STATE OF OKLAHOMA
1st Session of the 59th Legislature (2023)
HOUSE BILL 2107 By: Pae
AS INTRODUCED
An Act relating to controlled dangerous substances ;
authorizing certain entities to conduct scientific
research and clinical trials related to psilocybin
and psilocyn; specifying certain uses for which
scientific research or clinical trials are
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 with 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 clinical trial
participants; prescribing content of written
certifications; providing for expiration of
certifications; providing immunity to persons
conducting or participating in research or clinical
trials; requiring submission of written reports by
certain date; providing for confidentiality of
certain personal information; req uiring 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.
Req. No. 5332 Page 2
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. 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 and
clinical trials on psilocybin and psilocyn for the treatment of
persons eighteen (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;
9. Opioid use disorder; or
10. Moderate to severe chronic pain.
B. The university or institution of higher education may enter
into no more than one memorand um of agreement with a resear ch Req. No. 5332 Page 3
facility for the purposes of c onducting scientific research under
this section.
C. In conducting such scientific research as described in
subsection A of this section, the studies shall:
1. Perform clinical trials on the therapeutic efficacy of using
psilocybin or psilocyn in the treatment of the medical conditions
listed in subsection A 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 A of this section, and
b. the access persons have to psilocybin and psilocyn for
the treatment of the medical conditions listed in
subsection A 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.
D. 1. Eligible entities as described in subsection A of this
section shall register with the State Department of Health and the
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 Req. No. 5332 Page 4
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
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 Req. No. 5332 Page 5
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. The registration required by this
subsection shall satisfy and supersede all other 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 F orestry, and the Oklahoma
State Bureau of Narcotics and Dangerous Drugs Control.
E. 1. A written certification shall be issued to persons
qualifying for participation in a clinical trial described in this
section by a physician participating in the clinical trial. The
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 to whom the
written certification is issued,
c. the date on which the written certificati on was made,
d. the signature of the physician, Req. No. 5332 Page 6
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 expiration.
F. 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 psil ocybin 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 a clinical trial under a valid
written certification issued in accordance with this section 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.
3. In any prosecution involving possess ion 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 Req. No. 5332 Page 7
or circumstances listed in subsection A of this section. This
subsection shall not be understood to be the decrimin alization of
psilocybin or psilocyn.
G. 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, 202 6.
H. Researching entities shall ensure any protected health
information collected during the clinical trials done in accordance
with this section does not personally identify any individual.
I. 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 inaction any
protected health information. The protected health information of
clinical trial participants shall be exempt from the Oklahoma Open
Records Act.
J. 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. Req. No. 5332 Page 8
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 ag ainst diversion of
particular controlled dangerous substances and any Schedule I or II
substance compounded therefrom into other than legitim ate medical,
scientific or industrial chann els, including examination of the
fitness of his or her employees or age nts to handle dangerous
substances;
2. Compliance with applicabl e state and local law;
3. Has been found g uilty of, entered a plea of guilt y or nolo
contendere to a charge under the Uniform Controlled Dangerous
Substances Act or any other state or federa l 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 S tates; Req. No. 5332 Page 9
4. Furnishing by the applicant false or fraudulent material
information in any application filed under Secti on 2-101 et seq. of
this title;
5. Past experience in the manufa cture, distribution,
dispensing, prescribin g, administering or use for scie ntific
purposes of controlled dangerous subs tances, and the existence in
the establishment of effective controls aga inst diversion;
6. Denial, suspension or revocation of the appli cant's federal
registration to manufacture, distribute or dispense controll ed
dangerous substances as authorized by fed eral law; and
7. Such other factors as may be relevant to and consisten t with
the public health and safe ty.
Nothing herein shall be deem ed to require individual licensed
pharmacists to register under the provisi ons 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
dangerous substances in Schedule I or II other than those specified
in the registration.
C. Practitioners shall be registe red to dispense, prescribe,
administer or use for scientific purp oses controlled dangerous
substances in Schedules II through V i f they are authorized to carry
on their respective activities under the laws of this state. A Req. No. 5332 Page 10
registration application by a practitioner who wishes to conduct
research with Schedule I sub stances shall be accompanied by evidence
of the applicant's federal registration to conduct such activity and
shall be referred to the Oklahoma Medical Research Commission
Foundation for advice. The Oklahoma Medical Research Commission
Foundation shall promptly advise the Director concerning th e
qualifications of each practitioner requesting such registrat ion.
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 Oklahoma Medical Research Commission
Foundation 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 applic ant 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 register
who own or operate any establishmen t engaged in the manufacture ,
distribution, dispensing, prescribing, administer ing or use for
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 follo ws:
Practitioners and mid-level
practitioners $140.00 per year Req. No. 5332 Page 11
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 amo unt of
the above-listed fee for any renewal of registration received more
than thirty (30) days late.
3. A Ten Dollar ($10.00) fee s hall be charged for a dup licate
registration certificate.
E. Compliance by manufacturers and distributors with the
provisions of the Federal Controlled Substances Act, 21 U.S.C.,
Section 801 et seq., respecting registration, e xcluding fees, shall
be deemed sufficient to qualify f or registration under this act
Section 2-101 et seq. of this title. Req. No. 5332 Page 12
SECTION 3. This act shall become effect ive November 1, 2023.
59-1-5332 TJ 01/10/23