Rhode Island 2025 Regular Session

Rhode Island House Bill H5615 Compare Versions

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99 S T A T E O F R H O D E I S L A N D
1010 IN GENERAL ASSEMBLY
1111 JANUARY SESSION, A.D. 2025
1212 ____________
1313
1414 A N A C T
1515 RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCE S ACT
1616 Introduced By: Representative Matthew S. Dawson
1717 Date Introduced: February 26, 2025
1818 Referred To: House Health & Human Services
1919 (Dept. of Health)
2020
2121 It is enacted by the General Assembly as follows:
2222 SECTION 1. Sections 21-28-1.02, 21-28-3.20 and 21-28-3.20.1 of the General Laws in 1
2323 Chapter 21-28 entitled "Uniform Controlled Substances Act" are hereby amended to read as 2
2424 follows: 3
2525 21-28-1.02. Definitions. [Effective January 1, 2023; see Sunset Provision note.] 4
2626 Unless the context otherwise requires, the words and phrases as defined in this section are 5
2727 used in this chapter in the sense given them in the following definitions: 6
2828 (1) “Acute pain” means the normal, predicted physiological response to a noxious 7
2929 chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, 8
3030 trauma, and disease. Acute pain is generally pain of less than thirty (30) days duration. 9
3131 (1)(2) “Administer” refers to the direct application of controlled substances to the body of 10
3232 a patient or research subject by: 11
3333 (i) A practitioner Practitioners, or, in his or her their presence by his or her their authorized 12
3434 agent; or 13
3535 (ii) The patient or research subject at the direction and in the presence of the practitioner 14
3636 whether the application is by injection, inhalation, ingestion, or any other means. 15
3737 (2)(3) “Agent” means an authorized person who acts on behalf of, or at the direction of, a 16
3838 manufacturer, wholesaler, distributor, or dispenser; except that these terms do not include a 17
3939 common or contract carrier or warehouse operator when acting in the usual and lawful course of 18
4040 the carrier’s or warehouse operator’s business. 19
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4444 (3)(4) “Apothecary” means a registered pharmacist as defined by the laws of this state and, 1
4545 where the context requires, the owner of a licensed pharmacy or other place of business where 2
4646 controlled substances are compounded or dispensed by a registered pharmacist; and includes 3
4747 registered assistant pharmacists as defined by existing law, but nothing in this chapter shall be 4
4848 construed as conferring on a person who is not registered as a pharmacist any authority, right, or 5
4949 privilege that is not granted to him or her by the pharmacy laws of the state. 6
5050 (4)(5) “Automated data processing system” means a system utilizing computer software 7
5151 and hardware for the purposes of record keeping. 8
5252 (6) “Chronic intractable pain” means pain that is: excruciating; constant; incurable, and of 9
5353 such severity that it dominates virtually every conscious moment; and/or produces mental and 10
5454 physical debilitation. A diagnosis and written documentation of chronic intractable pain made by a 11
5555 physician licensed in the State of Rhode Island specializing in pain management, oncology, or 12
5656 similar specialty defined in regulations shall constitute proof that the patient suffers from chronic 13
5757 intractable pain. 14
5858 (7) “Chronic pain” means pain of greater than ninety (90) days duration, excluding chronic 15
5959 intractable pain. 16
6060 (5)(8) “Computer” means programmable electronic device capable of multi-functions, 17
6161 including, but not limited to: storage, retrieval, and processing of information. 18
6262 (6)(9) “Control” means to add a drug or other substance or immediate precursor to a 19
6363 schedule under this chapter, whether by transfer from another schedule or otherwise. 20
6464 (7)(10) “Controlled substance” means a drug, substance, immediate precursor, or synthetic 21
6565 drug in schedules I — V of this chapter. The term shall not include distilled spirits, wine, or malt 22
6666 beverages, as those terms are defined or used in chapter 1 of title 3, nor tobacco. 23
6767 (8)(11) “Co-prescribing” means issuing a prescription for an opioid antagonist along with 24
6868 a prescription for an opioid analgesic. 25
6969 (9)(12) “Counterfeit substance” means a controlled substance that, or the container or 26
7070 labeling of which, without authorization bears the trademark, trade name, or other identifying mark, 27
7171 imprint, number, or device, or any likeness of them, of a manufacturer, distributor, or dispenser, 28
7272 other than the person or persons who in fact manufactured, distributed, or dispensed the substance 29
7373 and that thereby falsely purports or is represented to be the product of, or to have been distributed 30
7474 by, the other manufacturer, distributor, or dispenser, or which substance is falsely purported to be 31
7575 or represented to be one of the controlled substances by a manufacturer, distributor, or dispenser. 32
7676 (10)(13) “CRT” means cathode ray tube used to impose visual information on a screen. 33
7777 (11)(14) “Deliver” or “delivery” means the actual, constructive, or attempted transfer of a 34
7878
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8181 controlled substance or imitation controlled substance, whether or not there exists an agency 1
8282 relationship. 2
8383 (12)(15) “Department” means the department of health of this state. 3
8484 (13)(16) “Depressant or stimulant drug” means: 4
8585 (i) A drug that contains any quantity of: 5
8686 (A) Barbituric acid or derivatives, compounds, mixtures, or preparations of barbituric acid; 6
8787 and 7
8888 (B) “Barbiturate” or “barbiturates” includes all hypnotic and/or somnifacient drugs, 8
8989 whether or not derivatives of barbituric acid, except that this definition shall not include bromides 9
9090 and narcotics. 10
9191 (ii) A drug that contains any quantity of: 11
9292 (A) Amphetamine or any of its optical isomers; 12
9393 (B) Any salt of amphetamine and/or desoxyephedrine or any salt of an optical isomer of 13
9494 amphetamine and/or desoxyephedrine, or any compound, mixture, or preparation of them. 14
9595 (iii) A drug that contains any quantity of coca leaves. “Coca leaves” includes cocaine, or 15
9696 any compound, manufacture, salt, derivative, mixture, or preparation of coca leaves, except 16
9797 derivatives of coca leaves, that do not contain cocaine, ecgonine, or substance from which cocaine 17
9898 or ecgonine may be synthesized or made. 18
9999 (iv) Any other drug or substance that contains any quantity of a substance that the attorney 19
100100 general of the United States, or the director of health, after investigation, has found to have, or by 20
101101 regulation designates as having, a potential for abuse because of its depressant or stimulant effect 21
102102 on the central nervous system. 22
