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STATE OF OKLAHOMA
2nd Session of the 58th Legislature (2022)
HOUSE BILL 3414 By: Pae
AS INTRODUCED
An Act relating to public health and safety ;
providing for the establishment of statewide
investigational clinical trials; authorizing
physicians to serve as principal investigators for
clinical trials under certain circumstances;
directing investigators to adhere to certain rules
and regulations; permitting Oklaho ma State Bureau of
Narcotics and Dangerous Drugs Control to inspect
facilities and certain samples; providing guidelines
for conducting clinical trials; providing exemptions
from criminal or civil penalties; permitting
Commissioner of Health to perfo rm certain acts;
requiring clinical trials to comply with certain
standards; providing termination date; requiring
certain approval for continuation of clinical trials;
requiring submission of certain report; specifying
contents of report; directing promulgation of rules
by certain entities; providing for codification;
providing an effectiv e date; and declaring an
emergency.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 3600 of Title 63, unless there
is created a duplication in numbering, reads as fol lows:
A. Universities, institutions of higher education located in
Oklahoma, and research facilities that have entered into a
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memorandum of agreement with a university or ins titution of higher
education located in Oklahoma are hereby authorized to conduct
scientific research and medical trials on psilocybin and psilocin
for the treatment of persons eighteen (18) years of age or older who
suffer from the following:
1. Post-traumatic stress disorder;
2. Treatment-resistant/refractory depression;
3. Treatment-resistant/refractory anxiety;
4. Treatment-resistant/refractory ob sessive compulsive
disorder;
5. Traumatic brain injury;
6. Early stage dementia;
7. Palliative care;
8. End-of-life care;
9. Opioid use disorder; or
10. Moderate to severe chronic pain.
B. Each university and institution of higher education located
in Oklahoma shall be permitted to enter into no more than one
memorandum of agreement with a research facility for the purposes of
conducting research pursuant to this act.
C. In conducting such research as described in subsection A of
this section, the studies shall:
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1. Perform clinical trials on the therapeutic efficacy of using
psilocybin or psilocin in the treatment of the aforementioned
medical conditions;
2. Review the current literature regarding:
a. the safety and efficacy of using psilocybin or
psilocin in the treatment of the aforementioned
medical conditions, and
b. the access persons have to psilocybin and psilocin for
the treatment of the aforementioned medical
conditions; and
3. Examine the science of cultivation, s ynthesis, extraction,
and processing of psilocybin an d psilocin as well as the fungi,
yeasts, and other naturally occu rring source organisms of these
molecules.
D. 1. Eligible entities as described in subsection A of this
section shall apply to the State Department of Health for a license
prior to and for the purposes of gro wing, studying, processing ,
and/or dispensing psilocybin containing fungi or other natur ally
occurring source organisms, or studying, extracting, synthesizing,
and/or dispensing psilocybin or psil ocin. The application shall
include:
a. the name and address of the resea rch facility,
b. a one- to three-page research prospectus, and
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c. if part of a postsecondary institution, proper
certification from the institution's internal revi ew
board if human trials are to be part of the research.
2. By submitting the app lication, the applicant acknowledges
and agrees that:
a. the information contained in th e application may be
provided to law enforcement agencies,
b. the applicant and any entit ies contracting with the
applicant shall allow and fully cooperate with any
inspections and sampling the Department deems
necessary, and
c. the applicant shall, should its application be
approved, submit all required reports by the
applicable deadlines specified by the Department.
3. The Department shall collect a one-time nonrefundable fee of
Five Hundred Dollars ($500.00) from the applicant at the time of
application, and the applicant shall, upon approval, register with
the Oklahoma State Bureau of Narcotics and Dan gerous Drugs Control
with a fee of Five Hundred Dollars ($500.00), to be paid annually so
long as the research re mains active. Denied applications for a
license may be resubmitted. The Department may waive the fee for
resubmitting applications. The Department may only reject an
application based upon failure to meet the criteria stated herein or
improper completion of the applica tion.
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4. A license issued pursuant to this act is valid for one (1)
year, effective from the approv al date of this act, and may be
renewed if the licensee remains in good standing. The Department
may set a separate fee schedule for renewals of existing licenses.
5. Within fourteen (14) business days of receiving their State
Department of Health license and receipt of confirmation of Oklahoma
State Bureau of Narcotics and Dangerous Drugs Control registration,
cultivators of psilocybin - or psilocin-containing fungi or plants
shall also register with the Oklahoma Department of Agriculture,
Food, and Forestry (ODAFF). ODAFF registrations shall include:
a. the name and address of the cultivation facility ,
b. a copy of the research prospectus submitted to the
State Department of Health, and
c. copies of the State Department of Health license and
Bureau registration;
6. The ODAFF shall collect a one -time nonrefundable fee of One
Hundred Dollars ($100.00) from the cultivator licensee at the time
of registration.
