Oklahoma 2023 Regular Session

Oklahoma House Bill HB2107 Compare Versions

Version 1 (Old)

Version 2 (New)

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3		-	ENGR. H. B. NO. 2107 Page 1 1
	3	+	HB2107 HFLR Page 1
	4	+	BOLD FACE denotes Committee Amendments. 1
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28		-	ENGROSSED HOUSE
29		-	BILL NO. 2107 By: Pae, Talley, Hefner and
30		-	Deck of the House
	29	+	HOUSE OF REPRESENTATIVES - FLOOR VERSION
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32		-	~~and~~
	31	+	STATE OF OKLAHOMA
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34		-	Brooks of the Senate
	33	+	1st Session of the 59th Legislature (2023)
	34	+
	35	+	COMMITTEE SUBSTITUTE
	36	+	FOR
	37	+	HOUSE BILL NO. 2107 By: Pae
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40		-	[ controlled dangerous substances - Oklahoma
41		-	Psilocybin Research Pilot Program - scientific
42		-	research related to psilocybin and psilocyn -
43		-	memoranda of agreement – studies – registration -
44		-	nonrefundable fees - written certifications –
45		-	immunity - written reports - providing for
46		-	confidentiality of personal information -
47		-	promulgation of rules - codification - effective
48		-	date ]
	43	+	COMMITTEE SUBSTITUTE
49	44
	45	+	An Act relating to controlled dangerous substances ;
	46	+	creating the Oklahoma Psilocybin Research Pilot
	47	+	Program; authorizing certain entities to conduct
	48	+	scientific research related to psilocybin and
	49	+	psilocyn; specifying certain uses for which
	50	+	scientific research is authorized; limiting number of
	51	+	memoranda of agreement that universities or
	52	+	institutions of higher education may enter into;
	53	+	imposing requirements with respect to studies;
	54	+	requiring registration wi th the State Department of
	55	+	Health and the Oklahoma Department of Agriculture,
	56	+	Food, and Forestry; prescribing requirements for
	57	+	registration information; providing for specified
	58	+	nonrefundable fees; requiring additional registration
	59	+	with the Oklahoma State Bureau of Narcotics and
	60	+	Dangerous Drugs Control; stipulating duration of
	61	+	registration; requiring certain notification of
	62	+	change of facility location; requiring written
	63	+	certifications for Pilot Program participants;
	64	+	prescribing content of written certifications;
	65	+	providing for expiration of certifications; providing
	66	+	immunity to persons conducting or participating in
	67	+	the Pilot Program; requiring submission of written
	68	+	reports by certain date; providing for
	69	+	confidentiality of certain personal information;
	70	+	requiring specified agencies to maintain
	71	+	confidentiality with respect t o information;
	72	+	directing promulgation of rules; amending 63 O.S.
	73	+	2021, Section 2-303, which relates to Oklahoma State
	74	+	Bureau of Narcotics and Dangerous Drugs Control
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51		-
52		-
53		-	BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
54		-	SECTION 1. NEW LAW A new section of law to be codified
55		-	in the Oklahoma Statutes as Section 2-811 of Title 63, unless there
56		-	is created a duplication in numbering, reads as follows:
57		-	A. This act shall be known and may be cited as the " Oklahoma
58		-	Psilocybin Research Pilot Program ".
59		-
60		-	ENGR. H. B. NO. 2107 Page 2 1
	76	+	HB2107 HFLR Page 2
	77	+	BOLD FACE denotes Committee Amendments. 1
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	102	+	registration; creating certain fee; providing for
	103	+	codification; and providing an effective date.
	104	+
	105	+
	106	+
	107	+
	108	+	BE IT ENACTED BY THE PE OPLE OF THE STATE OF OKLAHOMA:
	109	+	SECTION 1. NEW LAW A new section of law to be codified
	110	+	in the Oklahoma Statutes as Section 2-811 of Title 63, unless there
	111	+	is created a duplication in numbering, reads as follows:
	112	+	A. This act shall be known and may be cited as the " Oklahoma
	113	+	Psilocybin Research Pilot Program ".
