Download Zipped Enrolled WordPerfect SB0014.ZIP
[Introduced][Status][Bill Documents][Fiscal Note][Bills Directory]
S.B. 14 Enrolled
7 LONG TITLE
8 General Description:
9 This bill amends the Pharmacy Practice Act.
10 Highlighted Provisions:
11 This bill:
12 . defines "research using pharmaceuticals";
13 . exempts research using pharmaceuticals from licensure to engage in the practice of
14 pharmacy, telepharmacy, or the practice of a pharmacy technician;
15 . exempts research using pharmaceuticals from licensure to act as a pharmacy; and
16 . makes technical corrections.
17 Money Appropriated in this Bill:
19 Other Special Clauses:
21 Utah Code Sections Affected:
23 58-17b-102, as last amended by Laws of Utah 2012, Chapters 265 and 320
24 58-17b-301, as enacted by Laws of Utah 2004, Chapter 280
25 58-17b-302, as last amended by Laws of Utah 2007, Chapter 279
26 58-17b-612, as last amended by Laws of Utah 2010, Chapter 101
28 58-17b-309.6, Utah Code Annotated 1953
30 Be it enacted by the Legislature of the state of Utah:
31 Section 1. Section 58-17b-102 is amended to read:
32 58-17b-102. Definitions.
33 In addition to the definitions in Section 58-1-102 , as used in this chapter:
34 (1) "Administering" means:
35 (a) the direct application of a prescription drug or device, whether by injection,
36 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
37 by another person; or
38 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
39 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
40 means directed to the body of the animal by the owner or caretaker in accordance with written
41 or verbal directions of the veterinarian.
42 (2) "Adulterated drug or device" means a drug or device considered adulterated under
43 21 U.S.C.S. Sec. 351 (2003).
44 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
45 the purpose of analysis.
46 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
47 used as standards and controls in performing drug monitoring or drug screening analysis if the
48 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
49 components, organic solvents, or inorganic buffers at a concentration not exceeding one
50 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
52 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
53 the use of prescription drugs.
54 (5) "Automated pharmacy systems" includes mechanical systems which perform
55 operations or activities, other than compounding or administration, relative to the storage,
56 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
57 all transaction information.
58 (6) "Beyond use date" means the date determined by a pharmacist and placed on a
59 prescription label at the time of dispensing that indicates to the patient or caregiver a time
60 beyond which the contents of the prescription are not recommended to be used.
61 (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
62 in Section 58-17b-201 .
63 (8) "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 (9) "Centralized prescription processing" means the processing by a pharmacy of a
68 request from another pharmacy to fill or refill a prescription drug order or to perform
69 processing functions such as dispensing, drug utilization review, claims adjudication, refill
70 authorizations, and therapeutic interventions.
71 (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
72 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
73 prescription order.
74 (11) "Class B pharmacy":
75 (a) means a pharmacy located in Utah:
76 (i) that is authorized to provide pharmaceutical care for patients in an institutional
77 setting; and
78 (ii) whose primary purpose is to provide a physical environment for patients to obtain
79 health care services; and
80 (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
81 (ii) pharmaceutical administration and sterile product preparation facilities.
82 (12) "Class C pharmacy" means a pharmacy located in Utah that is authorized to
83 engage in the manufacture, production, wholesale, or distribution of drugs or devices.
84 (13) "Class D pharmacy" means a nonresident pharmacy.
85 (14) "Class E pharmacy" means all other pharmacies.
86 (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
87 defined and exclusive group of patients who have access to the services of the pharmacy
88 because they are treated by or have an affiliation with a specific entity, including a health
89 maintenance organization or an infusion company, but not including a hospital pharmacy, a
90 retailer of goods to the general public, or the office of a practitioner.
91 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
92 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
93 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
94 care functions authorized by the practitioner or practitioners under certain specified conditions
95 or limitations.
96 (17) "Collaborative pharmacy practice agreement" means a written and signed
97 agreement between one or more pharmacists and one or more practitioners that provides for
98 collaborative pharmacy practice for the purpose of drug therapy management of patients and
99 prevention of disease of human subjects.
100 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
101 labeling of a limited quantity drug, sterile product, or device:
102 (i) as the result of a practitioner's prescription order or initiative based on the
103 practitioner, patient, or pharmacist relationship in the course of professional practice;
104 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
105 not for sale or dispensing; or
106 (iii) in anticipation of prescription drug orders based on routine, regularly observed
107 prescribing patterns.
108 (b) "Compounding" does not include:
109 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
110 another pharmacist or pharmaceutical facility;
111 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
112 dosage form which is regularly and commonly available from a manufacturer in quantities and
113 strengths prescribed by a practitioner; or
114 (iii) the preparation of a prescription drug, sterile product, or device which has been
115 withdrawn from the market for safety reasons.
