1     
PHARMACY PRACTICE ACT AMENDMENTS

2     
2017 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Evan J. Vickers

5     
House Sponsor: Paul Ray

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          This bill provides a special effective date.
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; [and]
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[.]; and
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 multistate
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 multistate
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          [(a)] (i) the name, address, and telephone number of the pharmacy;
129          [(b)] (ii) the serial number of the prescription as assigned by the dispensing pharmacy;
130          [(c)] (iii) the filling date of the prescription or its last dispensing date;
131          [(d)] (iv) the name of the patient, or in the case of an animal, the name of the owner
132     and species of the animal;
133          [(e)] (v) the name of the prescriber;
134          [(f)] (vi) the directions for use and cautionary statements, if any, which are contained in
135     the prescription order or are needed;
136          [(g)] (vii) except as provided in Subsection (7), the trade, generic, or chemical name,

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          [(h)] (viii) the beyond use date.
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 physician, as that term is defined in Section 58-67-102 or Section
189     58-68-102, who issues the prescription to administer the drug.
190          Section 5. Effective date.

191          (1) Except as provided in Subsection (2), this bill takes effect on May 9, 2017.
192          (2) The amendments to Sections 58-17b-306 and 58-17b-308 take effect on October 1,
193     2017.