85	114		B. A university or other institution of higher education
86	115		located in this state, or a research facility that has entered into
87	116		a memorandum of agreement with a university or ins titution of higher
88	117		education located in this state, may conduct scientific research on
89	118		psilocybin and psilocyn for the treatment of persons ei ghteen (18)
90	119		years of age or older who experience any of the following medical
91	120		conditions:
92	121		1. Post-traumatic stress disorder;
93	122		2. Treatment-resistant/refractory depression;
94	123		3. Treatment-resistant/refractory anxiety;
95	124		4. Treatment-resistant/refractory obsessive-compulsive
96	125		disorder;
97	126		5. Traumatic brain injury;
98	127		6. Early-stage dementia;
99	128		7. Palliative care;
100		-	8. End-of-life care;
101		-	9. Opioid use disorder; or
102		-	10. Moderate to severe chronic pain.
103		-	C. The university or institution of higher education may enter
104		-	into no more than one memorandum of agreement with a resear ch
105		-	facility for the purposes of c onducting scientific research under
106		-	this section.
107		-	D. In conducting such scientific research as described in
108		-	subsection B of this section, the studies shall:
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110		-	ENGR. H. B. NO. 2107 Page 3 1
	130	+	HB2107 HFLR Page 3
	131	+	BOLD FACE denotes Committee Amendments. 1
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	156	+	8. End-of-life care;
	157	+	9. Opioid use disorder; or
	158	+	10. Moderate to severe chronic pain.
	159	+	C. The university or institution of higher education may enter
	160	+	into no more than one memorandum of agreement with a resear ch
	161	+	facility for the purposes of c onducting scientific research under
	162	+	this section.
	163	+	D. In conducting such scientific research as described in
	164	+	subsection B of this section, the studies shall:
135	165		1. Study the therapeutic efficacy of using psilocybin or
136	166		psilocyn in the treatment of the medical conditions listed in
137	167		subsection B of this section;
138	168		2. Review the current literature regarding:
139	169		a. the safety and efficacy of using psiloc ybin or
140	170		psilocyn in the treatment of the medical conditions
141	171		listed in subsection B of this section, and
142	172		b. the access persons have to psilocybin and psilocyn for
143	173		the treatment of the medical conditions listed in
144	174		subsection B of this section; and
145	175		3. Examine the science of cultivation, synthesis, extraction,
146	176		and processing of psilocybin an d psilocyn as well as the fungi,
147	177		yeasts, and other naturally o ccurring source organisms of these
148	178		molecules.
149		-	E. 1. Eligible entities as described in subsection B of this
150		-	section shall register with the State Department of Health and the
151		-	Oklahoma Department of Agriculture, Food, and For estry prior to and
152		-	for the purposes of growing, studying, processing, or dispensing
153		-	psilocybin-containing fungi or other naturally occurring source
154		-	organisms, or studying, extracting, synthesizing, or dispensing
155		-	psilocybin or psilocyn. The registration submission information
156		-	shall include:
157		-	a. the name and address of the research facility,
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159		-	ENGR. H. B. NO. 2107 Page 4 1
	180	+	HB2107 HFLR Page 4
	181	+	BOLD FACE denotes Committee Amendments. 1
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	206	+	E. 1. Eligible entities as described in subsection B of this
	207	+	section shall register with the State Department of Health and the
	208	+	Oklahoma Department of Agriculture, Food, and For estry prior to and
	209	+	for the purposes of growing, studying, processing, or dispensing
	210	+	psilocybin-containing fungi or other naturally occurring source
	211	+	organisms, or studying, extracting, synthesizing, or dispensing
	212	+	psilocybin or psilocyn. The registration submission information
	213	+	shall include:
	214	+	a. the name and address of the research facility,
184	215		b. a prospectus approved by a university or other
185	216		institution of higher education, and
186	217		c. certification from the institutional review board of
187	218		the university or institution of higher education if
188	219		human trials are part of the research.