103103 (14)(17) “Director” means the director of health. 23
104104 (15)(18) “Dispense” means to deliver, distribute, leave with, give away, or dispose of a 24
105105 controlled substance to the ultimate user or human research subject by or pursuant to the lawful 25
106106 order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the 26
107107 substance for that delivery. 27
108108 (16)(19) “Dispenser” is a practitioner who delivers a controlled substance to the ultimate 28
109109 user or human research subject. 29
110110 (17)(20) “Distribute” means to deliver (other than by administering or dispensing) a 30
111111 controlled substance or an imitation controlled substance and includes actual constructive, or 31
112112 attempted transfer. “Distributor” means a person who so delivers a controlled substance or an 32
113113 imitation controlled substance. 33
114114 (18)(21) “Downtime” means that period of time when a computer is not operable. 34
115115
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118118 (19)(22) “Drug addicted person” means a person who exhibits a maladaptive pattern of 1
119119 behavior resulting from drug use, including one or more of the following: impaired control over 2
120120 drug use; compulsive use; and/or continued use despite harm, and craving. 3
121121 (20)(23) “Drug Enforcement Administration” means the Drug Enforcement 4
122122 Administration, United States Department of Justice or its successor. 5
123123 (21)(24) “Federal law” means the Comprehensive Drug Abuse Prevention and Control Act 6
124124 of 1970, (84 stat. 1236) (see generally 21 U.S.C. § 801 et seq.), and all regulations pertaining to 7
125125 that federal act. 8
126126 (22)(25) “Hardware” means the fixed component parts of a computer. 9
127127 (23)(26) “Hospital” means an institution as defined in chapter 17 of title 23. 10
128128 (24)(27) “Imitation controlled substance” means a substance that is not a controlled 11
129129 substance, that by dosage unit, appearance (including color, shape, size, and markings), or by 12
130130 representations made, would lead a reasonable person to believe that the substance is a controlled 13
131131 substance and, which imitation controlled substances contain substances that if ingested, could be 14
132132 injurious to the health of a person. In those cases when the appearance of the dosage unit is not 15
133133 reasonably sufficient to establish that the substance is an “imitation controlled substance” (for 16
134134 example in the case of powder or liquid), the court or authority concerned should consider, in 17
135135 addition to all other logically relevant factors, the following factors as related to “representations 18
136136 made” in determining whether the substance is an “imitation controlled substance”: 19
137137 (i) Statement made by an owner, possessor, transferor, recipient, or by anyone else in 20
138138 control of the substance concerning the nature of the substance, or its use or effect. 21
139139 (ii) Statements made by the owner, possessor, or transferor, to the recipient that the 22
140140 substance may be resold for substantial profit. 23
141141 (iii) Whether the substance is packaged in a manner reasonably similar to packaging of 24
142142 illicit controlled substances. 25
143143 (iv) Whether the distribution or attempted distribution included an exchange of or demand 26
144144 for money or other property as consideration, and whether the amount of the consideration was 27
145145 substantially greater than the reasonable value of the non-controlled substance. 28
146146 (25)(28) “Immediate precursor” means a substance: 29
147147 (i) That the director of health has found to be, and by regulation designated as being, the 30
148148 principal compound used, or produced primarily for use, in the manufacture of a controlled 31
149149 substance; 32
150150 (ii) That is an immediate chemical intermediary used or likely to be used in the manufacture 33
151151 of those controlled substances; and 34
152152
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155155 (iii) The control of which is necessary to prevent, curtail, or limit the manufacture of that 1
156156 controlled substance. 2
157157 (26)(29) “Laboratory” means a laboratory approved by the department of health as proper 3
158158 to be entrusted with controlled substances and the use of controlled substances for scientific and 4
159159 medical purposes and for the purposes of instruction. 5
160160 (27)(30) “Manufacture” means the production, preparation, propagation, cultivation, 6
161161 compounding, or processing of a drug or other substance, including an imitation controlled 7
162162 substance, either directly or indirectly or by extraction from substances of natural origin, or 8
163163 independently by means of chemical synthesis or by a combination of extraction and chemical 9
164164 synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of 10
165165 its container in conformity with the general laws of this state except by a practitioner as an incident 11
166166 to his or her administration or dispensing of the drug or substance in the course of his or her 12
167167 professional practice. 13
168168 (28)(31) “Manufacturer” means a person who manufactures but does not include an 14
169169 apothecary who compounds controlled substances to be sold or dispensed on prescriptions. 15
170170 (29)(32) “Marijuana” means all parts of the plant cannabis sativa L., whether growing or 16
171171 not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, 17
172172 manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not 18
173173 include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the 19
174174 seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of 20
175175 mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the 21
176176 plant which is incapable of germination. Marijuana shall not include “industrial hemp” or 22
177177 “industrial hemp products” which satisfy the requirements of chapter 26 of title 2, nor shall it 23
178178 include products that have been approved for marketing as a prescription medication by the U.S. 24
179179 Food and Drug Administration and legally prescribed. 25
180180 (30)(33) “Narcotic drug” means any of the following, whether produced directly or 26
181181 indirectly by extraction from substances of vegetable origin, or independently by means of 27
182182 chemical synthesis or by a combination of extraction and chemical synthesis: 28
183183 (i) Opium and opiates. 29
184184 (ii) A compound, manufacture, salt, derivative, or preparation of opium or opiates. 30
185185 (iii) A substance (and any compound, manufacture, salt, derivative, or preparation of it) 31
186186 that is chemically identical with any of the substances referred to in subsections (30)(i) and (30)(ii). 32
187187 (iv) Any other substance that the attorney general of the United States, or his or her 33
188188 successor, or the director of health, after investigation, has found to have, and by regulation 34
189189
