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7 LONG TITLE
8 General Description:
9 This bill amends provisions relating to the practice of pharmacy.
10 Highlighted Provisions:
11 This bill:
12 ▸ amends the definition of "practice as a licensed pharmacy technician";
13 ▸ adds a drug to the list of long-acting injectable drug therapies that can be
14 administered by certain pharmacists;
15 ▸ changes the requirements for certain supervising pharmacists;
16 ▸ adds certain board certified urologists to the list of individuals who are qualified to
17 be a dispensing medical practitioner; and
18 ▸ reschedules certain drugs that are approved by the United States Food and Drug
19 Administration and contain a component of cannabis.
20 Money Appropriated in this Bill:
21 None
22 Other Special Clauses:
23 None
24 Utah Code Sections Affected:
25 AMENDS:
26 58-17b-102, as last amended by Laws of Utah 2018, Chapter 295
27 58-17b-612, as last amended by Laws of Utah 2014, Chapter 72
28 58-17b-625, as enacted by Laws of Utah 2017, Chapter 384
29 58-17b-805, as enacted by Laws of Utah 2014, Chapter 72
30 58-37-4, as last amended by Laws of Utah 2018, Chapter 146
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32 Be it enacted by the Legislature of the state of Utah:
33 Section 1. Section 58-17b-102 is amended to read:
34 58-17b-102. Definitions.
35 In addition to the definitions in Section 58-1-102, as used in this chapter:
36 (1) "Administering" means:
37 (a) the direct application of a prescription drug or device, whether by injection,
38 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
39 by another person; or
40 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
41 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
42 means directed to the body of the animal by the owner or caretaker in accordance with written
43 or verbal directions of the veterinarian.
44 (2) "Adulterated drug or device" means a drug or device considered adulterated under
45 21 U.S.C. Sec. 351 (2003).
46 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
47 the purpose of analysis.
48 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
49 used as standards and controls in performing drug monitoring or drug screening analysis if the
50 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
51 components, organic solvents, or inorganic buffers at a concentration not exceeding one
52 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
53 use.
54 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
55 the use of prescription drugs.
56 (5) "Automated pharmacy systems" includes mechanical systems which perform
57 operations or activities, other than compounding or administration, relative to the storage,
58 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
59 all transaction information.
60 (6) "Beyond use date" means the date determined by a pharmacist and placed on a
61 prescription label at the time of dispensing that indicates to the patient or caregiver a time
62 beyond which the contents of the prescription are not recommended to be used.
63 (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
64 in Section 58-17b-201.
65 (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
66 underserved area, used for the storage and dispensing of prescription drugs, which is dependent
67 upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
68 approved by the division as the parent pharmacy.
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, clinic, nuclear, and branch pharmacies; and
83 (ii) pharmaceutical administration and sterile product preparation facilities.
84 (12) "Class C pharmacy" means a pharmacy that engages in the manufacture,
85 production, wholesale, or distribution of drugs or devices in Utah.
86 (13) "Class D pharmacy" means a nonresident pharmacy.
87 (14) "Class E pharmacy" means all other pharmacies.
88 (15) "Closed-door pharmacy" means a pharmacy that provides pharmaceutical care to a
89 defined and exclusive group of patients who have access to the services of the pharmacy
90 because they are treated by or have an affiliation with a specific entity, including a health
91 maintenance organization or an infusion company, but not including a hospital pharmacy, a
92 retailer of goods to the general public, or the office of a practitioner.
93 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
94 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
95 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
96 care functions authorized by the practitioner or practitioners under certain specified conditions
97 or limitations.
98 (17) "Collaborative pharmacy practice agreement" means a written and signed
99 agreement between one or more pharmacists and one or more practitioners that provides for
100 collaborative pharmacy practice for the purpose of drug therapy management of patients and
101 prevention of disease of human subjects.
102 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
103 labeling of a limited quantity drug, sterile product, or device:
104 (i) as the result of a practitioner's prescription order or initiative based on the
105 practitioner, patient, or pharmacist relationship in the course of professional practice;
106 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
107 not for sale or dispensing; or
108 (iii) in anticipation of prescription drug orders based on routine, regularly observed
109 prescribing patterns.
110 (b) "Compounding" does not include:
111 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
112 another pharmacist or pharmaceutical facility;
113 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
114 dosage form which is regularly and commonly available from a manufacturer in quantities and
115 strengths prescribed by a practitioner; or
116 (iii) the preparation of a prescription drug, sterile product, or device which has been
117 withdrawn from the market for safety reasons.
118 (19) "Confidential information" has the same meaning as "protected health
119 information" under the Standards for Privacy of Individually Identifiable Health Information,
120 45 C.F.R. Parts 160 and 164.
121 (20) "Controlled substance" means the same as that term is defined in Section 58-37-2.
122 (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
123 417, Sec. 3a(ff) which is incorporated by reference.
124 (22) "Dispense" means the interpretation, evaluation, and implementation of a
125 prescription drug order or device or nonprescription drug or device under a lawful order of a
126 practitioner in a suitable container appropriately labeled for subsequent administration to or use
127 by a patient, research subject, or an animal.
128 (23) "Dispensing medical practitioner" means an individual who is:
129 (a) currently licensed as:
130 (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
131 (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
132 Practice Act;
133 (iii) a physician assistant under Chapter 70a, Physician Assistant Act;
134 (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
135 (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the optometrist
136 is acting within the scope of practice for an optometrist; and
137 (b) licensed by the division under the Pharmacy Practice Act to engage in the practice
138 of a dispensing medical practitioner.
139 (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
140 located within a licensed dispensing medical practitioner's place of practice.
141 (25) "Distribute" means to deliver a drug or device other than by administering or
142 dispensing.
143 (26) (a) "Drug" means:
144 (i) a substance recognized in the official United States Pharmacopoeia, official
145 Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any
146 supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
147 prevention of disease in humans or animals;
148 (ii) a substance that is required by any applicable federal or state law or rule to be
149 dispensed by prescription only or is restricted to administration by practitioners only;
150 (iii) a substance other than food intended to affect the structure or any function of the
151 body of humans or other animals; and
152 (iv) substances intended for use as a component of any substance specified in
153 Subsections (26)(a)(i), (ii), (iii), and (iv).
154 (b) "Drug" does not include dietary supplements.
