S.B. 142

This document includes Senate Committee Amendments incorporated into the bill on Tue, Feb 1, 2005 at 2:18 PM by rday. --> This document includes Senate 2nd Reading Floor Amendments incorporated into the bill on Thu, Feb 10, 2005 at 4:26 PM by rday. --> This document includes Senate 2^nd Reading Floor Amendments (CORRECTED) incorporated into the bill on Fri, Feb 11, 2005 at 8:57 AM by rday. --> This document includes Senate 2nd Reading Floor Amendments (CORRECTED) incorporated into the bill on Tue, Feb 15, 2005 at 3:21 PM by rday. --> This document includes Senate 2nd Reading Floor Amendments (CORRECTED) incorporated into the bill on Tue, Feb 15, 2005 at 3:52 PM by rday. -->

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Senate Committee Amendments 2-1-2005 rd/cjd 1

PHARMACY PRACTICE ACT AMENDMENTS
2 2005 GENERAL SESSION
3 STATE OF UTAH
4 Sponsor: Peter C. Knudson
5
6 LONG TITLE
7 General Description:
8 This bill makes technical and clarifying changes to the Pharmacy Practice Act.
9 Highlighted Provisions:
10 This bill:
11 . clarifies and modifies definitions;
12 . updates an organization name;
13 . amends the definition of "unprofessional conduct"; and
14 . makes technical and clarifying changes.
15 Monies Appropriated in this Bill:
16 None
17 Other Special Clauses:
18 None
19 Utah Code Sections Affected:
20 AMENDS:
21 58-17b-102, as enacted by Chapter 280, Laws of Utah 2004
22 58-17b-303, as enacted by Chapter 280, Laws of Utah 2004
23 58-17b-304, as enacted by Chapter 280, Laws of Utah 2004
24 58-17b-502, as enacted by Chapter 280, Laws of Utah 2004
25 58-17b-503, as enacted by Chapter 280, Laws of Utah 2004
25a S. 58-17b-609, as enacted by Chapter 280, Laws of Utah 2004 .S
26 58-17b-612, as enacted by Chapter 280, Laws of Utah 2004

27 REPEALS:

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- 2 - 28 58-17a-303, as last amended by Chapter 28, Laws of Utah 1998
29 58-17a-605.1, as last amended by Chapter 18, Laws of Utah 2002, Fifth Special Session
30
31 Be it enacted by the Legislature of the state of Utah:
32 Section 1. Section 58-17b-102 is amended to read:
33 58-17b-102. Definitions.
34 In addition to the definitions in Section 58-1-102 , as used in this chapter:
35 (1) "Administering" means:
36 (a) the direct application of a prescription drug or device, whether by injection,
37 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
38 by another person; or
39 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
40 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
41 means directed to the body of the animal by the owner or caretaker in accordance with written
42 or verbal directions of the veterinarian.
43 (2) "Adulterated drug or device" means a drug or device considered adulterated under
44 21 U.S.C.S. Sec. 351 (2003).
45 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
46 the purpose of analysis.
47 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
48 used as standards and controls in performing drug monitoring or drug screening analysis if the
49 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
50 components, organic solvents, or inorganic buffers at a concentration not exceeding one
51 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
52 use.
53 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
54 the use of prescription drugs.
55 (5) "Automated pharmacy systems" includes mechanical systems which perform
56 operations or activities, other than compounding or administration, relative to the storage,
57 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
58 all transaction information.

