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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 "closed door pharmacy" and "practice as a licensed
13 pharmacy technician";
14 ▸ changes the requirements for certain supervising pharmacists;
15 ▸ adds a drug to the list of long-acting injectable drug therapies that can be
16 administered by certain pharmacists;
17 ▸ adds certain board certified urologists to the list of individuals who are qualified to
18 be a dispensing medical practitioner; and
19 ▸ reschedules certain drugs that are approved by the United States Food and Drug
20 Administration and contain a component of cannabis.
21 Money Appropriated in this Bill:
22 None
23 Other Special Clauses:
24 None
25 Utah Code Sections Affected:
26 AMENDS:
27 58-17b-102, as last amended by Laws of Utah 2018, Chapter 295
28 58-17b-612, as last amended by Laws of Utah 2014, Chapter 72
29 58-17b-625, as enacted by Laws of Utah 2017, Chapter 384
30 58-17b-805, as enacted by Laws of Utah 2014, Chapter 72
31 58-37-4, as last amended by Laws of Utah 2018, Chapter 146
32
33 Be it enacted by the Legislature of the state of Utah:
34 Section 1. Section 58-17b-102 is amended to read:
35 58-17b-102. Definitions.
36 In addition to the definitions in Section 58-1-102, as used in this chapter:
37 (1) "Administering" means:
38 (a) the direct application of a prescription drug or device, whether by injection,
39 inhalation, ingestion, or by any other means, to the body of a human patient or research subject
40 by another person; or
41 (b) the placement by a veterinarian with the owner or caretaker of an animal or group
42 of animals of a prescription drug for the purpose of injection, inhalation, ingestion, or any other
43 means directed to the body of the animal by the owner or caretaker in accordance with written
44 or verbal directions of the veterinarian.
45 (2) "Adulterated drug or device" means a drug or device considered adulterated under
46 21 U.S.C. Sec. 351 (2003).
47 (3) (a) "Analytical laboratory" means a facility in possession of prescription drugs for
48 the purpose of analysis.
49 (b) "Analytical laboratory" does not include a laboratory possessing prescription drugs
50 used as standards and controls in performing drug monitoring or drug screening analysis if the
51 prescription drugs are prediluted in a human or animal body fluid, human or animal body fluid
52 components, organic solvents, or inorganic buffers at a concentration not exceeding one
53 milligram per milliliter when labeled or otherwise designated as being for in vitro diagnostic
54 use.
55 (4) "Animal euthanasia agency" means an agency performing euthanasia on animals by
56 the use of prescription drugs.
57 (5) "Automated pharmacy systems" includes mechanical systems which perform
58 operations or activities, other than compounding or administration, relative to the storage,
59 packaging, dispensing, or distribution of medications, and which collect, control, and maintain
60 all transaction information.
61 (6) "Beyond use date" means the date determined by a pharmacist and placed on a
62 prescription label at the time of dispensing that indicates to the patient or caregiver a time
63 beyond which the contents of the prescription are not recommended to be used.
64 (7) "Board of pharmacy" or "board" means the Utah State Board of Pharmacy created
65 in Section 58-17b-201.
66 (8) "Branch pharmacy" means a pharmacy or other facility in a rural or medically
67 underserved area, used for the storage and dispensing of prescription drugs, which is dependent
68 upon, stocked by, and supervised by a pharmacist in another licensed pharmacy designated and
69 approved by the division as the parent pharmacy.
70 (9) "Centralized prescription processing" means the processing by a pharmacy of a
71 request from another pharmacy to fill or refill a prescription drug order or to perform
72 processing functions such as dispensing, drug utilization review, claims adjudication, refill
73 authorizations, and therapeutic interventions.
74 (10) "Class A pharmacy" means a pharmacy located in Utah that is authorized as a
75 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
76 prescription order.
77 (11) "Class B pharmacy":
78 (a) means a pharmacy located in Utah:
79 (i) that is authorized to provide pharmaceutical care for patients in an institutional
80 setting; and
81 (ii) whose primary purpose is to provide a physical environment for patients to obtain
82 health care services; and
83 (b) (i) includes closed-door, hospital, clinic, nuclear, and branch pharmacies; and
84 (ii) pharmaceutical administration and sterile product preparation facilities.
85 (12) "Class C pharmacy" means a pharmacy that engages in the manufacture,
86 production, wholesale, or distribution of drugs or devices in Utah.
87 (13) "Class D pharmacy" means a nonresident pharmacy.
88 (14) "Class E pharmacy" means all other pharmacies.
89 (15) (a) "Closed-door pharmacy" means a pharmacy that:
90 (i) provides pharmaceutical care to a defined and exclusive group of patients who have
91 access to the services of the pharmacy because they are treated by or have an affiliation with a
92 specific entity, including a health maintenance organization or an infusion company[
93
94 (ii) engages exclusively in the practice of telepharmacy and does not serve walk-in
95 retail customers.
96 (b) "Closed-door pharmacy" does not include a hospital pharmacy, a retailer of goods
97 to the general public, or the office of a practitioner.
98 (16) "Collaborative pharmacy practice" means a practice of pharmacy whereby one or
99 more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or
100 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
101 care functions authorized by the practitioner or practitioners under certain specified conditions
102 or limitations.
103 (17) "Collaborative pharmacy practice agreement" means a written and signed
104 agreement between one or more pharmacists and one or more practitioners that provides for
105 collaborative pharmacy practice for the purpose of drug therapy management of patients and
106 prevention of disease of human subjects.
107 (18) (a) "Compounding" means the preparation, mixing, assembling, packaging, or
108 labeling of a limited quantity drug, sterile product, or device:
109 (i) as the result of a practitioner's prescription order or initiative based on the
110 practitioner, patient, or pharmacist relationship in the course of professional practice;
111 (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and
112 not for sale or dispensing; or
113 (iii) in anticipation of prescription drug orders based on routine, regularly observed
114 prescribing patterns.
115 (b) "Compounding" does not include:
116 (i) the preparation of prescription drugs by a pharmacist or pharmacy intern for sale to
117 another pharmacist or pharmaceutical facility;
118 (ii) the preparation by a pharmacist or pharmacy intern of any prescription drug in a
119 dosage form which is regularly and commonly available from a manufacturer in quantities and
120 strengths prescribed by a practitioner; or
121 (iii) the preparation of a prescription drug, sterile product, or device which has been
122 withdrawn from the market for safety reasons.
123 (19) "Confidential information" has the same meaning as "protected health
124 information" under the Standards for Privacy of Individually Identifiable Health Information,
125 45 C.F.R. Parts 160 and 164.
126 (20) "Controlled substance" means the same as that term is defined in Section 58-37-2.
127 (21) "Dietary supplement" has the same meaning as Public Law Title 103, Chapter
128 417, Sec. 3a(ff) which is incorporated by reference.
129 (22) "Dispense" means the interpretation, evaluation, and implementation of a
130 prescription drug order or device or nonprescription drug or device under a lawful order of a
131 practitioner in a suitable container appropriately labeled for subsequent administration to or use
132 by a patient, research subject, or an animal.
