2025 -- H 5615
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LC001419
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S T A T E O F R H O D E I S L A N D
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2025
____________
A N A C T
RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCE S ACT
Introduced By: Representative Matthew S. Dawson
Date Introduced: February 26, 2025
Referred To: House Health & Human Services
(Dept. of Health)
It is enacted by the General Assembly as follows:
SECTION 1. Sections 21-28-1.02, 21-28-3.20 and 21-28-3.20.1 of the General Laws in 1
Chapter 21-28 entitled "Uniform Controlled Substances Act" are hereby amended to read as 2
follows: 3
21-28-1.02. Definitions. [Effective January 1, 2023; see Sunset Provision note.] 4
Unless the context otherwise requires, the words and phrases as defined in this section are 5
used in this chapter in the sense given them in the following definitions: 6
(1) “Acute pain” means the normal, predicted physiological response to a noxious 7
chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, 8
trauma, and disease. Acute pain is generally pain of less than thirty (30) days duration. 9
(1)(2) “Administer” refers to the direct application of controlled substances to the body of 10
a patient or research subject by: 11
(i) A practitioner Practitioners, or, in his or her their presence by his or her their authorized 12
agent; or 13
(ii) The patient or research subject at the direction and in the presence of the practitioner 14
whether the application is by injection, inhalation, ingestion, or any other means. 15
(2)(3) “Agent” means an authorized person who acts on behalf of, or at the direction of, a 16
manufacturer, wholesaler, distributor, or dispenser; except that these terms do not include a 17
common or contract carrier or warehouse operator when acting in the usual and lawful course of 18
the carrier’s or warehouse operator’s business. 19
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(3)(4) “Apothecary” means a registered pharmacist as defined by the laws of this state and, 1
where the context requires, the owner of a licensed pharmacy or other place of business where 2
controlled substances are compounded or dispensed by a registered pharmacist; and includes 3
registered assistant pharmacists as defined by existing law, but nothing in this chapter shall be 4
construed as conferring on a person who is not registered as a pharmacist any authority, right, or 5
privilege that is not granted to him or her by the pharmacy laws of the state. 6
(4)(5) “Automated data processing system” means a system utilizing computer software 7
and hardware for the purposes of record keeping. 8
(6) “Chronic intractable pain” means pain that is: excruciating; constant; incurable, and of 9
such severity that it dominates virtually every conscious moment; and/or produces mental and 10
physical debilitation. A diagnosis and written documentation of chronic intractable pain made by a 11
physician licensed in the State of Rhode Island specializing in pain management, oncology, or 12
similar specialty defined in regulations shall constitute proof that the patient suffers from chronic 13
intractable pain. 14
(7) “Chronic pain” means pain of greater than ninety (90) days duration, excluding chronic 15
intractable pain. 16
(5)(8) “Computer” means programmable electronic device capable of multi-functions, 17
including, but not limited to: storage, retrieval, and processing of information. 18
(6)(9) “Control” means to add a drug or other substance or immediate precursor to a 19
schedule under this chapter, whether by transfer from another schedule or otherwise. 20
(7)(10) “Controlled substance” means a drug, substance, immediate precursor, or synthetic 21
drug in schedules I — V of this chapter. The term shall not include distilled spirits, wine, or malt 22
beverages, as those terms are defined or used in chapter 1 of title 3, nor tobacco. 23
(8)(11) “Co-prescribing” means issuing a prescription for an opioid antagonist along with 24
a prescription for an opioid analgesic. 25
(9)(12) “Counterfeit substance” means a controlled substance that, or the container or 26
labeling of which, without authorization bears the trademark, trade name, or other identifying mark, 27
imprint, number, or device, or any likeness of them, of a manufacturer, distributor, or dispenser, 28
other than the person or persons who in fact manufactured, distributed, or dispensed the substance 29
and that thereby falsely purports or is represented to be the product of, or to have been distributed 30
by, the other manufacturer, distributor, or dispenser, or which substance is falsely purported to be 31
or represented to be one of the controlled substances by a manufacturer, distributor, or dispenser. 32
(10)(13) “CRT” means cathode ray tube used to impose visual information on a screen. 33
(11)(14) “Deliver” or “delivery” means the actual, constructive, or attempted transfer of a 34
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controlled substance or imitation controlled substance, whether or not there exists an agency 1
relationship. 2
(12)(15) “Department” means the department of health of this state. 3
(13)(16) “Depressant or stimulant drug” means: 4
(i) A drug that contains any quantity of: 5
(A) Barbituric acid or derivatives, compounds, mixtures, or preparations of barbituric acid; 6
and 7
(B) “Barbiturate” or “barbiturates” includes all hypnotic and/or somnifacient drugs, 8
whether or not derivatives of barbituric acid, except that this definition shall not include bromides 9
and narcotics. 10
(ii) A drug that contains any quantity of: 11
(A) Amphetamine or any of its optical isomers; 12
(B) Any salt of amphetamine and/or desoxyephedrine or any salt of an optical isomer of 13
amphetamine and/or desoxyephedrine, or any compound, mixture, or preparation of them. 14
(iii) A drug that contains any quantity of coca leaves. “Coca leaves” includes cocaine, or 15
any compound, manufacture, salt, derivative, mixture, or preparation of coca leaves, except 16
derivatives of coca leaves, that do not contain cocaine, ecgonine, or substance from which cocaine 17
or ecgonine may be synthesized or made. 18
(iv) Any other drug or substance that contains any quantity of a substance that the attorney 19
general of the United States, or the director of health, after investigation, has found to have, or by 20