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- 3 - 59 (6) "Beyond use date" means [a] the date determined by a pharmacist and [should be]
60 placed on a prescription label at the time of dispensing that [is intended to indicate] indicates to
61 the patient or caregiver a time beyond which the contents of the prescription are not
62 recommended to be used.
63 (7) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
64 underserved area, used for the storage and dispensing of prescription drugs, which is dependent
65 upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
66 approved by the division as the parent pharmacy.
67 (8) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy [as]
68 created in Section 58-17b-201 .
69 (9) "Centralized prescription processing" means the processing by a pharmacy of a
70 request from another pharmacy to fill or refill a prescription drug order or to perform
71 processing functions such as dispensing, drug utilization review, claims adjudication, refill
72 authorizations, and therapeutic interventions.
73 (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
74 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
75 prescription order.
76 (11) "Class B pharmacy":
77 (a) means a pharmacy located in Utah:
78 (i) that is authorized to provide pharmaceutical care for patients in an institutional
79 setting; and
80 (ii) whose primary purpose is to provide a physical environment for patients to obtain
81 health care services; and
82 (b) (i) includes closed-door, hospital, [clinics] clinic, nuclear, and branch[,
83 pharmaceutical research facilities,] pharmacies; and
84 (ii) pharmaceutical administration [facilities,] and sterile product preparation facilities.
85 (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
86 engage in the manufacture, production, wholesale, or distribution of drugs or devices.
87 (13) "Class D pharmacy" means a nonresident pharmacy[, to include any pharmacy
88 outside of Utah, that is authorized to deliver drugs or devices to residents of Utah].
89 (14) "Class E pharmacy" means all other [pharmacy facilities] pharmacies.

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- 4 - 90 (15) "Closed-door["] pharmacy" means a pharmacy that provides pharmaceutical care
91 to a defined and exclusive group of patients who have access to the services of the pharmacy
92 because they are treated by or have an affiliation with a specific entity, including a health
93 maintenance [organizations and] organization or an infusion [companies, and does not include]
94 company, but not including a hospital [pharmacies, retail sales] pharmacy, a retailer of goods to
95 the general public, or the [offices of practitioners] office of a practitioner.
96 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
97 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
98 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
99 care functions authorized by the practitioner or practitioners under certain specified conditions
100 or limitations.
101 (17) "Collaborative pharmacy practice agreement" means a written and signed
102 agreement between one or more pharmacists and one or more practitioners that provides for
103 collaborative pharmacy practice for the purpose of drug therapy management of patients and
104 prevention of disease of human subjects.
105 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
106 labeling of a limited quantity drug, sterile product, or device:
107 (i) as the result of a practitioner's prescription order or initiative based on the
108 practitioner, patient, or pharmacist relationship in the course of professional practice;
109 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
110 not for sale or dispensing; or
111 (iii) in anticipation of prescription drug orders based on routine, regularly observed
112 prescribing patterns.
113 (b) "Compounding" does not include:
114 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
115 another pharmacist or pharmaceutical [administration] facility;
116 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
117 dosage form which is regularly and commonly available from a manufacturer in quantities and
118 strengths prescribed by a practitioner; or
119 (iii) the preparation of a prescription drug, sterile product, or device which has been
120 withdrawn from the market for safety reasons.

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- 5 - 121 (19) "Confidential information" has the same meaning as "protected health
122 information" under the Standards for Privacy of Individually Identifiable Health Information,
123 45 C.F.R. Parts 160 and 164.
124 (20) "Controlled substance" has the same definition as in Section 58-37-2 .
125 (21) "Device" means an instrument, apparatus, implement, machine, contrivance,
126 implant, in vitro reagent, or other similar or related article, including any component part or
127 accessory, which is required under federal or state law to be prescribed by a practitioner and
128 dispensed by a pharmacist or pharmacy intern.
129 (22) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
130 417, Sec. 3a(ff) which is incorporated by reference.
131 (23) "Dispense" means the interpretation, evaluation, and implementation of a
132 prescription drug order or device or nonprescription drug or device under a lawful order of a
133 practitioner in a suitable container appropriately labeled for subsequent administration to or use
134 by a patient, research subject, or an animal.
135 (24) "Distribute" means to deliver a drug or device other than by administering or
136 dispensing.
137 (25) "Drug" means:
138 (a) a substance recognized as a drug in any official compendium, or supplement
139 thereto, designated from time to time by the division in collaboration with the board for use in
140 the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals,
141 excluding nonprescription drugs or dietary supplements;
142 (b) a drug or device that is required by any applicable federal or state law or rule to be
143 dispensed on prescription only or is restricted to use by practitioners only;
144 (c) substances other than food intended to affect the structure or any function of the
145 body of humans or other animals, excluding nonprescription dietary supplements; and
146 (d) substances intended for use as a component of any substance specified in
147 Subsection (25)(a), (b), or (c).
148 (26) "Drug product equivalent" means a drug product that is designated as the
149 therapeutic equivalent of another drug product in the Approved Drug Products with
150 Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
151 of the Federal Food and Drug Administration.

