I 
117TH CONGRESS 
2D SESSION 
H. R. 8454 
To expand research on cannabidiol and marijuana, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 21, 2022 
Mr. BLUMENAUER (for himself, Mr. HARRIS, Mr. GRIFFITH, Mr. JOYCE of 
Ohio, Ms. NORTON, Ms. MACE, and Mr. PERLMUTTER) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To expand research on cannabidiol and marijuana, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medical Marijuana and Cannabidiol Research Expansion 
Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
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Sec. 1. Short title; table of contents. 
Sec. 2. Definitions. 
TITLE I—REGISTRATIONS FOR MARIJUANA RESEARCH 
Sec. 101. Marijuana research applications. 
Sec. 102. Research protocols. 
Sec. 103. Applications to manufacture marijuana for research. 
Sec. 104. Adequate and uninterrupted supply. 
Sec. 105. Security requirements. 
Sec. 106. Prohibition against reinstating interdisciplinary review process for 
non-NIH-funded researchers. 
TITLE II—DEVELOPMENT OF FDA-APPROVED DRUGS USING 
CANNABIDIOL AND MARIJUANA 
Sec. 201. Medical research on cannabidiol. 
Sec. 202. Registration for the commercial production and distribution of Food 
and Drug Administration-approved drugs. 
TITLE III—DOCTOR-PATIENT RELATIONSHIP 
Sec. 301. Doctor-patient relationship. 
TITLE IV—FEDERAL RESEARCH 
Sec. 401. Federal research. 
SEC. 2. DEFINITIONS. 
(a) IN GENERAL.—In this Act— 
(1) the term ‘‘appropriately registered’’ means 
that an individual or entity is registered under the 
Controlled Substances Act (21 U.S.C. 801 et seq.) 
to engage in the type of activity that is carried out 
by the individual or entity with respect to a con-
trolled substance on the schedule that is applicable 
to cannabidiol or marijuana, as applicable; 
(2) the term ‘‘cannabidiol’’ means— 
(A) the substance, cannabidiol, as derived 
from 
marijuana 
that 
has 
a 
delta-9- 
tetrahydrocannabinol level that is greater than 
0.3 percent; and 
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(B) the synthetic equivalent of the sub-
stance described in subparagraph (A); 
(3) the terms ‘‘controlled substance’’, ‘‘dis-
pense’’, ‘‘distribute’’, ‘‘manufacture’’, ‘‘marijuana’’, 
and ‘‘practitioner’’ have the meanings given such 
terms in section 102 of the Controlled Substances 
Act (21 U.S.C. 802), as amended by this Act; 
(4) the term ‘‘covered institution of higher edu-
cation’’ means an institution of higher education (as 
defined in section 101 of the Higher Education Act 
of 1965 (20 U.S.C. 1001)) that— 
(A)(i) has highest or higher research activ-
ity, as defined by the Carnegie Classification of 
Institutions of Higher Education; or 
(ii) is an accredited medical school or an 
accredited school of osteopathic medicine; and 
(B) is appropriately registered under the 
Controlled Substances Act (21 U.S.C. 801 et 
seq.); 
(5) the term ‘‘drug’’ has the meaning given the 
term in section 201(g)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)); 
(6) the term ‘‘medical research for drug devel-
opment’’ means medical research that is— 
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(A) a preclinical study or clinical investiga-
tion conducted in accordance with section 
505(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(i)) or otherwise per-
mitted by the Department of Health and 
Human Services to determine the potential 
medical benefits of marijuana or cannabidiol as 
a drug; and 
(B) conducted by a covered institution of 
higher education, practitioner, or manufacturer 
that is appropriately registered under the Con-
trolled Substances Act (21 U.S.C. 801 et seq.); 
and 
(7) the term ‘‘State’’ means any State of the 
United States, the District of Columbia, and any 
territory of the United States. 
(b) UPDATING TERM.—Section 102(16) of the Con-
trolled Substances Act (21 U.S.C. 802(16)) is amended— 
(1) in subparagraph (A), by striking ‘‘the term 
‘marihuana’ means’’ and inserting ‘‘the terms ‘mari-
huana’ and ‘marijuana’ mean’’; and 
(2) in subparagraph (B), by striking ‘‘The term 
‘marihuana’ does not’’ and inserting ‘‘The terms 
‘marihuana’ and ‘marijuana’ do not’’. 