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192192 designates as having, a potential for abuse similar to opium and opiates. 1
193193 (31)(34) “Official written order” means an order written on a form provided for that 2
194194 purpose by the Drug Enforcement Administration under any laws of the United States making 3
195195 provision for an official form, if order forms are authorized and required by federal law, and if no 4
196196 order form is provided then on an official form provided for that purpose by the director of health. 5
197197 (32) “Opiate” means any substance having an addiction-forming or addiction-sustaining 6
198198 liability similar to morphine or being capable of conversion into a drug having addiction-forming 7
199199 or addiction-sustaining liability. 8
200200 (33)(35) “Opioid analgesics” means and includes, but is not limited to, the medicines 9
201201 buprenophine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, 10
202202 methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, propoxyphene as well 11
203203 as their brand names, isomers, and combinations, or other medications approved by the department. 12
204204 (34)(36) “Opioid antagonist” means naloxone hydrochloride and any other drug approved 13
205205 by the United States Food and Drug Administration for the treatment of opioid overdose. 14
206206 (37) “Opioid therapy” means to prescribe, administer, or dispense controlled substances 15
207207 not prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner 16
208208 for a condition by any route of administration. 17
209209 (35)(38) “Opium poppy” means the plant of the species papaver somniferum L., except the 18
210210 seeds of the plant. 19
211211 (36)(39) “Ounce” means an avoirdupois ounce as applied to solids and semi-solids, and a 20
212212 fluid ounce as applied to liquids. 21
213213 (37)(40) “Person” means any corporation, association, partnership, or one or more 22
214214 individuals. 23
215215 (38)(41) “Physical dependence” means a state of adaptation that is manifested by a drug 24
216216 class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, 25
217217 decreasing blood level of the drug, and/or administration of an antagonist. 26
218218 (39)(42) “Poppy straw” means all parts, except the seeds, of the opium poppy, after 27
219219 mowing. 28
220220 (40)(43) “Practitioner” means: 29
221221 (i) A physician, osteopath, dentist, chiropodist, veterinarian, scientific investigator, or other 30
222222 person licensed, registered, or permitted to distribute, dispense, conduct research with respect to or 31
223223 to administer a controlled substance in the course of professional practice or research in this state. 32
224224 (ii) A pharmacy, hospital, or other institution licensed, registered or permitted to distribute, 33
225225 dispense, conduct research with respect to, or to administer a controlled substance in the course of 34
226226
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229229 professional practice or research in this state. 1
230230 (41)(44) “Printout” means a hard copy produced by computer that is readable without the 2
231231 aid of any special device. 3
232232 (42)(45) “Production” includes the manufacture, planting, cultivation, growing, or 4
233233 harvesting of a controlled substance. 5
234234 (43)(46) “Researcher” means a person authorized by the director of health to conduct a 6
235235 laboratory as defined in this chapter. 7
236236 (44)(47) “Sell” includes sale, barter, gift, transfer, or delivery in any manner to another, or 8
237237 to offer or agree to do the same. 9
238238 (45)(48) “Software” means programs, procedures, and storage of required information 10
239239 data. 11
240240 (46)(49) “Synthetic drugs” means any synthetic cannabinoids or piperazines or any 12
241241 synthetic cathinones as provided for in schedule I. 13
242242 (50) “Therapeutic purpose” means the use of controlled substances for the treatment of 14
243243 pain in appropriate doses as indicated by the patient’s medical record. Any other use is 15
244244 nontherapeutic. 16
245245 (47)(51) “Ultimate user” means a person who lawfully possesses a controlled substance for 17
246246 his or her own use or for the use of a member of his or her household, or for administering to an 18
247247 animal owned by him or her or by a member of his or her household. 19
248248 (48)(52) “Wholesaler” means a person who sells, vends, or distributes at wholesale, or as 20
249249 a jobber, broker agent, or distributor, or for resale in any manner in this state any controlled 21
250250 substance. 22
251251 21-28-3.20. Authority of practitioner to prescribe, administer, and dispense. 23
252252 (a)(1) A practitioner Practitioners, in good faith and in the course of his or her their 24
253253 professional practice only, may prescribe, administer, and dispense controlled substances, or he or 25
254254 she may cause the controlled substances to be administered by a nurse or intern under his or her 26
255255 their direction and supervision after completing an assessment of pain experienced by a patient. 27
256256 (2) Opioid therapy must only be initiated for acute pain unresponsive to non-opioid 28
257257 therapies or if, based on clinical assessment, benefits of opioid therapy for acute pain management 29
258258 outweigh risks. 30
259259 (2)(3) When issuing an initial a prescription for an opiate opioid to an adult patient, a 31
260260 practitioner shall not exceed the maximum daily dose requirements established by the department 32
261261 of health must prescribe the lowest effective dosage of an immediate-release opioid in a quantity 33
262262 sufficient to treat the expected duration of pain. 34
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266266 (3) Except as provided in subsection (a)(4) of this section, a practitioner shall not issue an 1
267267 opiate prescription to a minor for more than twenty (20) doses at any time. Prior to issuing an opiate 2
268268 prescription to a minor, a practitioner shall discuss with the parent or guardian of the minor the 3
269269 risks associated with opiate use and the reasons why the prescription is necessary. The practitioner 4
270270 shall document his or her discussion with the parent or guardian in the medical record. 5
271271 (4) Notwithstanding the limitations referenced in subsection (a)(3) of this section, if, in the 6
272272 professional medical judgment of a practitioner, a greater dosage or supply of an opiate is required 7
273273 to treat the minor patient’s acute medical condition or is necessary for the treatment of chronic pain 8
274274 management, sickle cell related pain, intractable pain treatment as defined in chapter 37.4 of title 9
275275 5, pain associated with a cancer diagnosis, or for palliative care, then the practitioner may issue a 10
276276 prescription for the quantity needed to treat the acute medical condition, chronic pain, sickle cell 11
277277 related pain, intractable pain, pain associated with a cancer diagnosis, or pain experienced while 12