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- 6 - 152 (27) "Drug regimen review" includes the following activities:
153 (a) evaluation of the prescription drug order and patient record for:
154 (i) known allergies;
155 (ii) rational therapy-contraindications;
156 (iii) reasonable dose and route of administration; and
157 (iv) reasonable directions for use;
158 (b) evaluation of the prescription drug order and patient record for duplication of
159 therapy;
160 (c) evaluation of the prescription drug order and patient record for the following
161 interactions:
162 (i) drug-drug;
163 (ii) drug-food;
164 (iii) drug-disease; and
165 (iv) adverse drug reactions; and
166 (d) evaluation of the prescription drug order and patient record for proper utilization,
167 including over- or under-utilization, and optimum therapeutic outcomes.
168 (28) "Drug sample" means a prescription drug packaged in small quantities consistent
169 with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
170 be sold, and is intended to be provided to practitioners for the immediate needs of patients for
171 trial purposes or to provide the drug to the patient until a prescription can be filled by the
172 patient.
173 (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
174 symbol, or process attached to or logically associated with a record and executed or adopted by
175 a person with the intent to sign the record.
176 (30) "Electronic transmission" means transmission of information in electronic form or
177 the transmission of the exact visual image of a document by way of electronic equipment.
178 (31) "Extern" means a college of pharmacy student enrolled in a college coordinated
179 practical experience program in a health care setting under the supervision of a preceptor, as
180 defined in this act, and approved by a college of pharmacy.
181 (32) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
182 inpatients of a general acute hospital or specialty hospital licensed by the Department of Health

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Senate 2nd Reading Amendments 2-10-2005 rd/cjd 183

under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
184 (33) "Licensed pharmacy technician" means an individual licensed with the division,
185 that may, under the supervision of a pharmacist, perform the activities involved in the
186 technician practice of pharmacy.
187 (34) "Manufacturer" means a person or business physically located in Utah licensed to
188 be engaged in the manufacturing of drugs or devices.
189 (35) (a) "Manufacturing" means:
190 (i) the production, preparation, propagation, conversion, or processing of a drug or
191 device, either directly or indirectly, by extraction from substances of natural origin or
192 independently by means of chemical or biological synthesis, or by a combination of extraction
193 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
194 or relabeling of its container; and
195 (ii) the promotion and marketing of such drugs or devices.
196 (b) "Manufacturing" includes the preparation and promotion of commercially available
197 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
198 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
199 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
200 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
201 analysis.
202 (36) "Medical order" means a lawful order of a practitioner which may include a
203 prescription drug order.
204 (37) "Medication profile" or "profile" means a record system maintained as to drugs or
205 devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
206 the profile to provide pharmaceutical care.
207 (38) "Misbranded drug or device" means a drug or device considered misbranded under
208 21 U.S.C.S. Sec. 352 (2003).
209 (39) "Nonprescription drug" means a drug which may be sold without a prescription
210 and which is labeled for use by the consumer in accordance with federal law and includes
211 homeopathic remedies.
212 (40) "Nonresident pharmacy" means [any] a pharmacy [that sells to anyone in Utah, but
213 is not physically] located [in] outside of Utah that sells to a S. [ patient ] person .S in Utah.

