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SENATE FLOOR VERSION
April 11, 2022
COMMITTEE SUBSTITUTE
FOR 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
[ controlled dangerous substances - research and
clinical trials related to psilocybin and psilocin -
confidentiality of certain personal information -
certain fee - codification ]
BE IT ENACTED BY THE P EOPLE 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 fol lows:
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 persons eighteen (18) years of age or older to
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study the use of psilocybin for palliative care or end -of-life care
or for treatment 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. Opioid use disorder; or
8. 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
facility for the purposes of c onducting research under this section.
C. In conducting such research as described in subsection A of
this section, the studies shall:
1. Perform clinical trials on the efficacy of using psilocybin
or psilocin for palliative care or end -of life care or 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
psilocin for palliative care or end -of life care or in
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the treatment of the medical conditions listed in
subsection A of this section, and
b. the access persons have to psilocybin and psilocin for
palliative care or end-of life care or in 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 psilocin as well as the fungi,
yeasts, and other naturally occurring 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 natur ally occurring source
organisms, or studying, extracting, synthesizing, or dispensing
psilocybin or psilocin. The registration submission information
shall include:
a. the name and address of the resea rch 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 .
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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 application and the Oklahoma Department of
Agriculture, Food, and For estry shall collect a one-time
nonrefundable fee of One Hundred Dollars ($100.00) from the
registrant at the time of application . The applicant shall, upon
completion of registration with the State Department of Health and
the Oklahoma Department of Agriculture, Food, and For estry, 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 remains
active.
4. Registration under this subsection is valid for one year,
effective upon confirmation and receipt of the final of the three
registrations required by this subsection.
5. 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
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(14) business days to the State Department of Health, to the
Oklahoma Department of Agriculture, Food, and F orestry, and to 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 issued the written
certification,
c. the date on which the written certificati on 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. The written certification issued under this subsection shall
expire one year after the date of its issuance unless the written
certification specifies an earlier date of exp iration.
F. 1. A 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 psilocin as long as the researcher’s
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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, prosecution, or any civil or
administrative penalty for the use or possession of psilocybin or
psilocin as long as the patient’s conduct is in compliance with the
provisions of this section.
G. Researching entities shall submit a written report to the
President Pro Tempor e of the Senate and the Speaker of the 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 5.
H. Researching entities shall ensure any protected health
information collected during the clinical trial s 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.
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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.
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 Con trol shall register an applicant to
own a medical facility as described in subsectio n 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 i n Schedules I through V of Section 2 -101 et
seq. of this title unless the Director d etermines that the issuance
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 dang erous 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 age nts to handle dangerous
substances;
2. Compliance with applicable 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 federa l law relating to any
substance defined herei n as a controlled dangerous 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 Secti on 2-101 et seq. of
this title;
5. Past experience in the manufacture, distribution,
dispensing, prescribin g, administering or use for scientifi c
purposes of controlled dangerous subs tances, and the existence in
the establishment of effective controls aga inst diversion;
6. Denial, suspension or rev ocation of the applicant’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 consisten t with
the public health and safety.
Nothing herein shall be deemed to require individual licensed
pharmacists to register under the provisions o f the Uniform
Controlled Dangerous Subs tances Act.
B. Registration gran ted under subsection A of this section
shall not entitle a registrant to manufacture , distribute, dispense,
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 registe red to dispense, prescribe,
administer or use for scientific purposes substances in Schedules II
through V if they are authorized to carry on the ir respective
activities under the laws of this state. A registration a pplication
by a practitioner who wishes to conduct research with Schedule I
substances shall be accompanied by evidence of the applicant ’s
federal registration to conduct such activity and shall be referred
to the Medical Research Commission for advice. T he 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 den ied
only on a ground specified in subsection A of Section 2 -304 of this
title or if there are reason able 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 medical or scient ific 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, administering o r use for
scientific purposes of any controlled dangerous subst ances prior to
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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, Hospices &
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 pseudoephedrine
or phenylpropanolamine $300.00 annually
Researcher of psilocybin or
psilocin $140.00 annually
2. A registrant shall be required to pay double the amo unt 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 shall 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.,
Section 801 et seq., respec ting registration, excluding fees, shall
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be deemed sufficient to qualify for registration under this act
Section 2-101 et seq. of this title.
COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
April 11, 2022 - DO PASS AS AMENDED