278278 the patient is in palliative care, provided that this dosage shall not exceed the maximum daily 13
279279 dosage permitted for the treatment of this pain as set forth in the department of health regulations. 14
280280 The medical condition triggering the prescription of an opiate shall opioid must be documented in 15
281281 the minor patient’s medical record, and the practitioner shall must indicate that a non-opiate non-16
282282 opioid alternative was not appropriate to address the medical condition. 17
283283 (5) Notwithstanding subsections (a)(2) and (a)(3) of this section, this section shall not apply 18
284284 to medications designed for the treatment of substance abuse or opioid dependence. 19
285285 (b) The prescription-monitoring drug monitoring program shall must be reviewed prior to 20
286286 starting any opioid. A prescribing practitioner, or designee as authorized by § 21-28-3.32(a)(3), 21
287287 shall must review the patient’s prescribed controlled substance use in the prescription-monitoring 22
288288 drug monitoring program prior to refilling or initiating opioid therapy with an intrathecal pump. 23
289289 For patients the prescribing practitioner is maintaining being maintained on continuous opioid 24
290290 therapy for pain for three (3) months or longer, the prescribing practitioner shall must review 25
291291 information from the prescription-monitoring drug monitoring program at least every three (3) 26
292292 months. Documentation of that review shall must be noted in the patient’s medical record. 27
293293 (c) The director of health shall develop regulations for prescribing practitioners on 28
294294 appropriate limits of opioid use in acute pain management. Initial prescriptions of opioids for acute 29
295295 pain management of outpatient adults shall not exceed thirty (30) morphine milligram equivalents 30
296296 (MMEs) total daily dose per day for a maximum total of twenty (20) doses, and, for pediatric 31
297297 patients, the appropriate opioid dosage maximum per the department of health. 32
298298 (d)(c) For the purposes of this section, acute pain management shall must not include 33
299299 management or treatment for chronic intractable pain management, pain associated with a cancer 34
300300
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303303 diagnosis, pain related to sickle cell disease, palliative or nursing home end-of-life care, intractable 1
304304 or chronic intractable pain, as provided in § 5-37.4-2, or other exception exceptions in accordance 2
305305 with department of health regulations. 3
306306 (e) Subsection (c) shall not apply to medications designed for the treatment of substance 4
307307 abuse or opioid dependence. 5
308308 (f) On or before September 1, 2018, the director of health shall develop, and make available 6
309309 to healthcare practitioners, information on best practices for co-prescribing opioid antagonists to 7
310310 patients. The best practices information shall identify situations in which co-prescribing an opioid 8
311311 antagonist may be appropriate, including, but not limited to: 9
312312 (1) In conjunction with a prescription for an opioid medication, under circumstances in 10
313313 which the healthcare practitioner determines the patient is at an elevated risk for an opioid drug 11
314314 overdose; 12
315315 (2) In conjunction with medications prescribed pursuant to a course of medication therapy 13
316316 management for the treatment of a substance use disorder involving opioids; or 14
317317 (3) Under any other circumstances in which a healthcare practitioner identifies a patient as 15
318318 being at an elevated risk for an opioid drug overdose. 16
319319 (g) The best practices information developed pursuant to subsection (f) of this section shall 17
320320 include guidelines for determining when a patient is at an elevated risk for an opioid drug overdose, 18
321321 including, but not limited to, situations in which the patient: 19
322322 (1) Meets the criteria provided in the opioid overdose toolkit published by the federal 20
323323 substance abuse and mental health service administration; 21
324324 (2) Is receiving high-dose, extended-release, or long-acting opioid medications; 22
325325 (3) Has a documented history of an alcohol or substance use disorder, or a mental health 23
326326 disorder; 24
327327 (4) Has a respiratory ailment or other co-morbidity that may be exacerbated by the use of 25
328328 opioid medications; 26
329329 (5) Has a known history of intravenous drug use or misuse of prescription opioids; 27
330330 (6) Has received emergency medical care or been hospitalized for an opioid overdose; or 28
331331 (7) Uses opioids with antidepressants, benzodiazepines, alcohol, or other drugs. 29
332332 (h) On or before September 1, 2018, the director of health and the secretary of the executive 30
333333 office of health and human services shall develop strategies that include: 31
334334 (1) Allowing practitioners in non-pharmacy settings to prescribe and dispense opioid 32
335335 antagonists; and 33
336336 (2) Ensuring that opioid antagonists that are distributed in a non-pharmacy setting are 34
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340340 eligible for reimbursement from any health insurance carrier, as defined under chapters 18, 19, 20, 1
341341 and 41 of title 27, and the Rhode Island medical assistance program, as defined under chapter 7.2 2
342342 of title 42. 3
343343 (d) The director of health may promulgate regulations for practitioners on opioid use in 4
344344 pain management. 5
345345 21-28-3.20.1. Authority of practitioner to prescribe, administer, and dispense — 6
346346 Cancer, palliative care, and chronic intractable pain. 7
347347 (a) A practitioner, in good faith and in the course of his or her professional practice 8
348348 managing pain associated with a cancer diagnosis, palliative or nursing home care, intractable or 9
349349 chronic intractable pain as provided in § 5-37.4-2, or other condition allowed by department of 10
350350 health regulations pursuant to the exception in § 21-28-3.20(d), may prescribe, administer, and 11
351351 dispense controlled substances without regard to the CDC Clinical Practice Guideline for 12
352352 Prescribing Opioids for Pain—United States, 2022. 13
353353 (b) The director of health may promulgate those rules and regulations necessary to 14
354354 effectuate the provisions of this section and ensure that rules governing pain management 15
355355 associated with a cancer diagnosis, palliative or nursing home care, intractable or chronic 16
356356 intractable pain as provided in § 5-37.4-2, or other condition allowed by department of health 17
357357 regulations pursuant to the exception created in § 21-28-3.20(d), shall: 18
358358 (1) Take into consideration the individualized needs of patients covered by this section; 19
359359 and 20
360360 (2) Make provisions for practitioners, acting in good faith, and in the course of their 21
