug":
83 (i) means an injectable prescription drug:
84 (A) prescribed to promote weight loss; and
85 (B) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule; and
87 (ii) does not include a prescription drug that is a controlled substance.
88 (c) "Prescribing practitioner" means an individual licensed under:
89 (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with

90 prescriptive practice;
91 (ii) Chapter 67, Utah Medical Practice Act;
92 (iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
93 (iv) Chapter 70a, Physician Assistant Act.
94 (2) In addition to the exemptions from licensure in Sections 58-1-307 [and],
95 58-17b-309.5 , 58-17b-309.6, and 58-17b-309.7 , the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter:
97 (a) [if the] an individual [is] described in Subsections (2)(b), (d), or (e), if the
98 individual notifies the division in writing of the individual's intent to dispense a drug under this
99 [subsection] Subsection (2);
100 (b) a person selling or providing contact lenses in accordance with Section 58-16a-801 ;
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule;
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioner's patient in accordance with
106 Subsection (4); or
107 (e) an optometrist, as defined in Section 58-16a-102 , acting within the optometrist's
108 scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses a cosmetic
109 drug to the optometrist's patient in accordance with Subsection (4).
110 (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
111 Subsection (2)(c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education, within the required time frame. This exemption
113 expires immediately upon notification of a failing score of an examination, and the individual
114 may not continue working as a pharmacy technician even under direct supervision.
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist:
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b); and
119 (ii) informs the patient:
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing

121 practitioner's or optometrist's office;
122 (B) of the directions for appropriate use of the drug;
123 (C) of potential side-effects to the use of the drug; and
124 (D) how to contact the prescribing practitioner or optometrist if the patient has
125 questions or concerns regarding the drug;
126 (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
127 practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
128 patients;
129 (c) follows labeling, record keeping, patient counseling, storage, purchasing and
130 distribution, operating, treatment, and quality of care requirements established by
131 administrative rule adopted by the division in consultation with the boards listed in Subsection
132 (5)(a); and
133 (d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to
134 patients is reconstituted or compounded.
135 (5) (a) The division, in consultation with the board under this chapter and the relevant
136 professional board, including the Physician Licensing Board, the Osteopathic Physician
137 Licensing Board, the Physician Assistant Licensing Board, the Board of Nursing, the
138 Optometrist Licensing Board, or the Online Prescribing, Dispensing, and Facilitation Board,
139 shall adopt administrative rules pursuant to Title 63G, Chapter 3, Utah Administrative
140 Rulemaking Act to designate:
141 (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
142 under this section; and
143 (ii) the requirements under Subsection (4)(c).
144 (b) When making a determination under Subsection (1)(a), the division and boards
145 listed in Subsection (5)(a) may consider any federal Food and Drug Administration indications
146 or approval associated with a drug when adopting a rule to designate a prescription drug that
147 may be dispensed under this section.
148 (c) The division may inspect the office of a prescribing practitioner or optometrist who
149 is dispensing under the provisions of this section, in order to determine whether the prescribing
150 practitioner or optometrist is in compliance with the provisions of this section. If a prescribing
151 practitioner or optometrist chooses to dispense under the provisions of this section, the

152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioner's or optometrist's office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist.
155 (d) If a prescribing practitioner or optometrist violates a provision of this section, the
156 prescribing practitioner or optometrist may be subject to discipline under:
157 (i) this chapter; and
158 (ii) (A) Chapter 16a, Utah Optometry Practice Act;
159 (B) Chapter 31b, Nurse Practice Act;
160 (C) Chapter 67, Utah Medical Practice Act;
161 (D) Chapter 68, Utah Osteopathic Medical Practice Act;
162 (E) Chapter 70a, Physician Assistant Act; or
163 (F) Chapter 83, Online Prescribing, Dispensing, and Facilitation Licensing Act.
164 (6) Except as provided in Subsection (2)(e), this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a, Utah
166 Optometry Practice Act.
167 Section 4. Section 58-17b-309.5 is amended to read:
168 58-17b-309.5. Exemption for prescribing practitioner of cancer drug regimen --
169 Division study of dispensing practitioners.
170 (1) [For purposes of] As used in this section, "cancer drug treatment regimen":
171 (a) means a prescription drug used to treat cancer, manage its symptoms, or provide
172 continuity of care for a cancer patient;
173 (b) includes:
174 (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
175 methods; and
176 (ii) a drug used to support cancer treatment, including to treat, alleviate, or minimize
177 physical and psychological symptoms or pain, or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy; and
179 (c) does not mean a drug listed under federal law as a Schedule I, II, or III drug.
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 , 58-17b-309, 58-17b-309.6 , and 58-17b-309.7 , the following individuals are exempt
182 from licensure under this chapter:

183 (a) an individual who:
184 (i) meets the requirements of Subsection (2)(b) or (c); and
185 (ii) notifies the division that the individual intends to dispense a cancer drug regimen
186 under this section;
187 (b) a prescribing practitioner who:
188 (i) treats a patient who is currently undergoing chemotherapy in an outpatient clinic
189 setting;
190 (ii) prescribes a cancer drug treatment regimen to the patient;
191 (iii) determines that providing the cancer drug treatment regimen to the patient in the
192 outpatient clinic setting is in the best interest of the patient, or provides better access to care for
193 the patient;
194 (iv) discloses to the patient that the cancer drug treatment regimen may be obtained
195 from a pharmacy unaffiliated with the prescribing practitioner and offers to the patient the
196 opportunity to consult with a pharmacist if the patient desires patient counseling;
197 (v) does not directly or indirectly mark up, charge a commission, or make a profit on
198 providing the cancer drug regimen, but may obtain payment for expenses and services related
199 to providing the cancer drug regimen;
200 (vi) provides the cancer drug treatment regimen to the patient, or directs another person
201 under Subsection (2)(c) to provide the cancer drug treatment regimen to the patient;
202 (vii) is certified or eligible to be certified by the American Board of Internal Medicine
203 in medical oncology;
204 (viii) reports to the Utah Controlled Substance Database in the same manner as
205 required by Section 58-37f-203 , and follows labeling, recordkeeping, patient counseling,
206 purchasing and distribution, operating, treatment, quality of care, and storage requirements
207 established by administrative rule adopted by the division in consultation with the board; and
208 (ix) follows the USP-NF 797 standards for sterile compounding if the drug dispensed
209 to the patient is reconstituted or compounded; and
210 (c) a person who is not a prescribing practitioner who:
211 (i) is employed as a health care provider by a prescribing practitioner or the outpatient
212 clinic setting in which the prescribing practitioner works and is acting within the individual's
213 scope of practice;

214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation, and who has complied with Subsection
216 (2)(b)(i);
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting; and
219 (iv) follows Subsections (2)(b)(iv), (v), and (viii).
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309 (2)(b), (d), and (e) and this section.
222 (b) The evaluation under this Subsection (3) shall include:
223 (i) practitioner compliance with the requirements of this section and Section
224 58-17b-309 ;
225 (ii) current research on dispensing and patient safety;
226 (iii) survey of other state dispensing laws; and
227 (iv) recommendations for future action concerning practitioner dispensing.
228 (c) The division shall report to the Legislature's Health and Human Services Interim
229 Committee by November 30, 2012, and by November 30, 2013, with the results and
230 recommendations from the evaluation required by this Subsection (3).
231 (4) This section sunsets in accordance with Section 63I-1-258 .
232 Section 5. Section 58-17b-309.7 is enacted to read:
233 58-17b-309.7. Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic.
235 (1) As used in this section:
236 (a) "Employer sponsored clinic" means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees' dependents.
238 (b) "Health care" is as defined in Section 31A-1-301 .
239 (c) "Prepackaged drug" means a prescription drug that:
240 (i) is not listed under federal or state law as a Schedule I, II, III, IV, or V drug; and
241 (ii) is packaged in a fixed quantity per package by:
242 (A) the drug manufacturer;
243 (B) a pharmaceutical wholesaler or distributor; or
244 (C) a pharmacy licensed under this title.

245 (d) "Prescribing practitioner" is as defined in Section 58-17b-309 .
246 (2) In addition to the exemptions described in Sections 58-1-307 , 58-17b-309 ,
247 58-17b-309.5 , and 58-17b-309.6 , a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner:
249 (a) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic;
251 (b) prescribes a prepackaged drug to the employee;
252 (c) dispenses the prepackaged drug at the employer sponsored clinic;
253 (d) notifies the division:
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic; and
256 (ii) of the drug the prescribing practitioner intends to dispense;
257 (e) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employee's best interest;
259 (f) informs the employee:
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner;
262 (ii) of the directions for appropriate use of the prepackaged drug;
263 (iii) of potential side effects to the use of the prepackaged drug; and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug;
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling; and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4).
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope of practice
272 requirements, the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67, Utah Medical Practice Act, or Chapter
274 68, Utah Osteopathic Medical Practice Act.
275 (4) The division shall, in consultation with the board of pharmacy and the Physicians

276 Licensing Board created in Section 58-67-201 , adopt administrative rules pursuant to Title
277 63G, Chapter 3, Utah Administrative Rulemaking Act, that establish labeling, record keeping,
278 patient counseling, purchasing and distribution, operating, treatment, quality of care, and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic.
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section.
283 (6) If a prescribing practitioner violates a provision of this section, the prescribing
284 practitioner may be subject to discipline under:
285 (a) this chapter; and
286 (b) any other chapter that governs the terms of the prescribing practitioner's license.
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislature's Health and Human Services Interim Committee by July 1, 2016, and by July 1,
289 2018, on the results of the evaluation and the division's recommendations regarding the
290 exemption.
291 Section 6. Section 63I-1-258 is amended to read:
292 63I-1-258. Repeal dates, Title 58.
293 (1) Title 58, Chapter 13, Health Care Providers Immunity from Liability Act, is
294 repealed July 1, 2016.
295 (2) Title 58, Chapter 15, Health Facility Administrator Act, is repealed July 1, 2015.
296 (3) Section 58-17b-309.5 is repealed July 1, 2015.
297 (4) Section 58-17b-309.7 is repealed on July 1, 2018.
298 [(4)] (5) Title 58, Chapter 20a, Environmental Health Scientist Act, is repealed July 1,
299 2018.
300 [(5)] (6) Title 58, Chapter 40, Recreational Therapy Practice Act, is repealed July 1,
301 2023.
302 [(6)] (7) Title 58, Chapter 41, Speech-language Pathology and Audiology Licensing
303 Act, is repealed July 1, 2019.
304 [(7)] (8) Title 58, Chapter 42a, Occupational Therapy Practice Act, is repealed July 1,
305 2015.
306 [(8)] (9) Title 58, Chapter 46a, Hearing Instrument Specialist Licensing Act, is

307 repealed July 1, 2023.
308 [(9)] (10) Title 58, Chapter 47b, Massage Therapy Practice Act, is repealed July 1,
309 2014.
310 [(10)] (11) Section 58-69-302.5 is repealed on July 1, 2015.
311 [(11)] (12) Title 58, Chapter 72, Acupuncture Licensing Act, is repealed July 1, 2017.




Legislative Review Note
as of 2-3-14 4:18 PM

Office of Legislative Research and General Counsel