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TITLE I—REGISTRATIONS FOR 
MARIJUANA RESEARCH 
SEC. 101. MARIJUANA RESEARCH APPLICATIONS. 
Section 303(f) of the Controlled Substances Act (21 
U.S.C. 823(f)) is amended— 
(1) by redesignating paragraphs (1) through 
(5) as subparagraphs (A) through (E), respectively; 
(2) by striking ‘‘(f) The Attorney General’’ and 
inserting ‘‘(f)(1) The Attorney General’’; 
(3) by striking ‘‘Registration applications’’ and 
inserting the following: 
‘‘(2)(A) Registration applications’’; 
(4) by striking ‘‘Article 7’’ and inserting the 
following: 
‘‘(3) Article 7’’; and 
(5) by inserting after paragraph (2)(A), as so 
designated, the following: 
‘‘(B)(i) The Attorney General shall register a practi-
tioner to conduct research with marijuana (including any 
derivative, extract, preparation, and compound thereof) 
if— 
‘‘(I) the applicant’s research protocol— 
‘‘(aa) has been reviewed and allowed— 
‘‘(AA) by the Secretary of Health and 
Human Services under section 505(i) of 
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the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(i)); 
‘‘(BB) by the National Institutes of 
Health or another Federal agency that 
funds scientific research; or 
‘‘(CC) pursuant to sections 1301.18 
and 1301.32 of title 21, Code of Federal 
Regulations, or any successors thereto; and 
‘‘(II) the applicant has demonstrated to the At-
torney General that there are effective procedures in 
place to adequately safeguard against diversion of 
the controlled substance for legitimate medical or 
scientific use pursuant to section 105 of the Medical 
Marijuana and Cannabidiol Research Expansion Act, 
including demonstrating that the security measures 
are adequate for storing the quantity of marijuana 
the applicant would be authorized to possess. 
‘‘(ii) The Attorney General may deny an application 
for registration under this subparagraph only if the Attor-
ney General determines that the issuance of the registra-
tion would be inconsistent with the public interest. In de-
termining the public interest, the Attorney General shall 
consider the factors listed in— 
‘‘(I) subparagraphs (B) through (E) of para-
graph (1); and 
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‘‘(II) subparagraph (A) of paragraph (1), if the 
applicable State requires practitioners conducting re-
search to register with a board or authority de-
scribed in such subparagraph (A). 
‘‘(iii)(I) Not later than 60 days after the date on 
which the Attorney General receives a complete applica-
tion for registration under this subparagraph, the Attor-
ney General shall— 
‘‘(aa) approve the application; or 
‘‘(bb) request supplemental information. 
‘‘(II) For purposes of subclause (I), an application 
shall be deemed complete when the applicant has sub-
mitted documentation showing that the requirements 
under clause (i) are satisfied. 
‘‘(iv) Not later than 30 days after the date on which 
the Attorney General receives supplemental information as 
described in clause (iii)(I)(bb) in connection with an appli-
cation described in this subparagraph, the Attorney Gen-
eral shall approve or deny the application. 
‘‘(v) If an application described in this subparagraph 
is denied, the Attorney General shall provide a written ex-
planation of the basis of denial to the applicant.’’. 
SEC. 102. RESEARCH PROTOCOLS. 
(a) IN GENERAL.—Paragraph (2)(B) of section 
303(f) of the Controlled Substances Act (21 U.S.C. 
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823(f)), as added by section 101 of this Act, is further 
amended by adding at the end the following: 
‘‘(vi)(I) If the Attorney General grants an application 
for registration under clause (i), the registrant may amend 
or supplement the research protocol without notification 
to, or review by, the Drug Enforcement Administration 
if the registrant does not change— 
‘‘(aa) the quantity or type of marijuana or 
cannabidiol (including any derivative, extract, prepa-
ration, and compound thereof); 
‘‘(bb) the source of such marijuana or 
cannabidiol; or 
‘‘(cc) the conditions under which such mari-
juana or cannabidiol is stored, tracked, or adminis-
tered. 