116 (19) "Confidential information" has the same meaning as "protected health
117 information" under the Standards for Privacy of Individually Identifiable Health Information,
118 45 C.F.R. Parts 160 and 164.
119 (20) "Controlled substance" has the same definition as in Section 58-37-2 .
120 (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
121 417, Sec. 3a(ff) which is incorporated by reference.
122 (22) "Dispense" means the interpretation, evaluation, and implementation of a
123 prescription drug order or device or nonprescription drug or device under a lawful order of a
124 practitioner in a suitable container appropriately labeled for subsequent administration to or use
125 by a patient, research subject, or an animal.
126 (23) "Distribute" means to deliver a drug or device other than by administering or
128 (24) (a) "Drug" means:
129 (i) a substance recognized in the official United States Pharmacopoeia, Official
130 Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or any
131 supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
132 prevention of disease in humans or animals;
133 (ii) a substance that is required by any applicable federal or state law or rule to be
134 dispensed by prescription only or is restricted to administration by practitioners only;
135 (iii) a substance other than food intended to affect the structure or any function of the
136 body of humans or other animals; and
137 (iv) substances intended for use as a component of any substance specified in
138 Subsections (24)(a)(i), (ii), (iii), and (iv).
139 (b) "Drug" does not include dietary supplements.
140 (25) "Drug product equivalent" means a drug product that is designated as the
141 therapeutic equivalent of another drug product in the Approved Drug Products with
142 Therapeutic Equivalence Evaluations prepared by the Center for Drug Evaluation and Research
143 of the Federal Food and Drug Administration.
144 (26) "Drug regimen review" includes the following activities:
145 (a) evaluation of the prescription drug order and patient record for:
146 (i) known allergies;
147 (ii) rational therapy-contraindications;
148 (iii) reasonable dose and route of administration; and
149 (iv) reasonable directions for use;
150 (b) evaluation of the prescription drug order and patient record for duplication of
152 (c) evaluation of the prescription drug order and patient record for the following
154 (i) drug-drug;
155 (ii) drug-food;
156 (iii) drug-disease; and
157 (iv) adverse drug reactions; and
158 (d) evaluation of the prescription drug order and patient record for proper utilization,
159 including over- or under-utilization, and optimum therapeutic outcomes.
160 (27) "Drug sample" means a prescription drug packaged in small quantities consistent
161 with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
162 be sold, and is intended to be provided to practitioners for the immediate needs of patients for
163 trial purposes or to provide the drug to the patient until a prescription can be filled by the
165 (28) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
166 symbol, or process attached to or logically associated with a record and executed or adopted by
167 a person with the intent to sign the record.
168 (29) "Electronic transmission" means transmission of information in electronic form or
169 the transmission of the exact visual image of a document by way of electronic equipment.
170 (30) "Extern" means a college of pharmacy student enrolled in a college coordinated
171 practical experience program in a health care setting under the supervision of a preceptor, as
172 defined in this act, and approved by a college of pharmacy.
173 (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
174 inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
175 under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
176 (32) "Legend drug" has the same meaning as prescription drug.
177 (33) "Licensed pharmacy technician" means an individual licensed with the division,
178 that may, under the supervision of a pharmacist, perform the activities involved in the
179 technician practice of pharmacy.
180 (34) "Manufacturer" means a person or business physically located in Utah licensed to
181 be engaged in the manufacturing of drugs or devices.
182 (35) (a) "Manufacturing" means:
183 (i) the production, preparation, propagation, conversion, or processing of a drug or
184 device, either directly or indirectly, by extraction from substances of natural origin or
185 independently by means of chemical or biological synthesis, or by a combination of extraction
186 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
187 or relabeling of its container; and
188 (ii) the promotion and marketing of such drugs or devices.
189 (b) "Manufacturing" includes the preparation and promotion of commercially available
190 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
191 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
192 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
193 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
195 (36) "Medical order" means a lawful order of a practitioner which may include a
196 prescription drug order.
197 (37) "Medication profile" or "profile" means a record system maintained as to drugs or
198 devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
199 the profile to provide pharmaceutical care.
200 (38) "Misbranded drug or device" means a drug or device considered misbranded under
201 21 U.S.C.S. Sec. 352 (2003).
202 (39) (a) "Nonprescription drug" means a drug which:
203 (i) may be sold without a prescription; and
204 (ii) is labeled for use by the consumer in accordance with federal law.
205 (b) "Nonprescription drug" includes homeopathic remedies.
206 (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
207 person in Utah.
208 (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
209 (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
210 outside the state that is licensed and in good standing in another state, that:
211 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
212 this state pursuant to a lawfully issued prescription;
213 (b) provides information to a patient in this state on drugs or devices which may
214 include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
216 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
217 effects of drugs.