133 (23) "Dispensing medical practitioner" means an individual who is:
134 (a) currently licensed as:
135 (i) a physician and surgeon under Chapter 67, Utah Medical Practice Act;
136 (ii) an osteopathic physician and surgeon under Chapter 68, Utah Osteopathic Medical
137 Practice Act;
138 (iii) a physician assistant under Chapter 70a, Physician Assistant Act;
139 (iv) a nurse practitioner under Chapter 31b, Nurse Practice Act; or
140 (v) an optometrist under Chapter 16a, Utah Optometry Practice Act, if the optometrist
141 is acting within the scope of practice for an optometrist; and
142 (b) licensed by the division under the Pharmacy Practice Act to engage in the practice
143 of a dispensing medical practitioner.
144 (24) "Dispensing medical practitioner clinic pharmacy" means a closed-door pharmacy
145 located within a licensed dispensing medical practitioner's place of practice.
146 (25) "Distribute" means to deliver a drug or device other than by administering or
147 dispensing.
148 (26) (a) "Drug" means:
149 (i) a substance recognized in the official United States Pharmacopoeia, official
150 Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any
151 supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or
152 prevention of disease in humans or animals;
153 (ii) a substance that is required by any applicable federal or state law or rule to be
154 dispensed by prescription only or is restricted to administration by practitioners only;
155 (iii) a substance other than food intended to affect the structure or any function of the
156 body of humans or other animals; and
157 (iv) substances intended for use as a component of any substance specified in
158 Subsections (26)(a)(i), (ii), (iii), and (iv).
159 (b) "Drug" does not include dietary supplements.
160 (27) "Drug regimen review" includes the following activities:
161 (a) evaluation of the prescription drug order and patient record for:
162 (i) known allergies;
163 (ii) rational therapy-contraindications;
164 (iii) reasonable dose and route of administration; and
165 (iv) reasonable directions for use;
166 (b) evaluation of the prescription drug order and patient record for duplication of
167 therapy;
168 (c) evaluation of the prescription drug order and patient record for the following
169 interactions:
170 (i) drug-drug;
171 (ii) drug-food;
172 (iii) drug-disease; and
173 (iv) adverse drug reactions; and
174 (d) evaluation of the prescription drug order and patient record for proper utilization,
175 including over- or under-utilization, and optimum therapeutic outcomes.
176 (28) "Drug sample" means a prescription drug packaged in small quantities consistent
177 with limited dosage therapy of the particular drug, which is marked "sample", is not intended to
178 be sold, and is intended to be provided to practitioners for the immediate needs of patients for
179 trial purposes or to provide the drug to the patient until a prescription can be filled by the
180 patient.
181 (29) "Electronic signature" means a trusted, verifiable, and secure electronic sound,
182 symbol, or process attached to or logically associated with a record and executed or adopted by
183 a person with the intent to sign the record.
184 (30) "Electronic transmission" means transmission of information in electronic form or
185 the transmission of the exact visual image of a document by way of electronic equipment.
186 (31) "Hospital pharmacy" means a pharmacy providing pharmaceutical care to
187 inpatients of a general acute hospital or specialty hospital licensed by the Department of Health
188 under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.
189 (32) "Legend drug" has the same meaning as prescription drug.
190 (33) "Licensed pharmacy technician" means an individual licensed with the division,
191 that may, under the supervision of a pharmacist, perform the activities involved in the
192 technician practice of pharmacy.
193 (34) "Manufacturer" means a person or business physically located in Utah licensed to
194 be engaged in the manufacturing of drugs or devices.
195 (35) (a) "Manufacturing" means:
196 (i) the production, preparation, propagation, conversion, or processing of a drug or
197 device, either directly or indirectly, by extraction from substances of natural origin or
198 independently by means of chemical or biological synthesis, or by a combination of extraction
199 and chemical synthesis, and includes any packaging or repackaging of the substance or labeling
200 or relabeling of its container; and
201 (ii) the promotion and marketing of such drugs or devices.
202 (b) "Manufacturing" includes the preparation and promotion of commercially available
203 products from bulk compounds for resale by pharmacies, practitioners, or other persons.
204 (c) "Manufacturing" does not include the preparation or compounding of a drug by a
205 pharmacist, pharmacy intern, or practitioner for that individual's own use or the preparation,
206 compounding, packaging, labeling of a drug, or incident to research, teaching, or chemical
207 analysis.
208 (36) "Medical order" means a lawful order of a practitioner which may include a
209 prescription drug order.
210 (37) "Medication profile" or "profile" means a record system maintained as to drugs or
211 devices prescribed for a pharmacy patient to enable a pharmacist or pharmacy intern to analyze
212 the profile to provide pharmaceutical care.
213 (38) "Misbranded drug or device" means a drug or device considered misbranded under
214 21 U.S.C. Sec. 352 (2003).
215 (39) (a) "Nonprescription drug" means a drug which:
216 (i) may be sold without a prescription; and
217 (ii) is labeled for use by the consumer in accordance with federal law.
218 (b) "Nonprescription drug" includes homeopathic remedies.
219 (40) "Nonresident pharmacy" means a pharmacy located outside of Utah that sells to a
220 person in Utah.
221 (41) "Nuclear pharmacy" means a pharmacy providing radio-pharmaceutical service.
222 (42) "Out-of-state mail service pharmacy" means a pharmaceutical facility located
223 outside the state that is licensed and in good standing in another state, that:
224 (a) ships, mails, or delivers by any lawful means a dispensed legend drug to a patient in
225 this state pursuant to a lawfully issued prescription;
226 (b) provides information to a patient in this state on drugs or devices which may
227 include, but is not limited to, advice relating to therapeutic values, potential hazards, and uses;
228 or
229 (c) counsels pharmacy patients residing in this state concerning adverse and therapeutic
230 effects of drugs.
231 (43) "Patient counseling" means the written and oral communication by the pharmacist
232 or pharmacy intern of information, to the patient or caregiver, in order to ensure proper use of
233 drugs, devices, and dietary supplements.
234 (44) "Pharmaceutical administration facility" means a facility, agency, or institution in
235 which:
236 (a) prescription drugs or devices are held, stored, or are otherwise under the control of
237 the facility or agency for administration to patients of that facility or agency;
238 (b) prescription drugs are dispensed to the facility or agency by a licensed pharmacist
239 or pharmacy intern with whom the facility has established a prescription drug supervising
240 relationship under which the pharmacist or pharmacy intern provides counseling to the facility
241 or agency staff as required, and oversees drug control, accounting, and destruction; and
242 (c) prescription drugs are professionally administered in accordance with the order of a
243 practitioner by an employee or agent of the facility or agency.
244 (45) (a) "Pharmaceutical care" means carrying out the following in collaboration with a
245 prescribing practitioner, and in accordance with division rule:
246 (i) designing, implementing, and monitoring a therapeutic drug plan intended to
247 achieve favorable outcomes related to a specific patient for the purpose of curing or preventing
248 the patient's disease;
249 (ii) eliminating or reducing a patient's symptoms; or
250 (iii) arresting or slowing a disease process.
