Session of 2025
HOUSE BILL No. 2218
By Committee on Health and Human Services
Requested by Steve Kearney on behalf of Compass Pathways
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AN ACT concerning the uniform controlled substances act; defining
psilocybin to exclude the pharmaceutical composition of crystalline
polymorph psilocybin; adding crystalline polymorph psilocybin to
schedule IV; amending K.S.A. 2024 Supp. 65-4101 and 65-4111 and
repealing the existing sections.
Be it enacted by the Legislature of the State of Kansas:
Section 1. On and after the date of publication in the Kansas register
of the certification prescribed in section 3, K.S.A. 2024 Supp. 65-4101 is
hereby amended to read as follows: 65-4101. As used in this act:
(a) "Administer" means the direct application of a controlled
substance, whether by injection, inhalation, ingestion or any other means,
to the body of a patient or research subject by:
(1) A practitioner or pursuant to the lawful direction of a practitioner;
or
(2) the patient or research subject at the direction and in the presence
of the a practitioner.
(b) "Agent" means an authorized person who acts on behalf of or at
the direction of a manufacturer, distributor or dispenser. "Agent" does not
include a common carrier, public warehouseman or employee of the carrier
or warehouseman.
(c) "Application service provider" means an entity that sells
electronic prescription or pharmacy prescription applications as a hosted
service where the entity controls access to the application and maintains
the software and records on its server.
(d) "Board" means the state board of pharmacy.
(e) "Bureau" means the bureau of narcotics and dangerous drugs, of
the United States department of justice, or its successor agency.
(f) "Controlled substance" means any drug, substance or immediate
precursor included in any of the schedules designated in K.S.A. 65-4105,
65-4107, 65-4109, 65-4111 and 65-4113, and amendments thereto.
(g) (1) "Controlled substance analog" means a substance that is
intended for human consumption, and at least one of the following:
(A) The chemical structure of the substance is substantially similar to
the chemical structure of a controlled substance listed in or added to the
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schedules designated in K.S.A. 65-4105 or 65-4107, and amendments
thereto;
(B) the substance has a stimulant, depressant or hallucinogenic effect
on the central nervous system substantially similar to the stimulant,
depressant or hallucinogenic effect on the central nervous system of a
controlled substance included in the schedules designated in K.S.A. 65-
4105 or 65-4107, and amendments thereto; or
(C) with respect to a particular individual, such individual represents
or intends the substance to have a stimulant, depressant or hallucinogenic
effect on the central nervous system substantially similar to the stimulant,
depressant or hallucinogenic effect on the central nervous system of a
controlled substance included in the schedules designated in K.S.A. 65-
4105 or 65-4107, and amendments thereto.
(2) "Controlled substance analog" does not include:
(A) A controlled substance;
(B) a substance for which there is an approved new drug application;
or
(C) a substance with respect to which an exemption is in effect for
investigational use by a particular person under section 505 of the federal
food, drug and cosmetic act, 21 U.S.C. § 355, to the extent conduct with
respect to the substance is permitted by the exemption.
(h) "Counterfeit substance" means a controlled substance that, or the
container or labeling of which, without authorization bears the trademark,
trade name or other identifying mark, imprint, number or device or any
likeness thereof of a manufacturer, distributor or dispenser other than the
person who in fact manufactured, distributed or dispensed the substance.
(i) "Cultivate" means the planting or promotion of growth of five or
more plants that contain or can produce controlled substances.
(j) "DEA" means the U.S. department of justice, drug enforcement
administration.
(k) "Deliver" or "delivery" means the actual, constructive or
attempted transfer from one person to another of a controlled substance,
whether or not there is an agency relationship.
(l) "Dispense" means to deliver a controlled substance to an ultimate
user or research subject by or pursuant to the lawful order of a practitioner,
including the packaging, labeling or compounding necessary to prepare the
substance for that delivery, or pursuant to the prescription of a mid-level
practitioner.
