1     
PHARMACY COMPOUNDING AMENDMENTS

2     
2017 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Raymond P. Ward

5     
Senate Sponsor: Evan J. Vickers

6     

7     LONG TITLE
8     General Description:
9          This bill amends certain state prohibitions against the compounding of drugs in the
10     Pharmacy Practice Act.
11     Highlighted Provisions:
12          This bill:
13          ▸     amends the definition of compounding; and
14          ▸     amends the definition of unprofessional conduct related to compounding of certain
15     drugs.
16     Money Appropriated in this Bill:
17          None
18     Other Special Clauses:
19          None
20     Utah Code Sections Affected:
21     AMENDS:
22          58-17b-102, as last amended by Laws of Utah 2015, Chapter 336
23          58-17b-502, as last amended by Laws of Utah 2016, Chapter 405
24     

25     Be it enacted by the Legislature of the state of Utah:
26          Section 1. Section 58-17b-102 is amended to read:
27          58-17b-102. Definitions.

28          In addition to the definitions in Section 58-1-102, as used in this chapter:
29          (1) "Administering" means:
30          (a) the direct application of a prescription drug or device, whether by injection,
31     inhalation, ingestion, or by any other means, to the body of a human patient or research subject
32     by another person; or
33          (b) the placement by a veterinarian with the owner or caretaker of an animal or group
34     of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
35     means directed to the body of the animal by the owner or caretaker in accordance with written
36     or verbal directions of the veterinarian.
37          (2) "Adulterated drug or device" means a drug or device considered adulterated under
38     21 U.S.C. Sec. 351 (2003).
39          (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
40     the purpose of analysis.
41          (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
42     used as standards and controls in performing drug monitoring or drug screening analysis if the
43     prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
44     components, organic solvents, or inorganic buffers at a concentration not exceeding one
45     milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
46     use.
47          (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
48     the use of prescription drugs.
49          (5) "Automated pharmacy systems" includes mechanical systems which perform
50     operations or activities, other than compounding or administration, relative to the storage,
51     packaging, dispensing, or distribution of medications, and which collect, control, and maintain
52     all transaction information.
53          (6) "Beyond use date" means the date determined by a pharmacist and placed on a
54     prescription label at the time of dispensing that indicates to the patient or caregiver a time
55     beyond which the contents of the prescription are not recommended to be used.
56          (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
57     in Section 58-17b-201.
58          (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically

59     underserved area, used for the storage and dispensing of prescription drugs, which is dependent
60     upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
61     approved by the division as the parent pharmacy.
62          (9) "Centralized prescription processing" means the processing by a pharmacy of a
63     request from another pharmacy to fill or refill a prescription drug order or to perform
64     processing functions such as dispensing, drug utilization review, claims adjudication, refill
65     authorizations, and therapeutic interventions.
66          (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
67     retail pharmacy to compound or dispense a drug or dispense a device to the public under a
68     prescription order.
69          (11) "Class B pharmacy":
70          (a) means a pharmacy located in Utah:
71          (i) that is authorized to provide pharmaceutical care for patients in an institutional
72     setting; and
73          (ii) whose primary purpose is to provide a physical environment for patients to obtain
74     health care services; and
75          (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
76          (ii) pharmaceutical administration and sterile product preparation facilities.
77          (12) "Class C pharmacy" means a pharmacy that engages in the manufacture,
78     production, wholesale, or distribution of drugs or devices in Utah.
79          (13) "Class D pharmacy" means a nonresident pharmacy.
80          (14) "Class E pharmacy" means all other pharmacies.
81          (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
82     defined and exclusive group of patients who have access to the services of the pharmacy
83     because they are treated by or have an affiliation with a specific entity, including a health
84     maintenance organization or an infusion company, but not including a hospital pharmacy, a
85     retailer of goods to the general public, or the office of a practitioner.
86          (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
87     more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
88     more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
89     care functions authorized by the practitioner or practitioners under certain specified conditions

