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STATE OF OKLAHOMA
1st Session of the 59th Legislature (2023)
COMMITTEE SUBSTITUTE
FOR
HOUSE BILL NO. 2107 By: Pae
COMMITTEE SUBSTITUTE
An Act relating to controlled dangerous substances ;
creating the Oklahoma Psilocybin Research Pilot
Program; authorizing certain entities to conduct
scientific research related to psilocybin and
psilocyn; specifying certain uses for which
scientific research is authorized; limiting number of
memoranda of agreement that universities or
institutions of higher education may enter into;
imposing requirements with respect to studies;
requiring registration wi th the State Department of
Health and the Oklahoma Department of Agriculture,
Food, and Forestry; prescribing requirements for
registration information; providing for specified
nonrefundable fees; requiring additional registration
with the Oklahoma State Bureau of Narcotics and
Dangerous Drugs Control; stipulating duration of
registration; requiring certain notification of
change of facility location; requiring written
certifications for Pilot Program participants;
prescribing content of written certifications;
providing for expiration of certifications; providing
immunity to persons conducting or participating in
the Pilot Program; requiring submission of written
reports by certain date; providing for
confidentiality of certain personal information;
requiring specified agencies to maintain
confidentiality with respect t o information;
directing promulgation of rules; amending 63 O.S.
2021, Section 2-303, which relates to Oklahoma State
Bureau of Narcotics and Dangerous Drugs Control
registration; creating certain fee; providing for
codification; and providing an effective date.
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BE IT ENACTED BY THE PE OPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-811 of Title 63, unless there
is created a duplication in numbering, reads as follows:
A. This act shall be known and may be cited as the " Oklahoma
Psilocybin Research Pilot Program ".
B. A university or other institution of higher education
located in this state, or a research facility that has entered into
a memorandum of agreement with a university or ins titution of higher
education located in this state, may conduct scientific research on
psilocybin and psilocyn for the treatment of persons ei ghteen (18)
years of age or older who experience any of the following medical
conditions:
1. Post-traumatic stress disorder;
2. Treatment-resistant/refractory depression;
3. Treatment-resistant/refractory anxiety;
4. Treatment-resistant/refractory obsessive-compulsive
disorder;
5. Traumatic brain injury;
6. Early-stage dementia;
7. Palliative care;
8. End-of-life care;
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9. Opioid use disorder; or
10. Moderate to severe chronic pain.
C. The university or institution of higher education may enter
into no more than one memorandum of agreement with a resear ch
facility for the purposes of c onducting scientific research under
this section.
D. In conducting such scientific research as described in
subsection B of this section, the studies shall:
1. Study the therapeutic efficacy of using psilocybin or
psilocyn in the treatment of the medical conditions listed in
subsection B of this section;
2. Review the current literature regarding:
a. the safety and efficacy of using psiloc ybin or
psilocyn in the treatment of the medical conditions
listed in subsection B of this section, and
b. the access persons have to psilocybin and psilocyn for
the treatment of the medical conditions listed in
subsection B of this section; and
3. Examine the science of cultivation, synthesis, extraction,
and processing of psilocybin an d psilocyn as well as the fungi,
yeasts, and other naturally o ccurring source organisms of these
molecules.
E. 1. Eligible entities as described in subsection B of this
section shall register with the State Department of Health and the
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Oklahoma Department of Agriculture, Food, and For estry prior to and
for the purposes of growing, studying, processing, or dispensing
psilocybin-containing fungi or other naturally occurring source
organisms, or studying, extracting, synthesizing, or dispensing
psilocybin or psilocyn. The registration submission information
shall include:
a. the name and address of the research facility,
b. a prospectus approved by a university or other
institution of higher education, and
c. certification from the institutional review board of
the university or institution of higher education if
human trials are part of the research.
2. By registering, the registrant acknowledges and agrees that:
a. the information contained in the registration
submissions may be provided to law enforcement
agencies, and
b. the registrant shall submit an annual report detailing
compliance with annual regulation requirements.
