Senator Evan J. Vickers proposes the following substitute bill:


1     
PHARMACY PRACTICE AMENDMENTS

2     
2022 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Evan J. Vickers

5     
House Sponsor: Steve Eliason

6     

7     LONG TITLE
8     General Description:
9          This bill amends the Pharmacy Practice Act.
10     Highlighted Provisions:
11          This bill:
12          ▸     amends provisions related to the accepting back and redistributing of an unused
13     drug;
14          ▸     amends refill provisions for insulin;
15          ▸     amends provisions related to the dispensing of diabetes supplies;
16          ▸     amends provisions related to the dispensing of prescription drugs by a hospital
17     pharmacy;
18          ▸     authorizes the dispensing of a drug to treat a sexually transmitted disease by a
19     physician treating a patient at a state or local health department clinic; and
20          ▸     makes technical changes.
21     Money Appropriated in this Bill:
22          None
23     Other Special Clauses:
24          None
25     Utah Code Sections Affected:
26     AMENDS:
27          58-17b-502, as last amended by Laws of Utah 2020, Chapter 25
28          58-17b-503, as last amended by Laws of Utah 2016, Chapter 405
29          58-17b-608.2, as enacted by Laws of Utah 2020, Chapter 310
30          58-17b-610.6, as enacted by Laws of Utah 2017, Chapter 44
31          58-17b-610.8, as enacted by Laws of Utah 2020, Chapter 372
32          58-17b-620, as last amended by Laws of Utah 2012, Chapter 150
33     

34     Be it enacted by the Legislature of the state of Utah:
35          Section 1. Section 58-17b-502 is amended to read:
36          58-17b-502. Unprofessional conduct.
37          (1) "Unprofessional conduct" includes:
38          (a) willfully deceiving or attempting to deceive the division, the board, or their agents
39     as to any relevant matter regarding compliance under this chapter;
40          (b) except as provided in Subsection (2):
41          (i) paying or offering rebates to practitioners or any other health care providers, or
42     receiving or soliciting rebates from practitioners or any other health care provider; or
43          (ii) paying, offering, receiving, or soliciting compensation in the form of a commission,
44     bonus, rebate, kickback, or split fee arrangement with practitioners or any other health care
45     provider, for the purpose of obtaining referrals;
46          (c) misbranding or adulteration of any drug or device or the sale, distribution, or
47     dispensing of any outdated, misbranded, or adulterated drug or device;
48          (d) engaging in the sale or purchase of drugs or devices that are samples or packages
49     bearing the inscription "sample" or "not for resale" or similar words or phrases;
50          (e) except as provided in Section 58-17b-503 [or Part 9, Charitable Prescription Drug
51     Recycling Act], accepting back and redistributing any unused drug, or a part of it, after it has
52     left the premises of [any] a pharmacy[, unless the drug is in a unit pack, as defined in Section
53     58-17b-503, or the manufacturer's sealed container, as defined in rule];
54          (f) an act in violation of this chapter committed by a person for any form of
55     compensation if the act is incidental to the person's professional activities, including the
56     activities of a pharmacist, pharmacy intern, or pharmacy technician;
57          (g) violating:
58          (i) the federal Controlled Substances Act, Title II, P.L. 91-513;
59          (ii) Title 58, Chapter 37, Utah Controlled Substances Act; or
60          (iii) rules or regulations adopted under either act;
61          (h) requiring or permitting pharmacy interns or technicians to engage in activities
62     outside the scope of practice for their respective license classifications, as defined in this
63     chapter and division rules made in collaboration with the board, or beyond their scope of
64     training and ability;
65          (i) administering:
66          (i) without appropriate training, as defined by rule;
67          (ii) without a physician's order, when one is required by law; and
68          (iii) in conflict with a practitioner's written guidelines or written protocol for
69     administering;
70          (j) disclosing confidential patient information in violation of the provisions of the
71     Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat.