7. Should the licensee change facility locations for the
cultivation, testing, synthesis, storage or dis pensing of psilocybin
or psilocin, it shall report such changes within fourteen (14)
business days to the Department and to the Oklahoma State Bureau of
Narcotics and Dangerous Drugs Control.
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8. The Department shall promulgate rules and regulations
necessary to implement the program authorized herein within ninety
(90) days of the effective date of this act .
9. Researchers and medical practitioners operating under a
valid license issued in accordance with this act shall not be
subject to arrest, prosecution, or any civil or administrative
penalty, for the possession, cultiva tion, synthesis, extraction, or
distribution of psil ocybin and psilocin insofar as their conduct is
in compliance with the provisions of this act.
10. The State Department of Health may deny, revok e, or suspend
a license if the licensee violates any provisions o f this act,
engages in fraud or deception with respe ct to any reporting
requirements stipulat ed by the State Department of Health or the
Bureau, refuses or fails to cooperate with an inspection, is no
longer operating within or under a memorandum of agreement with an
Oklahoma university or research facility, or refuses or fails to
provide any information required or requested by the State
Department of Health or the Bureau for purposes related to this act,
or refuses or fails to pay fees required under this act.
E. 1. A written certification shall be issued to persons
qualifying for participation in a clinical trial described herein.
Such 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 issued the
certification,
c. the date on which the written certification was made,
d. the signature of the physician,
e. the quantity of psilocybin or psilocin to be
dispensed, and
f. the form of psilocybin or psilocin to be dispensed.
2. Such written certification issu ed pursuant to this act shall
expire no later than one ( 1) year after its issuance unless such
written certification spe cifies an earlier date of exp iration.
F. Persons with a valid written certificatio n for participation
in a clinical trial as autho rized by this act shall not be subject
to arrest, prosecution, or any civil or adminis trative penalty, for
the possession of psilocybin and psilocin insofar as their
possession is in com pliance with the provi sions of this act. A
person without a valid lice nse as described in subsection D of this
section, without a written certification for participation in a
clinical trial as described in subsection E of this section, or
otherwise not in complian ce with the provision s of this act who is
in possession of less than o ne and one-half (1.5) ounces of
psilocybin- or psilocin-containing fungi or p lants shall be subject
to no more than a civil penalty of Four Hundred Dollars ( $400.00);
however possession in amounts more than one and one-half (1.5)
ounces of psilocybin - or psilocin-containing fungi or pla nts or
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their unlawful distribution shall remai n subject to the penalties as
stated under this act.
G. In any prosecution involving psilocybin or psilocin as
those terms are defined in subsection C of Section 2-204 of Title 63
of the Oklahoma Statutes , it shall be an affirmative defense that
the person is in possession of psilocybin or psilocin pu rsuant to
this act. Researchers so charged shall file a copy of their State
Department of Health and Bureau licenses pursuant to this act with
the court of jurisdiction at least ten (10) days prior to trial.
Such licenses shall be presumptive evidence that the psilocybin or
psilocin was possessed pursuant to this act. Persons participating
in a clinical trial who are so charged shall file a copy of their
written certification pursuant to this act with the co urt of
jurisdiction at least ten (10) days prior to trial. Such written
certification shall be presumptive evidence that psilocybin or
psilocin was possessed p ursuant to this act.
H. Study researchers shall submit a written report containing
the results of the studies conducted under this act and any
recommendations for legislative or other actions not later than
December 1, 2025.
I. Investigating entities shall ensure any protected health
information collected during the clinical trial s done in accordance
with this act does not personally identify any individual.
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J. The State Department of Health, the Oklahoma State Bureau
of Narcotics and Dangero us Drugs Control, the Oklahoma Department of
Agriculture, Food, and Forestry, and any other state agency w ith
access to the research programs authorized by this act shall n ot
release or allow to be released through inaction any protected
health information. The protected health information of clinical
trial participants shall be exempt from the Oklahoma Open Records
Act.
SECTION 2. This act shall become effective July 1, 2022.
SECTION 3. It being immediately necess ary for the preservation
of the public peace, health or safety, an emergency is hereby
declared to exist, by reaso n whereof this act shall take effect and
be in full force from and after it s passage and approval.
58-2-8859 KN 01/17/22