3. The State Department of Health shall collect a one-time,
nonrefundable fee of Five Hundred Dollars ($500.00) from the
registrant at the time of registration and the Oklahoma Department
of Agriculture, Food, and Forestry shall collect a one-time
nonrefundable fee of One Hundred Dollars ($100.00) from the
registrant at the time of registration. The registrant shall, upon
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completion of registration with the State Department of Health and
the Oklahoma Department of Agriculture, Food, and Forestry, register
with the Oklahoma State Bureau of Narcotics an d Dangerous Drugs
Control as provided by Section 2-301 et seq. of Title 63 of the
Oklahoma Statutes annually for as long as the research re mains
active.
4. Registration under this subsection is valid for one (1)
year, effective upon confirmation and receipt of all registrations
required by this subsection. Notwithstanding the registration fee
listed in Section 2 of th is act, the registration required by this
subsection shall satisfy and supersede all other registration and
reporting requirements otherwise impose d by state law.
5. Should the registrant change facility locations for the
cultivation, testing, synthesis, storage, or dispensing of
psilocybin or psilocyn, it shall report such changes within fourteen
(14) business days to the State Department of Health, the Oklahoma
Department of Agriculture, Food, and Forestry, and the Oklahoma
State Bureau of Narcotics and Dangerous Drugs Control.
F. 1. A written certification shall be issued to persons
qualifying for participation in the pilot program described in this
section by a physician participating in the pilot program. The
written certification shall contain the following:
a. the name, address, and telephone number of the issu ing
physician,
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b. the name and address of the patient to whom the
written certification is issued,
c. the date on which the written certification was made,
d. the signature of the physician,
e. the quantity of psilocybin or psilocyn to be
dispensed, and
f. the form of psilocybin or psilocyn to be dispensed.
2. The written certification issued under this subsection shall
expire one (1) year after its issuance unless the written
certification specifies an earlier date of exp iration.
G. 1. A scientific researcher or physician operating under a
valid registration issued in accordance with this section shall not
be subject to arrest, prosecution, or any civil or administrative
penalty for the possession, cultivation, synthesis, extraction, or
distribution of psilocybin or psilocyn insofar as the scientific
researcher's or physician's conduct is in compliance with the
provisions of this section.
2. A patient participating in the pilot program under a valid
written certification issued in accordance with this sec tion shall
not be subject to arrest, prosecutio n, or any civil or
administrative penalty for the use or possession of psilocybin or
psilocyn insofar as the patient's conduct is in compliance with t he
provisions of this section.
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3. In any prosecution invol ving possession of psilocybin or
psilocyn as those terms are specified in subsection C of Section 2-
204 of Title 63 of the Oklahoma Statutes, it shall be an affirmati ve
defense if a person can demonstrate by clear and convincing evidence
that he or she has one or more of the qualifying medical conditions
or circumstances listed in subsection B of this section. This
subsection shall not be understood to be the decrimin alization of
psilocybin or psilocyn.
H. Researching entities shall submit a written report to the
President Pro Tempore of the Oklahoma State Senate and the Speaker
of the Oklahoma House of Representatives containing the results of
the studies conducted under this section and any recommendations for
legislative or other actions not later than December 1, 2026.
I. Researching entities shall ensure any protected health
information collected during the pilot program done in accordance
with this section does not personally identify any individual.
J. The State Department of Health, the Oklahoma Department of
Agriculture, Food, and Forestry, the Oklahoma State Bureau of
Narcotics and Dangerous Drugs Control, and any other state agency
with access to the research programs authorized by this section
shall not release or allow to be released through i naction any
protected health information. The protected health information of
pilot program participants shall be exempt from the Oklahoma Open
Records Act.
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K. The State Commissioner of Health, the State Board of
Agriculture, and the Director of the Oklahoma State Bureau of
Narcotics and Dangerous Drugs Control shall promulgate rules
necessary to implement the program authorized in this section.