155 (27) "Drug regimen review" includes the following activities:
156 (a) evaluation of the prescription drug order and patient record for:
157 (i) known allergies;
158 (ii) rational therapy-contraindications;
159 (iii) reasonable dose and route of administration; and
160 (iv) reasonable directions for use;
161 (b) evaluation of the prescription drug order and patient record for duplication of
162 therapy;
163 (c) evaluation of the prescription drug order and patient record for the following
164 interactions:
165 (i) drug-drug;
166 (ii) drug-food;
167 (iii) drug-disease; and
168 (iv) adverse drug reactions; and
169 (d) evaluation of the prescription drug order and patient record for proper utilization,
170 including over- or under-utilization, and optimum therapeutic outcomes.
171 (28) "Drug sample" means a prescription drug packaged in small quantities consistent
172 with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
173 be sold, and is intended to be provided to practitioners for the immediate needs of patients for
174 trial purposes or to provide the drug to the patient until a prescription can be filled by the
175 patient.
176 (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
177 symbol, or process attached to or logically associated with a record and executed or adopted by
178 a person with the intent to sign the record.
179 (30) "Electronic transmission" means transmission of information in electronic form or
180 the transmission of the exact visual image of a document by way of electronic equipment.
181 (31) "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
183 under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
184 (32) "Legend drug" has the same meaning as prescription drug.
185 (33) "Licensed pharmacy technician" means an individual licensed with the division,
186 that may, under the supervision of a pharmacist, perform the activities involved in the
187 technician practice of pharmacy.
188 (34) "Manufacturer" means a person or business physically located in Utah licensed to
189 be engaged in the manufacturing of drugs or devices.
190 (35) (a) "Manufacturing" means:
191 (i) the production, preparation, propagation, conversion, or processing of a drug or
192 device, either directly or indirectly, by extraction from substances of natural origin or
193 independently by means of chemical or biological synthesis, or by a combination of extraction
194 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
195 or relabeling of its container; and
196 (ii) the promotion and marketing of such drugs or devices.
197 (b) "Manufacturing" includes the preparation and promotion of commercially available
198 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
199 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
200 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
201 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
202 analysis.
203 (36) "Medical order" means a lawful order of a practitioner which may include a
204 prescription drug order.
205 (37) "Medication profile" or "profile" means a record system maintained as to drugs or
206 devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
207 the profile to provide pharmaceutical care.
208 (38) "Misbranded drug or device" means a drug or device considered misbranded under
209 21 U.S.C. Sec. 352 (2003).
210 (39) (a) "Nonprescription drug" means a drug which:
211 (i) may be sold without a prescription; and
212 (ii) is labeled for use by the consumer in accordance with federal law.
213 (b) "Nonprescription drug" includes homeopathic remedies.
214 (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
215 person in Utah.
216 (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
217 (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
218 outside the state that is licensed and in good standing in another state, that:
219 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
220 this state pursuant to a lawfully issued prescription;
221 (b) provides information to a patient in this state on drugs or devices which may
222 include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
223 or
224 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
225 effects of drugs.
226 (43) "Patient counseling" means the written and oral communication by the pharmacist
227 or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
228 drugs, devices, and dietary supplements.
229 (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
230 which:
231 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
232 the facility or agency for administration to patients of that facility or agency;
233 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
234 or pharmacy intern with whom the facility has established a prescription drug supervising
235 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
236 or agency staff as required, and oversees drug control, accounting, and destruction; and
237 (c) prescription drugs are professionally administered in accordance with the order of a
238 practitioner by an employee or agent of the facility or agency.
239 (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
240 prescribing practitioner, and in accordance with division rule:
241 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
242 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
243 the patient's disease;
244 (ii) eliminating or reducing a patient's symptoms; or
245 (iii) arresting or slowing a disease process.
246 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
247 prescribing practitioner.
248 (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
249 distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
250 state.
251 (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
252 engaged in the business of wholesale vending or selling of a prescription drug or device to
253 other than a consumer or user of the prescription drug or device that the pharmaceutical facility
254 has not produced, manufactured, compounded, or dispensed.
255 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
256 facility carrying out the following business activities:
257 (i) intracompany sales;
258 (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
259 purchase, or trade a prescription drug or device, if the activity is carried out between one or
260 more of the following entities under common ownership or common administrative control, as
261 defined by division rule:
262 (A) hospitals;
263 (B) pharmacies;
264 (C) chain pharmacy warehouses, as defined by division rule; or
265 (D) other health care entities, as defined by division rule;
266 (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
267 purchase, or trade a prescription drug or device, for emergency medical reasons, including
268 supplying another pharmaceutical facility with a limited quantity of a drug, if:
269 (A) the facility is unable to obtain the drug through a normal distribution channel in
270 sufficient time to eliminate the risk of harm to a patient that would result from a delay in
271 obtaining the drug; and
272 (B) the quantity of the drug does not exceed an amount reasonably required for
273 immediate dispensing to eliminate the risk of harm;
274 (iv) the distribution of a prescription drug or device as a sample by representatives of a
275 manufacturer; and
276 (v) the distribution of prescription drugs, if:
277 (A) the facility's total distribution-related sales of prescription drugs does not exceed
278 5% of the facility's total prescription drug sales; and
279 (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
280 (48) "Pharmacist" means an individual licensed by this state to engage in the practice
281 of pharmacy.
282 (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
283 who accepts responsibility for the operation of a pharmacy in conformance with all laws and
284 rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
285 in full and actual charge of the pharmacy and all personnel.
286 (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
287 more years of licensed experience. The preceptor serves as a teacher, example of professional
288 conduct, and supervisor of interns in the professional practice of pharmacy.
289 (51) "Pharmacy" means any place where:
290 (a) drugs are dispensed;
291 (b) pharmaceutical care is provided;
292 (c) drugs are processed or handled for eventual use by a patient; or
293 (d) drugs are used for the purpose of analysis or research.
294 (52) "Pharmacy benefits manager or coordinator" means a person or entity that
295 provides a pharmacy benefits management service as defined in Section 49-20-502 on behalf of
296 a self-insured employer, insurance company, health maintenance organization, or other plan
297 sponsor, as defined by rule.
298 (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
299 as a pharmacy intern.
