Oklahoma 2022 Regular Session

Oklahoma House Bill HB3414 Compare Versions

Version 1 (Old)

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3		-	SENATE FLOOR VERSION - HB3414 SFLR Page 1
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29		-	SENATE FLOOR VERSION
30		-	April 11, 2022
	28	+	STATE OF OKLAHOMA
31	29
	30	+	2nd Session of the 58th Legislature (2022)
32	31
33	32		COMMITTEE SUBSTITUTE
34	33		FOR ENGROSSED
35		-	HOUSE BILL ~~NO.~~ 3414 By: Pae, Phillips, Rosecrants,
	34	+	HOUSE BILL 3414 By: Pae, Phillips, Rosecrants,
36	35		McEntire, Martinez,
37	36		Dempsey, Dollens, Humphrey,
38	37		Echols, Talley, McDugle,
39	38		Davis, Manger, Walke,
40	39		Brewer, and Munson of the
41	40		House
42	41
43	42		and
44	43
45	44		Paxton of the Senate
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47	46
48	47
	48	+	COMMITTEE SUBSTITUTE
49	49
	50	+	An Act relating to controlled dangerous substances ;
	51	+	authorizing certain entities to conduct research and
	52	+	clinical trials related to psilocybin and psilocin;
	53	+	specifying certain uses for which research or
	54	+	clinical trials are authorized; limiting number of
	55	+	memoranda of agreement that universities or
	56	+	institutions of higher education may enter into;
	57	+	imposing requirements with respect to studies;
	58	+	requiring registration with the State Department of
	59	+	Health and the Oklahoma Department of Agriculture,
	60	+	Food, and Forestry; prescribing requirements for
	61	+	registration information; providing for specified
	62	+	nonrefundable fees; requiring additional registration
	63	+	with the Oklahoma State Bureau of Narcotics and
	64	+	Dangerous Drugs Control; stipulating duration of
	65	+	registration; requiring certain notification of
	66	+	change of facility location; requiring written
	67	+	certifications for clinical trial participants;
	68	+	prescribing content of written certifications;
	69	+	providing for expiration of certifications; providing
	70	+	immunity to persons conducting or participating in
	71	+	research or clinical trials; requiring submission of
	72	+	written reports by certain date; providing for
	73	+	confidentiality of certain personal information;
	74	+	requiring specified agencies to maintain
50	75
51		-	[ controlled dangerous substances - research and
52		-	clinical trials related to psilocybin and psilocin -
53		-	confidentiality of certain personal information -
54		-	certain fee - codification ]
55		-
56		-
57		-
58		-
59		-	BE IT ENACTED BY THE P EOPLE OF THE STATE OF OKLAHOMA:
60		-	SECTION 1. NEW LAW A new section of law to be codified
61		-	in the Oklahoma Statutes as Section 2-811 of Title 63, unless there
62		-	is created a duplication in numbering, reads as fol lows:
63		-	A. A university or other institution of higher education
64		-	located in this state, or a research facility that has entered into
65		-	a memorandum of agreement with a university or ins titution of higher
66		-	education located in this state, may conduct scientific research and
67		-	clinical trials on persons eighteen (18) years of age or older to
68		-
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	101	+	confidentiality with respect to informatio n;
	102	+	directing promulgation of rules; amending 63 O.S.
	103	+	2021, Section 2-303, which relates to Oklahoma State
	104	+	Bureau of Narcotics and Dangerous Drugs Control
	105	+	registration; creating certain fee; and providing for
	106	+	codification.