(m) "Dispenser" means a practitioner or pharmacist who dispenses, or
a physician assistant who has authority to dispense prescription-only drugs
in accordance with K.S.A. 65-28a08(b), and amendments thereto.
(n) "Distribute" means to deliver other than by administering or
dispensing a controlled substance.
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(o) "Distributor" means a person who distributes.
(p) (1) "Drug" means substances:
(A) Recognized as drugs in the official United States pharmacopeia,
official homeopathic pharmacopoeia of the United States or official
national formulary or any supplement to any of them;
(B) intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in human or animals;
(C) other than food intended to affect the structure or any function of
the body of human or animals; and
(D) intended for use as a component of any article specified in
subparagraph (A), (B) or (C).
(2) "Drug" does not include devices or their components, parts or
accessories.
(q) "Immediate precursor" means a substance that the board has
found to be and by rule and regulation designates as being the principal
compound commonly used or produced primarily for use and that is an
immediate chemical intermediary used or likely to be used in the
manufacture of a controlled substance, the control of which is necessary to
prevent, curtail or limit manufacture.
(r) "Electronic prescription" means an electronically prepared
prescription that is authorized and transmitted from the prescriber to the
pharmacy by means of electronic transmission.
(s) "Electronic prescription application" means software that is used
to create electronic prescriptions and that is intended to be installed on the
prescriber's computers and servers where access and records are controlled
by the prescriber.
(t) "Electronic signature" means a confidential personalized digital
key, code, number or other method for secure electronic data transmissions
that identifies a particular person as the source of the message,
authenticates the signatory of the message and indicates the person's
approval of the information contained in the transmission.
(u) "Electronic transmission" means the transmission of an electronic
prescription, formatted as an electronic data file, from a prescriber's
electronic prescription application to a pharmacy's computer, where the
data file is imported into the pharmacy prescription application.
(v) "Electronically prepared prescription" means a prescription that is
generated using an electronic prescription application.
(w) "Facsimile transmission" or "fax transmission" means the
transmission of a digital image of a prescription from the prescriber or the
prescriber's agent to the pharmacy. "Facsimile transmission" includes, but
is not limited to, transmission of a written prescription between the
prescriber's fax machine and the pharmacy's fax machine;, transmission of
an electronically prepared prescription from the prescriber's electronic
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prescription application to the pharmacy's fax machine, computer or
printer; or transmission of an electronically prepared prescription from the
prescriber's fax machine to the pharmacy's fax machine, computer or
printer.
(x) "Intermediary" means any technology system that receives and
transmits an electronic prescription between the prescriber and the
pharmacy.
(y) "Isomer" means all enantiomers and diastereomers.
(z) "Manufacture" means the production, preparation, propagation,
compounding, conversion or processing of a controlled substance either
directly or indirectly or by extraction from substances of natural origin or
independently by means of chemical synthesis or by a combination of
extraction and chemical synthesis and includes any packaging or
repackaging of the substance or labeling or relabeling of its container,
except that this term "manufacture" does not include the preparation or
compounding of a controlled substance by an individual for the
individual's own lawful use or the preparation, compounding, packaging or
labeling of a controlled substance:
(1) By a practitioner or the practitioner's agent pursuant to a lawful
order of a practitioner as an incident to the practitioner's administering or
dispensing of a controlled substance in the course of the practitioner's
professional practice; or
(2) by a practitioner or by the practitioner's authorized agent under
such practitioner's supervision for the purpose of or as an incident to
research, teaching or chemical analysis or by a pharmacist or medical care
facility as an incident to dispensing of a controlled substance.