361361 profession, and managing pain associated with their patients’ illness to use their best judgment 22
362362 notwithstanding any statute, rule, or regulation to the contrary. may prescribe, administer, or 23
363363 dispense controlled substances not prohibited by law for a therapeutic purpose to a person 24
364364 diagnosed and treated by a practitioner for a condition resulting in chronic intractable pain, if this 25
365365 diagnosis and treatment has been documented in the practitioner’s medical records. 26
366366 (b) Concern about a patient’s substance use disorder or the possibility of a substance use 27
367367 disorder in and of itself is not a reason to withhold or prohibit prescribing, administering, or 28
368368 dispensing controlled substances for the therapeutic purpose of treatment of a person for chronic 29
369369 intractable pain. Provided, however, practitioners must check the patient’s prescribed controlled 30
370370 substances use in the prescription drug monitoring program, refer the patient to a substance use 31
371371 disorder specialist, as appropriate, and enter into a written patient treatment agreement in 32
372372 accordance with regulations promulgated by the department. 33
373373 (c) The provisions of subsection (a) of this section provide no authority to a practitioner to 34
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377377 prescribe, administer, or dispense controlled substances to a person the practitioner knows or should 1
378378 know to be using the prescribed, administered, or dispensed controlled substance 2
379379 nontherapeutically. 3
380380 (d) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from 4
381381 denying a prescription based on their best clinical judgment. 5
382382 (e) Nothing in this section shall deny the right of the director to deny, revoke, or suspend 6
383383 the license of any practitioner or discipline any practitioner who: 7
384384 (1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in 8
385385 nature or nontherapeutic in the manner in which it is prescribed, administered, or dispensed, or fails 9
386386 to keep complete and accurate ongoing records of the diagnosis and treatment plan; 10
387387 (2) Fails to keep complete and accurate records of controlled substances received, 11
388388 prescribed, dispensed, and administered, and disposal of drugs as required by law or of controlled 12
389389 substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 13
390390 U.S.C. § 801 et seq. A practitioner shall keep records of controlled substances received, prescribed, 14
391391 dispensed and administered, and disposal of these drugs shall include the date of receipt of the 15
392392 drugs, the sale or disposal of the drugs by the practitioner, the name and address of the person 16
393393 receiving the drugs, and the reason for the disposal or the dispensing of the drugs to the person; 17
394394 (3) Writes false or fictitious prescriptions for controlled substances as prohibited by law, 18
395395 or for controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control 19
396396 Act of 1970, 21 U.S.C. § 801 et seq.; or 20
397397 (4) Prescribes, administers, or dispenses in a manner that is inconsistent with provisions of 21
398398 the law, or the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. § 801 22
399399 et seq., any controlled substance. 23
400400 (f) The director of health may promulgate those rules and regulations necessary to 24
401401 effectuate the provisions of this section. 25
402402 SECTION 2. Chapter 5-37.4 of the General Laws entitled "Intractable Pain Treatment" is 26
403403 hereby repealed in its entirety. 27
404404 CHAPTER 5-37.4 28
405405 Intractable Pain Treatment 29
406406 5-37.4-1. Title. 30
407407 This chapter shall be known and may be cited as the “Intractable Pain Treatment Act.” 31
408408 5-37.4-2. Definitions. 32
409409 For purposes of this chapter: 33
410410 (1) “Chronic intractable pain” means pain that is: excruciating; constant; incurable, and of 34
411411
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414414 such severity that it dominates virtually every conscious moment; and/or produces mental and 1
415415 physical debilitation. A diagnosis and written documentation of chronic intractable pain made by a 2
416416 physician licensed in the state of Rhode Island specializing in pain management, oncology, or 3
417417 similar specialty defined in regulations shall constitute proof that the patient suffers from chronic 4
418418 intractable pain. 5
419419 (2) “Director” means the director of the department of health of the state of Rhode Island. 6
420420 (3) “Intractable pain” means a pain state that persists beyond the usual course of an acute 7
421421 disease or healing of an injury or results from a chronic disease or condition that causes continuous 8
422422 or intermittent pain over a period of months or years. Unless the context clearly indicates otherwise, 9
423423 the term intractable pain includes chronic intractable pain. 10
424424 (4) “Practitioner” means healthcare professionals licensed to distribute, dispense, or 11
425425 administer controlled substances in the course of professional practice as defined in § 21-28-12
426426 1.02(41). 13
427427 (5) “Therapeutic purpose” means the use of controlled substances for the treatment of pain 14
428428 in appropriate doses as indicated by the patient’s medical record. Any other use is nontherapeutic. 15
429429 5-37.4-3. Controlled substances. 16
430430 (a) A practitioner may prescribe, administer, or dispense controlled substances not 17
431431 prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner for 18
432432 a condition resulting in intractable pain, if this diagnosis and treatment has been documented in the 19
433433 practitioner’s medical records. No practitioner shall be subject to disciplinary action by the board 20
434434 solely for prescribing, administering, or dispensing controlled substances when prescribed, 21
435435 administered, or dispensed for a therapeutic purpose for a person diagnosed and treated by a 22
436436 practitioner for a condition resulting in intractable pain, if this diagnosis and treatment has been 23
437437 documented in the practitioner’s medical records. 24
438438 (b) The provisions of subsection (a) of this section do not apply to those persons being 25
439439 treated by a practitioner for chemical dependency because of their use of controlled substances not 26
440440 related to the therapeutic purposes of treatment of intractable pain. 27
441441 (c) The provisions of subsection (a) of this section provide no authority to a practitioner to 28
442442 prescribe, administer, or dispense controlled substances to a person the practitioner knows or should 29
443443 know to be using the prescribed, administered, or dispensed controlled substance 30
444444 nontherapeutically. 31
445445 (d) Drug dependency or the possibility of drug dependency in and of itself is not a reason 32
446446 to withhold or prohibit prescribing, administering, or dispensing controlled substances for the 33