218 (43) "Patient counseling" means the written and oral communication by the pharmacist
219 or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
220 drugs, devices, and dietary supplements.
221 (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
223 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
224 the facility or agency for administration to patients of that facility or agency;
225 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
226 or pharmacy intern with whom the facility has established a prescription drug supervising
227 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
228 or agency staff as required, and oversees drug control, accounting, and destruction; and
229 (c) prescription drugs are professionally administered in accordance with the order of a
230 practitioner by an employee or agent of the facility or agency.
231 (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
232 prescribing practitioner, and in accordance with division rule:
233 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
234 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
235 the patient's disease;
236 (ii) eliminating or reducing a patient's symptoms; or
237 (iii) arresting or slowing a disease process.
238 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
239 prescribing practitioner.
240 (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
241 distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
243 (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
244 engaged in the business of wholesale vending or selling of any prescription drug or device to
245 other than the consumer or user of the prescription drug or device, which the pharmaceutical
246 facility has not produced, manufactured, compounded, or dispensed.
247 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
248 facility carrying out the following business activities:
249 (i) intracompany sales;
250 (ii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
251 purchase or trade a prescription drug or device between hospitals or other health care facilities
252 that are under common ownership or control of the management and operation of the facilities;
253 (iii) the sale, purchase, or trade of a prescription drug or device, or offer to sell,
254 purchase, or trade a prescription drug or device for emergency medical reasons, or to supply
255 another pharmaceutical facility to alleviate a temporary shortage; or
256 (iv) the distribution of a prescription drug or device as a sample by representatives of a
258 (48) "Pharmacist" means an individual licensed by this state to engage in the practice
259 of pharmacy.
260 (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
261 who accepts responsibility for the operation of a pharmacy in conformance with all laws and
262 rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
263 in full and actual charge of the pharmacy and all personnel.
264 (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
265 more years of licensed experience. The preceptor serves as a teacher, example of professional
266 conduct, and supervisor of interns in the professional practice of pharmacy.
267 (51) "Pharmacy" means any place where:
268 (a) drugs are dispensed;
269 (b) pharmaceutical care is provided;
270 (c) drugs are processed or handled for eventual use by a patient; or
271 (d) drugs are used for the purpose of analysis or research.
272 (52) "Pharmacy benefits manager or coordinator" means a person or entity that
273 provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
274 self-insured employer, insurance company, health maintenance organization, or other plan
275 sponsor, as defined by rule.
276 (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
277 as a pharmacy intern.
278 (54) "Pharmacy technician training program" means an approved technician training
279 program providing education for pharmacy technicians.
280 (55) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a
281 pharmacy technician under the general supervision of a licensed pharmacist and in accordance
282 with a scope of practice defined by division rule made in collaboration with the board.
283 (b) "Practice as a licensed pharmacy technician" does not include:
284 (i) performing a drug utilization review, prescription drug order clarification from a
285 prescriber, final review of the prescription and prescribed drug prepared for dispensing,
286 dispensing of the drug, or counseling a patient with respect to a prescription drug;
287 (ii) counseling regarding nonprescription drugs and dietary supplements unless
288 delegated by the supervising pharmacist; or
289 (iii) receiving new prescription drug orders when communicating telephonically or
290 electronically unless the original information is recorded so the pharmacist may review the
291 prescription drug order as transmitted.
292 (56) "Practice of pharmacy" includes the following:
293 (a) providing pharmaceutical care;
294 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
295 practice agreement;
296 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
297 distribution of prescription drugs or devices, provided that the administration of a prescription
298 drug or device is:
299 (i) pursuant to a lawful order of a practitioner when one is required by law; and
300 (ii) in accordance with written guidelines or protocols:
301 (A) established by the licensed facility in which the prescription drug or device is to be
302 administered on an inpatient basis; or
303 (B) approved by the division, in collaboration with the board and the Physicians
304 Licensing Board, created in Section 58-67-201 , if the prescription drug or device is to be
305 administered on an outpatient basis solely by a licensed pharmacist;
306 (d) participating in drug utilization review;
307 (e) ensuring proper and safe storage of drugs and devices;
308 (f) maintaining records of drugs and devices in accordance with state and federal law
309 and the standards and ethics of the profession;
310 (g) providing information on drugs or devices, which may include advice relating to
311 therapeutic values, potential hazards, and uses;
312 (h) providing drug product equivalents;
313 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
315 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
316 (k) providing emergency refills as defined by rule;
317 (l) telepharmacy; and
318 (m) formulary management intervention.
319 (57) "Practice of telepharmacy" means the practice of pharmacy through the use of
320 telecommunications and information technologies.
321 (58) "Practice of telepharmacy across state lines" means the practice of pharmacy
322 through the use of telecommunications and information technologies that occurs when the
323 patient is physically located within one jurisdiction and the pharmacist is located in another
325 (59) "Practitioner" means an individual currently licensed, registered, or otherwise
326 authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
327 professional practice.