300 (54) "Pharmacy technician training program" means an approved technician training
301 program providing education for pharmacy technicians.
302 (55) (a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
303 specifically relating to the dispensing of a prescription drug in accordance with Part 8,
304 Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, and
305 division rule adopted after consultation with the Board of pharmacy and the governing boards
306 of the practitioners described in Subsection (23)(a).
307 (b) "Practice as a dispensing medical practitioner" does not include:
308 (i) using a vending type of dispenser as defined by the division by administrative rule;
309 or
310 (ii) except as permitted by Section 58-17b-805, dispensing of a controlled substance as
311 defined in Section 58-37-2.
312 (56) [
313 pharmacy technician under the general supervision of a licensed pharmacist and in accordance
314 with a scope of practice defined by division rule made in collaboration with the board.
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326 (57) "Practice of pharmacy" includes the following:
327 (a) providing pharmaceutical care;
328 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
329 practice agreement;
330 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
331 distribution of prescription drugs or devices, provided that the administration of a prescription
332 drug or device is:
333 (i) pursuant to a lawful order of a practitioner when one is required by law; and
334 (ii) in accordance with written guidelines or protocols:
335 (A) established by the licensed facility in which the prescription drug or device is to be
336 administered on an inpatient basis; or
337 (B) approved by the division, in collaboration with the board and the Physicians
338 Licensing Board, created in Section 58-67-201, if the prescription drug or device is to be
339 administered on an outpatient basis solely by a licensed pharmacist;
340 (d) participating in drug utilization review;
341 (e) ensuring proper and safe storage of drugs and devices;
342 (f) maintaining records of drugs and devices in accordance with state and federal law
343 and the standards and ethics of the profession;
344 (g) providing information on drugs or devices, which may include advice relating to
345 therapeutic values, potential hazards, and uses;
346 (h) providing drug product equivalents;
347 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
348 technicians;
349 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
350 (k) providing emergency refills as defined by rule;
351 (l) telepharmacy;
352 (m) formulary management intervention; and
353 (n) prescribing and dispensing a self-administered hormonal contraceptive in
354 accordance with Title 26, Chapter 64, Family Planning Access Act.
355 (58) "Practice of telepharmacy" means the practice of pharmacy through the use of
356 telecommunications and information technologies.
357 (59) "Practice of telepharmacy across state lines" means the practice of pharmacy
358 through the use of telecommunications and information technologies that occurs when the
359 patient is physically located within one jurisdiction and the pharmacist is located in another
360 jurisdiction.
361 (60) "Practitioner" means an individual currently licensed, registered, or otherwise
362 authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
363 professional practice.
364 (61) "Prescribe" means to issue a prescription:
365 (a) orally or in writing; or
366 (b) by telephone, facsimile transmission, computer, or other electronic means of
367 communication as defined by division rule.
368 (62) "Prescription" means an order issued:
369 (a) by a licensed practitioner in the course of that practitioner's professional practice or
370 by collaborative pharmacy practice agreement; and
371 (b) for a controlled substance or other prescription drug or device for use by a patient
372 or an animal.
373 (63) "Prescription device" means an instrument, apparatus, implement, machine,
374 contrivance, implant, in vitro reagent, or other similar or related article, and any component
375 part or accessory, which is required under federal or state law to be prescribed by a practitioner
376 and dispensed by or through a person or entity licensed under this chapter or exempt from
377 licensure under this chapter.
378 (64) "Prescription drug" means a drug that is required by federal or state law or rule to
379 be dispensed only by prescription or is restricted to administration only by practitioners.
380 (65) "Repackage":
381 (a) means changing the container, wrapper, or labeling to further the distribution of a
382 prescription drug; and
383 (b) does not include:
384 (i) Subsection (65)(a) when completed by the pharmacist responsible for dispensing the
385 product to a patient; or
386 (ii) changing or altering a label as necessary for a dispensing practitioner under Part 8,
387 Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, for
388 dispensing a product to a patient.
389 (66) "Research using pharmaceuticals" means research:
390 (a) conducted in a research facility, as defined by division rule, that is associated with a
391 university or college in the state accredited by the Northwest Commission on Colleges and
392 Universities;
393 (b) requiring the use of a controlled substance, prescription drug, or prescription
394 device;
395 (c) that uses the controlled substance, prescription drug, or prescription device in
396 accordance with standard research protocols and techniques, including, if required, those
397 approved by an institutional review committee; and
398 (d) that includes any documentation required for the conduct of the research and the
399 handling of the controlled substance, prescription drug, or prescription device.
400 (67) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
401 and devices to the general public.
402 (68) (a) "Self-administered hormonal contraceptive" means a self-administered
403 hormonal contraceptive that is approved by the United States Food and Drug Administration to
404 prevent pregnancy.
405 (b) "Self-administered hormonal contraceptive" includes an oral hormonal
406 contraceptive, a hormonal vaginal ring, and a hormonal contraceptive patch.
407 (c) "Self-administered hormonal contraceptive" does not include any drug intended to
408 induce an abortion, as that term is defined in Section 76-7-301.
409 (69) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
410 with this chapter.
411 (70) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
412 the pharmacy during a given day or shift.
413 (71) "Supportive personnel" means unlicensed individuals who:
414 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
415 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
416 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
417 those duties may be further defined by division rule adopted in collaboration with the board;
418 and
419 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
420 collaboration with the board.
421 (72) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501
422 and 58-17b-501.
423 (73) "Unprofessional conduct" means the same as that term is defined in Sections
424 58-1-501 and 58-17b-502 and may be further defined by rule.
425 (74) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
426 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
427 for animals.
428 Section 2. Section 58-17b-612 is amended to read:
429 58-17b-612. Supervision -- Pharmacist-in-charge.
430 (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
431 pharmacy, or class E pharmacy, shall be under the general supervision of at least one
432 pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
433 as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
434 (b) Notwithstanding Subsection 58-17b-102[
435 not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
436 for immediate contact with the supervised pharmacy technician or pharmacy intern if:
437 (i) the pharmacy is located in[
438 consultation with the board, by rule made in accordance with Title 63G, Chapter 3, Utah
439 Administrative Rulemaking Act;
440 [
441 [
442 (ii) the supervising pharmacist described in Subsection (1)(a) is not available; [
443 (iii) the telepharmacy system maintains records and files quarterly reports as required
444 by division rule to assure that patient safety is not compromised[
445 (iv) the arrangement is approved by the division in collaboration with the board.