447447 therapeutic purpose of treatment of a person for intractable pain, nor shall dependency relating 34
448448
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451451 solely to this prescribing, administering, or dispensing subject a practitioner to disciplinary action 1
452452 by the director. 2
453453 (e) In coordination with §§ 21-28-3.20 and 21-28-3.20.1, the director of health may 3
454454 promulgate rules and regulations necessary to effectuate the purpose of this chapter and ensure that 4
455455 patients with intractable or chronic intractable pain are treated or referred to an appropriate 5
456456 specialist. 6
457457 (f) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from 7
458458 denying a prescription based on their best clinical judgment. 8
459459 (g) Nothing in this section shall deny the right of the director to deny, revoke, or suspend 9
460460 the license of any practitioner or discipline any practitioner who: 10
461461 (1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in 11
462462 nature or nontherapeutic in the manner in which it is prescribed, administered, or dispensed, or fails 12
463463 to keep complete and accurate ongoing records of the diagnosis and treatment plan; 13
464464 (2) Fails to keep complete and accurate records of controlled substances received, 14
465465 prescribed, dispensed, and administered, and disposal of drugs as required by law or of controlled 15
466466 substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 16
467467 U.S.C. § 801 et seq. A practitioner shall keep records of controlled substances received, prescribed, 17
468468 dispensed and administered, and disposal of these drugs shall include the date of receipt of the 18
469469 drugs, the sale or disposal of the drugs by the practitioner, the name and address of the person 19
470470 receiving the drugs, and the reason for the disposal or the dispensing of the drugs to the person; 20
471471 (3) Writes false or fictitious prescriptions for controlled substances as prohibited by law, 21
472472 or for controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control 22
473473 Act of 1970, 21 U.S.C § 801 et seq.; or 23
474474 (4) Prescribes, administers, or dispenses in a manner which is inconsistent with provisions 24
475475 of the law, or the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. § 25
476476 801 et seq., any controlled substance. 26
477477 (h) A practitioner may administer a controlled substance prescribed by a practitioner and 27
478478 not prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner 28
479479 for a condition resulting in intractable pain, if this diagnosis and treatment has been documented in 29
480480 the practitioner’s medical records. No practitioner shall be subject to disciplinary action by the 30
481481 director solely for administering controlled substances when prescribed or dispensed for a 31
482482 therapeutic purpose for a person diagnosed and treated by a practitioner for a condition resulting in 32
483483 intractable pain, if this diagnosis and treatment has been documented in the practitioner’s medical 33
484484 records of the patient. 34
485485
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488488 SECTION 3. Section 21-28-1.02 of the General Laws in Chapter 21-28 entitled "Uniform 1
489489 Controlled Substances Act" is hereby repealed. 2
490490 21-28-1.02. Definitions. [Effective until January 1, 2023; see Sunset Provision note.] 3
491491 Unless the context otherwise requires, the words and phrases as defined in this section are 4
492492 used in this chapter in the sense given them in the following definitions: 5
493493 (1) “Administer” refers to the direct application of controlled substances to the body of a 6
494494 patient or research subject by: 7
495495 (i) A practitioner, or, in his or her presence by his or her authorized agent; or 8
496496 (ii) The patient or research subject at the direction and in the presence of the practitioner 9
497497 whether the application is by injection, inhalation, ingestion, or any other means. 10
498498 (2) “Agent” means an authorized person who acts on behalf of, or at the direction of, a 11
499499 manufacturer, wholesaler, distributor, or dispenser; except that these terms do not include a 12
500500 common or contract carrier or warehouse operator when acting in the usual and lawful course of 13
501501 the carrier’s or warehouse operator’s business. 14
502502 (3) “Apothecary” means a registered pharmacist as defined by the laws of this state and, 15
503503 where the context requires, the owner of a licensed pharmacy or other place of business where 16
504504 controlled substances are compounded or dispensed by a registered pharmacist; and includes 17
505505 registered assistant pharmacists as defined by existing law, but nothing in this chapter shall be 18
506506 construed as conferring on a person who is not registered as a pharmacist any authority, right, or 19
507507 privilege that is not granted to him or her by the pharmacy laws of the state. 20
508508 (4) “Automated data processing system” means a system utilizing computer software and 21
509509 hardware for the purposes of record keeping. 22
510510 (5) “Certified law enforcement prescription drug diversion investigator” means a certified 23
511511 law enforcement officer assigned by his or her qualified law enforcement agency to investigate 24
512512 prescription drug diversion. 25
513513 (6) “Computer” means programmable electronic device capable of multi-functions, 26
514514 including, but not limited to: storage, retrieval, and processing of information. 27
515515 (7) “Control” means to add a drug or other substance or immediate precursor to a schedule 28
516516 under this chapter, whether by transfer from another schedule or otherwise. 29
517517 (8) “Controlled substance” means a drug, substance, immediate precursor, or synthetic 30
518518 drug in schedules I — V of this chapter. The term shall not include distilled spirits, wine, or malt 31
519519 beverages, as those terms are defined or used in chapter 1 of title 3, nor tobacco. 32
520520 (9) “Co-prescribing” means issuing a prescription for an opioid antagonist along with a 33
521521 prescription for an opioid analgesic. 34
522522
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525525 (10) “Counterfeit substance” means a controlled substance that, or the container or labeling 1
526526 of which, without authorization bears the trademark, trade name, or other identifying mark, imprint, 2
527527 number, or device, or any likeness of them, of a manufacturer, distributor, or dispenser, other than 3
528528 the person or persons who in fact manufactured, distributed, or dispensed the substance and that 4
529529 thereby falsely purports or is represented to be the product of, or to have been distributed by, the 5
530530 other manufacturer, distributor, or dispenser, or which substance is falsely purported to be or 6