328 (60) "Prescribe" means to issue a prescription:
329 (a) orally or in writing; or
330 (b) by telephone, facsimile transmission, computer, or other electronic means of
331 communication as defined by division rule.
332 (61) "Prescription" means an order issued:
333 (a) by a licensed practitioner in the course of that practitioner's professional practice or
334 by collaborative pharmacy practice agreement; and
335 (b) for a controlled substance or other prescription drug or device for use by a patient
336 or an animal.
337 (62) "Prescription device" means an instrument, apparatus, implement, machine,
338 contrivance, implant, in vitro reagent, or other similar or related article, and any component
339 part or accessory, which is required under federal or state law to be prescribed by a practitioner
340 and dispensed by or through a person or entity licensed under this chapter or exempt from
341 licensure under this chapter.
342 (63) "Prescription drug" means a drug that is required by federal or state law or rule to
343 be dispensed only by prescription or is restricted to administration only by practitioners.
344 (64) "Research using pharmaceuticals" means research:
345 (a) conducted in a research facility, as defined by division rule, that is associated with a
346 university or college in the state accredited by the Northwest Commission on Colleges and
348 (b) requiring the use of a controlled substance, prescription drug, or prescription
350 (c) that uses the controlled substance, prescription drug, or prescription device in
351 accordance with standard research protocols and techniques, including, if required, those
352 approved by an institutional review committee; and
353 (d) that includes any documentation required for the conduct of the research and the
354 handling of the controlled substance, prescription drug, or prescription device.
356 drugs and devices to the general public.
358 compliance with this chapter.
360 operation of the pharmacy during a given day or shift.
362 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
363 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
364 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
365 those duties may be further defined by division rule adopted in collaboration with the board;
367 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
368 collaboration with the board.
371 58-17b-502 and may be further defined by rule.
373 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
374 for animals.
375 Section 2. Section 58-17b-301 is amended to read:
376 58-17b-301. License required -- License classifications for individuals.
377 (1) A license is required to engage in the practice of pharmacy, telepharmacy, or the
378 practice of a pharmacy technician, except as specifically provided in Section 58-1-307 [
379 58-17b-309 , or 58-17-309.6 .
380 (2) The division shall issue to an individual who qualifies under this chapter a license
381 in the classification of:
382 (a) pharmacist;
383 (b) pharmacy intern; or
384 (c) pharmacy technician.
385 Section 3. Section 58-17b-302 is amended to read:
386 58-17b-302. License required -- License classifications for pharmacy facilities.
387 (1) A license is required to act as a pharmacy, except as specifically exempted from
388 licensure under Section 58-1-307 or 58-17-309.6 .
389 (2) The division shall issue a pharmacy license to a facility that qualifies under this
390 chapter in the classification of a:
391 (a) class A pharmacy;
392 (b) class B pharmacy;
393 (c) class C pharmacy;
394 (d) class D pharmacy; or
395 (e) class E pharmacy.
396 (3) Each place of business shall require a separate license. If multiple pharmacies exist
397 at the same address, a separate license shall be required for each pharmacy.
398 (4) The division may further define or supplement the classifications of pharmacies.
399 The division may impose restrictions upon classifications to protect the public health, safety,
400 and welfare.
401 (5) Each pharmacy shall have a pharmacist-in-charge, except as otherwise provided by
403 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy,
404 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
405 of the pharmacy, regardless of the form of the business organization.
406 Section 4. Section 58-17b-309.6 is enacted to read:
407 58-17b-309.6. Exemptions from licensure for research using pharmaceuticals.
408 Research using pharmaceuticals, as defined in Subsection 58-17b-102 (64), is exempt
409 from licensure under Sections 58-17b-301 and 58-17b-302 .
410 Section 5. Section 58-17b-612 is amended to read:
411 58-17b-612. Supervision -- Pharmacist-in-charge.
412 (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
413 pharmacy, or class E pharmacy, shall be under the general supervision of at least one
414 pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
415 as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
416 (b) Notwithstanding Subsection 58-17b-102 [
417 not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
418 for immediate contact with the supervised pharmacy technician or pharmacy intern if:
419 (i) the pharmacy is located in:
420 (A) a remote rural hospital, as defined in Section 26-21-13.6 ; or
421 (B) a clinic located in a remote rural county with less than 20 people per square mile;
422 (ii) the supervising pharmacist described in Subsection (1)(a) is not available; and
423 (iii) the telepharmacy system maintains records and files quarterly reports as required
424 by division rule to assure that patient safety is not compromised.
425 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
426 a pharmacist holding a current license in good standing issued by the state in which the
427 pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
[Bill Documents][Bills Directory]