251 (b) "Pharmaceutical care" does not include prescribing of drugs without consent of a
252 prescribing practitioner.
253 (46) "Pharmaceutical facility" means a business engaged in the dispensing, delivering,
254 distributing, manufacturing, or wholesaling of prescription drugs or devices within or into this
255 state.
256 (47) (a) "Pharmaceutical wholesaler or distributor" means a pharmaceutical facility
257 engaged in the business of wholesale vending or selling of a prescription drug or device to
258 other than a consumer or user of the prescription drug or device that the pharmaceutical facility
259 has not produced, manufactured, compounded, or dispensed.
260 (b) "Pharmaceutical wholesaler or distributor" does not include a pharmaceutical
261 facility carrying out the following business activities:
262 (i) intracompany sales;
263 (ii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
264 purchase, or trade a prescription drug or device, if the activity is carried out between one or
265 more of the following entities under common ownership or common administrative control, as
266 defined by division rule:
267 (A) hospitals;
268 (B) pharmacies;
269 (C) chain pharmacy warehouses, as defined by division rule; or
270 (D) other health care entities, as defined by division rule;
271 (iii) the sale, purchase, or trade of a prescription drug or device, or an offer to sell,
272 purchase, or trade a prescription drug or device, for emergency medical reasons, including
273 supplying another pharmaceutical facility with a limited quantity of a drug, if:
274 (A) the facility is unable to obtain the drug through a normal distribution channel in
275 sufficient time to eliminate the risk of harm to a patient that would result from a delay in
276 obtaining the drug; and
277 (B) the quantity of the drug does not exceed an amount reasonably required for
278 immediate dispensing to eliminate the risk of harm;
279 (iv) the distribution of a prescription drug or device as a sample by representatives of a
280 manufacturer; and
281 (v) the distribution of prescription drugs, if:
282 (A) the facility's total distribution-related sales of prescription drugs does not exceed
283 5% of the facility's total prescription drug sales; and
284 (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11.
285 (48) "Pharmacist" means an individual licensed by this state to engage in the practice
286 of pharmacy.
287 (49) "Pharmacist-in-charge" means a pharmacist currently licensed in good standing
288 who accepts responsibility for the operation of a pharmacy in conformance with all laws and
289 rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally
290 in full and actual charge of the pharmacy and all personnel.
291 (50) "Pharmacist preceptor" means a licensed pharmacist in good standing with one or
292 more years of licensed experience. The preceptor serves as a teacher, example of professional
293 conduct, and supervisor of interns in the professional practice of pharmacy.
294 (51) "Pharmacy" means any place where:
295 (a) drugs are dispensed;
296 (b) pharmaceutical care is provided;
297 (c) drugs are processed or handled for eventual use by a patient; or
298 (d) drugs are used for the purpose of analysis or research.
299 (52) "Pharmacy benefits manager or coordinator" means a person or entity that
300 provides a pharmacy benefits management service as defined in Section 49-20-502 on behalf of
301 a self-insured employer, insurance company, health maintenance organization, or other plan
302 sponsor, as defined by rule.
303 (53) "Pharmacy intern" means an individual licensed by this state to engage in practice
304 as a pharmacy intern.
305 (54) "Pharmacy technician training program" means an approved technician training
306 program providing education for pharmacy technicians.
307 (55) (a) "Practice as a dispensing medical practitioner" means the practice of pharmacy,
308 specifically relating to the dispensing of a prescription drug in accordance with Part 8,
309 Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, and
310 division rule adopted after consultation with the Board of pharmacy and the governing boards
311 of the practitioners described in Subsection (23)(a).
312 (b) "Practice as a dispensing medical practitioner" does not include:
313 (i) using a vending type of dispenser as defined by the division by administrative rule;
314 or
315 (ii) except as permitted by Section 58-17b-805, dispensing of a controlled substance as
316 defined in Section 58-37-2.
317 (56) [
318 pharmacy technician under the general supervision of a licensed pharmacist and in accordance
319 with a scope of practice defined by division rule made in collaboration with the board.
320 [
321 [
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324 [
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331 (57) "Practice of pharmacy" includes the following:
332 (a) providing pharmaceutical care;
333 (b) collaborative pharmacy practice in accordance with a collaborative pharmacy
334 practice agreement;
335 (c) compounding, packaging, labeling, dispensing, administering, and the coincident
336 distribution of prescription drugs or devices, provided that the administration of a prescription
337 drug or device is:
338 (i) pursuant to a lawful order of a practitioner when one is required by law; and
339 (ii) in accordance with written guidelines or protocols:
340 (A) established by the licensed facility in which the prescription drug or device is to be
341 administered on an inpatient basis; or
342 (B) approved by the division, in collaboration with the board and the Physicians
343 Licensing Board, created in Section 58-67-201, if the prescription drug or device is to be
344 administered on an outpatient basis solely by a licensed pharmacist;
345 (d) participating in drug utilization review;
346 (e) ensuring proper and safe storage of drugs and devices;
347 (f) maintaining records of drugs and devices in accordance with state and federal law
348 and the standards and ethics of the profession;
349 (g) providing information on drugs or devices, which may include advice relating to
350 therapeutic values, potential hazards, and uses;
351 (h) providing drug product equivalents;
352 (i) supervising pharmacist's supportive personnel, pharmacy interns, and pharmacy
353 technicians;
354 (j) providing patient counseling, including adverse and therapeutic effects of drugs;
355 (k) providing emergency refills as defined by rule;
356 (l) telepharmacy;
357 (m) formulary management intervention; and
358 (n) prescribing and dispensing a self-administered hormonal contraceptive in
359 accordance with Title 26, Chapter 64, Family Planning Access Act.
360 (58) "Practice of telepharmacy" means the practice of pharmacy through the use of
361 telecommunications and information technologies.
362 (59) "Practice of telepharmacy across state lines" means the practice of pharmacy
363 through the use of telecommunications and information technologies that occurs when the
364 patient is physically located within one jurisdiction and the pharmacist is located in another
365 jurisdiction.
366 (60) "Practitioner" means an individual currently licensed, registered, or otherwise
367 authorized by the appropriate jurisdiction to prescribe and administer drugs in the course of
368 professional practice.
369 (61) "Prescribe" means to issue a prescription:
370 (a) orally or in writing; or
371 (b) by telephone, facsimile transmission, computer, or other electronic means of
372 communication as defined by division rule.
373 (62) "Prescription" means an order issued:
374 (a) by a licensed practitioner in the course of that practitioner's professional practice or
375 by collaborative pharmacy practice agreement; and
376 (b) for a controlled substance or other prescription drug or device for use by a patient
377 or an animal.
378 (63) "Prescription device" means an instrument, apparatus, implement, machine,
379 contrivance, implant, in vitro reagent, or other similar or related article, and any component
380 part or accessory, which is required under federal or state law to be prescribed by a practitioner
381 and dispensed by or through a person or entity licensed under this chapter or exempt from
382 licensure under this chapter.
383 (64) "Prescription drug" means a drug that is required by federal or state law or rule to
384 be dispensed only by prescription or is restricted to administration only by practitioners.