531531 represented to be one of the controlled substances by a manufacturer, distributor, or dispenser. 7
532532 (11) “CRT” means cathode ray tube used to impose visual information on a screen. 8
533533 (12) “Deliver” or “delivery” means the actual, constructive, or attempted transfer of a 9
534534 controlled substance or imitation controlled substance, whether or not there exists an agency 10
535535 relationship. 11
536536 (13) “Department” means the department of health of this state. 12
537537 (14) “Depressant or stimulant drug” means: 13
538538 (i) A drug that contains any quantity of: 14
539539 (A) Barbituric acid or derivatives, compounds, mixtures, or preparations of barbituric acid; 15
540540 and 16
541541 (B) “Barbiturate” or “barbiturates” includes all hypnotic and/or somnifacient drugs, 17
542542 whether or not derivatives of barbituric acid, except that this definition shall not include bromides 18
543543 and narcotics. 19
544544 (ii) A drug that contains any quantity of: 20
545545 (A) Amphetamine or any of its optical isomers; 21
546546 (B) Any salt of amphetamine and/or desoxyephedrine or any salt of an optical isomer of 22
547547 amphetamine and/or desoxyephedrine, or any compound, mixture, or preparation of them. 23
548548 (iii) A drug that contains any quantity of coca leaves. “Coca leaves” includes cocaine, or 24
549549 any compound, manufacture, salt, derivative, mixture, or preparation of coca leaves, except 25
550550 derivatives of coca leaves, that do not contain cocaine, ecgonine, or substance from which cocaine 26
551551 or ecgonine may be synthesized or made. 27
552552 (iv) Any other drug or substance that contains any quantity of a substance that the attorney 28
553553 general of the United States, or the director of health, after investigation, has found to have, or by 29
554554 regulation designates as having, a potential for abuse because of its depressant or stimulant effect 30
555555 on the central nervous system. 31
556556 (15) “Director” means the director of health. 32
557557 (16) “Dispense” means to deliver, distribute, leave with, give away, or dispose of a 33
558558 controlled substance to the ultimate user or human research subject by or pursuant to the lawful 34
559559
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562562 order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the 1
563563 substance for that delivery. 2
564564 (17) “Dispenser” is a practitioner who delivers a controlled substance to the ultimate user 3
565565 or human research subject. 4
566566 (18) “Distribute” means to deliver (other than by administering or dispensing) a controlled 5
567567 substance or an imitation controlled substance and includes actual constructive, or attempted 6
568568 transfer. “Distributor” means a person who so delivers a controlled substance or an imitation 7
569569 controlled substance. 8
570570 (19) “Downtime” means that period of time when a computer is not operable. 9
571571 (20) “Drug addicted person” means a person who exhibits a maladaptive pattern of 10
572572 behavior resulting from drug use, including one or more of the following: impaired control over 11
573573 drug use; compulsive use; and/or continued use despite harm, and craving. 12
574574 (21) “Drug Enforcement Administration” means the Drug Enforcement Administration, 13
575575 United States Department of Justice or its successor. 14
576576 (22) “Federal law” means the Comprehensive Drug Abuse Prevention and Control Act of 15
577577 1970, (84 stat. 1236) (see generally 21 U.S.C. § 801 et seq.), and all regulations pertaining to that 16
578578 federal act. 17
579579 (23) “Hardware” means the fixed component parts of a computer. 18
580580 (24) “Hospital” means an institution as defined in chapter 17 of title 23. 19
581581 (25) “Imitation controlled substance” means a substance that is not a controlled substance, 20
582582 that by dosage unit, appearance (including color, shape, size, and markings), or by representations 21
583583 made, would lead a reasonable person to believe that the substance is a controlled substance and, 22
584584 which imitation controlled substances contain substances that if ingested, could be injurious to the 23
585585 health of a person. In those cases when the appearance of the dosage unit is not reasonably sufficient 24
586586 to establish that the substance is an “imitation controlled substance” (for example in the case of 25
587587 powder or liquid), the court or authority concerned should consider, in addition to all other logically 26
588588 relevant factors, the following factors as related to “representations made” in determining whether 27
589589 the substance is an “imitation controlled substance”: 28
590590 (i) Statement made by an owner, possessor, transferor, recipient, or by anyone else in 29
591591 control of the substance concerning the nature of the substance, or its use or effect. 30
592592 (ii) Statements made by the owner, possessor, or transferor, to the recipient that the 31
593593 substance may be resold for substantial profit. 32
594594 (iii) Whether the substance is packaged in a manner reasonably similar to packaging of 33
595595 illicit controlled substances. 34
596596
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599599 (iv) Whether the distribution or attempted distribution included an exchange of or demand 1
600600 for money or other property as consideration, and whether the amount of the consideration was 2
601601 substantially greater than the reasonable value of the non-controlled substance. 3
602602 (26) “Immediate precursor” means a substance: 4
603603 (i) That the director of health has found to be, and by regulation designated as being, the 5
604604 principal compound used, or produced primarily for use, in the manufacture of a controlled 6
605605 substance; 7
606606 (ii) That is an immediate chemical intermediary used, or likely to be used, in the 8
607607 manufacture of those controlled substances; and 9
608608 (iii) The control of which is necessary to prevent, curtail, or limit the manufacture of that 10
609609 controlled substance. 11
610610 (27) “Laboratory” means a laboratory approved by the department of health as proper to 12
611611 be entrusted with controlled substances and the use of controlled substances for scientific and 13
612612 medical purposes and for the purposes of instruction. 14
613613 (28) “Manufacture” means the production, preparation, propagation, cultivation, 15
614614 compounding, or processing of a drug or other substance, including an imitation controlled 16
615615 substance, either directly or indirectly or by extraction from substances of natural origin, or 17
616616 independently by means of chemical synthesis or by a combination of extraction and chemical 18
617617 synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of 19
618618 its container in conformity with the general laws of this state except by a practitioner as an incident 20
619619 to his or her administration or dispensing of the drug or substance in the course of his or her 21