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- 8 - 214 (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
215 (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
216 outside the state that is licensed and in good standing in another state, that:
217 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a [resident]
218 patient in this state pursuant to a [legally] lawfully issued prescription;
219 (b) provides information to a [resident of] patient in this state on drugs or devices
220 which may include, but is not limited to, advice relating to therapeutic values, potential
221 hazards, and uses; or
222 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
223 effects of drugs.
224 (43) "Patient counseling" means the written and oral communication by the
225 pharmacist[, pharmacy preceptor,] or pharmacy intern of information, to the patient or
226 caregiver, in order to ensure proper use of drugs, devices, and dietary supplements.
227 (44) "Pharmaceutical administration facility" means a [health care] facility [or],
228 agency, or institution in which:
229 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
230 the facility or agency for administration to patients of that facility or agency;
231 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
232 or pharmacy intern with whom the facility has established a prescription drug supervising
233 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
234 or agency staff as required, and oversees drug control, accounting, and destruction; and
235 (c) prescription drugs are professionally administered in accordance with the order of a
236 practitioner by an employee or agent of the facility or agency.
237 (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
238 prescribing practitioner, and in accordance with division rule:
239 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
240 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
241 the patient's disease;
242 (ii) eliminating or reducing a patient's symptoms; or
243 (iii) arresting or slowing a disease process.
244 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a

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- 9 - 245 prescribing practitioner.
246 (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
247 distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
248 state.
249 [(47) (a) "Pharmaceutical research facility" means a facility engaged in conducting
250 scientific research regarding drugs and their use in accordance with standard research protocols
251 and techniques, who maintains competent documentation with respect to the research, and
252 who uses prescription drugs in the conduct of the research.]
253 [(b) "Pharmaceutical research facility" does not include any licensed facility or clinic
254 whose primary researchers are licensed practitioners.]
255 [(48)] (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical
256 facility engaged in the business of wholesale vending or selling of any prescription drug or
257 device to other than the consumer or user of the prescription drug or device, which the
258 pharmaceutical facility has not produced, manufactured, compounded, or dispensed.
259 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
260 facility carrying out the following business activities:
261 (i) intracompany sales;
262 (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
263 purchase or trade a prescription drug or device between hospitals or other health care facilities
264 that are under common ownership or control of the management and operation of the facilities;
265 (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
266 purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
267 another pharmaceutical facility to alleviate a temporary shortage; or
268 (iv) the distribution of a prescription drug or device as a sample by representatives of a
269 manufacturer.
270 [(49)] (48) "Pharmacist" means an individual licensed by this state to engage in the
271 practice of pharmacy.
272 [(50)] (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good
273 standing who accepts responsibility for the operation of a pharmacy in conformance with all
274 laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is
275 personally in full and actual charge of the pharmacy and all personnel.

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- 10 - 276 [(51)] (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with
277 two or more years of licensed experience [whose name appears on a division list of approved
278 preceptors]. The preceptor serves as a teacher, example of professional conduct, and
279 supervisor of interns in the professional practice of pharmacy.
280 [(52)] (51) "Pharmacy" means any place [within Utah] where:
281 (a) drugs are dispensed [and];
282 (b) pharmaceutical care is provided [and any place outside of Utah where drugs are
283 dispensed and pharmaceutical care is provided to residents of Utah.];
284 (c) drugs are processed or handled for eventual use by a patient; or
285 (d) drugs are used for the purpose of analysis or research.
286 [(53)] (52) "Pharmacy benefits manager or coordinator" means a person or entity that
287 administers the prescription drug or device portion of a health insurance [plans] plan on behalf
288 of [plan sponsors, such as] a self-insured [employers] employer, insurance [companies]
289 company, [and] health maintenance [organizations, and may be further] organization, or other
290 plan sponsor, as defined by rule.
291 [(54)] (53) "Pharmacy intern" means an individual licensed by this state to engage in
292 practice as a pharmacy intern.
293 [(55)] (54) "Pharmacy technician training program" means an approved technician
294 training program providing education for pharmacy technicians.
295 [(56)] (55) (a) "Practice as a licensed pharmacy technician" means engaging in practice
296 as a pharmacy technician under the general supervision of a licensed pharmacist and in
297 accordance with a scope of practice [as] defined by division rule made in collaboration with the
298 board.
299 (b) "Practice as a licensed pharmacy technician" does not include:
300 (i) performing a drug utilization review, prescription drug order clarification from a
301 prescriber, final review of the prescription and prescribed drug prepared for dispensing,
302 dispensing of the drug, or counseling a patient with respect to a prescription drug;
303 (ii) counseling regarding nonprescription drugs and dietary supplements unless
304 delegated by the supervising pharmacist; or
305 (iii) receiving new prescription drug orders when communicating telephonically or
306 electronically unless the original information is recorded so the pharmacist may review the