regulation designates as having, a potential for abuse because of its depressant or stimulant effect 21
on the central nervous system. 22
(14)(17) “Director” means the director of health. 23
(15)(18) “Dispense” means to deliver, distribute, leave with, give away, or dispose of a 24
controlled substance to the ultimate user or human research subject by or pursuant to the lawful 25
order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the 26
substance for that delivery. 27
(16)(19) “Dispenser” is a practitioner who delivers a controlled substance to the ultimate 28
user or human research subject. 29
(17)(20) “Distribute” means to deliver (other than by administering or dispensing) a 30
controlled substance or an imitation controlled substance and includes actual constructive, or 31
attempted transfer. “Distributor” means a person who so delivers a controlled substance or an 32
imitation controlled substance. 33
(18)(21) “Downtime” means that period of time when a computer is not operable. 34
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(19)(22) “Drug addicted person” means a person who exhibits a maladaptive pattern of 1
behavior resulting from drug use, including one or more of the following: impaired control over 2
drug use; compulsive use; and/or continued use despite harm, and craving. 3
(20)(23) “Drug Enforcement Administration” means the Drug Enforcement 4
Administration, United States Department of Justice or its successor. 5
(21)(24) “Federal law” means the Comprehensive Drug Abuse Prevention and Control Act 6
of 1970, (84 stat. 1236) (see generally 21 U.S.C. § 801 et seq.), and all regulations pertaining to 7
that federal act. 8
(22)(25) “Hardware” means the fixed component parts of a computer. 9
(23)(26) “Hospital” means an institution as defined in chapter 17 of title 23. 10
(24)(27) “Imitation controlled substance” means a substance that is not a controlled 11
substance, that by dosage unit, appearance (including color, shape, size, and markings), or by 12
representations made, would lead a reasonable person to believe that the substance is a controlled 13
substance and, which imitation controlled substances contain substances that if ingested, could be 14
injurious to the health of a person. In those cases when the appearance of the dosage unit is not 15
reasonably sufficient to establish that the substance is an “imitation controlled substance” (for 16
example in the case of powder or liquid), the court or authority concerned should consider, in 17
addition to all other logically relevant factors, the following factors as related to “representations 18
made” in determining whether the substance is an “imitation controlled substance”: 19
(i) Statement made by an owner, possessor, transferor, recipient, or by anyone else in 20
control of the substance concerning the nature of the substance, or its use or effect. 21
(ii) Statements made by the owner, possessor, or transferor, to the recipient that the 22
substance may be resold for substantial profit. 23
(iii) Whether the substance is packaged in a manner reasonably similar to packaging of 24
illicit controlled substances. 25
(iv) Whether the distribution or attempted distribution included an exchange of or demand 26
for money or other property as consideration, and whether the amount of the consideration was 27
substantially greater than the reasonable value of the non-controlled substance. 28
(25)(28) “Immediate precursor” means a substance: 29
(i) That the director of health has found to be, and by regulation designated as being, the 30
principal compound used, or produced primarily for use, in the manufacture of a controlled 31
substance; 32
(ii) That is an immediate chemical intermediary used or likely to be used in the manufacture 33
of those controlled substances; and 34
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(iii) The control of which is necessary to prevent, curtail, or limit the manufacture of that 1
controlled substance. 2
(26)(29) “Laboratory” means a laboratory approved by the department of health as proper 3
to be entrusted with controlled substances and the use of controlled substances for scientific and 4
medical purposes and for the purposes of instruction. 5
(27)(30) “Manufacture” means the production, preparation, propagation, cultivation, 6
compounding, or processing of a drug or other substance, including an imitation controlled 7
substance, either directly or indirectly or by extraction from substances of natural origin, or 8
independently by means of chemical synthesis or by a combination of extraction and chemical 9
synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of 10
its container in conformity with the general laws of this state except by a practitioner as an incident 11
to his or her administration or dispensing of the drug or substance in the course of his or her 12
professional practice. 13
(28)(31) “Manufacturer” means a person who manufactures but does not include an 14
apothecary who compounds controlled substances to be sold or dispensed on prescriptions. 15
(29)(32) “Marijuana” means all parts of the plant cannabis sativa L., whether growing or 16
not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, 17
manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not 18
include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the 19
seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of 20
mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the 21
plant which is incapable of germination. Marijuana shall not include “industrial hemp” or 22
“industrial hemp products” which satisfy the requirements of chapter 26 of title 2, nor shall it 23
include products that have been approved for marketing as a prescription medication by the U.S. 24
Food and Drug Administration and legally prescribed. 25
(30)(33) “Narcotic drug” means any of the following, whether produced directly or 26
indirectly by extraction from substances of vegetable origin, or independently by means of 27
chemical synthesis or by a combination of extraction and chemical synthesis: 28
(i) Opium and opiates. 29
(ii) A compound, manufacture, salt, derivative, or preparation of opium or opiates. 30
(iii) A substance (and any compound, manufacture, salt, derivative, or preparation of it) 31
that is chemically identical with any of the substances referred to in subsections (30)(i) and (30)(ii). 32
(iv) Any other substance that the attorney general of the United States, or his or her 33