	107	+
	108	+
	109	+
	110	+
	111	+	BE IT ENACTED BY THE PE OPLE OF THE STATE OF OKLAHOMA:
	112	+	SECTION 1. NEW LAW A new section of law to be codified
	113	+	in the Oklahoma Statutes as Section 2-811 of Title 63, unless there
	114	+	is created a duplication in numbering, reads as fol lows:
	115	+	A. A university or other institution of higher education
	116	+	located in this state, or a research facility that has entered into
	117	+	a memorandum of agreement with a university or ins titution of higher
	118	+	education located in this state, may conduct scientific research and
	119	+	clinical trials on persons eighteen (18) years of age or older to
95	120		study the use of psilocybin for palliative care or end -of-life care
96	121		or for treatment of the following medical conditions:
97	122		1. Post-traumatic stress disorder;
98	123		2. Treatment-resistant/refractory depression;
99	124		3. Treatment-resistant/refractory anxiety;
100	125		4. Treatment-resistant/refractory obsessive-compulsive
101	126		disorder;
102	127		5. Traumatic brain injury;
103	128		6. Early stage dementia;
104	129		7. Opioid use disorder; or
105		-	8. Moderate to severe chronic pain.
106		-	B. The university or institution of higher education may enter
107		-	into no more than one memorand um of agreement with a resear ch
108		-	facility for the purposes of c onducting research under this section.
109		-	C. In conducting such research as described in subsection A of
110		-	this section, the studies shall:
111		-	1. Perform clinical trials on the efficacy of using psilocybin
112		-	or psilocin for palliative care or end -of life care or in the
113		-	treatment of the medical conditions listed in subsection A of this
114		-	section;
115		-	2. Review the current literature regarding:
116		-	a. the safety and efficacy of using psiloc ybin or
117		-	psilocin for palliative care or end -of life care or in
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	156	+	8. Moderate to severe chronic pain.
	157	+	B. The university or institution of higher educati on may enter
	158	+	into no more than one memorand um of agreement with a resear ch
	159	+	facility for the purposes of c onducting research under this section.
	160	+	C. In conducting such research as described in subsection A of
	161	+	this section, the studies shall:
	162	+	1. Perform clinical trials on the efficacy of using psilocybin
	163	+	or psilocin for palliative care or end -of life care or in the
	164	+	treatment of the medical conditions listed in subsection A of this
	165	+	section;
	166	+	2. Review the current literature regarding:
	167	+	a. the safety and efficacy of using psiloc ybin or
	168	+	psilocin for palliative care or end -of life care or in
145	169		the treatment of the medical conditions listed in
146	170		subsection A of this section, and
147	171		b. the access persons have to psilocybin and psilocin for
148	172		palliative care or end -of life care or in the
149	173		treatment of the medical conditions listed in
150	174		subsection A of this section ; and
151	175		3. Examine the science of cultivation, synthesis, extraction,
152	176		and processing of psilocybin an d psilocin as well as the fungi,
153	177		yeasts, and other naturally occu rring source organisms of these
154	178		molecules.
155		-	D. 1. Eligible entities as described in subsection A of this
156		-	section shall register with the State Department of Health and the
157		-	Oklahoma Department of Agriculture, Food, and For estry prior to and
158		-	for the purposes of growing, studying, processing, or dispensing
159		-	psilocybin-containing fungi or other natur ally occurring source
160		-	organisms, or studying, extracting, synthesizing, or dispensing
161		-	psilocybin or psilocin. The registration submission information
162		-	shall include:
163		-	a. the name and address of the resea rch facility,
164		-	b. a prospectus approved by a university or other
165		-	institution of higher education, and
166		-	c. certification from the institutional review board of
167		-	the university or institution of higher education if
168		-	human trials are part of the research .
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	205	+	D. 1. Eligible entities as described in subsection A of this
	206	+	section shall register with the State Department of Health and the
	207	+	Oklahoma Department of Agriculture, Food, and For estry prior to and
	208	+	for the purposes of gro wing, studying, processing, or dispensing
	209	+	psilocybin-containing fungi or other natur ally occurring source
	210	+	organisms, or studying, extracting, synthesizing, or dispensing
	211	+	psilocybin or psilocin. The registration submission information
	212	+	shall include:
	213	+	a. the name and address of the resea rch facility,
	214	+	b. a prospectus approved by a university or other
	215	+	institution of higher education, and
	216	+	c. certification from the institutional review board of
	217	+	the university or institution of higher education if
	218	+	human trials are part of the research .