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- 11 - 307 prescription drug order as transmitted.
308 [(57)] (56) "Practice of pharmacy" includes the following:
309 (a) providing pharmaceutical care;
310 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
311 practice agreement;
312 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
313 distribution of prescription drugs or devices, provided that the administration of a prescription
314 drug or device is:
315 (i) pursuant to a lawful order of a practitioner when one is required by law; and
316 (ii) in accordance with written guidelines or protocols:
317 (A) established by the licensed facility in which the prescription drug or device is to be
318 administered on an inpatient basis; or
319 (B) approved by the division, in collaboration with the board and the Physicians
320 Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
321 administered on an outpatient basis solely by a licensed pharmacist;
322 (d) participating in drug utilization review;
323 (e) ensuring proper and safe storage of drugs and devices;
324 (f) maintaining records of drugs and devices in accordance with state and federal law
325 and the standards and ethics of the profession;
326 (g) providing information on drugs or devices, which may include advice relating to
327 therapeutic values, potential hazards, and uses;
328 (h) providing drug product equivalents;
329 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
330 technicians;
331 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
332 (k) providing emergency refills as defined by rule;
333 (l) telepharmacy; and
334 (m) formulary management intervention.
335 [(58)] (57) "Practice of telepharmacy" means the practice of pharmacy through the use
336 of telecommunications and information technologies.
337 [(59)] (58) "Practice of telepharmacy across state lines" means the practice of

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- 12 - 338 pharmacy through the use of telecommunications and information technologies that occurs
339 when the patient is physically located within one jurisdiction and the pharmacist is located in
340 another jurisdiction.
341 [(60)] (59) "Practitioner" means an individual currently licensed, registered, or
342 otherwise authorized by the appropriate jurisdiction to prescribe and administer drugs in the
343 course of professional practice.
344 [(61)] (60) "Prescription" means an order:
345 (a) issued by a licensed practitioner:
346 (i) orally, in writing, by telephone, facsimile transmission, computer, or other
347 electronic means of communication as defined by division rule;
348 (ii) in the course of the practitioner's professional practice; or
349 (iii) by collaborative pharmacy practice agreement; and
350 (b) for a controlled substance, other prescription drug, or device with the intent that the
351 controlled substance, prescription drug, or device will be used by a patient or an animal.
352 [(62)] (61) "Prescription drug or device" means:
353 (a) a legend drug or device; or
354 (b) a drug or device that is required by an applicable federal or state law or rule to be
355 dispensed on prescription only or is restricted to use by practitioners only.
356 [(63)] (62) "Retail pharmacy" means a pharmaceutical facility dispensing prescription
357 drugs and devices to the general public.
358 [(64)] (63) "Self-audit" means an internal evaluation of a pharmacy to determine
359 compliance with this chapter.
360 [(65)] (64) "Supervising pharmacist" means a pharmacist who is overseeing the
361 operation of the pharmacy during a given day or shift.
362 [(66)] (65) "Supportive personnel" means unlicensed individuals who:
363 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
364 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
365 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
366 those duties may be further defined by division rule adopted in collaboration with the board;
367 and
368 (b) are supervised by a pharmacist in accordance with rules adopted by the division in