189	220		2. By registering, the registrant acknowledges and agrees that:
190	221		a. the information contained in the registration
191	222		submissions may be provided to law enforcement
192	223		agencies, and
193	224		b. the registrant shall submit an annual report detailing
194	225		compliance with annual regulation requirements.
195	226		3. The State Department of Health shall collect a one-time,
196	227		nonrefundable fee of Five Hundred Dollars ($500.00) from the
197	228		registrant at the time of registration and the Oklahoma Department
198	229		of Agriculture, Food, and Forestry shall collect a one-time
199		-	nonrefundable fee of One Hundred Dollars ($100.00) from the
200		-	registrant at the time of registration. The registrant shall, upon
201		-	completion of registration with the State Department of Health and
202		-	the Oklahoma Department of Agriculture, Food, and Forestry, register
203		-	with the Oklahoma State Bureau of Narcotics an d Dangerous Drugs
204		-	Control as provided by Section 2-301 et seq. of Title 63 of the
205		-	Oklahoma Statutes annually for as long as the research re mains
206		-	active.
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208		-	ENGR. H. B. NO. 2107 Page 5 1
	231	+	HB2107 HFLR Page 5
	232	+	BOLD FACE denotes Committee Amendments. 1
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	257	+	nonrefundable fee of One Hundred Dollars ($100.00) from the
	258	+	registrant at the time of registration. The registrant shall, upon
	259	+	completion of registration with the State Department of Health and
	260	+	the Oklahoma Department of Agriculture, Food, and Forestry, register
	261	+	with the Oklahoma State Bureau of Narcotics an d Dangerous Drugs
	262	+	Control as provided by Section 2-301 et seq. of Title 63 of the
	263	+	Oklahoma Statutes annually for as long as the research re mains
	264	+	active.
233	265		4. Registration under this subsection is valid for one (1)
234	266		year, effective upon confirmation and receipt of all registrations
235	267		required by this subsection. Notwithstanding the registration fee
236		-	listed in Section 2-303 of Title 63 of the Oklahoma Statutes, the
237		-	registration required by this subsection shall satisfy and supersede
238		-	all other registration and reporting requirements otherwise impose d
239		-	by state law.
	268	+	listed in Section 2 of th is act, the registration required by this
	269	+	subsection shall satisfy and supersede all other registration and
	270	+	reporting requirements otherwise impose d by state law.
240	271		5. Should the registrant change facility locations for the
241	272		cultivation, testing, synthesis, storage, or dispensing of
242	273		psilocybin or psilocyn, it shall report such changes within fourteen
243	274		(14) business days to the State Department of Health, the Oklahoma
244	275		Department of Agriculture, Food, and Forestry, and the Oklahoma
245	276		State Bureau of Narcotics and Dangerous Drugs Control.
246	277		F. 1. A written certification shall be issued to persons
247	278		qualifying for participation in the pilot program described in this
248	279		section by a physician participating in the pilot program. The
249	280		written certification shall contain the following:
250		-	a. the name, address, and telephone number of the issu ing
251		-	physician,
252		-	b. the name and address of the patient to whom the
253		-	written certification is issued,
254		-	c. the date on which the written certification was made,
255		-	d. the signature of the physician,
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257		-	ENGR. H. B. NO. 2107 Page 6 1
	282	+	HB2107 HFLR Page 6
	283	+	BOLD FACE denotes Committee Amendments. 1
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	308	+	a. the name, address, and telephone number of the issu ing
	309	+	physician,
	310	+	b. the name and address of the patient to whom the
	311	+	written certification is issued,
	312	+	c. the date on which the written certification was made,
	313	+	d. the signature of the physician,
282	314		e. the quantity of psilocybin or psilocyn to be
283	315		dispensed, and
284	316		f. the form of psilocybin or psilocyn to be dispensed.
285	317		2. The written certification issued under this subsection shall
286	318		expire one (1) year after its issuance unless the written
287	319		certification specifies an earlier date of exp iration.