90     or limitations.
91          (17) "Collaborative pharmacy practice agreement" means a written and signed
92     agreement between one or more pharmacists and one or more practitioners that provides for
93     collaborative pharmacy practice for the purpose of drug therapy management of patients and
94     prevention of disease of human subjects.
95          (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
96     labeling of a limited quantity drug, sterile product, or device:
97          (i) as the result of a practitioner's prescription order or initiative based on the
98     practitioner, patient, or pharmacist relationship in the course of professional practice;
99          (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
100     not for sale or dispensing; or
101          (iii) in anticipation of prescription drug orders based on routine, regularly observed
102     prescribing patterns.
103          (b) "Compounding" does not include:
104          (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
105     another pharmacist or pharmaceutical facility; or
106          [(ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
107     dosage form which is regularly and commonly available from a manufacturer in quantities and
108     strengths prescribed by a practitioner; or]
109          [(iii)] (ii) the preparation of a prescription drug, sterile product, or device [which] that
110     has been withdrawn from the market for safety reasons.
111          (19) "Confidential information" has the same meaning as "protected health
112     information" under the Standards for Privacy of Individually Identifiable Health Information,
113     45 C.F.R. Parts 160 and 164.
114          (20) "Controlled substance" means the same as that term is defined in Section 58-37-2.
115          (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
116     417, Sec. 3a(ff) which is incorporated by reference.
117          (22) "Dispense" means the interpretation, evaluation, and implementation of a
118     prescription drug order or device or nonprescription drug or device under a lawful order of a
119     practitioner in a suitable container appropriately labeled for subsequent administration to or use
120     by a patient, research subject, or an animal.

121          (23) "Dispensing medical practitioner" means an individual who is:
122          (a) currently licensed as:
123          (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
124          (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
125     Practice Act;
126          (iii) a physician assistant under Chapter 70a, Physician Assistant Act;
127          (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
128          (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the optometrist
129     is acting within the scope of practice for an optometrist; and
130          (b) licensed by the division under the Pharmacy Practice Act to engage in the practice
131     of a dispensing medical practitioner.
132          (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
133     located within a licensed dispensing medical practitioner's place of practice.
134          (25) "Distribute" means to deliver a drug or device other than by administering or
135     dispensing.
136          (26) (a) "Drug" means:
137          (i) a substance recognized in the official United States Pharmacopoeia, official
138     Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any
139     supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
140     prevention of disease in humans or animals;
141          (ii) a substance that is required by any applicable federal or state law or rule to be
142     dispensed by prescription only or is restricted to administration by practitioners only;
143          (iii) a substance other than food intended to affect the structure or any function of the
144     body of humans or other animals; and
145          (iv) substances intended for use as a component of any substance specified in
146     Subsections (26)(a)(i), (ii), (iii), and (iv).
147          (b) "Drug" does not include dietary supplements.
148          (27) "Drug regimen review" includes the following activities:
149          (a) evaluation of the prescription drug order and patient record for:
150          (i) known allergies;
151          (ii) rational therapy-contraindications;

152          (iii) reasonable dose and route of administration; and
153          (iv) reasonable directions for use;
154          (b) evaluation of the prescription drug order and patient record for duplication of
155     therapy;
156          (c) evaluation of the prescription drug order and patient record for the following
157     interactions:
158          (i) drug-drug;
159          (ii) drug-food;
160          (iii) drug-disease; and
161          (iv) adverse drug reactions; and
162          (d) evaluation of the prescription drug order and patient record for proper utilization,
163     including over- or under-utilization, and optimum therapeutic outcomes.
164          (28) "Drug sample" means a prescription drug packaged in small quantities consistent
165     with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
166     be sold, and is intended to be provided to practitioners for the immediate needs of patients for
167     trial purposes or to provide the drug to the patient until a prescription can be filled by the
168     patient.
169          (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
170     symbol, or process attached to or logically associated with a record and executed or adopted by
171     a person with the intent to sign the record.
172          (30) "Electronic transmission" means transmission of information in electronic form or
173     the transmission of the exact visual image of a document by way of electronic equipment.
174          (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
175     inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
176     under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
177          (32) "Legend drug" has the same meaning as prescription drug.
178          (33) "Licensed pharmacy technician" means an individual licensed with the division,
179     that may, under the supervision of a pharmacist, perform the activities involved in the
180     technician practice of pharmacy.
181          (34) "Manufacturer" means a person or business physically located in Utah licensed to
182     be engaged in the manufacturing of drugs or devices.