successor, or the director of health, after investigation, has found to have, and by regulation 34
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designates as having, a potential for abuse similar to opium and opiates. 1
(31)(34) “Official written order” means an order written on a form provided for that 2
purpose by the Drug Enforcement Administration under any laws of the United States making 3
provision for an official form, if order forms are authorized and required by federal law, and if no 4
order form is provided then on an official form provided for that purpose by the director of health. 5
(32) “Opiate” means any substance having an addiction-forming or addiction-sustaining 6
liability similar to morphine or being capable of conversion into a drug having addiction-forming 7
or addiction-sustaining liability. 8
(33)(35) “Opioid analgesics” means and includes, but is not limited to, the medicines 9
buprenophine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, 10
methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, propoxyphene as well 11
as their brand names, isomers, and combinations, or other medications approved by the department. 12
(34)(36) “Opioid antagonist” means naloxone hydrochloride and any other drug approved 13
by the United States Food and Drug Administration for the treatment of opioid overdose. 14
(37) “Opioid therapy” means to prescribe, administer, or dispense controlled substances 15
not prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner 16
for a condition by any route of administration. 17
(35)(38) “Opium poppy” means the plant of the species papaver somniferum L., except the 18
seeds of the plant. 19
(36)(39) “Ounce” means an avoirdupois ounce as applied to solids and semi-solids, and a 20
fluid ounce as applied to liquids. 21
(37)(40) “Person” means any corporation, association, partnership, or one or more 22
individuals. 23
(38)(41) “Physical dependence” means a state of adaptation that is manifested by a drug 24
class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, 25
decreasing blood level of the drug, and/or administration of an antagonist. 26
(39)(42) “Poppy straw” means all parts, except the seeds, of the opium poppy, after 27
mowing. 28
(40)(43) “Practitioner” means: 29
(i) A physician, osteopath, dentist, chiropodist, veterinarian, scientific investigator, or other 30
person licensed, registered, or permitted to distribute, dispense, conduct research with respect to or 31
to administer a controlled substance in the course of professional practice or research in this state. 32
(ii) A pharmacy, hospital, or other institution licensed, registered or permitted to distribute, 33
dispense, conduct research with respect to, or to administer a controlled substance in the course of 34
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professional practice or research in this state. 1
(41)(44) “Printout” means a hard copy produced by computer that is readable without the 2
aid of any special device. 3
(42)(45) “Production” includes the manufacture, planting, cultivation, growing, or 4
harvesting of a controlled substance. 5
(43)(46) “Researcher” means a person authorized by the director of health to conduct a 6
laboratory as defined in this chapter. 7
(44)(47) “Sell” includes sale, barter, gift, transfer, or delivery in any manner to another, or 8
to offer or agree to do the same. 9
(45)(48) “Software” means programs, procedures, and storage of required information 10
data. 11
(46)(49) “Synthetic drugs” means any synthetic cannabinoids or piperazines or any 12
synthetic cathinones as provided for in schedule I. 13
(50) “Therapeutic purpose” means the use of controlled substances for the treatment of 14
pain in appropriate doses as indicated by the patient’s medical record. Any other use is 15
nontherapeutic. 16
(47)(51) “Ultimate user” means a person who lawfully possesses a controlled substance for 17
his or her own use or for the use of a member of his or her household, or for administering to an 18
animal owned by him or her or by a member of his or her household. 19
(48)(52) “Wholesaler” means a person who sells, vends, or distributes at wholesale, or as 20
a jobber, broker agent, or distributor, or for resale in any manner in this state any controlled 21
substance. 22
21-28-3.20. Authority of practitioner to prescribe, administer, and dispense. 23
(a)(1) A practitioner Practitioners, in good faith and in the course of his or her their 24
professional practice only, may prescribe, administer, and dispense controlled substances, or he or 25
she may cause the controlled substances to be administered by a nurse or intern under his or her 26
their direction and supervision after completing an assessment of pain experienced by a patient. 27
(2) Opioid therapy must only be initiated for acute pain unresponsive to non-opioid 28
therapies or if, based on clinical assessment, benefits of opioid therapy for acute pain management 29
outweigh risks. 30
(2)(3) When issuing an initial a prescription for an opiate opioid to an adult patient, a 31
practitioner shall not exceed the maximum daily dose requirements established by the department 32
of health must prescribe the lowest effective dosage of an immediate-release opioid in a quantity 33
sufficient to treat the expected duration of pain. 34
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(3) Except as provided in subsection (a)(4) of this section, a practitioner shall not issue an 1
opiate prescription to a minor for more than twenty (20) doses at any time. Prior to issuing an opiate 2
prescription to a minor, a practitioner shall discuss with the parent or guardian of the minor the 3
risks associated with opiate use and the reasons why the prescription is necessary. The practitioner 4
shall document his or her discussion with the parent or guardian in the medical record. 5
(4) Notwithstanding the limitations referenced in subsection (a)(3) of this section, if, in the 6
professional medical judgment of a practitioner, a greater dosage or supply of an opiate is required 7
to treat the minor patient’s acute medical condition or is necessary for the treatment of chronic pain 8
management, sickle cell related pain, intractable pain treatment as defined in chapter 37.4 of title 9
5, pain associated with a cancer diagnosis, or for palliative care, then the practitioner may issue a 10
prescription for the quantity needed to treat the acute medical condition, chronic pain, sickle cell 11