(aa) "Marijuana" means all parts of all varieties of the plant Cannabis
whether growing or not, the seeds thereof, the resin extracted from any
part of the plant and every compound, manufacture, salt, derivative,
mixture or preparation of the plant, its seeds or resin. It does not include:
(1) The mature stalks of the plant, fiber produced from the stalks, oil
or cake made from the seeds of the plant, any other compound,
manufacture, salt, derivative, mixture or preparation of the mature stalks,
except the resin extracted therefrom, fiber, oil or cake or the sterilized seed
of the plant that is incapable of germination;
(2) any substance listed in schedules II through V of the uniform
controlled substances act;
(3) drug products approved by the United States food and drug
administration as of the effective date of this act;
(4) cannabidiol (other trade name: 2-[(3-methyl-6-(1-methylethenyl)-
2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol); or
(5) industrial hemp as defined in K.S.A. 2-3901, and amendments
thereto, when cultivated, produced, possessed or used for activities
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authorized by the commercial industrial hemp act.
(bb) "Medical care facility" shall have the meaning ascribed to that
term means the same as defined in K.S.A. 65-425, and amendments
thereto.
(cc) "Mid-level practitioner" means a certified nurse-midwife
engaging in the independent practice of midwifery under the independent
practice of midwifery act, an advanced practice registered nurse issued a
license pursuant to K.S.A. 65-1131, and amendments thereto, who has
authority to prescribe drugs under K.S.A. 65-1130, and amendments
thereto, or a physician assistant licensed under the physician assistant
licensure act who has authority to prescribe drugs pursuant to a written
agreement with a supervising physician under K.S.A. 65-28a08, and
amendments thereto.
(dd) "Narcotic drug" means any of the following whether produced
directly or indirectly by extraction from substances of vegetable origin or
independently by means of chemical synthesis or by a combination of
extraction and chemical synthesis:
(1) Opium and opiate and any salt, compound, derivative or
preparation of opium or opiate;
(2) any salt, compound, isomer, derivative or preparation thereof that
is chemically equivalent or identical with any of the substances referred to
in paragraph (1) but not including the isoquinoline alkaloids of opium;
(3) opium poppy and poppy straw;
(4) coca leaves and any salt, compound, derivative or preparation of
coca leaves, and any salt, compound, isomer, derivative or preparation
thereof that is chemically equivalent or identical with any of these
substances, but not including decocainized coca leaves or extractions of
coca leaves that do not contain cocaine or ecgonine.
(ee) "Opiate" means any substance having an addiction-forming or
addiction-sustaining liability similar to morphine or being capable of
conversion into a drug having addiction-forming or addiction-sustaining
liability. It does not include, unless specifically designated as controlled
under K.S.A. 65-4102, and amendments thereto, the dextrorotatory isomer
of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). It does
include its racemic and levorotatory forms.
(ff) "Opium poppy" means the plant of the species Papaver
somniferum l. except its seeds.
(gg) "Person" means an individual, corporation, government, or
governmental subdivision or agency, business trust, estate, trust,
partnership or association or any other legal entity.
(hh) "Pharmacist" means any natural person licensed under K.S.A.
65-1625 et seq., and amendments thereto, to practice pharmacy.
(ii) "Pharmacist intern" means: (1) A student currently enrolled in an
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accredited pharmacy program; (2) a graduate of an accredited pharmacy
program serving such person's internship; or (3) a graduate of a pharmacy
program located outside of the United States that is not accredited and who
had successfully passed equivalency examinations approved by the board.
(jj) "Pharmacy prescription application" means software that is used
to process prescription information, is installed on a pharmacy's computers
and servers, and is controlled by the pharmacy.
(kk) "Poppy straw" means all parts, except the seeds, of the opium
poppy, after mowing.
(ll) "Practitioner" means a person licensed to practice medicine and
surgery, dentist, podiatrist, veterinarian, optometrist, or scientific
investigator or other person authorized by law to use a controlled
substance in teaching or chemical analysis or to conduct research with
respect to a controlled substance.
(mm) "Prescriber" means a practitioner or a mid-level practitioner.
(nn) "Production" includes the manufacture, planting, cultivation,
growing or harvesting of a controlled substance.