183          (35) (a) "Manufacturing" means:
184          (i) the production, preparation, propagation, conversion, or processing of a drug or
185     device, either directly or indirectly, by extraction from substances of natural origin or
186     independently by means of chemical or biological synthesis, or by a combination of extraction
187     and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
188     or relabeling of its container; and
189          (ii) the promotion and marketing of such drugs or devices.
190          (b) "Manufacturing" includes the preparation and promotion of commercially available
191     products from bulk compounds for resale by pharmacies, practitioners, or other persons.
192          (c) "Manufacturing" does not include the preparation or compounding of a drug by a
193     pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
194     compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
195     analysis.
196          (36) "Medical order" means a lawful order of a practitioner which may include a
197     prescription drug order.
198          (37) "Medication profile" or "profile" means a record system maintained as to drugs or
199     devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
200     the profile to provide pharmaceutical care.
201          (38) "Misbranded drug or device" means a drug or device considered misbranded under
202     21 U.S.C. Sec. 352 (2003).
203          (39) (a) "Nonprescription drug" means a drug which:
204          (i) may be sold without a prescription; and
205          (ii) is labeled for use by the consumer in accordance with federal law.
206          (b) "Nonprescription drug" includes homeopathic remedies.
207          (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
208     person in Utah.
209          (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
210          (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
211     outside the state that is licensed and in good standing in another state, that:
212          (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
213     this state pursuant to a lawfully issued prescription;

214          (b) provides information to a patient in this state on drugs or devices which may
215     include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
216     or
217          (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
218     effects of drugs.
219          (43) "Patient counseling" means the written and oral communication by the pharmacist
220     or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
221     drugs, devices, and dietary supplements.
222          (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
223     which:
224          (a) prescription drugs or devices are held, stored, or are otherwise under the control of
225     the facility or agency for administration to patients of that facility or agency;
226          (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
227     or pharmacy intern with whom the facility has established a prescription drug supervising
228     relationship under which the pharmacist or pharmacy intern provides counseling to the facility
229     or agency staff as required, and oversees drug control, accounting, and destruction; and
230          (c) prescription drugs are professionally administered in accordance with the order of a
231     practitioner by an employee or agent of the facility or agency.
232          (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
233     prescribing practitioner, and in accordance with division rule:
234          (i) designing, implementing, and monitoring a therapeutic drug plan intended to
235     achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
236     the patient's disease;
237          (ii) eliminating or reducing a patient's symptoms; or
238          (iii) arresting or slowing a disease process.
239          (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
240     prescribing practitioner.
241          (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
242     distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
243     state.
244          (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility

245     engaged in the business of wholesale vending or selling of a prescription drug or device to
246     other than a consumer or user of the prescription drug or device that the pharmaceutical facility
247     has not produced, manufactured, compounded, or dispensed.
248          (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
249     facility carrying out the following business activities:
250          (i) intracompany sales;
251          (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
252     purchase, or trade a prescription drug or device, if the activity is carried out between one or
253     more of the following entities under common ownership or common administrative control, as
254     defined by division rule:
255          (A) hospitals;
256          (B) pharmacies;
257          (C) chain pharmacy warehouses, as defined by division rule; or
258          (D) other health care entities, as defined by division rule;
259          (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
260     purchase, or trade a prescription drug or device, for emergency medical reasons, including
261     supplying another pharmaceutical facility with a limited quantity of a drug, if:
262          (A) the facility is unable to obtain the drug through a normal distribution channel in
263     sufficient time to eliminate the risk of harm to a patient that would result from a delay in
264     obtaining the drug; and
265          (B) the quantity of the drug does not exceed an amount reasonably required for
266     immediate dispensing to eliminate the risk of harm;
267          (iv) the distribution of a prescription drug or device as a sample by representatives of a
268     manufacturer; and
269          (v) the distribution of prescription drugs, if:
270          (A) the facility's total distribution-related sales of prescription drugs does not exceed
271     5% of the facility's total prescription drug sales; and
272          (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
273          (48) "Pharmacist" means an individual licensed by this state to engage in the practice
274     of pharmacy.
275          (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing

276     who accepts responsibility for the operation of a pharmacy in conformance with all laws and
277     rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
278     in full and actual charge of the pharmacy and all personnel.
279          (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
280     more years of licensed experience. The preceptor serves as a teacher, example of professional
281     conduct, and supervisor of interns in the professional practice of pharmacy.
282          (51) "Pharmacy" means any place where:
283          (a) drugs are dispensed;
284          (b) pharmaceutical care is provided;
285          (c) drugs are processed or handled for eventual use by a patient; or
286          (d) drugs are used for the purpose of analysis or research.
287          (52) "Pharmacy benefits manager or coordinator" means a person or entity that
288     provides pharmacy benefit management services as defined in Section 49-20-502 on behalf of a
289     self-insured employer, insurance company, health maintenance organization, or other plan
290     sponsor, as defined by rule.
291          (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
292     as a pharmacy intern.
293          (54) "Pharmacy technician training program" means an approved technician training
294     program providing education for pharmacy technicians.
295          (55) (a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
296     specifically relating to the dispensing of a prescription drug in accordance with Part 8,
297     Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, and
298     division rule adopted after consultation with the Board of pharmacy and the governing boards
299     of the practitioners described in Subsection (23)(a).
300          (b) "Practice as a dispensing medical practitioner" does not include:
301          (i) using a vending type of dispenser as defined by the division by administrative rule;
302     or
303          (ii) except as permitted by Section 58-17b-805, dispensing of a controlled substance as
304     defined in Section 58-37-2.
305          (56) (a) "Practice as a licensed pharmacy technician" means engaging in practice as a
306     pharmacy technician under the general supervision of a licensed pharmacist and in accordance