288	320		G. 1. A scientific researcher or physician operating under a
289	321		valid registration issued in accordance with this section shall not
290	322		be subject to arrest, prosecution, or any civil or administrative
291	323		penalty for the possession, cultivation, synthesis, extraction, or
292	324		distribution of psilocybin or psilocyn insofar as the scientific
293	325		researcher's or physician's conduct is in compliance with the
294	326		provisions of this section.
295	327		2. A patient participating in the pilot program under a valid
296	328		written certification issued in a ccordance with this sec tion shall
297	329		not be subject to arrest, prosecutio n, or any civil or
298	330		administrative penalty for the use or possession of psilocybin or
299		-	psilocyn insofar as the patient's conduct is in complianc e with the
300		-	provisions of this section.
301		-	3. In any prosecution invol ving possession of psilocybin or
302		-	psilocyn as those terms are specified in subsection C of Section 2-
303		-	204 of Title 63 of the Oklahoma Statutes, it shall be an affirmati ve
304		-	defense if a person can demonstrate by clear and convincing evidence
305		-	that he or she has one or more of the qualifying medical conditions
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307		-	ENGR. H. B. NO. 2107 Page 7 1
	332	+	HB2107 HFLR Page 7
	333	+	BOLD FACE denotes Committee Amendments. 1
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	358	+	psilocyn insofar as the patient's conduct is in compliance with t he
	359	+	provisions of this section.
	360	+	3. In any prosecution invol ving possession of psilocybin or
	361	+	psilocyn as those terms are specified in subsection C of Section 2-
	362	+	204 of Title 63 of the Oklahoma Statutes, it shall be an affirmati ve
	363	+	defense if a person can demonstrate by clear and convincing evid ence
	364	+	that he or she has one or more of the qualifying medical conditions
332	365		or circumstances listed in subsection B of this section. This
333	366		subsection shall not be understood to be the decrimin alization of
334	367		psilocybin or psilocyn.
335	368		H. Researching entities shall submit a written report to the
336	369		President Pro Tempore of the Oklahoma State Senate and the Speaker
337	370		of the Oklahoma House of Representatives containing the results of
338	371		the studies conducted under this section and any recommendations for
339	372		legislative or other actions not later than December 1, 2026.
340	373		I. Researching entities shall ensure any protected health
341	374		information collected during the pilot program done in accordance
342	375		with this section does not personally identify any individual.
343	376		J. The State Department of Health, the Oklahoma Department of
344	377		Agriculture, Food, and Forestry, the Oklahoma State Bureau of
345	378		Narcotics and Dangerous Drugs Control, and any other state agency
346	379		with access to the research programs authorized by this section
347	380		shall not release or allow t o be released through i naction any
348	381		protected health information. The protected health information of
349		-	pilot program participants shall be exempt from the Oklahoma Open
350		-	Records Act.
351		-	K. The State Commissioner of Health, the State Board of
352		-	Agriculture, and the Director of the Oklahoma State Bureau of
353		-	Narcotics and Dangerous Drugs Control shall promulgate rules
354		-	necessary to implement the program authorized in this section.
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356		-	ENGR. H. B. NO. 2107 Page 8 1
	383	+	HB2107 HFLR Page 8
	384	+	BOLD FACE denotes Committee Amendments. 1
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	409	+	pilot program participants shall be exempt from the Oklahoma Open
	410	+	Records Act.
	411	+	K. The State Commissioner of Health, the State Board of
	412	+	Agriculture, and the Director of the Oklahoma State Bureau of
	413	+	Narcotics and Dangerous Drugs Control shall promulgate rules
	414	+	necessary to implement the program authorized in this section.