196	219		2. By registering, the registrant acknowledges and agrees that:
197	220		a. the information contained in the registration
198	221		submissions may be provided to law enforcement
199	222		agencies, and
200	223		b. the registrant shall submit an annual report detailing
201	224		compliance with annual regulation requirements .
202	225		3. The State Department of Health shall collect a one-time
203	226		nonrefundable fee of Five Hundred Dollars ($500.00) from the
204	227		registrant at the time of application and the Oklahoma Department of
205	228		Agriculture, Food, and For estry shall collect a one-time
206		-	nonrefundable fee of One Hundred Dollars ($100.00) from the
207		-	registrant at the time of application . The applicant shall, upon
208		-	completion of registration with the State Department of Health and
209		-	the Oklahoma Department of Agriculture, Food, and For estry, register
210		-	with the Oklahoma State Bureau of Narcotics an d Dangerous Drugs
211		-	Control as provided by Section 2 -301 et seq. of Title 63 of the
212		-	Oklahoma Statutes annually for as long as the research remains
213		-	active.
214		-	4. Registration under this subsection is valid for one year,
215		-	effective upon confirmation and receipt of the final of the three
216		-	registrations required by this subsection.
217		-	5. Should the registrant change facility locations for the
218		-	cultivation, testing, synthesis, storage, or dispensing of
219		-	psilocybin or psilocin, it shall report such changes within fourteen
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	255	+	nonrefundable fee of One Hundred Dollars ($100.00) from the
	256	+	registrant at the time of application . The applicant shall, upon
	257	+	completion of registration with the State Department of Health and
	258	+	the Oklahoma Department of Agriculture, Food, and For estry, register
	259	+	with the Oklahoma State Bureau of Narcotics an d Dangerous Drugs
	260	+	Control as provided by Section 2 -301 et seq. of Title 63 of the
	261	+	Oklahoma Statutes annually for as long as the research re mains
	262	+	active.
	263	+	4. Registration under this subsection is valid for one year,
	264	+	effective upon confirmation and receipt of the final of the three
	265	+	registrations required by this subsection.
	266	+	5. Should the registrant change facility locations for the
	267	+	cultivation, testing, synthesis, storage , or dispensing of
	268	+	psilocybin or psilocin, it shall report such changes within fourteen
247	269		(14) business days to the State Department of Health, to the
248	270		Oklahoma Department of Agriculture, Food, and F orestry, and to the
249	271		Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
250	272		E. 1. A written certification shall be issued to persons
251	273		qualifying for participation in a clinical trial described in this
252	274		section by a physician participating in the clinical trial. The
253	275		written certification shall contain the following:
254	276		a. the name, address, and telephone number of the issu ing
255	277		physician,
256		-	b. the name and address of the patient issued the written
257		-	certification,
258		-	c. the date on which the written certificati on was made,
259		-	d. the signature of the physician,
260		-	e. the quantity of psilocybin or psilocin to be
261		-	dispensed, and
262		-	f. the form of psilocybin or psilocin to be dispensed.
263		-	2. The written certification issued under this subsection shall
264		-	expire one year after the date of its issuance unless the written
265		-	certification specifies an earlier date of exp iration.
266		-	F. 1. A researcher or physician operating under a valid
267		-	registration issued in accordance with this section shall not be
268		-	subject to arrest, prosecution, or any civil or administrative
269		-	penalty for the possession, cultivation, synthesis, extraction, or
270		-	distribution of psil ocybin or psilocin as long as the researcher’s
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	304	+	b. the name and address of the patient issued the written
	305	+	certification,
	306	+	c. the date on which the written certificati on was made,
	307	+	d. the signature of the physician,
	308	+	e. the quantity of psilocybin or psilocin to be
	309	+	dispensed, and
	310	+	f. the form of psilocybin or psilocin to be dispensed.
	311	+	2. The written certification issued under this subsection shall
	312	+	expire one year after the date of its issuance unless the written
	313	+	certification specifies an earlier date of exp iration.