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- 13 - 369 collaboration with the board.
370 [(67)] (66) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-17b-501 .
371 [(68)] (67) "Unprofessional conduct" is as defined in Sections 58-1-501 and
372 58-17b-502 and may be further defined by rule.
373 [(69)] (68) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
374 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
375 for animals.
376 Section 2. Section 58-17b-303 is amended to read:
377 58-17b-303. Qualifications for licensure as a pharmacist.
378 (1) Each applicant for licensure as a pharmacist shall:
379 (a) submit an application in a form prescribed by the division;
380 (b) pay a fee as determined by the department under Section 63-38-3.2 ;
381 (c) produce satisfactory evidence of good moral character as it relates to the applicant's
382 ability to practice pharmacy;
383 (d) complete a criminal background check and be free from criminal convictions as
384 required by Section 58-17b-307 , or as described in Section 58-1-501 ;
385 (e) have no physical or mental condition of a nature which prevents the applicant from
386 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
387 public;
388 (f) have graduated and received a professional entry degree from a school or college of
389 pharmacy which is accredited by the [American Council on Pharmaceutical Education]
390 Accreditation Council on Pharmacy Education;
391 (g) have completed an internship meeting standards established by division rule made
392 in collaboration with the board; and
393 (h) have successfully passed examinations required by division rule made in
394 collaboration with the board.
395 (2) Each applicant for licensure as a pharmacist whose pharmacy education was
396 completed at a foreign pharmacy school shall, in addition to the requirements under
397 Subsections (1)(a) through (e), (g), and (h), obtain a certification of equivalency from a
398 credentialing agency required by division rule made in collaboration with the board.
399 (3) Each applicant for a license by endorsement as a pharmacist under this section

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- 14 - 400 shall:
401 (a) submit a written application in the form prescribed by the division;
402 (b) pay the fee determined by the department under Section 63-38-3.2 ;
403 (c) be of good moral character as required of applicants for licensure as pharmacists
404 under Subsection (1);
405 (d) complete a criminal background check and be free from criminal convictions as
406 required by Section 58-17b-307 , or as otherwise described in Section 58-1-501 ;
407 (e) have no physical or mental condition of a nature which prevents the applicant from
408 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the
409 public;
410 (f) have lawfully practiced as a licensed pharmacist a minimum of 2,000 hours in the
411 four years immediately preceding the date of application;
412 (g) produce satisfactory evidence of completing the professional education required
413 under Subsection (1);
414 (h) be currently licensed in good standing as a pharmacist in another state, territory, or
415 possession of the United States;
416 (i) produce satisfactory evidence that the examination requirements are or were at the
417 time the license was issued, equal to those of this state; and
418 (j) pass the jurisprudence examination prescribed by division rule made in
419 collaboration with the board.
420 Section 3. Section 58-17b-304 is amended to read:
421 58-17b-304. Qualifications for licensure of pharmacy intern.
422 Each applicant for licensure as a pharmacy intern shall:
423 (1) submit an application in a form prescribed by the division;
424 (2) pay a fee determined by the department under Section 63-38-3.2 ;
425 (3) produce satisfactory evidence of good moral character as it relates to the applicant's
426 ability to practice pharmacy;
427 (4) complete a criminal background check and be free from criminal convictions as
428 required by Section 58-17b-307 , or as otherwise described in Section 58-1-501 ;
429 (5) have no physical or mental condition of a nature which prevents the applicant from
430 engaging in the practice of pharmacy with reasonable skill, competency, and safety to the