385 (65) "Repackage":
386 (a) means changing the container, wrapper, or labeling to further the distribution of a
387 prescription drug; and
388 (b) does not include:
389 (i) Subsection (65)(a) when completed by the pharmacist responsible for dispensing the
390 product to a patient; or
391 (ii) changing or altering a label as necessary for a dispensing practitioner under Part 8,
392 Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy, for
393 dispensing a product to a patient.
394 (66) "Research using pharmaceuticals" means research:
395 (a) conducted in a research facility, as defined by division rule, that is associated with a
396 university or college in the state accredited by the Northwest Commission on Colleges and
397 Universities;
398 (b) requiring the use of a controlled substance, prescription drug, or prescription
399 device;
400 (c) that uses the controlled substance, prescription drug, or prescription device in
401 accordance with standard research protocols and techniques, including, if required, those
402 approved by an institutional review committee; and
403 (d) that includes any documentation required for the conduct of the research and the
404 handling of the controlled substance, prescription drug, or prescription device.
405 (67) "Retail pharmacy" means a pharmaceutical facility dispensing prescription drugs
406 and devices to the general public.
407 (68) (a) "Self-administered hormonal contraceptive" means a self-administered
408 hormonal contraceptive that is approved by the United States Food and Drug Administration to
409 prevent pregnancy.
410 (b) "Self-administered hormonal contraceptive" includes an oral hormonal
411 contraceptive, a hormonal vaginal ring, and a hormonal contraceptive patch.
412 (c) "Self-administered hormonal contraceptive" does not include any drug intended to
413 induce an abortion, as that term is defined in Section 76-7-301.
414 (69) "Self-audit" means an internal evaluation of a pharmacy to determine compliance
415 with this chapter.
416 (70) "Supervising pharmacist" means a pharmacist who is overseeing the operation of
417 the pharmacy during a given day or shift.
418 (71) "Supportive personnel" means unlicensed individuals who:
419 (a) may assist a pharmacist, pharmacist preceptor, pharmacy intern, or licensed
420 pharmacy technician in nonjudgmental duties not included in the definition of the practice of
421 pharmacy, practice of a pharmacy intern, or practice of a licensed pharmacy technician, and as
422 those duties may be further defined by division rule adopted in collaboration with the board;
423 and
424 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
425 collaboration with the board.
426 (72) "Unlawful conduct" means the same as that term is defined in Sections 58-1-501
427 and 58-17b-501.
428 (73) "Unprofessional conduct" means the same as that term is defined in Sections
429 58-1-501 and 58-17b-502 and may be further defined by rule.
430 (74) "Veterinary pharmaceutical facility" means a pharmaceutical facility that
431 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
432 for animals.
433 Section 2. Section 58-17b-612 is amended to read:
434 58-17b-612. Supervision -- Pharmacist-in-charge.
435 (1) (a) Any pharmacy, except a wholesaler, distributor, out-of-state mail service
436 pharmacy, or class E pharmacy, shall be under the general supervision of at least one
437 pharmacist licensed to practice in Utah. One pharmacist licensed in Utah shall be designated
438 as the pharmacist-in-charge, whose responsibility it is to oversee the operation of the pharmacy.
439 (b) Notwithstanding Subsection 58-17b-102[
440 not have to be in the pharmacy or care facility but shall be available via a telepharmacy system
441 for immediate contact with the supervised pharmacy technician or pharmacy intern if:
442 (i) the pharmacy is located in[
443 consultation with the board, by rule made in accordance with Title 63G, Chapter 3, Utah
444 Administrative Rulemaking Act;
445 [
446 [
447 (ii) the supervising pharmacist described in Subsection (1)(a) is not available; [
448 (iii) the telepharmacy system maintains records and files quarterly reports as required
449 by division rule to assure that patient safety is not compromised[
450 (iv) the arrangement is approved by the division in collaboration with the board.
451 (c) Subsection (1)(b) applies to a pharmacy that is located in a hospital only if the
452 hospital is controlled by a local board that owns no more than two hospitals; and
453 (d) A supervising pharmacist may not supervise more than two pharmacies
454 simultaneously under Subsection (1)(b).
455 (2) Each out-of-state mail service pharmacy shall designate and identify to the division
456 a pharmacist holding a current license in good standing issued by the state in which the
457 pharmacy is located and who serves as the pharmacist-in-charge for all purposes under this
458 chapter.
459 Section 3. Section 58-17b-625 is amended to read:
460 58-17b-625. Administration of a long-acting injectable drug therapy.
461 (1) A pharmacist may, in accordance with this section, administer a drug described in
462 Subsection (2).
463 (2) Notwithstanding the provisions of Subsection 58-17b-102(57)(c)(ii)(B), the
464 division shall make rules, in accordance with Title 63G, Chapter 3, Utah Administrative
465 Rulemaking Act, establishing training for a pharmacist to administer the following long-acting
466 injectables intramuscularly:
467 (a) aripiprazole;
468 (b) aripiprazole lauroxil;
469 [
470 [
471 [
472 [
473 [
474 [
475 Administration for the treatment of the Human Immunodeficiency Virus.
476 (3) A pharmacist may not administer a drug listed under Subsection (2) unless the
477 pharmacist:
478 (a) completes the training described in Subsection (2);
479 (b) administers the drug at a clinic or community pharmacy, as those terms are defined
480 by the division, by administrative rule made in accordance with Title 63G, Chapter 3, Utah
481 Administrative Rulemaking Act; and
482 (c) is directed by the physician, as that term is defined in Section 58-67-102 or Section
483 58-68-102, who issues the prescription to administer the drug.
484 Section 4. Section 58-17b-805 is amended to read:
485 58-17b-805. Dispensing medical practitioner -- Cancer drug treatment regimen.
486 (1) For purposes of this section:
487 (a) "Cancer drug treatment regimen" means a prescription drug used to treat cancer,
488 manage its symptoms, or provide continuity of care for a cancer patient.
489 (b) "Cancer drug treatment regimen" includes:
490 (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
491 methods; and
492 (ii) a drug used to support cancer treatment, including a drug used to treat, alleviate, or
493 minimize physical and psychological symptoms or pain, to improve patient tolerance of cancer
494 treatments, or to prepare a patient for a subsequent course of therapy.
495 (c) "Cancer drug treatment regimen" does not mean a drug listed under federal law as a
496 Schedule I, II, or III drug.
497 (2) An individual may be licensed as a dispensing medical practitioner with a scope of
498 practice that permits the dispensing medical practitioner to prescribe and dispense a cancer
499 drug treatment regimen if the individual:
500 (a) is licensed as described in Subsections 58-17b-102(23)(a)(i) and (ii); and
501 (b) is certified or eligible to be certified by:
502 (i) the American Board of Internal Medicine in medical oncology[
503 (ii) the American Board of Urology.
504 (3) A dispensing medical practitioner authorized to prescribe and dispense a cancer
505 drug treatment regimen under this section may prescribe and dispense a cancer drug treatment
506 regimen:
507 (a) to the practitioner's patient who is currently undergoing chemotherapy in an
508 outpatient clinic setting; and
509 (b) if the practitioner determines that providing the cancer drug treatment regimen to
510 the patient in the outpatient clinic setting is in the best interest of the patient or provides better
511 access to care for the patient.
