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ENGROSSED HOUSE
BILL NO. 3414 By: Pae, Phillips, Rosecrants,
McEntire, Martinez,
Dempsey, Dollens, Humphrey,
Echols, Talley, McDugle ,
Davis, Manger, Walke,
Brewer, and Munson of the
House
and
Paxton of the Senate
An Act relating to public health and safety;
authorizing certain governmental entities to conduct
research or medical trials r elated to psilocybin and
psilocin; specifying certain medic al conditions for
which research or clinical trials authorized;
authorizing universities or institutions of higher
education to enter into memoranda of agreement;
imposing requirements with respect to studies;
requiring registration with the Oklahoma State
Department of Health; requiring license; prescribing
requirements for registration information; providing
for nonrefundable fee; specifying fee amount;
providing for duration of re gistration; requiring
additional registration with the Oklahoma Department
of Agriculture, Food, and Forestry; prescribing
content of registration; authorizing nonrefundable
fee; prescribing fee amount; requiring administrative
rules; providing immunity for certain persons
conducting activity pursuant to valid license;
providing for written certifications; prescribing
content thereof; providing for expiration of
certifications; providing immunity to certain persons
for participation in clinical trials; providing for
certain quantities of substance as basis for
immunity; providing for applicability of Uniform
Controlled Dangerous Substances Act; providing for
assertion of affirmative defense; providing for
effect of registrations; requiring written reports;
imposing deadline; providing for confidentiali ty of
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certain personal information; requiring enumerated
agencies to maintain confidentiality with respect to
information; and providing for codification.
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
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 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.
B. Each university and institution of higher education l ocated
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:
1. Perform clinical trials on the therapeutic efficacy of using
psilocybin or psilocin in the treatment of the aforementione d
medical conditions;
2. Review the current literature regarding:
a. the safety and efficacy of using psiloc ybin 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, synthesis, 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 register with the State Department of Health for a
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license prior to and for the purposes of gro wing, studying,
processing, and/or dispensing psilocybin-containing fungi or other
naturally occurring source organisms, or studying, extracting,
synthesizing, and/or dispensing psilocybin or psil ocin. The
registration submission information shall include:
a. the name and address of the resea rch facility,
b. a research-university-approved prospectus, and
c. certification from the university's or institution of
higher education's institutional revi ew board if human
trials are part of the research .
2. By registering, the registrant acknowledges and agrees that:
a. the information contained in th e 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 Department shall collect a one-time nonrefundable fee of
Five Hundred Dollars ($500.00) from the registrant at the time of
application, and the applicant shall, upon completion of
registration, register with the Oklahoma State Bureau of Narcotics
and Dangerous Drugs Control with a fee of Five Hundred Dollars
($500.00), to be paid annually so long as the research re mains
active.
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4. Registration pursuant to this act is valid for one (1) year,
effective from confirmation and receipt of both the State Department
of Health registration and Oklahoma State Bureau of Narcotics and
Dangerous Drugs Control registration .
5. Within fourteen (14) busin ess days of receiving their State
Department of Health registration and receipt of confirmation of
Oklahoma State Bureau of Narcotics and Dangerous Drugs Control
registration, cultivators of psilo cybin- or psilocin-containing
fungi or plants shall also reg ister with the Oklahoma Department of
Agriculture, Food, and For estry (ODAFF). ODAFF registrations shall
include:
a. the name and address of the cultivation facility ,
b. a copy of the approved research prospectus submitted
to the State Department of Health, and
c. copies of the State Department of Health registration
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 registrant change facility locations for the
cultivation, testing, synthesis, storage , or dispensing of
psilocybin or psilocin, it shall report such changes within fourteen
(14) business days to the State Department of Health and to the
Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
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8. The State Department of Health shall promulgate rules and
regulations necessary to implement the program authorized herein.
9. Researchers and physicians operating under a valid
registration issued in accordance with this act shall not be subject
to arrest, prosecution, or any civil or administrative penalty, for
the possession, cultivation, synthesis, extraction, or distribution
of psilocybin and psilocin insofar as their conduct is in compliance
with the provisions of this act.
E. 1. A written certification shall be issued to persons
qualifying for participation by a physician participating 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,
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 one (1) year after its issuance unless such written
certification specifies an earlier date of exp iration.
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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, prosecutio n, or any civil or adminis trative penalty, for
the possession of psilocybin and psilocin insofar as their
possession is in compliance with the provi sions of this act. A
person without a registration license 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 plants or
their unlawful distribution shall remai n subject to the penalties as
stated under the Uniform Controlled Dangerous Subs tances 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 def ense that
the person is in possession of psilocybin or psilo cin pursuant to
this act. Researchers so charged shall file a copy of their State
Department of Health registration and Bureau registration pursuant
to this act with the court of jurisdiction at least ten (10) days
prior to trial. Such registrations shall be presumptive evidence
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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 certi fication pursuant to this act with
the court of jurisdiction at least ten (10) days prior to trial.
Such written certification shall be presumptive evidence that
psilocybin or psilocin was possessed pursuant 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. Researching 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.
J. The State Department of Health, the Oklahoma State Bureau
of Narcotics and Dangerous 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 cl inical
trial participants shall be exempt from the Oklahoma Open Records
Act.
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Passed the House of Representatives the 7th day of March, 2022.
Presiding Officer of the House
of Representatives
Passed the Senate the ___ day of __________, 2022.
Presiding Officer of the Senate