related pain, intractable pain, pain associated with a cancer diagnosis, or pain experienced while 12
the patient is in palliative care, provided that this dosage shall not exceed the maximum daily 13
dosage permitted for the treatment of this pain as set forth in the department of health regulations. 14
The medical condition triggering the prescription of an opiate shall opioid must be documented in 15
the minor patient’s medical record, and the practitioner shall must indicate that a non-opiate non-16
opioid alternative was not appropriate to address the medical condition. 17
(5) Notwithstanding subsections (a)(2) and (a)(3) of this section, this section shall not apply 18
to medications designed for the treatment of substance abuse or opioid dependence. 19
(b) The prescription-monitoring drug monitoring program shall must be reviewed prior to 20
starting any opioid. A prescribing practitioner, or designee as authorized by § 21-28-3.32(a)(3), 21
shall must review the patient’s prescribed controlled substance use in the prescription-monitoring 22
drug monitoring program prior to refilling or initiating opioid therapy with an intrathecal pump. 23
For patients the prescribing practitioner is maintaining being maintained on continuous opioid 24
therapy for pain for three (3) months or longer, the prescribing practitioner shall must review 25
information from the prescription-monitoring drug monitoring program at least every three (3) 26
months. Documentation of that review shall must be noted in the patient’s medical record. 27
(c) The director of health shall develop regulations for prescribing practitioners on 28
appropriate limits of opioid use in acute pain management. Initial prescriptions of opioids for acute 29
pain management of outpatient adults shall not exceed thirty (30) morphine milligram equivalents 30
(MMEs) total daily dose per day for a maximum total of twenty (20) doses, and, for pediatric 31
patients, the appropriate opioid dosage maximum per the department of health. 32
(d)(c) For the purposes of this section, acute pain management shall must not include 33
management or treatment for chronic intractable pain management, pain associated with a cancer 34
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diagnosis, pain related to sickle cell disease, palliative or nursing home end-of-life care, intractable 1
or chronic intractable pain, as provided in § 5-37.4-2, or other exception exceptions in accordance 2
with department of health regulations. 3
(e) Subsection (c) shall not apply to medications designed for the treatment of substance 4
abuse or opioid dependence. 5
(f) On or before September 1, 2018, the director of health shall develop, and make available 6
to healthcare practitioners, information on best practices for co-prescribing opioid antagonists to 7
patients. The best practices information shall identify situations in which co-prescribing an opioid 8
antagonist may be appropriate, including, but not limited to: 9
(1) In conjunction with a prescription for an opioid medication, under circumstances in 10
which the healthcare practitioner determines the patient is at an elevated risk for an opioid drug 11
overdose; 12
(2) In conjunction with medications prescribed pursuant to a course of medication therapy 13
management for the treatment of a substance use disorder involving opioids; or 14
(3) Under any other circumstances in which a healthcare practitioner identifies a patient as 15
being at an elevated risk for an opioid drug overdose. 16
(g) The best practices information developed pursuant to subsection (f) of this section shall 17
include guidelines for determining when a patient is at an elevated risk for an opioid drug overdose, 18
including, but not limited to, situations in which the patient: 19
(1) Meets the criteria provided in the opioid overdose toolkit published by the federal 20
substance abuse and mental health service administration; 21
(2) Is receiving high-dose, extended-release, or long-acting opioid medications; 22
(3) Has a documented history of an alcohol or substance use disorder, or a mental health 23
disorder; 24
(4) Has a respiratory ailment or other co-morbidity that may be exacerbated by the use of 25
opioid medications; 26
(5) Has a known history of intravenous drug use or misuse of prescription opioids; 27
(6) Has received emergency medical care or been hospitalized for an opioid overdose; or 28
(7) Uses opioids with antidepressants, benzodiazepines, alcohol, or other drugs. 29
(h) On or before September 1, 2018, the director of health and the secretary of the executive 30
office of health and human services shall develop strategies that include: 31
(1) Allowing practitioners in non-pharmacy settings to prescribe and dispense opioid 32
antagonists; and 33
(2) Ensuring that opioid antagonists that are distributed in a non-pharmacy setting are 34
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eligible for reimbursement from any health insurance carrier, as defined under chapters 18, 19, 20, 1
and 41 of title 27, and the Rhode Island medical assistance program, as defined under chapter 7.2 2
of title 42. 3
(d) The director of health may promulgate regulations for practitioners on opioid use in 4
pain management. 5
21-28-3.20.1. Authority of practitioner to prescribe, administer, and dispense — 6
Cancer, palliative care, and chronic intractable pain. 7
(a) A practitioner, in good faith and in the course of his or her professional practice 8
managing pain associated with a cancer diagnosis, palliative or nursing home care, intractable or 9
chronic intractable pain as provided in § 5-37.4-2, or other condition allowed by department of 10
health regulations pursuant to the exception in § 21-28-3.20(d), may prescribe, administer, and 11
dispense controlled substances without regard to the CDC Clinical Practice Guideline for 12
Prescribing Opioids for Pain—United States, 2022. 13
(b) The director of health may promulgate those rules and regulations necessary to 14
effectuate the provisions of this section and ensure that rules governing pain management 15
associated with a cancer diagnosis, palliative or nursing home care, intractable or chronic 16
intractable pain as provided in § 5-37.4-2, or other condition allowed by department of health 17
regulations pursuant to the exception created in § 21-28-3.20(d), shall: 18
(1) Take into consideration the individualized needs of patients covered by this section; 19
and 20