512 Section 5. Section 58-37-4 is amended to read:
513 58-37-4. Schedules of controlled substances -- Schedules I through V -- Findings
514 required -- Specific substances included in schedules.
515 (1) There are established five schedules of controlled substances known as Schedules I,
516 II, III, IV, and V which consist of substances listed in this section.
517 (2) Schedules I, II, III, IV, and V consist of the following drugs or other substances by
518 the official name, common or usual name, chemical name, or brand name designated:
519 (a) Schedule I:
520 (i) Unless specifically excepted or unless listed in another schedule, any of the
521 following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and
522 ethers, when the existence of the isomers, esters, ethers, and salts is possible within the specific
523 chemical designation:
524 (A) Acetyl-alpha-methylfentanyl
525 (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N-phenylacetamide);
526 (B) Acetyl fentanyl: (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide);
527 (C) Acetylmethadol;
528 (D) Acryl fentanyl (N-(1-Phenethylpiperidin-4-yl)-N-phenylacrylamide);
529 (E) Allylprodine;
530 (F) Alphacetylmethadol, except levo-alphacetylmethadol also known as
531 levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM;
532 (G) Alphameprodine;
533 (H) Alphamethadol;
534 (I) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-piperidyl]
535 propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine);
536 (J) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-
537 piperidinyl]-N-phenylpropanamide);
538 (K) Benzylpiperazine;
539 (L) Benzethidine;
540 (M) Betacetylmethadol;
541 (N) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-
542 piperidinyl]-N-phenylpropanamide);
543 (O) Beta-hydroxy-3-methylfentanyl, other name: N-[1-(2-hydroxy-2-
544 phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide;
545 (P) Betameprodine;
546 (Q) Betamethadol;
547 (R) Betaprodine;
548 (S) Butyryl fentanyl (N-(1-(2-phenylethyl)-4-piperidinyl)-N-phenylbutyramide);
549 (T) Clonitazene;
550 (U) Cyclopropyl fentanyl
551 (N-(1-Phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide);
552 (V) Dextromoramide;
553 (W) Diampromide;
554 (X) Diethylthiambutene;
555 (Y) Difenoxin;
556 (Z) Dimenoxadol;
557 (AA) Dimepheptanol;
558 (BB) Dimethylthiambutene;
559 (CC) Dioxaphetyl butyrate;
560 (DD) Dipipanone;
561 (EE) Ethylmethylthiambutene;
562 (FF) Etizolam
563 (1-Methyl-6-o-chlorophenyl-8-ethyl-4H-s-triazolo[3,4-c]thieno[2,3-e]1,4-diazepine);
564 (GG) Etonitazene;
565 (HH) Etoxeridine;
566 (II) Furanyl fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]
567 furan-2-carboxamide);
568 (JJ) Furethidine;
569 (KK) Hydroxypethidine;
570 (LL) Ketobemidone;
571 (MM) Levomoramide;
572 (NN) Levophenacylmorphan;
573 (OO) Methoxyacetyl fentanyl
574 (2-Methoxy-N-(1-phenylethylpiperidinyl-4-yl)-N-acetamide);
575 (PP) Morpheridine;
576 (QQ) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine);
577 (RR) Noracymethadol;
578 (SS) Norlevorphanol;
579 (TT) Normethadone;
580 (UU) Norpipanone;
581 (VV) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-4- piperidinyl]
582 propanamide);
583 (WW) Para-fluoroisobutyryl fentanyl
584 (N-(4-Fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide);
585 (XX) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine);
586 (YY) Phenadoxone;
587 (ZZ) Phenampromide;
588 (AAA) Phenomorphan;
589 (BBB) Phenoperidine;
590 (CCC) Piritramide;
591 (DDD) Proheptazine;
592 (EEE) Properidine;
593 (FFF) Propiram;
594 (GGG) Racemoramide;
595 (HHH) Tetrahydrofuran fentanyl
596 (N-(1-Phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide);
597 (III) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]- propanamide;
598 (JJJ) Tilidine;
599 (KKK) Trimeperidine;
600 (LLL) 3-methylfentanyl, including the optical and geometric isomers
601 (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]- N-phenylpropanamide);
602 (MMM) 3-methylthiofentanyl
603 (N-[(3-methyl-1-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide);
604 (NNN) 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide also
605 known as U-47700; and
606 (OOO) 4-cyano CUMYL-BUTINACA.
607 (ii) Unless specifically excepted or unless listed in another schedule, any of the
608 following opium derivatives, their salts, isomers, and salts of isomers when the existence of the
609 salts, isomers, and salts of isomers is possible within the specific chemical designation:
610 (A) Acetorphine;
611 (B) Acetyldihydrocodeine;
612 (C) Benzylmorphine;
613 (D) Codeine methylbromide;
614 (E) Codeine-N-Oxide;
615 (F) Cyprenorphine;
616 (G) Desomorphine;
617 (H) Dihydromorphine;
618 (I) Drotebanol;
619 (J) Etorphine (except hydrochloride salt);
620 (K) Heroin;
621 (L) Hydromorphinol;
622 (M) Methyldesorphine;
623 (N) Methylhydromorphine;
624 (O) Morphine methylbromide;
625 (P) Morphine methylsulfonate;
626 (Q) Morphine-N-Oxide;
627 (R) Myrophine;
628 (S) Nicocodeine;
629 (T) Nicomorphine;
630 (U) Normorphine;
631 (V) Pholcodine; and
632 (W) Thebacon.