SECTION 2. AMENDATORY 63 O.S . 2021, Section 2-303, is
amended to read as fol lows:
Section 2-303. A. The Director of the Oklahoma State Bureau of
Narcotics and Dangerous Drugs Control shall register an applicant to
own a medical facility as described in subsection C of Section 2 -302
of this title, or to manufacture, distribu te, dispense, prescribe,
administer or use for scientific purposes controlle d dangerous
substances included in Schedules I through V of Section 2-101 et
seq. of this title unless th e Director determines that the i ssuance
of such registration is inconsisten t with the public interest. In
determining the public interest, the followi ng factors shall be
considered:
1. Maintenance of effective controls against diversion of
particular controlled dangerous substances and any Schedule I or II
substance compounded therefrom into other than legitimate medical,
scientific or industrial chann els, including examination of the
fitness of his or her employees or agents to handle dangerous
substances;
2. Compliance with applicabl e state and local law;
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3. Has been found g uilty of, entered a plea of guilty or nolo
contendere to a charge under the Uniform Controlled Dangerous
Substances Act or any other state or federal law relating to any
substance defined herein as a controlled da ngerous substance or any
felony under the laws of any state or the United States;
4. Furnishing by the applicant false or fraudulent material
information in any application filed under Section 2-101 et seq. of
this title;
5. Past experience in the manufa cture, distribution,
dispensing, prescribin g, administering or use for scientific
purposes of controlled dangerous subs tances, and the existence in
the establishment of effective controls against diversion;
6. Denial, suspension or revocation of the appli cant's federal
registration to manufacture, distribute or dispense controlled
dangerous substances as authorized by fed eral law; and
7. Such other factors as may be relevant to and consistent with
the public health and safe ty.
Nothing herein shall be deem ed to require individual licensed
pharmacists to register under the provisions of the Uniform
Controlled Dangerous Subs tances Act.
B. Registration granted under subsection A of this section
shall not entitle a registrant to manufacture, distribute, dispen se,
prescribe, administer or use for scient ific purposes controlled
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dangerous substances in Schedule I or II other than those specified
in the registration.
C. Practitioners shall be registered to dispense, prescribe,
administer or use for scientific purp oses controlled dangerous
substances in Schedules II thro ugh V if they are authorized to carry
on their respective activities under the laws of this state. A
registration application by a practitioner who wishes to conduct
research with Schedule I sub stances shall be accompan ied by evidence
of the applicant's federal registration to conduct such activity and
shall be referred to the Medical Research Commission for advice.
The Medical Research Commission shall promptly advise the Director
concerning the qualifications of each practitioner requesting such
registration. Registration for the purpose of bona fide research or
of use for scientific purposes with Schedule I substan ces by a
practitioner deemed qualified by the Medical Research Commission may
be denied only on a ground specified in subsection A of Section 2-
304 of this title or if there are reasonable grounds to believe that
the applicant will abuse or unlawfully tran sfer such substances or
fail to safeguard adequately such applicant 's supply of such
substances against diversion from legitimate medi cal or scientific
use.
D. 1. The Director shall initially permit persons to r egister
who own or operate any establishmen t engaged in the manufacture,
distribution, dispensing, prescribing, administer ing or use for
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scientific purposes of any controlled da ngerous substances prior to
June 4, 1991, and who are registered or licensed by the state. Fees
for registration under th is section shall be as follows:
Practitioners and mid-level
practitioners $140.00 per year
of registration
Home Care Agencies, Hospic es &
Home Care Services $140.00 annually
Medical Facility Owners $300.00 annually
Distributors $300.00 annually
Manufacturers $500.00 annually
Manufacturer, Wholesaler, or
Distributor of drug products
containing pseudoephedrin e
or phenylpropanolamine $300.00 annually
Researchers of psilocybin or
psilocyn $140.00 annually
2. A registrant shall be required to pay double the am ount of
the above-listed fee for any ren ewal of registration received more
than thirty (30) days late.
3. A Ten Dollar ($10.00) fee s hall be charged for a duplicate
registration certificate.
E. Compliance by manufacturers and distributors with the
provisions of the Federal Controlled Substance s Act, 21 U.S.C.,
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Section 801 et seq., respecting registration, e xcluding fees, shall
be deemed sufficient to qualify for registration under this act
Section 2-101 et seq. of this title.
SECTION 3. This act shall become effective November 1, 2023.
59-1-7479 JL 02/15/23