72     1936, as amended, or other applicable law;
73          (k) engaging in the practice of pharmacy without a licensed pharmacist designated as
74     the pharmacist-in-charge;
75          (l) failing to report to the division any adverse action taken by another licensing
76     jurisdiction, government agency, law enforcement agency, or court for conduct that in
77     substance would be considered unprofessional conduct under this section;
78          (m) as a pharmacist or pharmacy intern, compounding a prescription drug in a dosage
79     form which is regularly and commonly available from a manufacturer in quantities and
80     strengths prescribed by a practitioner;
81          (n) failing to act in accordance with Title 26, Chapter 64, Family Planning Access Act,
82     when dispensing a self-administered hormonal contraceptive under a standing order;
83          (o) violating the requirements of Title 26, Chapter 61a, Utah Medical Cannabis Act; or
84          (p) falsely making an entry in, or altering, a medical record with the intent to conceal:
85          (i) a wrongful or negligent act or omission of an individual licensed under this chapter
86     or an individual under the direction or control of an individual licensed under this chapter; or
87          (ii) conduct described in Subsections (1)(a) through (o) or Subsection 58-1-501(1).
88          (2) Subsection (1)(b) does not apply to:
89          (a) giving or receiving a price discount based on purchase volume;
90          (b) passing along a pharmaceutical manufacturer's rebate; or
91          (c) providing compensation for services to a veterinarian.
92          (3) "Unprofessional conduct" does not include, in accordance with Title 26, Chapter
93     61a, Utah Medical Cannabis Act:
94          (a) when registered as a pharmacy medical provider, as that term is defined in Section
95     26-61a-102, providing pharmacy medical provider services in a medical cannabis pharmacy; or
96          (b) when acting as a state central patient portal medical provider, as that term is defined
97     in Section 26-61a-102, providing state central patient portal medical provider services.
98          (4) Notwithstanding Subsection (3), the division, in consultation with the board and in
99     accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, shall define
100     unprofessional conduct for a pharmacist described in Subsections (3)(a) and (b).
101          Section 2. Section 58-17b-503 is amended to read:
102          58-17b-503. Exception to unprofessional conduct.
103          (1) For purposes of this section:
104          (a) "Licensed intermediate care facility for people with an intellectual disability" means
105     an intermediate care facility for people with an intellectual disability that is licensed as a
106     nursing care facility or a small health care facility under Title 26, Chapter 21, Health Care
107     Facility Licensing and Inspection Act.
108          (b) "Nursing care facility" means the same as that term is defined in Section 26-21-2.
109          (c) "Unit pack" means a tamper-resistant nonreusable single-dose single-drug package
110     with identification that indicates the lot number and expiration date for the drug.
111          (2) A pharmacist may accept and redistribute an unused drug, or part of it, after it has
112     left the premises of the pharmacy:
113          (a) [accept and redistribute an unused drug under] in accordance with Part 9, Charitable
114     Prescription Drug Recycling Act; [or]
115          (b) [accept back and redistribute any unused drug, or a part of it, after it has left the
116     premises of the pharmacy] if:
117          (i) the drug was prescribed to a patient in a nursing care facility, licensed intermediate
118     care facility for people with an intellectual disability, or state prison facility, county jail, or state
119     hospital;
120          (ii) the drug was stored under the supervision of a licensed health care provider
121     according to manufacturer recommendations;
122          (iii) the drug is in a unit pack or in the manufacturer's sealed container;
123          (iv) the drug was returned to the original dispensing pharmacy;
124          (v) the drug was initially dispensed by a licensed pharmacist or licensed pharmacy
125     intern; and
126          (vi) accepting back and redistributing of the drug complies with federal Food and Drug
127     Administration and Drug Enforcement Administration regulations[.];
128          (c) if:
129          (i) the pharmacy has attempted to deliver the drug to a patient or a patient's agent via
130     the United States Postal Service, a licensed common carrier, or supportive personnel;
131          (ii) the drug is returned to the pharmacy by the same person or carrier that attempted to
132     deliver the drug; and
133          (iii) in accordance with United States Food and Drug Administration regulations and
134     rules established by the division, a pharmacist at the pharmacy determines that the drug has not
135     been adversely affected by the drug's attempted delivery and return.
136          Section 3. Section 58-17b-608.2 is amended to read:
137          58-17b-608.2. Insulin prescriptions and diabetes supplies.
138          (1) As used in this section, "exhausted prescription" means a prescription for an insulin
139     that the patient is currently using that:
140          (a) expired no earlier than six months before the patient requests the pharmacist for a
141     refill; or
142          (b) is not expired and has no refills remaining.