633 (iii) Unless specifically excepted or unless listed in another schedule, any material,
634 compound, mixture, or preparation which contains any quantity of the following hallucinogenic
635 substances, or which contains any of their salts, isomers, and salts of isomers when the
636 existence of the salts, isomers, and salts of isomers is possible within the specific chemical
637 designation; as used in this Subsection (2)(a)(iii) only, "isomer" includes the optical, position,
638 and geometric isomers:
639 (A) Alpha-ethyltryptamine, some trade or other names: etryptamine; Monase;
640 α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; α-ET; and AET;
641 (B) 4-bromo-2,5-dimethoxy-amphetamine, some trade or other names:
642 4-bromo-2,5-dimethoxy-α-methylphenethylamine; 4-bromo-2,5-DMA;
643 (C) 4-bromo-2,5-dimethoxyphenethylamine, some trade or other names:
644 2-(4-bromo-2,5-dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus;
645 (D) 2,5-dimethoxyamphetamine, some trade or other names:
646 2,5-dimethoxy-α-methylphenethylamine; 2,5-DMA;
647 (E) 2,5-dimethoxy-4-ethylamphetamine, some trade or other names: DOET;
648 (F) 4-methoxyamphetamine, some trade or other names:
649 4-methoxy-α-methylphenethylamine; paramethoxyamphetamine, PMA;
650 (G) 5-methoxy-3,4-methylenedioxyamphetamine;
651 (H) 4-methyl-2,5-dimethoxy-amphetamine, some trade and other names:
652 4-methyl-2,5-dimethoxy-α-methylphenethylamine; "DOM"; and "STP";
653 (I) 3,4-methylenedioxy amphetamine;
654 (J) 3,4-methylenedioxymethamphetamine (MDMA);
655 (K) 3,4-methylenedioxy-N-ethylamphetamine, also known as N-ethyl-
656 alpha-methyl-3,4(methylenedioxy)phenethylamine, N-ethyl MDA, MDE, MDEA;
657 (L) N-hydroxy-3,4-methylenedioxyamphetamine, also known as
658 N-hydroxy-alpha-methyl-3,4(methylenedioxy)phenethylamine, and N-hydroxy MDA;
659 (M) 3,4,5-trimethoxy amphetamine;
660 (N) Bufotenine, some trade and other names:
661 3-(β-Dimethylaminoethyl)-5-hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N,
662 N-dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine;
663 (O) Diethyltryptamine, some trade and other names: N,N-Diethyltryptamine; DET;
664 (P) Dimethyltryptamine, some trade or other names: DMT;
665 (Q) Ibogaine, some trade and other names:
666 7-Ethyl-6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1', 2':1,2] azepino
667 [5,4-b] indole; Tabernanthe iboga;
668 (R) Lysergic acid diethylamide;
669 (S) Marijuana;
670 (T) Mescaline;
671 (U) Parahexyl, some trade or other names:
672 3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl;
673 (V) Peyote, meaning all parts of the plant presently classified botanically as
674 Lophophora williamsii Lemaire, whether growing or not, the seeds thereof, any extract from
675 any part of such plant, and every compound, manufacture, salts, derivative, mixture, or
676 preparation of such plant, its seeds or extracts (Interprets 21 USC 812(c), Schedule I(c) (12));
677 (W) N-ethyl-3-piperidyl benzilate;
678 (X) N-methyl-3-piperidyl benzilate;
679 (Y) Psilocybin;
680 (Z) Psilocyn;
681 (AA) Tetrahydrocannabinols, naturally contained in a plant of the genus Cannabis
682 (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis
683 plant, or in the resinous extractives of Cannabis, sp. and/or synthetic substances, derivatives,
684 and their isomers with similar chemical structure and pharmacological activity to those
685 substances contained in the plant, such as the following: Δ1 cis or trans tetrahydrocannabinol,
686 and their optical isomers Δ6 cis or trans tetrahydrocannabinol, and their optical isomers Δ3,4
687 cis or trans tetrahydrocannabinol, and its optical isomers, and since nomenclature of these
688 substances is not internationally standardized, compounds of these structures, regardless of
689 numerical designation of atomic positions covered;
690 (BB) Ethylamine analog of phencyclidine, some trade or other names:
691 N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine,
692 N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE;
693 (CC) Pyrrolidine analog of phencyclidine, some trade or other names:
694 1-(1-phenylcyclohexyl)-pyrrolidine, PCPy, PHP;
695 (DD) Thiophene analog of phencyclidine, some trade or other names:
696 1-[1-(2-thienyl)-cyclohexyl]-piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP; and
697 (EE) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine, some other names: TCPy.
698 (iv) Unless specifically excepted or unless listed in another schedule, any material
699 compound, mixture, or preparation which contains any quantity of the following substances
700 having a depressant effect on the central nervous system, including its salts, isomers, and salts
701 of isomers when the existence of the salts, isomers, and salts of isomers is possible within the
702 specific chemical designation:
703 (A) Mecloqualone; and
704 (B) Methaqualone.
705 (v) Any material, compound, mixture, or preparation containing any quantity of the
706 following substances having a stimulant effect on the central nervous system, including their
707 salts, isomers, and salts of isomers:
708 (A) Aminorex, some other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; or
709 4,5-dihydro-5-phenyl-2-oxazolamine;
710 (B) Cathinone, some trade or other names: 2-amino-1-phenyl-1-propanone,
711 alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone;
712 (C) Fenethylline;
713 (D) Methcathinone, some other names: 2-(methylamino)-propiophenone;
714 alpha-(methylamino)propiophenone; 2-(methylamino)-1-phenylpropan-1-one;
715 alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone;
716 methylcathinone; AL-464; AL-422; AL-463 and UR1432, its salts, optical isomers, and salts of
717 optical isomers;
718 (E) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine);
719 (F) N-ethylamphetamine; and
720 (G) N,N-dimethylamphetamine, also known as
721 N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine.
722 (vi) Any material, compound, mixture, or preparation which contains any quantity of
723 the following substances, including their optical isomers, salts, and salts of isomers, subject to
724 temporary emergency scheduling:
725 (A) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide (benzylfentanyl); and
726 (B) N-[1- (2-thienyl)methyl-4-piperidyl]-N-phenylpropanamide (thenylfentanyl).
727 (vii) Unless specifically excepted or unless listed in another schedule, any material,
728 compound, mixture, or preparation which contains any quantity of gamma hydroxy butyrate
729 (gamma hydrobutyric acid), including its salts, isomers, and salts of isomers.
730 (b) Schedule II:
731 (i) Unless specifically excepted or unless listed in another schedule, any of the
732 following substances whether produced directly or indirectly by extraction from substances of
733 vegetable origin, or independently by means of chemical synthesis, or by a combination of
734 extraction and chemical synthesis:
735 (A) Opium and opiate, and any salt, compound, derivative, or preparation of opium or
736 opiate, excluding apomorphine, dextrorphan, nalbuphine, nalmefene, naloxone, and naltrexone,
737 and their respective salts, but including:
738 (I) Raw opium;
739 (II) Opium extracts;
740 (III) Opium fluid;
741 (IV) Powdered opium;
742 (V) Granulated opium;
743 (VI) Tincture of opium;
744 (VII) Codeine;
745 (VIII) Ethylmorphine;
746 (IX) Etorphine hydrochloride;
747 (X) Hydrocodone;
748 (XI) Hydromorphone;
749 (XII) Metopon;
750 (XIII) Morphine;
751 (XIV) Oxycodone;
752 (XV) Oxymorphone; and
753 (XVI) Thebaine;
754 (B) Any salt, compound, derivative, or preparation which is chemically equivalent or
755 identical with any of the substances referred to in Subsection (2)(b)(i)(A), except that these
756 substances may not include the isoquinoline alkaloids of opium;
757 (C) Opium poppy and poppy straw;
758 (D) Coca leaves and any salt, compound, derivative, or preparation of coca leaves, and
759 any salt, compound, derivative, or preparation which is chemically equivalent or identical with
760 any of these substances, and includes cocaine and ecgonine, their salts, isomers, derivatives,
761 and salts of isomers and derivatives, whether derived from the coca plant or synthetically
762 produced, except the substances may not include decocainized coca leaves or extraction of coca
763 leaves, which extractions do not contain cocaine or ecgonine; and
764 (E) Concentrate of poppy straw, which means the crude extract of poppy straw in either
765 liquid, solid, or powder form which contains the phenanthrene alkaloids of the opium poppy.