‘‘(II)(aa) If a registrant under clause (i) seeks to 
change the type of marijuana or cannabidiol (including 
any derivative, extract, preparation, and compound there-
of), the source of such marijuana or cannabidiol, or the 
conditions under which such marijuana or cannabidiol is 
stored, tracked, or administered, the registrant shall notify 
the Attorney General via registered mail, or an electronic 
means permitted by the Attorney General, not later than 
30 days before implementing an amended or supplemental 
research protocol. 
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‘‘(bb) A registrant may proceed with an amended or 
supplemental research protocol described in item (aa) if 
the Attorney General does not explicitly object during the 
30-day period beginning on the date on which the Attorney 
General receives the notice under item (aa). 
‘‘(cc) The Attorney General may only object to an 
amended or supplemental research protocol under this 
subclause if additional security measures are needed to 
safeguard against diversion or abuse. 
‘‘(dd) If a registrant under clause (i) seeks to address 
additional security measures identified by the Attorney 
General under item (cc), the registrant shall notify the At-
torney General via registered mail, or an electronic means 
permitted by the Attorney General, not later than 30 days 
before implementing an amended or supplemental research 
protocol. 
‘‘(ee) A registrant may proceed with an amended or 
supplemental research protocol described in item (dd) if 
the Attorney General does not explicitly object during the 
30-day period beginning on the date on which the Attorney 
General receives the notice under item (dd). 
‘‘(III)(aa) If a registrant under clause (i) seeks to 
change the quantity of marijuana needed for research and 
the change in quantity does not impact the factors de-
scribed in item (bb) or (cc) of subclause (I) of this clause, 
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not later than 3 days after receipt of the notification 
by the Attorney General. 
‘‘(dd)(AA) On and after the date described in subitem 
(BB), a registrant that submits a notification in accord-
ance with item (aa) may proceed with the research as if 
the change in quantity has been approved on such date, 
unless the Attorney General notifies the registrant of an 
objection described in item (ee). 
‘‘(BB) The date described in this subitem is the date 
on which a registrant submitting a notification under item 
(aa) receives the registered mail return receipt with re-
spect to the notification or the date on which the reg-
istrant receives notice that the notification using an elec-
tronic means permitted under item (aa) was received by 
the Attorney General, as the case may be. 
‘‘(ee) A notification submitted under item (aa) shall 
be deemed to be approved unless the Attorney General, 
not later than 10 days after receiving the notification, ex-
plicitly objects based on a finding that the change in quan-
tity— 
‘‘(AA) does impact the source of the marijuana 
or cannabidiol or the conditions under which the 
marijuana or cannabidiol is stored, tracked, or ad-
ministered; or 
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‘‘(BB) necessitates that the registrant imple-
ment additional security measures to safeguard 
against diversion or abuse. 
‘‘(IV) Nothing in this clause shall limit the authority 
of the Secretary of Health and Human Services over re-
quirements related to research protocols, including 
changes in— 
‘‘(aa) the method of administration of mari-
juana or cannabidiol; 
‘‘(bb) the dosing of marijuana or cannabidiol; 
and 
‘‘(cc) the number of individuals or patients in-
volved in research.’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of enactment of this Act, the Attorney General shall 
promulgate regulations to carry out the amendment made 
by this section. 
SEC. 103. APPLICATIONS TO MANUFACTURE MARIJUANA 
FOR RESEARCH. 
(a) IN GENERAL.—Section 303 of the Controlled 
Substances Act (21 U.S.C. 823), as amended by sections 
101 and 102 of this Act, is further amended— 
(1) by redesignating subsections (c) through (k) 
as subsections (d) through (l), respectively; 
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(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c)(1)(A) As it relates to applications to manufac-
ture marijuana for research purposes, when the Attorney 
General places a notice in the Federal Register to increase 
the number of entities registered under this Act to manu-
facture marijuana to supply appropriately registered re-
searchers in the United States, the Attorney General shall, 
not later than 60 days after the date on which the Attor-
ney General receives a completed application— 
‘‘(i) approve the application; or 
‘‘(ii) request supplemental information. 
‘‘(B) For purposes of subparagraph (A), an applica-
tion shall be deemed complete when the applicant has sub-
mitted documentation showing each of the following: 
‘‘(i) The requirements designated in the notice 
in the Federal Register are satisfied. 
‘‘(ii) The requirements under this Act are satis-
fied. 