143          (2) If a valid prescription for insulin includes an authorization for one or more refills, a
144     pharmacist may combine refills to dispense a supply for [90] 100 days but may not exceed the
145     total supply authorized by the refills.
146          (3) Notwithstanding Section 58-17b-608 and Subsection (2), a pharmacist may, on an
147     emergency basis, dispense a refill for an exhausted prescription based on the prescribing
148     practitioner's instructions for the exhausted prescription in an amount up to a supply for 60
149     days.
150          (4) A pharmacist may dispense insulin for an exhausted prescription described in
151     Subsection (3) no more than one time per exhausted prescription.
152          (5) Before a pharmacist may dispense insulin under Subsection (3), the pharmacist
153     shall:
154          (a) attempt to contact the prescribing practitioner to inform the prescribing practitioner
155     that the patient's prescription has expired; and
156          (b) notify the patient of the outcome of the attempt described in Subsection (5)(a).
157          (6) Within 30 days after the day on which a pharmacist dispenses insulin under
158     Subsection (3), the pharmacist shall inform the prescribing practitioner of:
159          (a) the amount of insulin dispensed; and
160          (b) the type of insulin dispensed.
161          [(7) The division, in consultation with the Board of Pharmacy and the Physicians
162     Licensing Board, shall make rules in accordance with Title 63G, Chapter 3, Utah
163     Administrative Rulemaking Act, to ensure the safe dispensing of insulin under Subsection (3).]
164          [(8) Notwithstanding Section 58-17b-605.5, a pharmacist, when filling a prescription
165     for insulin, may dispense an interchangeable biological product, as defined in Subsection
166     58-17b-605.5(1), except that the pharmacist may not dispense an interchangeable biological
167     product if a prescribing practitioner prohibits the substitution through a method described in
168     Subsection 58-17b-605.5(6).]
169          [(9)] (7) A pharmacist may dispense [the] a therapeutic equivalent when filling a
170     prescription for:
171          (a) a glucometer;
172          (b) diabetes test strips;
173          (c) lancets; [or]
174          (d) syringes[.];
175          (e) needles; or
176          (f) other supplies for treating diabetes designated by rule made by the division in
177     accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
178          Section 4. Section 58-17b-610.6 is amended to read:
179          58-17b-610.6. Hospital pharmacy dispensing prescription drugs.
180          (1) The division shall make rules, in accordance with Title 63G, Chapter 3, Utah
181     Administrative Rulemaking Act, in consultation with hospital pharmacies, to establish
182     guidelines under which a hospital pharmacy may dispense a limited supply of a prescription
183     drug to an individual who is no longer a patient in the hospital setting if:
184          (a) the individual is discharged from the hospital on the same day that the hospital
185     pharmacy dispenses the prescription drug to the individual;
186          [(b) the prescription drug relates to the reason for which the individual was a patient at
187     the hospital before being discharged;]
188          [(c)] (b) the class A pharmacy with which the patient has an established
189     pharmacy-patient relationship:
190          (i) is not open at the time of the patient's discharge; or
191          (ii) unable to dispense the medication for any reason;
192          [(d)] (c) the hospital pharmacy dispenses a quantity of the prescription drug that is [the
193     lesser of:(i)] not more than a 72-hour supply; [or] and
194          [(ii) an adequate amount to treat the discharged patient through the first day on which
195     the pharmacy described in Subsection (1)(c) is open after the patient's discharge from the
196     hospital; and]
197          [(e)] (d) dispensing the prescription drug complies with protocols established by the
198     hospital pharmacy.
199          (2) A hospital pharmacy may dispense a prescription drug in accordance with rules
200     made under Subsection (1).
201          Section 5. Section 58-17b-610.8 is amended to read:
202          58-17b-610.8. Prescription devices.
203          (1) The following documents from a prescribing practitioner shall be considered a
204     prescription for purposes of dispensing of and payment for a device described in Subsection
205     (3), if the device is prescribed or indicated by the document and the document is on file with a
206     pharmacy:
207          (a) a written prescription; or
208          (b) a written record of a patient's:
209          (i) current diagnosis; or
210          (ii) treatment protocol.
