This document includes Senate Committee Amendments incorporated into the bill on Thu, Feb 23, 2017 at 11:16 AM by lpoole.
This document includes House Committee Amendments incorporated into the bill on Fri, Mar 3, 2017 at 10:10 AM by ryoung.
1
2
3
4
5
6
7 LONG TITLE
8 General Description:
9 This bill amends the Pharmacy Practice Act.
10 Highlighted Provisions:
11 This bill:
12 ▸ requires certain Utah-licensed nonresident pharmacies to submit to an inspection as
13 a prerequisite for licensure;
14 ▸ excludes drugs administered under certain conditions from certain drug-container
15 labeling requirements;
16 ▸ permits certain pharmacists to administer long-acting injectable drugs
17 intramuscularly under certain conditions; and
18 ▸ makes technical changes.
19 Money Appropriated in this Bill:
20 None
21 Other Special Clauses:
22 Ĥ→ [
23 Utah Code Sections Affected:
24 AMENDS:
25 58-17b-306, as last amended by Laws of Utah 2009, Chapter 183
26 58-17b-308, as last amended by Laws of Utah 2015, Chapter 258
27 58-17b-602, as last amended by Laws of Utah 2014, Chapter 72
28 ENACTS:
29 58-17b-625, Utah Code Annotated 1953
30
31 Be it enacted by the Legislature of the state of Utah:
32 Section 1. Section 58-17b-306 is amended to read:
33 58-17b-306. Qualifications for licensure as a pharmacy.
34 (1) Each applicant for licensure under this section, except for those applying for a class
35 D license, shall:
36 (a) submit a written application in the form prescribed by the division;
37 (b) pay a fee as determined by the department under Section 63J-1-504;
38 (c) satisfy the division that the applicant, and each owner, officer, or manager of the
39 applicant have not engaged in any act, practice, or omission, which when considered with the
40 duties and responsibilities of a licensee under this section indicates there is cause to believe
41 that issuing a license to the applicant is inconsistent with the interest of the public's health,
42 safety, or welfare;
43 (d) demonstrate the licensee's operations will be in accordance with all federal, state,
44 and local laws relating to the type of activity engaged in by the licensee, including regulations
45 of the Federal Drug Enforcement Administration and Food and Drug Administration;
46 (e) maintain operating standards established by division rule made in collaboration
47 with the board; and
48 (f) acknowledge the division's authority to inspect the licensee's business premises
49 pursuant to Section 58-17b-103.
50 (2) Each applicant applying for a class D license shall:
51 (a) submit a written application in the form prescribed by the division;
52 (b) pay a fee as determined by the department under Section 63J-1-504;
53 (c) present to the division verification of licensure in the state where physically located
54 and verification that such license is in good standing;
55 (d) provide a statement of the scope of pharmacy services that will be provided and a
56 detailed description of the protocol as described by rule by which pharmacy care will be
57 provided, including any collaborative practice arrangements with other health care
58 practitioners;
59 (e) sign an affidavit attesting that any healthcare practitioners employed by the
60 applicant and physically located in Utah have the appropriate license issued by the division and
61 in good standing; [
62 (f) sign an affidavit attesting that the applicant will abide by the pharmacy laws and
63 regulations of the jurisdiction in which the pharmacy is located[
64 (g) if an applicant engages in compounding, submit the most recent inspection report:
65 (i) conducted within two years before the application for licensure; and
66 (ii) (A) conducted as part of the National Association of Boards of Pharmacy Verified
67 Pharmacy Program; or
68 (B) performed by the state licensing agency of the state in which the applicant is a
69 resident and in accordance with the National Association of Boards of Pharmacy
69a Ĥ→ [
70 inspection blueprint program.
71 (3) Each license issued under this section shall be issued for a single, specific address,
72 and is not transferable or assignable.
73 Section 2. Section 58-17b-308 is amended to read:
74 58-17b-308. Term of license -- Expiration -- Renewal.
75 (1) Except as provided in Subsection (2), each license issued under this chapter shall be
76 issued in accordance with a two-year renewal cycle established by rule. A renewal period may
77 be extended or shortened by as much as one year to maintain established renewal cycles or to
78 change an established renewal cycle. Each license automatically expires on the expiration date
79 shown on the license unless renewed by the licensee in accordance with Section 58-1-308.
80 (2) The duration of a pharmacy intern license may be no longer than:
81 (a) one year for a license issued under Subsection 58-17b-304(7)(b); or
82 (b) five years for a license issued under Subsection 58-17b-304(7)(a).
83 (3) A pharmacy intern license issued under this chapter may not be renewed, but may
84 be extended by the division in collaboration with the board.
85 (4) As a prerequisite for renewal of a class D pharmacy license of a pharmacy that
86 engages in compounding, a licensee shall submit the most recent inspection report:
87 (a) conducted within two years before the application for renewal; and
88 (b) (i) conducted as part of the National Association of Boards of Pharmacy Verified
89 Pharmacy Program; or
90 (ii) performed by the state licensing agency of the state in which the applicant is a
91 resident and in accordance with the National Association of Boards of Pharmacy
91a Ĥ→ [
92 inspection blueprint program.