(2) Make provisions for practitioners, acting in good faith, and in the course of their 21
profession, and managing pain associated with their patients’ illness to use their best judgment 22
notwithstanding any statute, rule, or regulation to the contrary. may prescribe, administer, or 23
dispense controlled substances not prohibited by law for a therapeutic purpose to a person 24
diagnosed and treated by a practitioner for a condition resulting in chronic intractable pain, if this 25
diagnosis and treatment has been documented in the practitioner’s medical records. 26
(b) Concern about a patient’s substance use disorder or the possibility of a substance use 27
disorder in and of itself is not a reason to withhold or prohibit prescribing, administering, or 28
dispensing controlled substances for the therapeutic purpose of treatment of a person for chronic 29
intractable pain. Provided, however, practitioners must check the patient’s prescribed controlled 30
substances use in the prescription drug monitoring program, refer the patient to a substance use 31
disorder specialist, as appropriate, and enter into a written patient treatment agreement in 32
accordance with regulations promulgated by the department. 33
(c) The provisions of subsection (a) of this section provide no authority to a practitioner to 34
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prescribe, administer, or dispense controlled substances to a person the practitioner knows or should 1
know to be using the prescribed, administered, or dispensed controlled substance 2
nontherapeutically. 3
(d) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from 4
denying a prescription based on their best clinical judgment. 5
(e) Nothing in this section shall deny the right of the director to deny, revoke, or suspend 6
the license of any practitioner or discipline any practitioner who: 7
(1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in 8
nature or nontherapeutic in the manner in which it is prescribed, administered, or dispensed, or fails 9
to keep complete and accurate ongoing records of the diagnosis and treatment plan; 10
(2) Fails to keep complete and accurate records of controlled substances received, 11
prescribed, dispensed, and administered, and disposal of drugs as required by law or of controlled 12
substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 13
U.S.C. § 801 et seq. A practitioner shall keep records of controlled substances received, prescribed, 14
dispensed and administered, and disposal of these drugs shall include the date of receipt of the 15
drugs, the sale or disposal of the drugs by the practitioner, the name and address of the person 16
receiving the drugs, and the reason for the disposal or the dispensing of the drugs to the person; 17
(3) Writes false or fictitious prescriptions for controlled substances as prohibited by law, 18
or for controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control 19
Act of 1970, 21 U.S.C. § 801 et seq.; or 20
(4) Prescribes, administers, or dispenses in a manner that is inconsistent with provisions of 21
the law, or the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. § 801 22
et seq., any controlled substance. 23
(f) The director of health may promulgate those rules and regulations necessary to 24
effectuate the provisions of this section. 25
SECTION 2. Chapter 5-37.4 of the General Laws entitled "Intractable Pain Treatment" is 26
hereby repealed in its entirety. 27
CHAPTER 5-37.4 28
Intractable Pain Treatment 29
5-37.4-1. Title. 30
This chapter shall be known and may be cited as the “Intractable Pain Treatment Act.” 31
5-37.4-2. Definitions. 32
For purposes of this chapter: 33
(1) “Chronic intractable pain” means pain that is: excruciating; constant; incurable, and of 34
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such severity that it dominates virtually every conscious moment; and/or produces mental and 1
physical debilitation. A diagnosis and written documentation of chronic intractable pain made by a 2
physician licensed in the state of Rhode Island specializing in pain management, oncology, or 3
similar specialty defined in regulations shall constitute proof that the patient suffers from chronic 4
intractable pain. 5
(2) “Director” means the director of the department of health of the state of Rhode Island. 6
(3) “Intractable pain” means a pain state that persists beyond the usual course of an acute 7
disease or healing of an injury or results from a chronic disease or condition that causes continuous 8
or intermittent pain over a period of months or years. Unless the context clearly indicates otherwise, 9
the term intractable pain includes chronic intractable pain. 10
(4) “Practitioner” means healthcare professionals licensed to distribute, dispense, or 11
administer controlled substances in the course of professional practice as defined in § 21-28-12
1.02(41). 13
(5) “Therapeutic purpose” means the use of controlled substances for the treatment of pain 14
in appropriate doses as indicated by the patient’s medical record. Any other use is nontherapeutic. 15
5-37.4-3. Controlled substances. 16
(a) A practitioner may prescribe, administer, or dispense controlled substances not 17
prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner for 18
a condition resulting in intractable pain, if this diagnosis and treatment has been documented in the 19
practitioner’s medical records. No practitioner shall be subject to disciplinary action by the board 20
solely for prescribing, administering, or dispensing controlled substances when prescribed, 21
administered, or dispensed for a therapeutic purpose for a person diagnosed and treated by a 22
practitioner for a condition resulting in intractable pain, if this diagnosis and treatment has been 23
documented in the practitioner’s medical records. 24
(b) The provisions of subsection (a) of this section do not apply to those persons being 25
treated by a practitioner for chemical dependency because of their use of controlled substances not 26
related to the therapeutic purposes of treatment of intractable pain. 27
(c) The provisions of subsection (a) of this section provide no authority to a practitioner to 28
prescribe, administer, or dispense controlled substances to a person the practitioner knows or should 29
know to be using the prescribed, administered, or dispensed controlled substance 30
nontherapeutically. 31
(d) Drug dependency or the possibility of drug dependency in and of itself is not a reason 32