620620 professional practice. 22
621621 (29) “Manufacturer” means a person who manufactures but does not include an apothecary 23
622622 who compounds controlled substances to be sold or dispensed on prescriptions. 24
623623 (30) “Marijuana” means all parts of the plant cannabis sativa L., whether growing or not; 25
624624 the seeds of the plant; the resin extracted from any part of the plant; and every compound, 26
625625 manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not 27
626626 include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the 28
627627 seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of 29
628628 mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the 30
629629 plant which is incapable of germination. Marijuana shall not include “industrial hemp” or 31
630630 “industrial hemp products” which satisfy the requirements of chapter 26 of title 2, nor shall it 32
631631 include products that have been approved for marketing as a prescription medication by the U.S. 33
632632 Food and Drug Administration and legally prescribed. 34
633633
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636636 (31) “Narcotic drug” means any of the following, whether produced directly or indirectly 1
637637 by extraction from substances of vegetable origin, or independently by means of chemical synthesis 2
638638 or by a combination of extraction and chemical synthesis: 3
639639 (i) Opium and opiates. 4
640640 (ii) A compound, manufacture, salt, derivative, or preparation of opium or opiates. 5
641641 (iii) A substance (and any compound, manufacture, salt, derivative, or preparation of it) 6
642642 that is chemically identical with any of the substances referred to in subsections 31(i) and (31)(ii). 7
643643 (iv) Any other substance that the attorney general of the United States, or his or her 8
644644 successor, or the director of health, after investigation, has found to have, and by regulation 9
645645 designates as having, a potential for abuse similar to opium and opiates. 10
646646 (32) “Official written order” means an order written on a form provided for that purpose 11
647647 by the Drug Enforcement Administration under any laws of the United States making provision for 12
648648 an official form, if order forms are authorized and required by federal law, and if no order form is 13
649649 provided, then on an official form provided for that purpose by the director of health. 14
650650 (33) “Opiate” means any substance having an addiction-forming or addiction-sustaining 15
651651 liability similar to morphine or being capable of conversion into a drug having addiction-forming 16
652652 or addiction-sustaining liability. 17
653653 (34) “Opioid analgesics” means and includes, but is not limited to, the medicines 18
654654 buprenophine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, 19
655655 methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, propoxyphene as well 20
656656 as their brand names, isomers, and combinations, or other medications approved by the department. 21
657657 (35) “Opioid antagonist” means naloxone hydrochloride and any other drug approved by 22
658658 the United States Food and Drug Administration for the treatment of opioid overdose. 23
659659 (36) “Opium poppy” means the plant of the species papaver somniferum L., except the 24
660660 seeds of the plant. 25
661661 (37) “Ounce” means an avoirdupois ounce as applied to solids and semi-solids, and a fluid 26
662662 ounce as applied to liquids. 27
663663 (38) “Person” means any corporation, association, partnership, or one or more individuals. 28
664664 (39) “Physical dependence” means a state of adaptation that is manifested by a drug class 29
665665 specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, 30
666666 decreasing blood level of the drug, and/or administration of an antagonist. 31
667667 (40) “Poppy straw” means all parts, except the seeds, of the opium poppy, after mowing. 32
668668 (41) “Practitioner” means: 33
669669 (i) A physician, osteopath, dentist, chiropodist, veterinarian, scientific investigator, or other 34
670670
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673673 person licensed, registered, or permitted to distribute, dispense, conduct research with respect to or 1
674674 to administer a controlled substance in the course of professional practice or research in this state. 2
675675 (ii) A pharmacy, hospital, or other institution licensed, registered, or permitted to distribute, 3
676676 dispense, conduct research with respect to, or to administer a controlled substance in the course of 4
677677 professional practice or research in this state. 5
678678 (42) “Printout” means a hard copy produced by computer that is readable without the aid 6
679679 of any special device. 7
680680 (43) “Production” includes the manufacture, planting, cultivation, growing, or harvesting 8
681681 of a controlled substance. 9
682682 (44) “Qualified law enforcement agency” means the U.S. Food and Drug Administration, 10
683683 Drug Enforcement Administration, Federal Bureau of Investigation, Office of Inspector General of 11
684684 the U.S. Department of Health & Human Services, or the Medicaid Fraud and Patient Abuse Unit 12
685685 in the Office of the Attorney General. 13
686686 (45) “Researcher” means a person authorized by the director of health to conduct a 14
687687 laboratory as defined in this chapter. 15
688688 (46) “Sell” includes sale, barter, gift, transfer, or delivery in any manner to another, or to 16
689689 offer or agree to do the same. 17
690690 (47) “Software” means programs, procedures, and storage of required information data. 18
691691 (48) “Synthetic drugs” means any synthetic cannabinoids or piperazines or any synthetic 19
692692 cathinones as provided for in schedule I. 20
693693 (49) “Ultimate user” means a person who lawfully possesses a controlled substance for his 21
694694 or her own use or for the use of a member of his or her household, or for administering to an animal 22
695695 owned by him or her or by a member of his or her household. 23
696696 (50) “Wholesaler” means a person who sells, vends, or distributes at wholesale, or as a 24
697697 jobber, broker agent, or distributor, or for resale in any manner in this state any controlled 25
698698 substance. 26
699699 SECTION 4. This act shall take effect upon passage. 27
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706706 EXPLANATION
707707 BY THE LEGISLATIVE COUNCIL
708708 OF
709709 A N A C T
710710 RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT
711711 ***
712712 This act would revise sections of the uniform controlled substances act to remove specific 1
713713 opioid dosage requirements and revise the uniform controlled substances act in accordance with 2
714714 current standards of professional practice and would repeal chapter 37.4 of title 5 relating to 3
715715 intractable pain treatment. 4
716716 This act would take effect upon passage. 5
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