381	415		SECTION 2. AMENDATORY 63 O.S . 2021, Section 2-303, is
382	416		amended to read as follows:
383	417		Section 2-303. A. The Director of the Oklahoma State Bureau of
384	418		Narcotics and Dangerous Drugs Control shall register an applicant to
385	419		own a medical facility as described in subsection C of Section 2 -302
386	420		of this title, or to manufacture, distribute, dispense, prescribe,
387	421		administer or use for scientific purposes controlle d dangerous
388	422		substances included in Schedules I through V of Section 2-101 et
389	423		seq. of this title unless th e Director determines that the i ssuance
390	424		of such registration is in consistent with the public interest. In
391	425		determining the public interest, the followi ng factors shall be
392	426		considered:
393	427		1. Maintenance of effective controls against diversion of
394	428		particular controlled dangerous substances and any Schedule I or II
395	429		substance compounded therefrom into other than legitimate medical,
396	430		scientific or industrial chann els, including examination of the
397	431		fitness of his or her employees or agents to handle dangerous
398	432		substances;
399		-	2. Compliance with applicable state and local law;
400		-	3. Has been found guilty of, entered a plea of guilty or nolo
401		-	contendere to a charge under the Uniform Controlled Dangerous
402		-	Substances Act or any other state or federal law relating to any
403		-	substance defined herein as a controlled dangerous substance or any
404		-	felony under the laws of any state or the United States;
405	433
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	434	+	HB2107 HFLR Page 9
	435	+	BOLD FACE denotes Committee Amendments. 1
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	460	+	2. Compliance with applicabl e state and local law;
	461	+	3. Has been found guilty of, entered a plea of guilty or nolo
	462	+	contendere to a charge under the Uniform Controlled Dangerous
	463	+	Substances Act or any other state or federal law relating to any
	464	+	substance defined herein as a controlled da ngerous substance or any
	465	+	felony under the laws of any state or the United States;
431	466		4. Furnishing by the applicant false or fraudulent material
432	467		information in any application filed under Section 2-101 et seq. of
433	468		this title;
434	469		5. Past experience in the manufa cture, distribution,
435	470		dispensing, prescribing, administering or use for scientific
436	471		purposes of controlled dangerous subs tances, and the existence in
437	472		the establishment of effective controls against diversion;
438	473		6. Denial, suspension or revocation of the appli cant's federal
439	474		registration to manufacture, distribute or dispense controlled
440	475		dangerous substances as authorized by fed eral law; and
441	476		7. Such other factors as may be relevant to and consistent with
442	477		the public health and safe ty.
443	478		Nothing herein shall be deem ed to require individual licensed
444	479		pharmacists to register under the provisions of the Uniform
445	480		Controlled Dangerous Subs tances Act.
446	481		B. Registration granted under subsection A of this section
447	482		shall not entitle a registrant to manufacture, distribute, dispen se,
448	483		prescribe, administer or use f or scientific purposes controlled
449		-	dangerous substances in Schedule I or II other than those specified
450		-	in the registration.
451		-	C. Practitioners shall be registered to dispense, prescribe,
452		-	administer or use for scientific purposes controlled dangerous
453		-	substances in Schedules II thro ugh V if they are authorized to carry
454		-	on their respective activities under the laws of this state. A
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	485	+	HB2107 HFLR Page 10
	486	+	BOLD FACE denotes Committee Amendments. 1
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	511	+	dangerous substances in Schedule I or II other than those specified
	512	+	in the registration.
	513	+	C. Practitioners shall be registered to dispense, prescribe,
	514	+	administer or use for scientific purp oses controlled dangerous
	515	+	substances in Schedules II thro ugh V if they are authorized to carry
	516	+	on their respective activities under the laws of this state. A
481	517		registration application by a practitioner who wishes to conduct
482	518		research with Schedule I sub stances shall be accompan ied by evidence
483	519		of the applicant's federal registration to conduct such activity and
484	520		shall be referred to the Medical Research Commission for advice.
485	521		The Medical Research Commission shall promptly advise the Director
486	522		concerning the qualifications of each practitioner requesting such
487	523		registration. Registration for the purpose of bona fide research or
488	524		of use for scientific purposes with Schedule I substan ces by a
489	525		practitioner deemed qualified by the Medical Research Commission may
490	526		be denied only on a ground specified in subsection A of Section 2-
491	527		304 of this title or if there are reasonable grounds to believe that
492	528		the applicant will abuse or unlawfully tran sfer such substances or
493	529		fail to safeguard adequately such applicant 's supply of such
494	530		substances against diversion from legitimate medical or scientific
495	531		use.