to withhold or prohibit prescribing, administering, or dispensing controlled substances for the 33
therapeutic purpose of treatment of a person for intractable pain, nor shall dependency relating 34
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solely to this prescribing, administering, or dispensing subject a practitioner to disciplinary action 1
by the director. 2
(e) In coordination with §§ 21-28-3.20 and 21-28-3.20.1, the director of health may 3
promulgate rules and regulations necessary to effectuate the purpose of this chapter and ensure that 4
patients with intractable or chronic intractable pain are treated or referred to an appropriate 5
specialist. 6
(f) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from 7
denying a prescription based on their best clinical judgment. 8
(g) Nothing in this section shall deny the right of the director to deny, revoke, or suspend 9
the license of any practitioner or discipline any practitioner who: 10
(1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in 11
nature or nontherapeutic in the manner in which it is prescribed, administered, or dispensed, or fails 12
to keep complete and accurate ongoing records of the diagnosis and treatment plan; 13
(2) Fails to keep complete and accurate records of controlled substances received, 14
prescribed, dispensed, and administered, and disposal of drugs as required by law or of controlled 15
substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 16
U.S.C. § 801 et seq. A practitioner shall keep records of controlled substances received, prescribed, 17
dispensed and administered, and disposal of these drugs shall include the date of receipt of the 18
drugs, the sale or disposal of the drugs by the practitioner, the name and address of the person 19
receiving the drugs, and the reason for the disposal or the dispensing of the drugs to the person; 20
(3) Writes false or fictitious prescriptions for controlled substances as prohibited by law, 21
or for controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control 22
Act of 1970, 21 U.S.C § 801 et seq.; or 23
(4) Prescribes, administers, or dispenses in a manner which is inconsistent with provisions 24
of the law, or the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. § 25
801 et seq., any controlled substance. 26
(h) A practitioner may administer a controlled substance prescribed by a practitioner and 27
not prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner 28
for a condition resulting in intractable pain, if this diagnosis and treatment has been documented in 29
the practitioner’s medical records. No practitioner shall be subject to disciplinary action by the 30
director solely for administering controlled substances when prescribed or dispensed for a 31
therapeutic purpose for a person diagnosed and treated by a practitioner for a condition resulting in 32
intractable pain, if this diagnosis and treatment has been documented in the practitioner’s medical 33
records of the patient. 34
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SECTION 3. Section 21-28-1.02 of the General Laws in Chapter 21-28 entitled "Uniform 1
Controlled Substances Act" is hereby repealed. 2
21-28-1.02. Definitions. [Effective until January 1, 2023; see Sunset Provision note.] 3
Unless the context otherwise requires, the words and phrases as defined in this section are 4
used in this chapter in the sense given them in the following definitions: 5
(1) “Administer” refers to the direct application of controlled substances to the body of a 6
patient or research subject by: 7
(i) A practitioner, or, in his or her presence by his or her authorized agent; or 8
(ii) The patient or research subject at the direction and in the presence of the practitioner 9
whether the application is by injection, inhalation, ingestion, or any other means. 10
(2) “Agent” means an authorized person who acts on behalf of, or at the direction of, a 11
manufacturer, wholesaler, distributor, or dispenser; except that these terms do not include a 12
common or contract carrier or warehouse operator when acting in the usual and lawful course of 13
the carrier’s or warehouse operator’s business. 14
(3) “Apothecary” means a registered pharmacist as defined by the laws of this state and, 15
where the context requires, the owner of a licensed pharmacy or other place of business where 16
controlled substances are compounded or dispensed by a registered pharmacist; and includes 17
registered assistant pharmacists as defined by existing law, but nothing in this chapter shall be 18
construed as conferring on a person who is not registered as a pharmacist any authority, right, or 19
privilege that is not granted to him or her by the pharmacy laws of the state. 20
(4) “Automated data processing system” means a system utilizing computer software and 21
hardware for the purposes of record keeping. 22
(5) “Certified law enforcement prescription drug diversion investigator” means a certified 23
law enforcement officer assigned by his or her qualified law enforcement agency to investigate 24
prescription drug diversion. 25
(6) “Computer” means programmable electronic device capable of multi-functions, 26
including, but not limited to: storage, retrieval, and processing of information. 27
(7) “Control” means to add a drug or other substance or immediate precursor to a schedule 28
under this chapter, whether by transfer from another schedule or otherwise. 29
(8) “Controlled substance” means a drug, substance, immediate precursor, or synthetic 30
drug in schedules I — V of this chapter. The term shall not include distilled spirits, wine, or malt 31
beverages, as those terms are defined or used in chapter 1 of title 3, nor tobacco. 32
(9) “Co-prescribing” means issuing a prescription for an opioid antagonist along with a 33
prescription for an opioid analgesic. 34
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(10) “Counterfeit substance” means a controlled substance that, or the container or labeling 1
of which, without authorization bears the trademark, trade name, or other identifying mark, imprint, 2
number, or device, or any likeness of them, of a manufacturer, distributor, or dispenser, other than 3
the person or persons who in fact manufactured, distributed, or dispensed the substance and that 4
thereby falsely purports or is represented to be the product of, or to have been distributed by, the 5