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- 15 - 431 public;
432 (6) meet the preliminary educational qualifications required by division rule made in
433 collaboration with the board; and
434 (7) meet one of the following educational criteria:
435 (a) be a current pharmacy student, a resident, or fellow in a program approved by
436 division rule in collaboration with the board;
437 (b) have graduated and received a pharmacy degree from a school or college of
438 pharmacy which is accredited by the [American Council on Pharmaceutical Education]
439 Accreditation Council on Pharmacy Education; or
440 (c) have graduated from a foreign pharmacy school and received certification of
441 equivalency from a credentialing agency approved by the division rule in collaboration with the
442 board.
443 Section 4. Section 58-17b-502 is amended to read:
444 58-17b-502. Unprofessional conduct.
445 "Unprofessional conduct" includes:
446 (1) willfully deceiving or attempting to deceive the division, the board, or their agents
447 as to any relevant matter regarding compliance under this chapter;
448 (2) [(a)] except for price discounts conditional upon volume purchases:
449 (a) paying rebates to practitioners or any other health care providers[, or]; and
450 (b) entering into any agreement with a medical practitioner or any other person for the
451 payment or acceptance of compensation or its economic equivalent for recommending the
452 professional services of either party[, except as allowed under Subsection (2)(b); and];
453 [(b) price discounts conditional upon volume purchases are not prohibited under
454 Subsection (2)(a);]
455 (3) misbranding or adulteration of any drug or device or the sale, distribution, or
456 dispensing of any outdated, misbranded, or adulterated drug or device;
457 (4) engaging in the sale or purchase of drugs or devices that are samples or packages
458 bearing the inscription "sample" or "not for resale" or similar words or phrases;
459 (5) except as provided in Section 58-17b-503 , accepting back and redistributing of any
460 unused drug, or a part of it, after it has left the premises of any pharmacy, unless the drug is in
461 [the original sealed unit dose package] a unit pack, as defined in Section 58-17b-503 , or the

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- 16 - 462 manufacturer's sealed container, as defined in rule[, except as provided in Section 58-17b-503 ];
463 (6) being employed as a pharmacist, pharmacy intern, or pharmacy technician, or
464 sharing or receiving compensation in any form arising out of an act incidental to professional
465 activities in the course of which any person requires him to engage in any aspect of the practice
466 of pharmacy in violation of this chapter;
467 (7) violating Federal Title II, P.L. 91, Controlled Substances Act, or Title 58, Chapter
468 37, Utah Controlled Substances Act, or rules and regulations adopted under either act;
469 (8) requiring or permitting pharmacy interns or technicians to engage in activities
470 outside the scope of practice for their respective license classifications as defined in this
471 chapter and division rules made in collaboration with the board, or beyond an individual's
472 scope of training and ability;
473 (9) administering:
474 (a) without appropriate training, as defined by rule[:];
475 [(a) written guidelines or protocols of a practitioner or in conflict with such guidelines
476 or protocols; or]
477 (b) without a [lawful] physician's order, when one is required by law; and
478 (c) in conflict with a practitioner's written guidelines or written protocol for
479 administering;
480 (10) disclosing confidential patient information in violation of the provisions of the
481 Health Insurance Portability and Accountability Act of 1996 or other applicable law;
482 (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
483 the pharmacist-in-charge;
484 (12) failing to report to the division any adverse action taken by another licensing
485 jurisdiction, government agency, law enforcement agency, or court for conduct that would
486 constitute grounds for action, as defined in this section;
487 (13) preparing as a pharmacist or pharmacy intern, a prescription drug for sale to
488 another pharmacist or pharmaceutical facility; and
489 (14) preparing as a pharmacist or pharmacy intern, a prescription drug in a dosage form
490 which is regularly and commonly available from a manufacturer in quantities and strengths
491 prescribed by a practitioner.
492 Section 5. Section 58-17b-503 is amended to read:

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Senate Committee Amendments 2-1-2005 rd/cjd 493