	314	+	F. 1. A researcher or physician operating under a valid
	315	+	registration issued in accordance with this section shall not be
	316	+	subject to arrest, prosecution, or any civil or administrative
	317	+	penalty for the possession, cultivation, synthesis, extraction, or
	318	+	distribution of psil ocybin or psilocin as long as the researcher’s
298	319		or physician’s conduct is in compliance with the provisions of this
299	320		section.
300	321		2. A patient participating in a clinical trial under a valid
301	322		written certification issued in accordance with this section shall
302	323		not be subject to arrest, prosecution, or any civil or
303	324		administrative penalty for the use or possession of psilocybin or
304	325		psilocin as long as the patient’s conduct is in compliance with t he
305	326		provisions of this section.
306		-	G. Researching entities shall submit a written report to the
307		-	President Pro Tempor e of the Senate and the Speaker of the House of
308		-	Representatives containing the results of the studies conducted
309		-	under this section and any recommendations for legislative or other
310		-	actions not later than December 1, 202 5.
311		-	H. Researching entities shall ensure any protected health
312		-	information collected during the clinical trial s done in accordance
313		-	with this section does not personally identify any individual.
314		-	I. The State Department of Health, the Oklahoma Department of
315		-	Agriculture, Food, and Forestry, the Oklahoma State Bureau of
316		-	Narcotics and Dangerous Drugs Control, and any other state agency
317		-	with access to the research programs authorized by this section
318		-	shall not release or allow to be released through inaction any
319		-	protected health information. The protected health information of
320		-	clinical trial participants shall be exempt from the Oklahoma Open
321		-	Records Act.
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	353	+	G. Researching entities shall submit a written report to the
	354	+	President Pro Tempor e of the Senate and the Speaker of the House of
	355	+	Representatives containing the results of the studies conducted
	356	+	under this section and any recommendations for legislative or other
	357	+	actions not later than December 1, 202 5.
	358	+	H. Researching entities shall ensure any protected health
	359	+	information collected during the clinical trials done in accordance
	360	+	with this section does not personally identify any individual.
	361	+	I. The State Department of Health, the Oklahoma Department of
	362	+	Agriculture, Food, and Forestry, the Oklahoma State Bureau of
	363	+	Narcotics and Dangerous Drugs Control, and any other state agency
	364	+	with access to the research programs authorized by this section
	365	+	shall not release or allow to be released through inaction any
	366	+	protected health information. The protected health information of
	367	+	clinical trial participants shall be exempt from the Oklahoma Open
	368	+	Records Act.
349	369		J. The State Commissioner of Health, the State Board of
350	370		Agriculture, and the Director of the Oklahoma State Bureau of
351	371		Narcotics and Dangerous Drugs Control shall promulgate rules
352	372		necessary to implement the program authorized in this section.
353	373		SECTION 2. AMENDATORY 63 O.S. 2021, Section 2 -303, is
354	374		amended to read as fol lows:
355	375		Section 2-303. A. The Director of the Oklahoma State Bureau of
356	376		Narcotics and Dangerous Drugs Con trol shall register an applicant to
357		-	own a medical facility as described in subsectio n C of Section 2-302
358		-	of this title, or to manufacture, distribu te, dispense, prescribe,
359		-	administer or use for scientific purposes controlle d dangerous
360		-	substances included i n Schedules I through V of Section 2 -101 et
361		-	seq. of this title unless the Director d etermines that the issuance
362		-	of such registration is inconsisten t with the public interest. In
363		-	determining the public interest, the followi ng factors shall be
364		-	considered:
365		-	1. Maintenance of effective controls ag ainst diversion of
366		-	particular controlled dang erous substances and any Schedule I or II
367		-	substance compounded therefrom into other than legitimate medical,
368		-	scientific or industrial chann els, including examination of the
369		-	fitness of his or her employees or age nts to handle dangerous
370		-	substances;
371		-	2. Compliance with applicable state and local law;
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	403	+	own a medical facility as described in subsection C of Section 2 -302
	404	+	of this title, or to manufacture, distribu te, dispense, prescribe,