(oo) "Psilocybin" does not include the pharmaceutical composition of
crystalline polymorph psilocybin, known as COMP 360 or any such trade
name approved by the United States food and drug administration.
(pp) "Readily retrievable" means that records kept by automatic data
processing applications or other electronic or mechanized recordkeeping
systems can be separated out from all other records within a reasonable
time not to exceed 48 hours of a request from the board or other authorized
agent or that hard-copy records are kept on which certain items are
asterisked, redlined or in some other manner visually identifiable apart
from other items appearing on the records.
(pp)(qq) "Ultimate user" means a person who lawfully possesses a
controlled substance for such person's own use or for the use of a member
of such person's household or for administering to an animal owned by
such person or by a member of such person's household.
Sec. 2. On and after the date of publication in the Kansas register of
the notice prescribed in section 3, K.S.A. 2024 Supp. 65-4111 is hereby
amended to read as follows: 65-4111. (a) The controlled substances listed
in this section are included in schedule IV and the number set forth
opposite each drug or substance is the DEA controlled substances code
that has been assigned to it.
(b) Any material, compound, mixture or preparation that contains any
quantity of the following substances including its salts, isomers and salts
of isomers whenever the existence of such salts, isomers and salts of
isomers is possible within the specific chemical designation and having a
potential for abuse associated with a depressant effect on the central
nervous system:
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(1)Alprazolam.............................................................................2882
(2)Barbital...................................................................................2145
(3)Brexanolone...........................................................................2400
(4)Bromazepam .........................................................................2748
(5) Camazepam............................................................................2749
(6) Carisoprodol...........................................................................8192
(7) Chloral betaine.......................................................................2460
(8) Chloral hydrate.......................................................................2465
(9) Chlordiazepoxide...................................................................2744
(10) Clobazam................................................................................2751
(11) Clonazepam............................................................................2737
(12) Clorazepate.............................................................................2768
(13) Clotiazepam............................................................................2752
(14) Cloxazolam............................................................................2753
(15) Daridorexant...........................................................................2410
(16)Delorazepam..........................................................................2754
(17) Diazepam................................................................................2765
(18) Dichloralphenazone................................................................2467
(19) Estazolam...............................................................................2756
(20) Ethchlorvynol.........................................................................2540
(21) Ethinamate..............................................................................2545
(22) Ethyl loflazepate.....................................................................2758
(23) Fludiazepam...........................................................................2759
(24) Flunitrazepam.........................................................................2763
(25) Flurazepam.............................................................................2767
(26) Fospropofol............................................................................2138
(27) Halazepam..............................................................................2762
(28) Haloxazolam..........................................................................2771
(29) Ketazolam..............................................................................2772
(30) Lemborexant..........................................................................2245
(31)Loprazolam............................................................................2773
(32)Lorazepam..............................................................................2885
(33) Lormetazepam........................................................................2774
(34) Mebutamate............................................................................2800
(35) Medazepam............................................................................2836
(36) Meprobamate..........................................................................2820
(37) Methohexital..........................................................................2264
(38) Methylphenobarbital (mephobarbital)...................................2250
(39) Midazolam..............................................................................2884
(40) Nimetazepam..........................................................................2837
(41) Nitrazepam.............................................................................2834
(42) Nordiazepam..........................................................................2838
(43) Oxazepam...............................................................................2835
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(44) Oxazolam...............................................................................2839
(45) Paraldehyde............................................................................2585
(46) Petrichloral.............................................................................2591
(47) Phenobarbital..........................................................................2285
(48) Pinazepam..............................................................................2883
(49) Prazepam................................................................................2764
(50) Quazepam...............................................................................2881
(51) Remimazolam........................................................................2846
(52) Temazepam.............................................................................2925
(53) Tetrazepam.............................................................................2886
(54) Triazolam...............................................................................2887
(55) Zolpidem................................................................................2783
(56) Zaleplon..................................................................................2781
(57) Zopiclone................................................................................2784
(58) Alfaxalone..............................................................................2731
(59) Suvorexant..............................................................................2223
(c) Any material, compound, mixture or preparation that contains any
quantity of lorcaserin (1625), including its salts, isomers and salts of such
isomers, whenever the existence of such salts, isomers and salts of isomers
is possible (21 U.S.C. § 812; 21 C.F.R. § 1308.14).