446 (c) Subsection (1)(b) applies to a pharmacy that is located in a hospital only if the
447 hospital is controlled by a local board that owns no more than two hospitals; and
448 (d) A supervising pharmacist may not supervise more than two pharmacies
449 simultaneously under Subsection (1)(b).
450 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
451 a pharmacist holding a current license in good standing issued by the state in which the
452 pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
453 chapter.
454 Section 3. Section 58-17b-625 is amended to read:
455 58-17b-625. Administration of a long-acting injectable drug therapy.
456 (1) A pharmacist may, in accordance with this section, administer a drug described in
457 Subsection (2).
458 (2) Notwithstanding the provisions of Subsection 58-17b-102(57)(c)(ii)(B), the
459 division shall make rules, in accordance with Title 63G, Chapter 3, Utah Administrative
460 Rulemaking Act, establishing training for a pharmacist to administer the following long-acting
461 injectables intramuscularly:
462 (a) aripiprazole;
463 (b) aripiprazole lauroxil;
464 [
465 [
466 [
467 [
468 [
469 [
470 Administration for the treatment of the Human Immunodeficiency Virus.
471 (3) A pharmacist may not administer a drug listed under Subsection (2) unless the
472 pharmacist:
473 (a) completes the training described in Subsection (2);
474 (b) administers the drug at a clinic or community pharmacy, as those terms are defined
475 by the division, by administrative rule made in accordance with Title 63G, Chapter 3, Utah
476 Administrative Rulemaking Act; and
477 (c) is directed by the physician, as that term is defined in Section 58-67-102 or Section
478 58-68-102, who issues the prescription to administer the drug.
479 Section 4. Section 58-17b-805 is amended to read:
480 58-17b-805. Dispensing medical practitioner -- Cancer drug treatment regimen.
481 (1) For purposes of this section:
482 (a) "Cancer drug treatment regimen" means a prescription drug used to treat cancer,
483 manage its symptoms, or provide continuity of care for a cancer patient.
484 (b) "Cancer drug treatment regimen" includes:
485 (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
486 methods; and
487 (ii) a drug used to support cancer treatment, including a drug used to treat, alleviate, or
488 minimize physical and psychological symptoms or pain, to improve patient tolerance of cancer
489 treatments, or to prepare a patient for a subsequent course of therapy.
490 (c) "Cancer drug treatment regimen" does not mean a drug listed under federal law as a
491 Schedule I, II, or III drug.
492 (2) An individual may be licensed as a dispensing medical practitioner with a scope of
493 practice that permits the dispensing medical practitioner to prescribe and dispense a cancer
494 drug treatment regimen if the individual:
495 (a) is licensed as described in Subsections 58-17b-102(23)(a)(i) and (ii); and
496 (b) is certified or eligible to be certified by:
497 (i) the American Board of Internal Medicine in medical oncology[
498 (ii) the American Board of Urology.
499 (3) A dispensing medical practitioner authorized to prescribe and dispense a cancer
500 drug treatment regimen under this section may prescribe and dispense a cancer drug treatment
501 regimen:
502 (a) to the practitioner's patient who is currently undergoing chemotherapy in an
503 outpatient clinic setting; and
504 (b) if the practitioner determines that providing the cancer drug treatment regimen to
505 the patient in the outpatient clinic setting is in the best interest of the patient or provides better
506 access to care for the patient.
507 Section 5. Section 58-37-4 is amended to read:
508 58-37-4. Schedules of controlled substances -- Schedules I through V -- Findings
509 required -- Specific substances included in schedules.
510 (1) There are established five schedules of controlled substances known as Schedules I,
511 II, III, IV, and V which consist of substances listed in this section.
512 (2) Schedules I, II, III, IV, and V consist of the following drugs or other substances by
513 the official name, common or usual name, chemical name, or brand name designated:
514 (a) Schedule I:
515 (i) Unless specifically excepted or unless listed in another schedule, any of the
516 following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and
517 ethers, when the existence of the isomers, esters, ethers, and salts is possible within the specific
518 chemical designation:
519 (A) Acetyl-alpha-methylfentanyl
520 (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N-phenylacetamide);
521 (B) Acetyl fentanyl: (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide);
522 (C) Acetylmethadol;
523 (D) Acryl fentanyl (N-(1-Phenethylpiperidin-4-yl)-N-phenylacrylamide);
524 (E) Allylprodine;
525 (F) Alphacetylmethadol, except levo-alphacetylmethadol also known as
526 levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM;
527 (G) Alphameprodine;
528 (H) Alphamethadol;
529 (I) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-piperidyl]
530 propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine);
531 (J) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-
532 piperidinyl]-N-phenylpropanamide);
533 (K) Benzylpiperazine;
534 (L) Benzethidine;
535 (M) Betacetylmethadol;
536 (N) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-
537 piperidinyl]-N-phenylpropanamide);
538 (O) Beta-hydroxy-3-methylfentanyl, other name: N-[1-(2-hydroxy-2-
539 phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide;
540 (P) Betameprodine;
541 (Q) Betamethadol;
542 (R) Betaprodine;
543 (S) Butyryl fentanyl (N-(1-(2-phenylethyl)-4-piperidinyl)-N-phenylbutyramide);
544 (T) Clonitazene;
545 (U) Cyclopropyl fentanyl
546 (N-(1-Phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide);
547 (V) Dextromoramide;
548 (W) Diampromide;
549 (X) Diethylthiambutene;
550 (Y) Difenoxin;
551 (Z) Dimenoxadol;
552 (AA) Dimepheptanol;
553 (BB) Dimethylthiambutene;
554 (CC) Dioxaphetyl butyrate;
555 (DD) Dipipanone;
556 (EE) Ethylmethylthiambutene;
557 (FF) Etizolam
558 (1-Methyl-6-o-chlorophenyl-8-ethyl-4H-s-triazolo[3,4-c]thieno[2,3-e]1,4-diazepine);
559 (GG) Etonitazene;
560 (HH) Etoxeridine;
561 (II) Furanyl fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]
562 furan-2-carboxamide);
563 (JJ) Furethidine;
564 (KK) Hydroxypethidine;
565 (LL) Ketobemidone;
566 (MM) Levomoramide;
567 (NN) Levophenacylmorphan;
568 (OO) Methoxyacetyl fentanyl
569 (2-Methoxy-N-(1-phenylethylpiperidinyl-4-yl)-N-acetamide);
570 (PP) Morpheridine;
571 (QQ) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine);
572 (RR) Noracymethadol;
573 (SS) Norlevorphanol;
574 (TT) Normethadone;
575 (UU) Norpipanone;
576 (VV) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-4- piperidinyl]
577 propanamide);
578 (WW) Para-fluoroisobutyryl fentanyl
579 (N-(4-Fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide);
580 (XX) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine);
581 (YY) Phenadoxone;
582 (ZZ) Phenampromide;
583 (AAA) Phenomorphan;
584 (BBB) Phenoperidine;
585 (CCC) Piritramide;
586 (DDD) Proheptazine;
587 (EEE) Properidine;
588 (FFF) Propiram;
589 (GGG) Racemoramide;
590 (HHH) Tetrahydrofuran fentanyl
591 (N-(1-Phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide);
592 (III) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]- propanamide;
593 (JJJ) Tilidine;
594 (KKK) Trimeperidine;
595 (LLL) 3-methylfentanyl, including the optical and geometric isomers
596 (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]- N-phenylpropanamide);
597 (MMM) 3-methylthiofentanyl
598 (N-[(3-methyl-1-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide);
599 (NNN) 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide also
600 known as U-47700; and
601 (OOO) 4-cyano CUMYL-BUTINACA.