93 Section 3. Section 58-17b-602 is amended to read:
94 58-17b-602. Prescription orders -- Information required -- Alteration -- Labels --
95 Signatures -- Dispensing in pharmacies.
96 (1) Except as provided in Section 58-1-501.3, the minimum information that shall be
97 included in a prescription order, and that may be defined by rule, is:
98 (a) the prescriber's name, address, and telephone number, and, if the order is for a
99 controlled substance, the patient's age and the prescriber's DEA number;
100 (b) the patient's name and address or, in the case of an animal, the name of the owner
101 and species of the animal;
102 (c) the date of issuance;
103 (d) the name of the medication or device prescribed and dispensing instructions, if
104 necessary;
105 (e) the directions, if appropriate, for the use of the prescription by the patient or animal
106 and any refill, special labeling, or other instructions;
107 (f) the prescriber's signature if the prescription order is written;
108 (g) if the order is an electronically transmitted prescription order, the prescribing
109 practitioner's electronic signature; and
110 (h) if the order is a hard copy prescription order generated from electronic media, the
111 prescribing practitioner's electronic or manual signature.
112 (2) The requirement of Subsection (1)(a) does not apply to prescription orders
113 dispensed for inpatients by hospital pharmacies if the prescriber is a current member of the
114 hospital staff and the prescription order is on file in the patient's medical record.
115 (3) Unless it is for a Schedule II controlled substance, a prescription order may be
116 dispensed by a pharmacist or pharmacy intern upon an oral prescription of a practitioner only if
117 the oral prescription is promptly reduced to writing.
118 (4) (a) Except as provided under Subsection (4)(b), a pharmacist or pharmacy intern
119 may not dispense or compound any prescription of a practitioner if the prescription shows
120 evidence of alteration, erasure, or addition by any person other than the person writing the
121 prescription.
122 (b) A pharmacist or pharmacy intern dispensing or compounding a prescription may
123 alter or make additions to the prescription after receiving permission of the prescriber and may
124 make entries or additions on the prescription required by law or necessitated in the
125 compounding and dispensing procedures.
126 (5) (a) Each drug dispensed shall have a label securely affixed to the container
127 indicating the following minimum information:
128 [
129 [
130 [
131 [
132 and species of the animal;
133 [
134 [
135 the prescription order or are needed;
136 [
137 amount dispensed and the strength of dosage form, but if multiple ingredient products with
138 established proprietary or nonproprietary names are prescribed, those products' names may be
139 used; and
140 [
141 (b) The requirements described in Subsections (5)(a)(i) through (vi) do not apply to a
142 label on the container of a drug that a health care provider administers to a patient at:
143 (i) a pharmaceutical administration facility; or
144 (ii) a hospital licensed under Title 26, Chapter 21, Health Care Facility Licensing and
145 Inspection Act.
146 (6) A hospital pharmacy that dispenses a prescription drug that is packaged in a
147 multidose container to a hospital patient may provide the drug in the multidose container to the
148 patient when the patient is discharged from the hospital if:
149 (a) the pharmacy receives a discharge order for the patient; and
150 (b) the pharmacy labels the drug with the:
151 (i) patient's name;
152 (ii) drug's name and strength;
153 (iii) directions for use of the drug, if applicable; and
154 (iv) pharmacy's name and phone number.
155 (7) If the prescriber specifically indicates the name of the prescription product should
156 not appear on the label, then any of the trade, generic, chemical, established proprietary, and
157 established nonproprietary names and the strength of dosage form may not be included.
158 (8) Prescribers are encouraged to include on prescription labels the information
159 described in Section 58-17b-602.5 in accordance with the provisions of that section.
160 (9) A pharmacy may only deliver a prescription drug to a patient or a patient's agent:
161 (a) in person at the pharmacy; or
162 (b) via the United States Postal Service, a licensed common carrier, or supportive
163 personnel, if the pharmacy takes reasonable precautions to ensure the prescription drug is:
164 (i) delivered to the patient or patient's agent; or
165 (ii) returned to the pharmacy.
166 Section 4. Section 58-17b-625 is enacted to read:
167 58-17b-625. Administration of a long-acting injectable drug therapy.
168 (1) A pharmacist may, in accordance with this section, administer a drug described in
169 Subsection (2).
170 (2) Notwithstanding the provisions of Subsection 58-17b-102(57)(c)(ii)(B), the
171 division shall make rules, in accordance with Title 63G, Chapter 3, Utah Administrative
172 Rulemaking Act, establishing training for a pharmacist to administer the following long-acting
173 injectables intramuscularly:
174 (a) aripiprazole;
175 (b) paliperidone;
176 (c) risperidone;
177 (d) olanzapine;
178 (e) naltrexone;
179 (f) naloxone; and
180 (g) drugs approved and regulated by the United States Food and Drug Administration
181 for the treatment of the Human Immunodeficiency Virus.
182 (3) A pharmacist may not administer a drug listed under Subsection (2) unless the
183 pharmacist:
184 (a) completes the training described in Subsection (2);
185 (b) administers the drug at a clinic or community pharmacy, as those terms are defined
186 by the division, by administrative rule made in accordance with Title 63G, Chapter 3, Utah
187 Administrative Rulemaking Act; and
188 (c) is directed by the Ŝ→ [
188a Section 58-67-102 or Section 58-68-102, ←Ŝ who issues the prescription to administer the drug.
188b Ĥ→ Section 5. Effective date.
188c (1) Except as provided in Subsection (2), this bill takes effect on May 9, 2017.
188d (2) The amendments to Sections 58-17b-306 and 58-17b-308 take effect on October
188e 1, 2017. ←Ĥ