766 (ii) Unless specifically excepted or unless listed in another schedule, any of the
767 following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and
768 ethers, when the existence of the isomers, esters, ethers, and salts is possible within the specific
769 chemical designation, except dextrorphan and levopropoxyphene:
770 (A) Alfentanil;
771 (B) Alphaprodine;
772 (C) Anileridine;
773 (D) Bezitramide;
774 (E) Bulk dextropropoxyphene (nondosage forms);
775 (F) Carfentanil;
776 (G) Dihydrocodeine;
777 (H) Diphenoxylate;
778 (I) Fentanyl;
779 (J) Isomethadone;
780 (K) Levo-alphacetylmethadol, some other names: levo-alpha-acetylmethadol,
781 levomethadyl acetate, or LAAM;
782 (L) Levomethorphan;
783 (M) Levorphanol;
784 (N) Metazocine;
785 (O) Methadone;
786 (P) Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl butane;
787 (Q) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic
788 acid;
789 (R) Pethidine (meperidine);
790 (S) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine;
791 (T) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate;
792 (U) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid;
793 (V) Phenazocine;
794 (W) Piminodine;
795 (X) Racemethorphan;
796 (Y) Racemorphan;
797 (Z) Remifentanil; and
798 (AA) Sufentanil.
799 (iii) Unless specifically excepted or unless listed in another schedule, any material,
800 compound, mixture, or preparation which contains any quantity of the following substances
801 having a stimulant effect on the central nervous system:
802 (A) Amphetamine, its salts, optical isomers, and salts of its optical isomers;
803 (B) Methamphetamine, its salts, isomers, and salts of its isomers;
804 (C) Phenmetrazine and its salts; and
805 (D) Methylphenidate.
806 (iv) Unless specifically excepted or unless listed in another schedule, any material,
807 compound, mixture, or preparation which contains any quantity of the following substances
808 having a depressant effect on the central nervous system, including its salts, isomers, and salts
809 of isomers when the existence of the salts, isomers, and salts of isomers is possible within the
810 specific chemical designation:
811 (A) Amobarbital;
812 (B) Glutethimide;
813 (C) Pentobarbital;
814 (D) Phencyclidine;
815 (E) Phencyclidine immediate precursors: 1-phenylcyclohexylamine and
816 1-piperidinocyclohexanecarbonitrile (PCC); and
817 (F) Secobarbital.
818 (v) (A) Unless specifically excepted or unless listed in another schedule, any material,
819 compound, mixture, or preparation which contains any quantity of Phenylacetone.
820 (B) Some of these substances may be known by trade or other names:
821 phenyl-2-propanone; P2P; benzyl methyl ketone; and methyl benzyl ketone.
822 (vi) Nabilone, another name for nabilone:
823 (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,
824 6-dimethyl-9H-dibenzo[b,d]pyran-9-one.
825 (vii) A drug product or preparation that contains any component of marijuana,
826 including tetrahydrocannabinol, and is approved by the United States Food and Drug
827 Administration and scheduled by the Drug Enforcement Administration in Schedule II of the
828 federal Controlled Substances Act, Title II, P.L. 91-513.
829 (c) Schedule III:
830 (i) Unless specifically excepted or unless listed in another schedule, any material,
831 compound, mixture, or preparation which contains any quantity of the following substances
832 having a stimulant effect on the central nervous system, including its salts, isomers whether
833 optical, position, or geometric, and salts of the isomers when the existence of the salts, isomers,
834 and salts of isomers is possible within the specific chemical designation:
835 (A) Those compounds, mixtures, or preparations in dosage unit form containing any
836 stimulant substances listed in Schedule II, which compounds, mixtures, or preparations were
837 listed on August 25, 1971, as excepted compounds under Section 1308.32 of Title 21 of the
838 Code of Federal Regulations, and any other drug of the quantitive composition shown in that
839 list for those drugs or which is the same except that it contains a lesser quantity of controlled
840 substances;
841 (B) Benzphetamine;
842 (C) Chlorphentermine;
843 (D) Clortermine; and
844 (E) Phendimetrazine.
845 (ii) Unless specifically excepted or unless listed in another schedule, any material,
846 compound, mixture, or preparation which contains any quantity of the following substances
847 having a depressant effect on the central nervous system:
848 (A) Any compound, mixture, or preparation containing amobarbital, secobarbital,
849 pentobarbital, or any salt of any of them, and one or more other active medicinal ingredients
850 which are not listed in any schedule;
851 (B) Any suppository dosage form containing amobarbital, secobarbital, or
852 pentobarbital, or any salt of any of these drugs which is approved by the Food and Drug
853 Administration for marketing only as a suppository;
854 (C) Any substance which contains any quantity of a derivative of barbituric acid or any
855 salt of any of them;
856 (D) Chlorhexadol;
857 (E) Buprenorphine;
858 (F) Any drug product containing gamma hydroxybutyric acid, including its salts,
859 isomers, and salts of isomers, for which an application is approved under the federal Food,
860 Drug, and Cosmetic Act, Section 505;
861 (G) Ketamine, its salts, isomers, and salts of isomers, some other names for ketamine:
862 ± -2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone;
863 (H) Lysergic acid;
864 (I) Lysergic acid amide;
865 (J) Methyprylon;
866 (K) Sulfondiethylmethane;
867 (L) Sulfonethylmethane;
868 (M) Sulfonmethane; and
869 (N) Tiletamine and zolazepam or any of their salts, some trade or other names for a
870 tiletamine-zolazepam combination product: Telazol, some trade or other names for tiletamine:
871 2-(ethylamino)-2-(2-thienyl)-cyclohexanone, some trade or other names for zolazepam:
872 4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-e] [1,4]-diazepin-7(1H)-one,
873 flupyrazapon.
874 (iii) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a
875 U.S. Food and Drug Administration approved drug product, some other names for dronabinol:
876 (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol, or
877 (-)-delta-9-(trans)-tetrahydrocannabinol.
878 (iv) Nalorphine.
879 (v) Unless specifically excepted or unless listed in another schedule, any material,
880 compound, mixture, or preparation containing limited quantities of any of the following
881 narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid:
882 (A) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90
883 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of
884 opium;
885 (B) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90
886 milligrams per dosage unit, with one or more active non-narcotic ingredients in recognized
887 therapeutic amounts;
888 (C) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more
889 than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline
890 alkaloid of opium;
891 (D) Not more than 300 milligrams of dihydrocodeinone 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 (E) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90
895 milligrams per dosage unit, with one or more active non-narcotic ingredients in recognized
896 therapeutic amounts;
897 (F) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more
898 than 15 milligrams per dosage unit, with one or more active, non-narcotic ingredients in
899 recognized therapeutic amounts;
900 (G) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not
901 more than 25 milligrams per dosage unit, with one or more active, non-narcotic ingredients in
902 recognized therapeutic amounts; and
903 (H) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with
904 one or more active, non-narcotic ingredients in recognized therapeutic amounts.