602 (ii) Unless specifically excepted or unless listed in another schedule, any of the
603 following opium derivatives, their salts, isomers, and salts of isomers when the existence of the
604 salts, isomers, and salts of isomers is possible within the specific chemical designation:
605 (A) Acetorphine;
606 (B) Acetyldihydrocodeine;
607 (C) Benzylmorphine;
608 (D) Codeine methylbromide;
609 (E) Codeine-N-Oxide;
610 (F) Cyprenorphine;
611 (G) Desomorphine;
612 (H) Dihydromorphine;
613 (I) Drotebanol;
614 (J) Etorphine (except hydrochloride salt);
615 (K) Heroin;
616 (L) Hydromorphinol;
617 (M) Methyldesorphine;
618 (N) Methylhydromorphine;
619 (O) Morphine methylbromide;
620 (P) Morphine methylsulfonate;
621 (Q) Morphine-N-Oxide;
622 (R) Myrophine;
623 (S) Nicocodeine;
624 (T) Nicomorphine;
625 (U) Normorphine;
626 (V) Pholcodine; and
627 (W) Thebacon.
628 (iii) Unless specifically excepted or unless listed in another schedule, any material,
629 compound, mixture, or preparation which contains any quantity of the following hallucinogenic
630 substances, or which contains any of their salts, isomers, and salts of isomers when the
631 existence of the salts, isomers, and salts of isomers is possible within the specific chemical
632 designation; as used in this Subsection (2)(a)(iii) only, "isomer" includes the optical, position,
633 and geometric isomers:
634 (A) Alpha-ethyltryptamine, some trade or other names: etryptamine; Monase;
635 α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; α-ET; and AET;
636 (B) 4-bromo-2,5-dimethoxy-amphetamine, some trade or other names:
637 4-bromo-2,5-dimethoxy-α-methylphenethylamine; 4-bromo-2,5-DMA;
638 (C) 4-bromo-2,5-dimethoxyphenethylamine, some trade or other names:
639 2-(4-bromo-2,5-dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus;
640 (D) 2,5-dimethoxyamphetamine, some trade or other names:
641 2,5-dimethoxy-α-methylphenethylamine; 2,5-DMA;
642 (E) 2,5-dimethoxy-4-ethylamphetamine, some trade or other names: DOET;
643 (F) 4-methoxyamphetamine, some trade or other names:
644 4-methoxy-α-methylphenethylamine; paramethoxyamphetamine, PMA;
645 (G) 5-methoxy-3,4-methylenedioxyamphetamine;
646 (H) 4-methyl-2,5-dimethoxy-amphetamine, some trade and other names:
647 4-methyl-2,5-dimethoxy-α-methylphenethylamine; "DOM"; and "STP";
648 (I) 3,4-methylenedioxy amphetamine;
649 (J) 3,4-methylenedioxymethamphetamine (MDMA);
650 (K) 3,4-methylenedioxy-N-ethylamphetamine, also known as N-ethyl-
651 alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA, MDE, MDEA;
652 (L) N-hydroxy-3,4-methylenedioxyamphetamine, also known as
653 N-hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-hydroxy MDA;
654 (M) 3,4,5-trimethoxy amphetamine;
655 (N) Bufotenine, some trade and other names:
656 3-(β-Dimethylaminoethyl)-5-hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N,
657 N-dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine;
658 (O) Diethyltryptamine, some trade and other names: N,N-Diethyltryptamine; DET;
659 (P) Dimethyltryptamine, some trade or other names: DMT;
660 (Q) Ibogaine, some trade and other names:
661 7-Ethyl-6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1', 2':1,2] azepino
662 [5,4-b] indole; Tabernanthe iboga;
663 (R) Lysergic acid diethylamide;
664 (S) Marijuana;
665 (T) Mescaline;
666 (U) Parahexyl, some trade or other names:
667 3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl;
668 (V) Peyote, meaning all parts of the plant presently classified botanically as
669 Lophophora williamsii Lemaire, whether growing or not, the seeds thereof, any extract from
670 any part of such plant, and every compound, manufacture, salts, derivative, mixture, or
671 preparation of such plant, its seeds or extracts (Interprets 21 USC 812(c), Schedule I(c) (12));
672 (W) N-ethyl-3-piperidyl benzilate;
673 (X) N-methyl-3-piperidyl benzilate;
674 (Y) Psilocybin;
675 (Z) Psilocyn;
676 (AA) Tetrahydrocannabinols, naturally contained in a plant of the genus Cannabis
677 (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis
678 plant, or in the resinous extractives of Cannabis, sp. and/or synthetic substances, derivatives,
679 and their isomers with similar chemical structure and pharmacological activity to those
680 substances contained in the plant, such as the following: Δ1 cis or trans tetrahydrocannabinol,
681 and their optical isomers Δ6 cis or trans tetrahydrocannabinol, and their optical isomers Δ3,4
682 cis or trans tetrahydrocannabinol, and its optical isomers, and since nomenclature of these
683 substances is not internationally standardized, compounds of these structures, regardless of
684 numerical designation of atomic positions covered;
685 (BB) Ethylamine analog of phencyclidine, some trade or other names:
686 N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine,
687 N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE;
688 (CC) Pyrrolidine analog of phencyclidine, some trade or other names:
689 1-(1-phenylcyclohexyl)-pyrrolidine, PCPy, PHP;
690 (DD) Thiophene analog of phencyclidine, some trade or other names:
691 1-[1-(2-thienyl)-cyclohexyl]-piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP; and
692 (EE) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine, some other names: TCPy.