307     with a scope of practice defined by division rule made in collaboration with the board.
308          (b) "Practice as a licensed pharmacy technician" does not include:
309          (i) performing a drug utilization review, prescription drug order clarification from a
310     prescriber, final review of the prescription, dispensing of the drug, or counseling a patient with
311     respect to a prescription drug;
312          (ii) except as permitted by rules made by the division in consultation with the board,
313     final review of a prescribed drug prepared for dispensing;
314          (iii) counseling regarding nonprescription drugs and dietary supplements unless
315     delegated by the supervising pharmacist; or
316          (iv) receiving new prescription drug orders when communicating telephonically or
317     electronically unless the original information is recorded so the pharmacist may review the
318     prescription drug order as transmitted.
319          (57) "Practice of pharmacy" includes the following:
320          (a) providing pharmaceutical care;
321          (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
322     practice agreement;
323          (c) compounding, packaging, labeling, dispensing, administering, and the coincident
324     distribution of prescription drugs or devices, provided that the administration of a prescription
325     drug or device is:
326          (i) pursuant to a lawful order of a practitioner when one is required by law; and
327          (ii) in accordance with written guidelines or protocols:
328          (A) established by the licensed facility in which the prescription drug or device is to be
329     administered on an inpatient basis; or
330          (B) approved by the division, in collaboration with the board and the Physicians
331     Licensing Board, created in Section 58-67-201, if the prescription drug or device is to be
332     administered on an outpatient basis solely by a licensed pharmacist;
333          (d) participating in drug utilization review;
334          (e) ensuring proper and safe storage of drugs and devices;
335          (f) maintaining records of drugs and devices in accordance with state and federal law
336     and the standards and ethics of the profession;
337          (g) providing information on drugs or devices, which may include advice relating to

338     therapeutic values, potential hazards, and uses;
339          (h) providing drug product equivalents;
340          (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
341     technicians;
342          (j) providing patient counseling, including adverse and therapeutic effects of drugs;
343          (k) providing emergency refills as defined by rule;
344          (l) telepharmacy; and
345          (m) formulary management intervention.
346          (58) "Practice of telepharmacy" means the practice of pharmacy through the use of
347     telecommunications and information technologies.
348          (59) "Practice of telepharmacy across state lines" means the practice of pharmacy
349     through the use of telecommunications and information technologies that occurs when the
350     patient is physically located within one jurisdiction and the pharmacist is located in another
351     jurisdiction.
352          (60) "Practitioner" means an individual currently licensed, registered, or otherwise
353     authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
354     professional practice.
355          (61) "Prescribe" means to issue a prescription:
356          (a) orally or in writing; or
357          (b) by telephone, facsimile transmission, computer, or other electronic means of
358     communication as defined by division rule.
359          (62) "Prescription" means an order issued:
360          (a) by a licensed practitioner in the course of that practitioner's professional practice or
361     by collaborative pharmacy practice agreement; and
362          (b) for a controlled substance or other prescription drug or device for use by a patient
363     or an animal.
364          (63) "Prescription device" means an instrument, apparatus, implement, machine,
365     contrivance, implant, in vitro reagent, or other similar or related article, and any component
366     part or accessory, which is required under federal or state law to be prescribed by a practitioner
367     and dispensed by or through a person or entity licensed under this chapter or exempt from
368     licensure under this chapter.