other manufacturer, distributor, or dispenser, or which substance is falsely purported to be or 6
represented to be one of the controlled substances by a manufacturer, distributor, or dispenser. 7
(11) “CRT” means cathode ray tube used to impose visual information on a screen. 8
(12) “Deliver” or “delivery” means the actual, constructive, or attempted transfer of a 9
controlled substance or imitation controlled substance, whether or not there exists an agency 10
relationship. 11
(13) “Department” means the department of health of this state. 12
(14) “Depressant or stimulant drug” means: 13
(i) A drug that contains any quantity of: 14
(A) Barbituric acid or derivatives, compounds, mixtures, or preparations of barbituric acid; 15
and 16
(B) “Barbiturate” or “barbiturates” includes all hypnotic and/or somnifacient drugs, 17
whether or not derivatives of barbituric acid, except that this definition shall not include bromides 18
and narcotics. 19
(ii) A drug that contains any quantity of: 20
(A) Amphetamine or any of its optical isomers; 21
(B) Any salt of amphetamine and/or desoxyephedrine or any salt of an optical isomer of 22
amphetamine and/or desoxyephedrine, or any compound, mixture, or preparation of them. 23
(iii) A drug that contains any quantity of coca leaves. “Coca leaves” includes cocaine, or 24
any compound, manufacture, salt, derivative, mixture, or preparation of coca leaves, except 25
derivatives of coca leaves, that do not contain cocaine, ecgonine, or substance from which cocaine 26
or ecgonine may be synthesized or made. 27
(iv) Any other drug or substance that contains any quantity of a substance that the attorney 28
general of the United States, or the director of health, after investigation, has found to have, or by 29
regulation designates as having, a potential for abuse because of its depressant or stimulant effect 30
on the central nervous system. 31
(15) “Director” means the director of health. 32
(16) “Dispense” means to deliver, distribute, leave with, give away, or dispose of a 33
controlled substance to the ultimate user or human research subject by or pursuant to the lawful 34
LC001419 - Page 16 of 20
order of a practitioner, including the packaging, labeling, or compounding necessary to prepare the 1
substance for that delivery. 2
(17) “Dispenser” is a practitioner who delivers a controlled substance to the ultimate user 3
or human research subject. 4
(18) “Distribute” means to deliver (other than by administering or dispensing) a controlled 5
substance or an imitation controlled substance and includes actual constructive, or attempted 6
transfer. “Distributor” means a person who so delivers a controlled substance or an imitation 7
controlled substance. 8
(19) “Downtime” means that period of time when a computer is not operable. 9
(20) “Drug addicted person” means a person who exhibits a maladaptive pattern of 10
behavior resulting from drug use, including one or more of the following: impaired control over 11
drug use; compulsive use; and/or continued use despite harm, and craving. 12
(21) “Drug Enforcement Administration” means the Drug Enforcement Administration, 13
United States Department of Justice or its successor. 14
(22) “Federal law” means the Comprehensive Drug Abuse Prevention and Control Act of 15
1970, (84 stat. 1236) (see generally 21 U.S.C. § 801 et seq.), and all regulations pertaining to that 16
federal act. 17
(23) “Hardware” means the fixed component parts of a computer. 18
(24) “Hospital” means an institution as defined in chapter 17 of title 23. 19
(25) “Imitation controlled substance” means a substance that is not a controlled substance, 20
that by dosage unit, appearance (including color, shape, size, and markings), or by representations 21
made, would lead a reasonable person to believe that the substance is a controlled substance and, 22
which imitation controlled substances contain substances that if ingested, could be injurious to the 23
health of a person. In those cases when the appearance of the dosage unit is not reasonably sufficient 24
to establish that the substance is an “imitation controlled substance” (for example in the case of 25
powder or liquid), the court or authority concerned should consider, in addition to all other logically 26
relevant factors, the following factors as related to “representations made” in determining whether 27
the substance is an “imitation controlled substance”: 28
(i) Statement made by an owner, possessor, transferor, recipient, or by anyone else in 29
control of the substance concerning the nature of the substance, or its use or effect. 30
(ii) Statements made by the owner, possessor, or transferor, to the recipient that the 31
substance may be resold for substantial profit. 32
(iii) Whether the substance is packaged in a manner reasonably similar to packaging of 33
illicit controlled substances. 34
LC001419 - Page 17 of 20
(iv) Whether the distribution or attempted distribution included an exchange of or demand 1
for money or other property as consideration, and whether the amount of the consideration was 2
substantially greater than the reasonable value of the non-controlled substance. 3
(26) “Immediate precursor” means a substance: 4
(i) That the director of health has found to be, and by regulation designated as being, the 5
principal compound used, or produced primarily for use, in the manufacture of a controlled 6
substance; 7
(ii) That is an immediate chemical intermediary used, or likely to be used, in the 8
manufacture of those controlled substances; and 9
(iii) The control of which is necessary to prevent, curtail, or limit the manufacture of that 10
controlled substance. 11
(27) “Laboratory” means a laboratory approved by the department of health as proper to 12
be entrusted with controlled substances and the use of controlled substances for scientific and 13
medical purposes and for the purposes of instruction. 14
(28) “Manufacture” means the production, preparation, propagation, cultivation, 15
compounding, or processing of a drug or other substance, including an imitation controlled 16
substance, either directly or indirectly or by extraction from substances of natural origin, or 17
independently by means of chemical synthesis or by a combination of extraction and chemical 18
synthesis and includes any packaging or repackaging of the substance or labeling or relabeling of 19
its container in conformity with the general laws of this state except by a practitioner as an incident 20