496	532		D. 1. The Director shall initially permit persons to r egister
497	533		who own or operate any establishmen t engaged in the manufacture,
498	534		distribution, dispensing, prescribing, administer ing or use for
499		-	scientific purposes of any controlled dangerous substances prior to
500		-	June 4, 1991, and who are registered or licensed by the state. Fees
501		-	for registration under th is section shall be as follows:
502		-	Practitioners and mid-level
503		-	practitioners $140.00 per year
504		-	of registration
505	535
506		-	ENGR. H. B. NO. 2107 Page 11 1
	536	+	HB2107 HFLR Page 11
	537	+	BOLD FACE denotes Committee Amendments. 1
507	538		2
508	539		3
509	540		4
510	541		5
511	542		6
512	543		7
513	544		8
514	545		9
515	546		10
516	547		11
517	548		12
518	549		13
519	550		14
520	551		15
521	552		16
522	553		17
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524	555		19
525	556		20
526	557		21
527	558		22
528	559		23
529	560		24
530	561
	562	+	scientific purposes of any controlled dangerous substances prior to
	563	+	June 4, 1991, and who are registered or licensed by the state. Fees
	564	+	for registration under th is section shall be as follows:
	565	+	Practitioners and mid-level
	566	+	practitioners $140.00 per year
	567	+	of registration
531	568		Home Care Agencies, Hospices &
532	569		Home Care Services $140.00 annually
533	570		Medical Facility Owners $300.00 annually
534	571		Distributors $300.00 annually
535	572		Manufacturers $500.00 annually
536	573		Manufacturer, Wholesaler, or
537	574		Distributor of drug products
538	575		containing pseudoephedrin e
539	576		or phenylpropanolamine $300.00 annually
540	577		Researchers of psilocybin or
541	578		psilocyn $140.00 annually
542	579		2. A registrant shall be required to pay double the am ount of
543	580		the above-listed fee for any ren ewal of registration received more
544	581		than thirty (30) days late.
545	582		3. A Ten Dollar ($10.00) fee shall be charged for a duplicate
546	583		registration certificate.
547	584		E. Compliance by manufacturers and distributors with the
548	585		provisions of the Federal Controlled Substance s Act, 21 U.S.C.,
549		-	Section 801 et seq., respecting registration , excluding fees, shall
550		-	be deemed sufficient to qualify for registration under this act
551		-	Section 2-101 et seq. of this title.
552		-	SECTION 3. This act shall become effective November 1, 2023.
553	586
554		-	ENGR. H. B. NO. 2107 Page 12 1
	587	+	HB2107 HFLR Page 12
	588	+	BOLD FACE denotes Committee Amendments. 1
555	589		2
556	590		3
557	591		4
558	592		5
559	593		6
560	594		7
561	595		8
562	596		9
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566	600		13
567	601		14
568	602		15
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570	604		17
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572	606		19
573	607		20
574	608		21
575	609		22
576	610		23
577	611		24
578	612
579		-	Passed the House of Repr esentatives the 9th day of March, 2023.
	613	+	Section 801 et seq., respecting registration, e xcluding fees, shall
	614	+	be deemed sufficient to qualify for registration under this act
	615	+	Section 2-101 et seq. of this title.
	616	+	SECTION 3. This act shall become effective November 1, 2023.
580	617
581		-
582		-
583		-
584		-	Presiding Officer of the House
585		-	of Representatives
586		-
587		-
588		-
589		-	Passed the Senate the ___ day of __________, 2023.
590		-
591		-
592		-
593		-
594		-	Presiding Officer of the Senate
595		-
596		-
	618	+	COMMITTEE REPORT BY: COMMITTEE ON ALCOHOL, TOBACCO AND CONTROLLED
	619	+	SUBSTANCES, dated 02/15/2023 - DO PASS, As Amended.