369          (64) "Prescription drug" means a drug that is required by federal or state law or rule to
370     be dispensed only by prescription or is restricted to administration only by practitioners.
371          (65) "Repackage":
372          (a) means changing the container, wrapper, or labeling to further the distribution of a
373     prescription drug; and
374          (b) does not include:
375          (i) Subsection (65)(a) when completed by the pharmacist responsible for dispensing the
376     product to a patient; or
377          (ii) changing or altering a label as necessary for a dispensing practitioner under Part 8,
378     Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, for
379     dispensing a product to a patient.
380          (66) "Research using pharmaceuticals" means research:
381          (a) conducted in a research facility, as defined by division rule, that is associated with a
382     university or college in the state accredited by the Northwest Commission on Colleges and
383     Universities;
384          (b) requiring the use of a controlled substance, prescription drug, or prescription
385     device;
386          (c) that uses the controlled substance, prescription drug, or prescription device in
387     accordance with standard research protocols and techniques, including, if required, those
388     approved by an institutional review committee; and
389          (d) that includes any documentation required for the conduct of the research and the
390     handling of the controlled substance, prescription drug, or prescription device.
391          (67) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
392     and devices to the general public.
393          (68) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
394     with this chapter.
395          (69) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
396     the pharmacy during a given day or shift.
397          (70) "Supportive personnel" means unlicensed individuals who:
398          (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
399     pharmacy technician in nonjudgmental duties not included in the definition of the practice of

400     pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
401     those duties may be further defined by division rule adopted in collaboration with the board;
402     and
403          (b) are supervised by a pharmacist in accordance with rules adopted by the division in
404     collaboration with the board.
405          (71) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501
406     and 58-17b-501.
407          (72) "Unprofessional conduct" means the same as that term is defined in Sections
408     58-1-501 and 58-17b-502 and may be further defined by rule.
409          (73) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
410     dispenses drugs intended for use by animals or for sale to veterinarians for the administration
411     for animals.
412          Section 2. Section 58-17b-502 is amended to read:
413          58-17b-502. Unprofessional conduct.
414          "Unprofessional conduct" includes:
415          (1) willfully deceiving or attempting to deceive the division, the board, or their agents
416     as to any relevant matter regarding compliance under this chapter;
417          (2) (a) except as provided in Subsection (2)(b):
418          (i) paying or offering rebates to practitioners or any other health care providers, or
419     receiving or soliciting rebates from practitioners or any other health care provider; or
420          (ii) paying, offering, receiving, or soliciting compensation in the form of a commission,
421     bonus, rebate, kickback, or split fee arrangement with practitioners or any other health care
422     provider, for the purpose of obtaining referrals.
423          (b) Subsection (2)(a) does not apply to:
424          (i) giving or receiving price discounts based on purchase volume;
425          (ii) passing along pharmaceutical manufacturer's rebates; or
426          (iii) providing compensation for services to a veterinarian.
427          (3) misbranding or adulteration of any drug or device or the sale, distribution, or
428     dispensing of any outdated, misbranded, or adulterated drug or device;
429          (4) engaging in the sale or purchase of drugs or devices that are samples or packages
430     bearing the inscription "sample" or "not for resale" or similar words or phrases;

431          (5) except as provided in Section 58-17b-503 or Part 9, Charitable Prescription Drug
432     Recycling Act, accepting back and redistributing any unused drug, or a part of it, after it has
433     left the premises of any pharmacy, unless the drug is in a unit pack, as defined in Section
434     58-17b-503, or the manufacturer's sealed container, as defined in rule;
435          (6) an act in violation of this chapter committed by a person for any form of
436     compensation if the act is incidental to the person's professional activities, including the
437     activities of a pharmacist, pharmacy intern, or pharmacy technician;
438          (7) violating Federal Title II, P.L. 91, Controlled Substances Act, Title 58, Chapter 37,
439     Utah Controlled Substances Act, or rules or regulations adopted under either act;
440          (8) requiring or permitting pharmacy interns or technicians to engage in activities
441     outside the scope of practice for their respective license classifications, as defined in this
442     chapter and division rules made in collaboration with the board, or beyond their scope of
443     training and ability;
444          (9) administering:
445          (a) without appropriate training, as defined by rule;
446          (b) without a physician's order, when one is required by law; and
447          (c) in conflict with a practitioner's written guidelines or written protocol for
448     administering;
449          (10) disclosing confidential patient information in violation of the provisions of the
450     Health Insurance Portability and Accountability Act of 1996 or other applicable law;
451          (11) engaging in the practice of pharmacy without a licensed pharmacist designated as
452     the pharmacist-in-charge; and
453          (12) failing to report to the division any adverse action taken by another licensing
454     jurisdiction, government agency, law enforcement agency, or court for conduct that in
455     substance would be considered unprofessional conduct under this section[; and].
456          [(13) as a pharmacist or pharmacy intern, compounding a prescription drug in a dosage
457     form which is regularly and commonly available from a manufacturer in quantities and
458     strengths prescribed by a practitioner.]






Legislative Review Note
Office of Legislative Research and General Counsel