211          (2) A pharmacist or pharmacy intern at a pharmacy at which a document that is
212     considered a prescription under Subsection (1) is on file may dispense [a] under prescription a
213     device described in Subsection (3) to the patient in accordance with:
214          (a) the document that is considered a prescription under Subsection (1); and
215          (b) rules made by the division under Subsection (4).
216          (3) This section applies to:
217          (a) nebulizers;
218          (b) spacers for use with nebulizers or inhalers; and
219          (c) diabetic [testing] supplies.
220          (4) The division shall make rules in accordance with Title 63G, Chapter 3, Utah
221     Administrative Rulemaking Act, and in consultation with the board, the Physicians Licensing
222     Board created in Section 58-67-201, and the Osteopathic Physician and Surgeon's Licensing
223     Board created in Section 58-68-201, to implement this section.
224          Section 6. Section 58-17b-620 is amended to read:
225          58-17b-620. Prescriptions issued within the public health system.
226          (1) As used in this section:
227          (a) "Department of Health" means the state Department of Health created in Section
228     26-1-4.
229          (b) "Health department" means either the Department of Health or a local health
230     department.
231          (c) "Local health departments" mean the local health departments created in Title 26A,
232     Chapter 1, Local Health Departments.
233          (2) When it is necessary to treat a reportable disease or non-emergency condition that
234     has a direct impact on public health, a health department may implement the prescription
235     procedure described in Subsection (3) for a prescription drug that is not a controlled substance
236     for use in:
237          (a) a clinic; or
238          (b) a remote or temporary off-site location, including a triage facility established in the
239     community, that provides:
240          (i) treatment for sexually transmitted infections;
241          (ii) fluoride treatment;
242          (iii) travel immunization;
243          (iv) preventative treatment for an individual with latent tuberculosis infection;
244          (v) preventative treatment for an individual at risk for an infectious disease that has a
245     direct impact on public health when the treatment is indicated to prevent the spread of disease
246     or to mitigate the seriousness of infection in the exposed individual; or
247          (vi) other treatment as defined by the Department of Health rule.
248          (3) In a circumstance described in Subsection (2), an individual with prescriptive
249     authority may write a prescription for each contact, as defined in Section 26-6-2, of a patient of
250     the individual with prescriptive authority without a face-to-face exam, if:
251          (a) the individual with prescriptive authority is treating the patient for a reportable
252     disease or non-emergency condition having a direct impact on public health; and
253          (b) the contact's condition is the same as the patient of the individual with prescriptive
254     authority.
255          (4) The following prescription procedure shall be carried out in accordance with the
256     requirements of Subsection (5) and may be used only in the circumstances described under
257     Subsections (2) and (3):
258          (a) a physician writes and signs a prescription for a prescription drug, other than a
259     controlled substance, without the name and address of the patient and without the date the
260     prescription is provided to the patient; and
261          (b) the physician authorizes a registered nurse employed by the health department to
262     complete the prescription written under this Subsection (4) by inserting the patient's name and
263     address, and the date the prescription is provided to the patient, in accordance with the
264     physician's standing written orders and a written health department protocol approved by the
265     physician and the medical director of the state Department of Health.
266          (5) A physician assumes responsibility for all prescriptions issued under this section in
267     the physician's name.
268          (6) (a) All prescription forms to be used by a physician and health department in
269     accordance with this section shall be serially numbered according to a numbering system
270     assigned to that health department.
271          (b) All prescriptions issued shall contain all information required under this chapter
272     and rules adopted under this chapter.
273          (7) Notwithstanding Sections 58-17b-302 and 58-17b-309, a nurse who is employed by
274     a health department and licensed under Title 31b, Nurse Practice Act, may dispense a drug to
275     treat a sexually transmitted infection if the drug is:
276          (a) a prepackaged drug as defined in Section 58-17b-802;
277          (b) dispensed under a prescription authorized by this section;
278          (c) provided at a location that is described in Subsection (2)(a) or (b) and operated by
279     the health department;
280          (d) provided in accordance with a dispensing standard that is issued by a physician who
281     is employed by the health department; and
282          (e) if applicable, in accordance with requirements established by the division in
283     collaboration with the board under Subsection (8).
284          (8) The division may make rules in collaboration with the board and in accordance
285     with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, to establish specific
286     requirements regarding the dispensing of a drug under Subsection (7).