693 (iv) Unless specifically excepted or unless listed in another schedule, any material
694 compound, mixture, or preparation which contains any quantity of the following substances
695 having a depressant effect on the central nervous system, including its salts, isomers, and salts
696 of isomers when the existence of the salts, isomers, and salts of isomers is possible within the
697 specific chemical designation:
698 (A) Mecloqualone; and
699 (B) Methaqualone.
700 (v) Any material, compound, mixture, or preparation containing any quantity of the
701 following substances having a stimulant effect on the central nervous system, including their
702 salts, isomers, and salts of isomers:
703 (A) Aminorex, some other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; or
704 4,5-dihydro-5-phenyl-2-oxazolamine;
705 (B) Cathinone, some trade or other names: 2-amino-1-phenyl-1-propanone,
706 alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone;
707 (C) Fenethylline;
708 (D) Methcathinone, some other names: 2-(methylamino)-propiophenone;
709 alpha-(methylamino)propiophenone; 2-(methylamino)-1-phenylpropan-1-one;
710 alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone;
711 methylcathinone; AL-464; AL-422; AL-463 and UR1432, its salts, optical isomers, and salts of
712 optical isomers;
713 (E) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine);
714 (F) N-ethylamphetamine; and
715 (G) N,N-dimethylamphetamine, also known as
716 N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine.
717 (vi) Any material, compound, mixture, or preparation which contains any quantity of
718 the following substances, including their optical isomers, salts, and salts of isomers, subject to
719 temporary emergency scheduling:
720 (A) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide (benzylfentanyl); and
721 (B) N-[1- (2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide (thenylfentanyl).
722 (vii) Unless specifically excepted or unless listed in another schedule, any material,
723 compound, mixture, or preparation which contains any quantity of gamma hydroxy butyrate
724 (gamma hydrobutyric acid), including its salts, isomers, and salts of isomers.
725 (b) Schedule II:
726 (i) Unless specifically excepted or unless listed in another schedule, any of the
727 following substances whether produced directly or indirectly by extraction from substances of
728 vegetable origin, or independently by means of chemical synthesis, or by a combination of
729 extraction and chemical synthesis:
730 (A) Opium and opiate, and any salt, compound, derivative, or preparation of opium or
731 opiate, excluding apomorphine, dextrorphan, nalbuphine, nalmefene, naloxone, and naltrexone,
732 and their respective salts, but including:
733 (I) Raw opium;
734 (II) Opium extracts;
735 (III) Opium fluid;
736 (IV) Powdered opium;
737 (V) Granulated opium;
738 (VI) Tincture of opium;
739 (VII) Codeine;
740 (VIII) Ethylmorphine;
741 (IX) Etorphine hydrochloride;
742 (X) Hydrocodone;
743 (XI) Hydromorphone;
744 (XII) Metopon;
745 (XIII) Morphine;
746 (XIV) Oxycodone;
747 (XV) Oxymorphone; and
748 (XVI) Thebaine;
749 (B) Any salt, compound, derivative, or preparation which is chemically equivalent or
750 identical with any of the substances referred to in Subsection (2)(b)(i)(A), except that these
751 substances may not include the isoquinoline alkaloids of opium;
752 (C) Opium poppy and poppy straw;
753 (D) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and
754 any salt, compound, derivative, or preparation which is chemically equivalent or identical with
755 any of these substances, and includes cocaine and ecgonine, their salts, isomers, derivatives,
756 and salts of isomers and derivatives, whether derived from the coca plant or synthetically
757 produced, except the substances may not include decocainized coca leaves or extraction of coca
758 leaves, which extractions do not contain cocaine or ecgonine; and
759 (E) Concentrate of poppy straw, which means the crude extract of poppy straw in either
760 liquid, solid, or powder form which contains the phenanthrene alkaloids of the opium poppy.
761 (ii) Unless specifically excepted or unless listed in another schedule, any of the
762 following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and
763 ethers, when the existence of the isomers, esters, ethers, and salts is possible within the specific
764 chemical designation, except dextrorphan and levopropoxyphene:
765 (A) Alfentanil;
766 (B) Alphaprodine;
767 (C) Anileridine;
768 (D) Bezitramide;
769 (E) Bulk dextropropoxyphene (nondosage forms);
770 (F) Carfentanil;
771 (G) Dihydrocodeine;
772 (H) Diphenoxylate;
773 (I) Fentanyl;
774 (J) Isomethadone;
775 (K) Levo-alphacetylmethadol, some other names: levo-alpha-acetylmethadol,
776 levomethadyl acetate, or LAAM;
777 (L) Levomethorphan;
778 (M) Levorphanol;
779 (N) Metazocine;
780 (O) Methadone;
781 (P) Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl butane;
782 (Q) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic
783 acid;
784 (R) Pethidine (meperidine);
785 (S) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine;
786 (T) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate;
787 (U) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid;
788 (V) Phenazocine;
789 (W) Piminodine;
790 (X) Racemethorphan;
791 (Y) Racemorphan;
792 (Z) Remifentanil; and
793 (AA) Sufentanil.
794 (iii) Unless specifically excepted or unless listed in another schedule, any material,
795 compound, mixture, or preparation which contains any quantity of the following substances
796 having a stimulant effect on the central nervous system:
797 (A) Amphetamine, its salts, optical isomers, and salts of its optical isomers;
798 (B) Methamphetamine, its salts, isomers, and salts of its isomers;
799 (C) Phenmetrazine and its salts; and
800 (D) Methylphenidate.