58-17b-503. Exception to unprofessional conduct.
494 (1) For purposes of this section:
495 (a) "ICFMR" means an intermediate care facility for the mentally retarded licensed as a
496 nursing care facility or a small health care facility under Title 26, Chapter 21, Health Care
497 Facility Licensing and Inspection Act.
498 (b) "Nursing care facility" has the same definition as in Section 26-21-2 .
499 (c) "Unit pack" means a tamper-resistant nonreusable single-dose single-drug package
500 [which] with identification that indicates the lot number and expiration date for the drug.
501 (2) Notwithstanding the provisions of Subsection 58-17b-502 (5), a pharmacist may
502 accept back and redistribute any unused drug, or a part of it, after it has left the premises of the
503 pharmacy if:
504 (a) the drug was prescribed to a patient in a nursing care facility, an ICFMR, or state
505 prison facility, county jail, or state hospital;
506 (b) the drug was stored under the supervision of a licensed health care provider
507 according to manufacturer recommendations;
508 (c) the drug is in a unit pack or in the manufacturer's sealed container;
509 (d) the drug was returned to the original dispensing pharmacy;
510 (e) the drug was initially dispensed by a licensed pharmacist or licensed pharmacy
511 intern; and
512 (f) accepting back and redistribution of the drug complies with Federal Food and Drug
513 Administration and Drug Enforcement Administration regulations.
513a S. Section 6. Section 58-17B-609 is amended to read:
513b 58-17b-609. Limitation on prescriptions and refills -- Controlled Substances Act
513c not affected -- Legend drugs.
513d (1) [A] Except as provided in Subsection 58-16a-102, a prescription for any
513e1 prescription drug or device may not be dispensed
513e after one year from the date it was initiated except as otherwise provided in Chapter 37, Utah
513f Controlled Substances Act.
513g (2) A prescription authorized to be refilled may not be refilled after one year
513h from the original issue date.
513i (3) A practitioner may not be prohibited from issuing a new prescription for the same
513j drug orally, in writing, or by electronic transmission.
513k (4) Nothing in this chapter affects Chapter 37, Utah Controlled Substances Act.
513l (5) [Prescriptions] A prescription for a legend drug written by a licensed
513m prescribing practitioner in another state may be filled or refilled by a pharmacist or .S

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Senate Committee Amendments 2-1-2005 rd/cjd 513n

S. pharmacy intern in this state [, and] if the pharmacist or pharmacy intern [knows
513o the prescribing practitioner holds a current license] verifies that the prescription is valid..S
514 Section S. [ 6 ] 7 .S . Section 58-17b-612 is amended to read:
515 58-17b-612. Supervision -- Pharmacist-in-charge.
516 (1) (a) Any pharmacy, except a wholesaler, distributor, or out-of-state mail service
517 pharmacy, shall be under the general supervision of at least one pharmacist licensed to practice
518 in Utah. One pharmacist licensed in Utah shall be designated as the pharmacist-in-charge,
519 whose responsibility it is to oversee the operation of the pharmacy.
520 (b) Notwithstanding the provisions of Subsection 58-17b-102 [(63)](64), a supervising
521 pharmacist does not have to be in the pharmacy or care facility but shall be available via a
522 telepharmacy system for immediate contact with the supervised pharmacy technician or
523 pharmacy intern if:

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- 18 - 524 (i) the pharmacy is located in:
525 (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
526 (B) a clinic located in a remote rural county with less than 20 people per square mile;
527 (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
528 (iii) the telepharmacy system maintains records and files quarterly reports as required
529 by division rule to assure that patient safety is not compromised.
530 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
531 a pharmacist holding a current license in good standing issued by the state in which the
532 pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
533 chapter.
534 Section 7. Repealer.
535 This bill repeals:
536 Section 58-17a-303, License classifications of drug outlets and other facilities --
537 Qualifications for licensure.
538 Section 58-17a-605.1, Restrictive drug formulary prohibited.

Legislative Review Note
as of 1-24-05 5:33 PM

Based on a limited legal review, this legislation has not been determined to have a high
probability of being held unconstitutional.

Office of Legislative Research and General Counsel