	405	+	administer or use for scientific purposes controlle d dangerous
	406	+	substances included i n Schedules I through V of Section 2 -101 et
	407	+	seq. of this title unless the Director determines that the issuance
	408	+	of such registration is inconsisten t with the public interest. In
	409	+	determining the public interest, the followi ng factors shall be
	410	+	considered:
	411	+	1. Maintenance of effective controls ag ainst diversion of
	412	+	particular controlled dangerous substances and any Schedule I or II
	413	+	substance compounded therefrom into other than legitimate medical,
	414	+	scientific or industrial chann els, including examination of the
	415	+	fitness of his or her employees or age nts to handle dangerous
	416	+	substances;
	417	+	2. Compliance with applicable state and local law;
399	418		3. Has been found g uilty of, entered a plea of guilty or nolo
400	419		contendere to a charge under the Uniform Controlled Dangerous
401	420		Substances Act or any other state or federa l law relating to any
402	421		substance defined herein as a controlled dangerous substance or any
403	422		felony under the laws of any state or the United States ;
404	423		4. Furnishing by the applicant false or fraudulent material
405	424		information in any application filed under Secti on 2-101 et seq. of
406	425		this title;
407		-	5. Past experience in the manufacture, distribution,
408		-	dispensing, prescribin g, administering or use for scientifi c
409		-	purposes of controlled dangerous subs tances, and the existence in
410		-	the establishment of effective controls aga inst diversion;
411		-	6. Denial, suspension or rev ocation of the applicant’s federal
412		-	registration to manufacture, distribute or dispense controlled
413		-	dangerous substances as authorized by fed eral law; and
414		-	7. Such other factors as may be relevant to and consisten t with
415		-	the public health and safety.
416		-	Nothing herein shall be deemed to require individual licensed
417		-	pharmacists to register under the provisions o f the Uniform
418		-	Controlled Dangerous Subs tances Act.
419		-	B. Registration gran ted under subsection A of this section
420		-	shall not entitle a registrant to manufacture , distribute, dispense,
421		-	prescribe, administer or use for scient ific purposes controlled
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448	451
	452	+	5. Past experience in the manufacture, distribution,
	453	+	dispensing, prescribin g, administering or use for scientifi c
	454	+	purposes of controlled dangerous subs tances, and the existence in
	455	+	the establishment of effective controls aga inst diversion;
	456	+	6. Denial, suspension or revocation of the applicant ’s federal
	457	+	registration to manufacture, distribute or dispense controlled
	458	+	dangerous substances as authorized by fed eral law; and
	459	+	7. Such other factors as may be relevant to and consisten t with
	460	+	the public health and safety.
	461	+	Nothing herein shall be deemed to require individual licensed
	462	+	pharmacists to register under the provisions o f the Uniform
	463	+	Controlled Dangerous Subs tances Act.
	464	+	B. Registration gran ted under subsection A of this section
	465	+	shall not entitle a registrant to manufacture, distribute, dispense,
	466	+	prescribe, administer or use for scient ific purposes controlled
449	467		dangerous substances in Schedule I or II other than those specified
450	468		in the registration.
451	469		C. Practitioners shall be registe red to dispense, prescribe,
452	470		administer or use for scientific purposes substances in Schedules II
453	471		through V if they are authorized to carry on the ir respective
454	472		activities under the laws of this state. A registration a pplication
455	473		by a practitioner who wishes to conduct research with Schedule I
456	474		substances shall be accompanied by evidence of the applicant ’s
457	475		federal registration to conduct such activity and shall be referred
458		-	to the Medical Research Commission for advice. T he Medical Research
459		-	Commission shall promptly advise the Director concerning the
460		-	qualifications of each practitioner requesting such registration.
461		-	Registration for the purpose of bona fide research or of use for
462		-	scientific purposes with Schedule I substan ces by a practitioner
463		-	deemed qualified by the Medical Research Commission may be den ied
464		-	only on a ground specified in subsection A of Section 2 -304 of this
465		-	title or if there are reason able grounds to believe that the
466		-	applicant will abuse or unlawfully tran sfer such substances or fail
467		-	to safeguard adequately such applicant ’s supply of such substances
468		-	against diversion from legitimate medical or scient ific use.