801 (iv) Unless specifically excepted or unless listed in another schedule, any material,
802 compound, mixture, or preparation which contains any quantity of the following substances
803 having a depressant effect on the central nervous system, including its salts, isomers, and salts
804 of isomers when the existence of the salts, isomers, and salts of isomers is possible within the
805 specific chemical designation:
806 (A) Amobarbital;
807 (B) Glutethimide;
808 (C) Pentobarbital;
809 (D) Phencyclidine;
810 (E) Phencyclidine immediate precursors: 1-phenylcyclohexylamine and
811 1-piperidinocyclohexanecarbonitrile (PCC); and
812 (F) Secobarbital.
813 (v) (A) Unless specifically excepted or unless listed in another schedule, any material,
814 compound, mixture, or preparation which contains any quantity of Phenylacetone.
815 (B) Some of these substances may be known by trade or other names:
816 phenyl-2-propanone; P2P; benzyl methyl ketone; and methyl benzyl ketone.
817 (vi) Nabilone, another name for nabilone:
818 (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,
819 6-dimethyl-9H-dibenzo[b,d]pyran-9-one.
820 (vii) Any component of marijuana in a drug product that is approved by the United
821 States Food and Drug Administration and scheduled by the Drug Enforcement Administration
822 in Schedule II of the federal Controlled Substances Act, Title II, P.L. 91-513.
823 (c) Schedule III:
824 (i) Unless specifically excepted or unless listed in another schedule, any material,
825 compound, mixture, or preparation which contains any quantity of the following substances
826 having a stimulant effect on the central nervous system, including its salts, isomers whether
827 optical, position, or geometric, and salts of the isomers when the existence of the salts, isomers,
828 and salts of isomers is possible within the specific chemical designation:
829 (A) Those compounds, mixtures, or preparations in dosage unit form containing any
830 stimulant substances listed in Schedule II, which compounds, mixtures, or preparations were
831 listed on August 25, 1971, as excepted compounds under Section 1308.32 of Title 21 of the
832 Code of Federal Regulations, and any other drug of the quantitive composition shown in that
833 list for those drugs or which is the same except that it contains a lesser quantity of controlled
834 substances;
835 (B) Benzphetamine;
836 (C) Chlorphentermine;
837 (D) Clortermine; and
838 (E) Phendimetrazine.
839 (ii) Unless specifically excepted or unless listed in another schedule, any material,
840 compound, mixture, or preparation which contains any quantity of the following substances
841 having a depressant effect on the central nervous system:
842 (A) Any compound, mixture, or preparation containing amobarbital, secobarbital,
843 pentobarbital, or any salt of any of them, and one or more other active medicinal ingredients
844 which are not listed in any schedule;
845 (B) Any suppository dosage form containing amobarbital, secobarbital, or
846 pentobarbital, or any salt of any of these drugs which is approved by the Food and Drug
847 Administration for marketing only as a suppository;
848 (C) Any substance which contains any quantity of a derivative of barbituric acid or any
849 salt of any of them;
850 (D) Chlorhexadol;
851 (E) Buprenorphine;
852 (F) Any drug product containing gamma hydroxybutyric acid, including its salts,
853 isomers, and salts of isomers, for which an application is approved under the federal Food,
854 Drug, and Cosmetic Act, Section 505;
855 (G) Ketamine, its salts, isomers, and salts of isomers, some other names for ketamine:
856 ± -2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone;
857 (H) Lysergic acid;
858 (I) Lysergic acid amide;
859 (J) Methyprylon;
860 (K) Sulfondiethylmethane;
861 (L) Sulfonethylmethane;
862 (M) Sulfonmethane; and
863 (N) Tiletamine and zolazepam or any of their salts, some trade or other names for a
864 tiletamine-zolazepam combination product: Telazol, some trade or other names for tiletamine:
865 2-(ethylamino)-2-(2-thienyl)-cyclohexanone, some trade or other names for zolazepam:
866 4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-e] [1,4]-diazepin-7(1H)-one,
867 flupyrazapon.
868 (iii) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a
869 U.S. Food and Drug Administration approved drug product, some other names for dronabinol:
870 (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol, or
871 (-)-delta-9-(trans)-tetrahydrocannabinol.
872 (iv) Nalorphine.
873 (v) Unless specifically excepted or unless listed in another schedule, any material,
874 compound, mixture, or preparation containing limited quantities of any of the following
875 narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid:
876 (A) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90
877 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of
878 opium;
879 (B) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90
880 milligrams per dosage unit, with one or more active non-narcotic ingredients in recognized
881 therapeutic amounts;
882 (C) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more
883 than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline
884 alkaloid of opium;
885 (D) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more
886 than 15 milligrams per dosage unit, with one or more active, non-narcotic ingredients in
887 recognized therapeutic amounts;
888 (E) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90
889 milligrams per dosage unit, with one or more active non-narcotic ingredients in recognized
890 therapeutic amounts;
891 (F) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more
892 than 15 milligrams per dosage unit, with one or more active, non-narcotic ingredients in
893 recognized therapeutic amounts;
894 (G) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not
895 more than 25 milligrams per dosage unit, with one or more active, non-narcotic ingredients in
896 recognized therapeutic amounts; and
897 (H) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with
898 one or more active, non-narcotic ingredients in recognized therapeutic amounts.
899 (vi) Unless specifically excepted or unless listed in another schedule, anabolic steroids
900 including any of the following or any isomer, ester, salt, or derivative of the following that
901 promotes muscle growth:
902 (A) Boldenone;
903 (B) Chlorotestosterone (4-chlortestosterone);
904 (C) Clostebol;
905 (D) Dehydrochlormethyltestosterone;
906 (E) Dihydrotestosterone (4-dihydrotestosterone);
907 (F) Drostanolone;
908 (G) Ethylestrenol;
909 (H) Fluoxymesterone;
910 (I) Formebulone (formebolone);
911 (J) Mesterolone;
912 (K) Methandienone;
913 (L) Methandranone;
914 (M) Methandriol;
915 (N) Methandrostenolone;
916 (O) Methenolone;
917 (P) Methyltestosterone;
918 (Q) Mibolerone;
919 (R) Nandrolone;
920 (S) Norethandrolone;
921 (T) Oxandrolone;
922 (U) Oxymesterone;
923 (V) Oxymetholone;
924 (W) Stanolone;
925 (X) Stanozolol;
926 (Y) Testolactone;
927 (Z) Testosterone; and
928 (AA) Trenbolone.
