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STATE OF OKLAHOMA
2nd Session of the 58th Legislature (202 2)
HOUSE BILL 3174 By: Phillips
AS INTRODUCED
An Act relating to public health; defining terms;
providing for the establishment of statewide
investigational new drug applications fo r psilocybin
clinical trials; authorizing physicians to serve as
principal investigators for clinical trials under
certain circumstances; providing for
subinvestigators; directing investigators and
subinvestigators to adhere to certain rules and
regulations; permitting Oklahoma State Bureau of
Narcotics and Dangerous Drugs Control to inspect
certain samples; providing guidelines for conducting
clinical trials; exempting person acting in
compliance from criminal or civil penalties;
permitting State Commissio ner of Health to perform
certain acts; requiring clinical trials to comply
with certain standards; providing termination date;
requiring certain approval for contin uation of
clinical trials; requ iring submission of certain
report; specifying contents of re port; authorizing
Commissioner to disclose certain data; directing
promulgation of rules by certain entities; providing
for codification; and providing an effective date.
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 2-821 of Title 63, unless there
is created a duplication in numberin g, reads as follows:
A. As used in this section:
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1. "Academic medical center " means a medical school and its
affiliated teaching hospitals and clinics in this state that:
a. operate a medical residency program for physicians,
and
b. conduct research that is overseen by the United States
Department of Health and Human Services and involves
human subjects;
2. "Approved source" means a provider approved by the United
States Food and Drug Administration (FDA) which produces psilocybin
that:
a. has been manufactured and tested in a facility
approved or certified by the FDA or similar national
regulatory agency in another country which has been
approved by the FDA, and
b. has been tested on animals to demonstrate preliminary
effectiveness and to ensure that it is safe to
administer to humans;
3. "Physician" means a doctor of medicine or doctor of
osteopathic medicine licensed by the State Board of Medical
Licensure and Supervision or th e State Board of Osteopathic
Examiners;
4. "Psilocybin" means a hallucinogenic chemical compound
obtained from certain types of fresh and dried mushrooms ; and
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5. "Qualifying patient" means any person eighteen (18) years of
age or older who is a veteran of the United States Armed Forces o r
the Oklahoma National Guard who suffers from major depressive
disorder, severe depression, or any other form of depression or
anxiety that is not adequately treated by traditional medical
therapies.
B. A statewide investigational new drug application may be
established in this state, if approved by the FDA, to conduct
clinical trials using psilocybin on qualifying patients .
C. Any physician licensed by the State Board of Medical
Licensure and Supervision or the State Board of Osteopathic
Examiners, practicing in this state, and treating qualifying
patients may serve as the principal investigator for such clinical
trials if such physici an:
1. Applies to and is approved by the FDA as the principal
investigator in a statewide investigational new drug application;
2. Receives a license from the Uni ted States Drug Enforcement
Administration; and
3. Receives a registration from the Oklahom a State Bureau of
Narcotics and Dangerous Drugs Control.
D. Such physician, acting as principal investiga tor, may
include subinvestigators who are also board certi fied, practice in
an academic medical center in this state, and treat qualifying
patients. Subinvestigators shall comply with the licensing
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requirement provided in paragraphs 2 and 3 of subsection C of this
section.
E. The principal investigator and all subinvestigators shall
adhere to the rules and regulations established by the relevant
institutional review board for each participating academic medical
center and by the FDA, the United States Drug Enforcement
Administration, the Oklahoma State Bureau of Narcotics and Dangerous
Drugs Control, and the National Institu te on Drug Abuse.
F. Nothing in this section shall be cons trued to prohibit a
physician licensed in Oklahoma from applying for Investigational New
Drug authorization from the FDA.
G. The Oklahoma State Bureau of N arcotics and Dangerous Drugs
Control shall have the authority to inspect and test samples of
psilocybin used in this state pursuant to the provisions of this
section.
H. Clinical trials conducted pursuant to a statewide
Investigational New Drug application established pursuant to the
provisions of this section shall only utilize psilocybin which is:
1. From an approved source; a nd
2. Approved by the FDA to be used for treatment of a condition
specified in an Investigational New Drug application.
I. The principal investigator and any subinvestigator may
receive psilocybin directly from an approved source or authorized
distributor for an approved source for use in the clinical trials.
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J. A person acting in complia nce with the provisions of this
section shall not be subject to arrest, prosecution, or any civil or
administrative penalty, including , but not limited to, a civil
penalty or disciplinary action by a professi onal licensing board, or
be denied any right or privilege, for the use, prescription,
administration, possession, manufacture, or distribution of medical
psilocybin.
K. The State Commissioner of Health shall have the authority to
approve physicians conducting clinical trials performed pursuant to
the provisions of this section. In the event of a substantial
violation of this section, the Commissioner shall pro vide written
notice to the Oklahoma State Bureau of Narcotics and Dangerous Drugs
Control and the Governor. The Governor, upon receipt of a notice
from the Commissioner, shall have the authority to terminate the
operations of a clinical trial found to be in violation of any
provision of this section.
L. The clinical trials and related research authorized by this
section shall adhere to the highest standards of acad emic research
including, but not limited to, peer review of research conducted
pursuant to this section.
M. The State Commissioner of Health shall submit a report to
the Speaker of the Oklahoma House of Representatives and the
President Pro Tempore of the Oklahoma State Senate on or before
December 31, 2023. The report shall include a summary o f findings
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from clinical trials authorized by this section. The Commissioner
shall, upon request by the Speaker or President Pro Tempore, make
available any data, excluding individual health records, relating to
clinical trials authorized by this section.
N. The Oklahoma State Bureau of Narcotics and Dangerous Drugs
Control, the Oklahoma State Department of Health, and the Oklahoma
State Regents for Higher Educatio n shall promulgate rules to
implement the provisions of this section.
SECTION 2. This act shall become effective November 1, 2022.
58-2-8946 EK 12/28/21