to his or her administration or dispensing of the drug or substance in the course of his or her 21
professional practice. 22
(29) “Manufacturer” means a person who manufactures but does not include an apothecary 23
who compounds controlled substances to be sold or dispensed on prescriptions. 24
(30) “Marijuana” means all parts of the plant cannabis sativa L., whether growing or not; 25
the seeds of the plant; the resin extracted from any part of the plant; and every compound, 26
manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not 27
include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the 28
seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of 29
mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the 30
plant which is incapable of germination. Marijuana shall not include “industrial hemp” or 31
“industrial hemp products” which satisfy the requirements of chapter 26 of title 2, nor shall it 32
include products that have been approved for marketing as a prescription medication by the U.S. 33
Food and Drug Administration and legally prescribed. 34
LC001419 - Page 18 of 20
(31) “Narcotic drug” means any of the following, whether produced directly or indirectly 1
by extraction from substances of vegetable origin, or independently by means of chemical synthesis 2
or by a combination of extraction and chemical synthesis: 3
(i) Opium and opiates. 4
(ii) A compound, manufacture, salt, derivative, or preparation of opium or opiates. 5
(iii) A substance (and any compound, manufacture, salt, derivative, or preparation of it) 6
that is chemically identical with any of the substances referred to in subsections 31(i) and (31)(ii). 7
(iv) Any other substance that the attorney general of the United States, or his or her 8
successor, or the director of health, after investigation, has found to have, and by regulation 9
designates as having, a potential for abuse similar to opium and opiates. 10
(32) “Official written order” means an order written on a form provided for that purpose 11
by the Drug Enforcement Administration under any laws of the United States making provision for 12
an official form, if order forms are authorized and required by federal law, and if no order form is 13
provided, then on an official form provided for that purpose by the director of health. 14
(33) “Opiate” means any substance having an addiction-forming or addiction-sustaining 15
liability similar to morphine or being capable of conversion into a drug having addiction-forming 16
or addiction-sustaining liability. 17
(34) “Opioid analgesics” means and includes, but is not limited to, the medicines 18
buprenophine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, 19
methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, propoxyphene as well 20
as their brand names, isomers, and combinations, or other medications approved by the department. 21
(35) “Opioid antagonist” means naloxone hydrochloride and any other drug approved by 22
the United States Food and Drug Administration for the treatment of opioid overdose. 23
(36) “Opium poppy” means the plant of the species papaver somniferum L., except the 24
seeds of the plant. 25
(37) “Ounce” means an avoirdupois ounce as applied to solids and semi-solids, and a fluid 26
ounce as applied to liquids. 27
(38) “Person” means any corporation, association, partnership, or one or more individuals. 28
(39) “Physical dependence” means a state of adaptation that is manifested by a drug class 29
specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, 30
decreasing blood level of the drug, and/or administration of an antagonist. 31
(40) “Poppy straw” means all parts, except the seeds, of the opium poppy, after mowing. 32
(41) “Practitioner” means: 33
(i) A physician, osteopath, dentist, chiropodist, veterinarian, scientific investigator, or other 34
LC001419 - Page 19 of 20
person licensed, registered, or permitted to distribute, dispense, conduct research with respect to or 1
to administer a controlled substance in the course of professional practice or research in this state. 2
(ii) A pharmacy, hospital, or other institution licensed, registered, or permitted to distribute, 3
dispense, conduct research with respect to, or to administer a controlled substance in the course of 4
professional practice or research in this state. 5
(42) “Printout” means a hard copy produced by computer that is readable without the aid 6
of any special device. 7
(43) “Production” includes the manufacture, planting, cultivation, growing, or harvesting 8
of a controlled substance. 9
(44) “Qualified law enforcement agency” means the U.S. Food and Drug Administration, 10
Drug Enforcement Administration, Federal Bureau of Investigation, Office of Inspector General of 11
the U.S. Department of Health & Human Services, or the Medicaid Fraud and Patient Abuse Unit 12
in the Office of the Attorney General. 13
(45) “Researcher” means a person authorized by the director of health to conduct a 14
laboratory as defined in this chapter. 15
(46) “Sell” includes sale, barter, gift, transfer, or delivery in any manner to another, or to 16
offer or agree to do the same. 17
(47) “Software” means programs, procedures, and storage of required information data. 18
(48) “Synthetic drugs” means any synthetic cannabinoids or piperazines or any synthetic 19
cathinones as provided for in schedule I. 20
(49) “Ultimate user” means a person who lawfully possesses a controlled substance for his 21
or her own use or for the use of a member of his or her household, or for administering to an animal 22
owned by him or her or by a member of his or her household. 23
(50) “Wholesaler” means a person who sells, vends, or distributes at wholesale, or as a 24
jobber, broker agent, or distributor, or for resale in any manner in this state any controlled 25
substance. 26
SECTION 4. This act shall take effect upon passage. 27
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LC001419 - Page 20 of 20
EXPLANATION
BY THE LEGISLATIVE COUNCIL
OF
A N A C T
RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT
***
This act would revise sections of the uniform controlled substances act to remove specific 1
opioid dosage requirements and revise the uniform controlled substances act in accordance with 2
current standards of professional practice and would repeal chapter 37.4 of title 5 relating to 3
intractable pain treatment. 4
This act would take effect upon passage. 5
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