(d) Unless specifically excepted or unless listed in another schedule,
any material, compound, mixture or preparation that contains any quantity
of the following substances having a stimulant effect on the central
nervous system, including its salts, isomers (whether optical, position or
geometric) and salts of such isomers whenever the existence of such salts,
isomers and salts of isomers is possible within the specific chemical
designation:
(1)Cathine ((+)-norpseudoephedrine).........................................1230
(2)Diethylpropion.......................................................................1610
(3)Fencamfamin..........................................................................1760
(4)Fenproporex...........................................................................1575
(5)Mazindol................................................................................1605
(6)Mefenorex..............................................................................1580
(7)Pemoline (including organometallic
complexes and chelates thereof)............................................1530
(8)Phentermine............................................................................1640
The provisions of subsection (d)(8) shall expire on the date
phentermine and its salts and isomers are removed from schedule IV of the
federal controlled substances act (21 U.S.C. § 812; 21 C.F.R. § 1308.14).
(9)Pipradrol.................................................................................1750
(10)Serdexmethylphenidate..........................................................1729
(11)SPA((-)-1-dimethylamino-1, 2-diphenylethane)....................1635
(12)Sibutramine............................................................................1675
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(13)Solriamfetol (2-amino-3-phenylpropyl carbamate;
benzenepropanol, beta-amino-, carbamate (ester))................1650
(14)Mondafinil..............................................................................1680
(e) Unless specifically excepted or unless listed in another schedule,
any material, compound, mixture or preparation that contains any quantity
of the following, including salts thereof:
(1)Pentazocine............................................................................9709
(2)Butorphanol (including its optical isomers)...........................9720
(3)Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-
dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-
yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its
optical isomers) and its salts, isomers, and salts of isomers. .9725
(f) Unless specifically excepted or unless listed in another schedule,
any material, compound, mixture or preparation containing any of the
following narcotic drugs, or their salts calculated as the free anhydrous
base or alkaloid, in limited quantities as set forth below:
(1)Not more than 1 milligram of difenoxin and not less than 25
micrograms of atropine sulfate per dosage unit.....................9167
(2)Dextropropoxyphene (alpha-(+)-4-dimethylamino-1, 2-diphenyl-
3-methyl-2-propion-oxybutane).............................................9278
(3)2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol,
its salts, optical and geometric isomers and salts of these isomers
(including tramadol)...............................................................9752
(g) Butyl nitrite and its salts, isomers, esters, ethers or their salts.
(h) Any pharmaceutical composition of crystalline polymorph
psilocybin approved by the United States food and drug administration.
(i) The board may except by rule and regulation any compound,
mixture or preparation containing any depressant substance listed in
subsection (b) from the application of all or any part of this act if the
compound, mixture or preparation contains one or more active medicinal
ingredients not having a depressant effect on the central nervous system,
and if the admixtures are included therein in combinations, quantity,
proportion or concentration that vitiate the potential for abuse of the
substances that have a depressant effect on the central nervous system.
New Sec. 3. When the pharmaceutical composition of crystalline
polymorph psilocybin is approved as a drug product by the United States
food and drug administration, the attorney general shall certify such drug
product's approval to the secretary of state within seven days after its
approval. Upon receipt of such certification, the secretary of state shall
publish such certification in the Kansas register.
Sec. 4. On and after the date of publication in the Kansas register of
the certification prescribed in section 3, K.S.A. 2024 Supp. 65-4101 and
K.S.A. 65-4111 is hereby repealed.
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Sec. 5. This act shall take effect and be in force from and after its
publication in the statute book.
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