469		-	D. 1. The Director shall initially permit persons to register
470		-	who own or operate any establishmen t engaged in the manufacture,
471		-	distribution, dispensing, prescribing, administering o r use for
472		-	scientific purposes of any controlled dangerous subst ances prior to
473	476
474		-	SENATE FLOOR VERSION - HB3414 SFLR Page 10
475		-	(Bold face denotes Committee Amendments) 1
	477	+	Req. No. 3797 Page 10 1
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	502	+	to the Medical Research Commission for advice. T he Medical Research
	503	+	Commission shall promptly advise the Director concerning the
	504	+	qualifications of each practitioner requesting such registration.
	505	+	Registration for the purpose of bona fide research or of use for
	506	+	scientific purposes with Schedule I substan ces by a practitioner
	507	+	deemed qualified by the Medical Research Commission may be denied
	508	+	only on a ground specified in subsection A of Section 2 -304 of this
	509	+	title or if there are reason able grounds to believe that the
	510	+	applicant will abuse or unlawfully tran sfer such substances or fail
	511	+	to safeguard adequately such applicant ’s supply of such substances
	512	+	against diversion from legitimate medical or scient ific use.
	513	+	D. 1. The Director shall initially permit persons to register
	514	+	who own or operate any establishmen t engaged in the manufacture,
	515	+	distribution, dispensing, prescribing, administering or use for
	516	+	scientific purposes of any controlled dangerous subst ances prior to
500	517		June 4, 1991, and who are registered or licensed by the state . Fees
501	518		for registration under th is section shall be as follows:
502	519		Practitioners and mid-level
503	520		practitioners $140.00 per year
504	521		of registration
505	522		Home Care Agencies, Hospices &
506	523		Home Care Services $140.00 annually
507	524		Medical Facility Owners $300.00 annually
508	525		Distributors $300.00 annually
509		-	Manufacturers $500.00 annually
510		-	Manufacturer, Wholesaler, or
511		-	Distributor of drug products
512		-	containing pseudoephedrine
513		-	or phenylpropanolamine $300.00 annually
514		-	Researcher of psilocybin or
515		-	psilocin $140.00 annually
516		-	2. A registrant shall be required to pay double the amo unt of
517		-	the above-listed fee for any ren ewal of registration received more
518		-	than thirty (30) days late.
519		-	3. A Ten Dollar ($10.00) fee shall be charged for a duplicate
520		-	registration certificate.
521		-	E. Compliance by manufacturers and distributors with the
522		-	provisions of the Federal Controlled Substance s Act, 21 U.S.C.,
523		-	Section 801 et seq., respec ting registration, excluding fees, shall
524	526
525		-	SENATE FLOOR VERSION - HB3414 SFLR Page 11
526		-	(Bold face denotes Committee Amendments) 1
	527	+	Req. No. 3797 Page 11 1
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	552	+	Manufacturers $500.00 annually
	553	+	Manufacturer, Wholesaler, or
	554	+	Distributor of drug products
	555	+	containing pseudoephedrine
	556	+	or phenylpropanolamine $300.00 annually
	557	+	Researcher of psilocybin or
	558	+	psilocin $140.00 annually
	559	+	2. A registrant shall be required to pay double the amo unt of
	560	+	the above-listed fee for any ren ewal of registration received more
	561	+	than thirty (30) days late.
	562	+	3. A Ten Dollar ($10.00) fee shall be charged for a duplicate
	563	+	registration certificate.
	564	+	E. Compliance by manufacturers and distributors with the
	565	+	provisions of the Federal Controlled Substance s Act, 21 U.S.C.,
	566	+	Section 801 et seq., respecting registration, excluding fees, shall
551	567		be deemed sufficient to qualify for registration under this act
552	568		Section 2-101 et seq. of this title.
553		-	~~COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES~~
554		-	~~April~~ 11, 2022 ~~- DO PASS AS AMENDED~~
	569	+
	570	+	58-2-3797 DC 4/11/2022 3:04:09 PM