929 (vii) Anabolic steroids expressly intended for administration through implants to cattle
930 or other nonhuman species, and approved by the Secretary of Health and Human Services for
931 use, may not be classified as a controlled substance.
932 (viii) Any component of marijuana in a drug product that is approved by the United
933 States Food and Drug Administration and scheduled by the Drug Enforcement Administration
934 in Schedule III of the federal Controlled Substances Act, Title II, P.L. 91-513.
935 (d) Schedule IV:
936 (i) Unless specifically excepted or unless listed in another schedule, any material,
937 compound, mixture, or preparation containing not more than 1 milligram of difenoxin and not
938 less than 25 micrograms of atropine sulfate per dosage unit, or any salts of any of them.
939 (ii) Unless specifically excepted or unless listed in another schedule, any material,
940 compound, mixture, or preparation which contains any quantity of the following substances,
941 including its salts, isomers, and salts of isomers when the existence of the salts, isomers, and
942 salts of isomers is possible within the specific chemical designation:
943 (A) Alprazolam;
944 (B) Barbital;
945 (C) Bromazepam;
946 (D) Butorphanol;
947 (E) Camazepam;
948 (F) Carisoprodol;
949 (G) Chloral betaine;
950 (H) Chloral hydrate;
951 (I) Chlordiazepoxide;
952 (J) Clobazam;
953 (K) Clonazepam;
954 (L) Clorazepate;
955 (M) Clotiazepam;
956 (N) Cloxazolam;
957 (O) Delorazepam;
958 (P) Diazepam;
959 (Q) Dichloralphenazone;
960 (R) Estazolam;
961 (S) Ethchlorvynol;
962 (T) Ethinamate;
963 (U) Ethyl loflazepate;
964 (V) Fludiazepam;
965 (W) Flunitrazepam;
966 (X) Flurazepam;
967 (Y) Halazepam;
968 (Z) Haloxazolam;
969 (AA) Ketazolam;
970 (BB) Loprazolam;
971 (CC) Lorazepam;
972 (DD) Lormetazepam;
973 (EE) Mebutamate;
974 (FF) Medazepam;
975 (GG) Meprobamate;
976 (HH) Methohexital;
977 (II) Methylphenobarbital (mephobarbital);
978 (JJ) Midazolam;
979 (KK) Nimetazepam;
980 (LL) Nitrazepam;
981 (MM) Nordiazepam;
982 (NN) Oxazepam;
983 (OO) Oxazolam;
984 (PP) Paraldehyde;
985 (QQ) Pentazocine;
986 (RR) Petrichloral;
987 (SS) Phenobarbital;
988 (TT) Pinazepam;
989 (UU) Prazepam;
990 (VV) Quazepam;
991 (WW) Temazepam;
992 (XX) Tetrazepam;
993 (YY) Triazolam;
994 (ZZ) Zaleplon; and
995 (AAA) Zolpidem.
996 (iii) Any material, compound, mixture, or preparation of fenfluramine which contains
997 any quantity of the following substances, including its salts, isomers whether optical, position,
998 or geometric, and salts of the isomers when the existence of the salts, isomers, and salts of
999 isomers is possible.
1000 (iv) Unless specifically excepted or unless listed in another schedule, any material,
1001 compound, mixture, or preparation which contains any quantity of the following substances
1002 having a stimulant effect on the central nervous system, including its salts, isomers whether
1003 optical, position, or geometric isomers, and salts of the isomers when the existence of the salts,
1004 isomers, and salts of isomers is possible within the specific chemical designation:
1005 (A) Cathine ((+)-norpseudoephedrine);
1006 (B) Diethylpropion;
1007 (C) Fencamfamine;
1008 (D) Fenproprex;
1009 (E) Mazindol;
1010 (F) Mefenorex;
1011 (G) Modafinil;
1012 (H) Pemoline, including organometallic complexes and chelates thereof;
1013 (I) Phentermine;
1014 (J) Pipradrol;
1015 (K) Sibutramine; and
1016 (L) SPA ((-)-1-dimethylamino-1,2-diphenylethane).
1017 (v) Unless specifically excepted or unless listed in another schedule, any material,
1018 compound, mixture, or preparation which contains any quantity of dextropropoxyphene
1019 (alpha-(+)-4-dimethylamino-1, 2-diphenyl-3-methyl-2-propionoxybutane), including its salts.
1020 (vi) Any component of marijuana in a drug product that is approved by the United
1021 States Food and Drug Administration and scheduled by the Drug Enforcement Administration
1022 in Schedule IV of the federal Controlled Substances Act, Title II, P.L. 91-513.
1023 (e) Schedule V:
1024 (i) Any compound, mixture, or preparation containing any of the following limited
1025 quantities of narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid,
1026 which includes one or more non-narcotic active medicinal ingredients in sufficient proportion
1027 to confer upon the compound, mixture, or preparation valuable medicinal qualities other than
1028 those possessed by the narcotic drug alone:
1029 (A) not more than 200 milligrams of codeine per 100 milliliters or per 100 grams;
1030 (B) not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100
1031 grams;
1032 (C) not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100
1033 grams;
1034 (D) not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of
1035 atropine sulfate per dosage unit;
1036 (E) not more than 100 milligrams of opium per 100 milliliters or per 100 grams;
1037 (F) not more than 0.5 milligram of difenoxin and not less than 25 micrograms of
1038 atropine sulfate per dosage unit;
1039 (G) unless specifically exempted or excluded or unless listed in another schedule, any
1040 material, compound, mixture, or preparation which contains Pyrovalerone having a stimulant
1041 effect on the central nervous system, including its salts, isomers, and salts of isomers; and
1042 (H) all forms of Tramadol.
1043 (ii) [
1044 product that is approved by the United States Food and Drug Administration and scheduled by
1045 the Drug Enforcement Administration in Schedule V of the federal Controlled Substances Act,
1046 Title II, P.L. 91-513.
1047