905 (vi) Unless specifically excepted or unless listed in another schedule, anabolic steroids
906 including any of the following or any isomer, ester, salt, or derivative of the following that
907 promotes muscle growth:
908 (A) Boldenone;
909 (B) Chlorotestosterone (4-chlortestosterone);
910 (C) Clostebol;
911 (D) Dehydrochlormethyltestosterone;
912 (E) Dihydrotestosterone (4-dihydrotestosterone);
913 (F) Drostanolone;
914 (G) Ethylestrenol;
915 (H) Fluoxymesterone;
916 (I) Formebulone (formebolone);
917 (J) Mesterolone;
918 (K) Methandienone;
919 (L) Methandranone;
920 (M) Methandriol;
921 (N) Methandrostenolone;
922 (O) Methenolone;
923 (P) Methyltestosterone;
924 (Q) Mibolerone;
925 (R) Nandrolone;
926 (S) Norethandrolone;
927 (T) Oxandrolone;
928 (U) Oxymesterone;
929 (V) Oxymetholone;
930 (W) Stanolone;
931 (X) Stanozolol;
932 (Y) Testolactone;
933 (Z) Testosterone; and
934 (AA) Trenbolone.
935 (vii) Anabolic steroids expressly intended for administration through implants to cattle
936 or other nonhuman species, and approved by the Secretary of Health and Human Services for
937 use, may not be classified as a controlled substance.
938 (viii) A drug product or preparation that contains any component of marijuana,
939 including tetrahydrocannabinol, and is approved by the United States Food and Drug
940 Administration and scheduled by the Drug Enforcement Administration in Schedule III of the
941 federal Controlled Substances Act, Title II, P.L. 91-513.
942 (d) Schedule IV:
943 (i) Unless specifically excepted or unless listed in another schedule, any material,
944 compound, mixture, or preparation containing not more than 1 milligram of difenoxin and not
945 less than 25 micrograms of atropine sulfate per dosage unit, or any salts of any of them.
946 (ii) Unless specifically excepted or unless listed in another schedule, any material,
947 compound, mixture, or preparation which contains any quantity of the following substances,
948 including its salts, isomers, and salts of isomers when the existence of the salts, isomers, and
949 salts of isomers is possible within the specific chemical designation:
950 (A) Alprazolam;
951 (B) Barbital;
952 (C) Bromazepam;
953 (D) Butorphanol;
954 (E) Camazepam;
955 (F) Carisoprodol;
956 (G) Chloral betaine;
957 (H) Chloral hydrate;
958 (I) Chlordiazepoxide;
959 (J) Clobazam;
960 (K) Clonazepam;
961 (L) Clorazepate;
962 (M) Clotiazepam;
963 (N) Cloxazolam;
964 (O) Delorazepam;
965 (P) Diazepam;
966 (Q) Dichloralphenazone;
967 (R) Estazolam;
968 (S) Ethchlorvynol;
969 (T) Ethinamate;
970 (U) Ethyl loflazepate;
971 (V) Fludiazepam;
972 (W) Flunitrazepam;
973 (X) Flurazepam;
974 (Y) Halazepam;
975 (Z) Haloxazolam;
976 (AA) Ketazolam;
977 (BB) Loprazolam;
978 (CC) Lorazepam;
979 (DD) Lormetazepam;
980 (EE) Mebutamate;
981 (FF) Medazepam;
982 (GG) Meprobamate;
983 (HH) Methohexital;
984 (II) Methylphenobarbital (mephobarbital);
985 (JJ) Midazolam;
986 (KK) Nimetazepam;
987 (LL) Nitrazepam;
988 (MM) Nordiazepam;
989 (NN) Oxazepam;
990 (OO) Oxazolam;
991 (PP) Paraldehyde;
992 (QQ) Pentazocine;
993 (RR) Petrichloral;
994 (SS) Phenobarbital;
995 (TT) Pinazepam;
996 (UU) Prazepam;
997 (VV) Quazepam;
998 (WW) Temazepam;
999 (XX) Tetrazepam;
1000 (YY) Triazolam;
1001 (ZZ) Zaleplon; and
1002 (AAA) Zolpidem.
1003 (iii) Any material, compound, mixture, or preparation of fenfluramine which contains
1004 any quantity of the following substances, including its salts, isomers whether optical, position,
1005 or geometric, and salts of the isomers when the existence of the salts, isomers, and salts of
1006 isomers is possible.
1007 (iv) Unless specifically excepted or unless listed in another schedule, any material,
1008 compound, mixture, or preparation which contains any quantity of the following substances
1009 having a stimulant effect on the central nervous system, including its salts, isomers whether
1010 optical, position, or geometric isomers, and salts of the isomers when the existence of the salts,
1011 isomers, and salts of isomers is possible within the specific chemical designation:
1012 (A) Cathine ((+)-norpseudoephedrine);
1013 (B) Diethylpropion;
1014 (C) Fencamfamine;
1015 (D) Fenproprex;
1016 (E) Mazindol;
1017 (F) Mefenorex;
1018 (G) Modafinil;
1019 (H) Pemoline, including organometallic complexes and chelates thereof;
1020 (I) Phentermine;
1021 (J) Pipradrol;
1022 (K) Sibutramine; and
1023 (L) SPA ((-)-1-dimethylamino-1,2-diphenylethane).
1024 (v) Unless specifically excepted or unless listed in another schedule, any material,
1025 compound, mixture, or preparation which contains any quantity of dextropropoxyphene
1026 (alpha-(+)-4-dimethylamino-1, 2-diphenyl-3-methyl-2-propionoxybutane), including its salts.
1027 (vi) A drug product or preparation that contains any component of marijuana and is
1028 approved by the United States Food and Drug Administration and scheduled by the Drug
1029 Enforcement Administration in Schedule IV of the federal Controlled Substances Act, Title II,
1030 P.L. 91-513.
1031 (e) Schedule V:
1032 (i) Any compound, mixture, or preparation containing any of the following limited
1033 quantities of narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid,
1034 which includes one or more non-narcotic active medicinal ingredients in sufficient proportion
1035 to confer upon the compound, mixture, or preparation valuable medicinal qualities other than
1036 those possessed by the narcotic drug alone:
1037 (A) not more than 200 milligrams of codeine per 100 milliliters or per 100 grams;
1038 (B) not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100
1039 grams;
1040 (C) not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100
1041 grams;
1042 (D) not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of
1043 atropine sulfate per dosage unit;
1044 (E) not more than 100 milligrams of opium per 100 milliliters or per 100 grams;
1045 (F) not more than 0.5 milligram of difenoxin and not less than 25 micrograms of
1046 atropine sulfate per dosage unit;
1047 (G) unless specifically exempted or excluded or unless listed in another schedule, any
1048 material, compound, mixture, or preparation which contains Pyrovalerone having a stimulant
1049 effect on the central nervous system, including its salts, isomers, and salts of isomers; and
1050 (H) all forms of Tramadol.
1051 (ii) [
1052 marijuana, including cannabidiol, and is approved by the United States Food and Drug
1053 Administration and scheduled by the Drug Enforcement Administration in Schedule V of the
1054 federal Controlled Substances Act, Title II, P.L. 91-513.