‘‘(iii) The applicant will limit the transfer and 
sale of any marijuana manufactured under this sub-
section— 
‘‘(I) to researchers who are registered 
under this Act to conduct research with con-
trolled substances in schedule I; and 
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‘‘(II) for purposes of use in preclinical re-
search or in a clinical investigation pursuant to 
an investigational new drug exemption under 
505(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(i)). 
‘‘(iv) The applicant will transfer or sell any 
marijuana manufactured under this subsection only 
with prior, written consent for the transfer or sale 
by the Attorney General. 
‘‘(v) The applicant has completed the applica-
tion and review process under subsection (a) for the 
bulk manufacture of controlled substances in sched-
ule I. 
‘‘(vi) The applicant has established and begun 
operation of a process for storage and handling of 
controlled substances in schedule I, including for in-
ventory control and monitoring security in accord-
ance with section 105 of the Medical Marijuana and 
Cannabidiol Research Expansion Act. 
‘‘(vii) The applicant is licensed by each State in 
which the applicant will conduct operations under 
this subsection, to manufacture marijuana, if that 
State requires such a license. 
‘‘(C) Not later than 30 days after the date on which 
the Attorney General receives supplemental information 
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requested under subparagraph (A)(ii) with respect to an 
application, the Attorney General shall approve or deny 
the application. 
‘‘(2) If an application described in this subsection is 
denied, the Attorney General shall provide a written expla-
nation of the basis of denial to the applicant.’’; 
(3) in subsection (h)(2), as so redesignated, by 
striking ‘‘subsection (f)’’ each place it appears and 
inserting ‘‘subsection (g)’’; 
(4) in subsection (j)(1), as so redesignated, by 
striking ‘‘subsection (d)’’ and inserting ‘‘subsection 
(e)’’; and 
(5) in subsection (k), as so redesignated, by 
striking ‘‘subsection (f)’’ each place it appears and 
inserting ‘‘subsection (g)’’. 
(b) TECHNICAL AND CONFORMING AMENDMENTS.— 
(1) The Controlled Substances Act (21 U.S.C. 
801 et seq.) is amended— 
(A) in section 102 (21 U.S.C. 802)— 
(i) in paragraph (52)(B)— 
(I) by striking ‘‘303(f)’’ each 
place 
it 
appears 
and 
inserting 
‘‘303(g)’’; and 
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(II) in clause (i), by striking 
‘‘(d), or (e)’’ and inserting ‘‘(e), or 
(f)’’; and 
(ii) in paragraph (54), by striking 
‘‘303(f)’’ each place it appears and insert-
ing ‘‘303(g)’’; 
(B) in section 302(g)(5)(A)(iii)(I)(bb) (21 
U.S.C. 822(g)(5)(A)(iii)(I)(bb)), by striking 
‘‘303(f)’’ and inserting ‘‘303(g)’’; 
(C) in section 304 (21 U.S.C. 824), by 
striking ‘‘303(g)(1)’’ each place it appears and 
inserting ‘‘303(h)(1)’’; 
(D) in section 307(d)(2) (21 U.S.C. 
827(d)(2)), by striking ‘‘303(f)’’ and inserting 
‘‘303(g)’’; 
(E) in section 309A(a)(2) (21 U.S.C. 
829a(a)(2)), in the matter preceding subpara-
graph (A), by striking ‘‘303(g)(2)’’ and insert-
ing ‘‘303(h)(2)’’; 
(F) in section 311(h) (21 U.S.C. 831(h)), 
by striking ‘‘303(f)’’ each place it appears and 
inserting ‘‘303(g)’’; 
(G) in section 401(h)(2) (21 U.S.C. 
841(h)(2)), by striking ‘‘303(f)’’ each place it 
appears and inserting ‘‘303(g)’’; 
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to Congress within 60 days of the determination on at 
least— 
(1) the factors contributing to the inadequate 
or interrupted supply of marijuana; 
(2) expected impacts of the inadequate or inter-
rupted supply on ongoing research protocols; and 
(3) specific steps the Attorney General will take 
to restore an adequate and uninterrupted supply of 
marijuana, including of specific strains, for research 
purposes. 
SEC. 105. SECURITY REQUIREMENTS. 
(a) IN GENERAL.—An individual or entity engaged 
in researching marijuana or its components shall store it 
in a securely locked, substantially constructed cabinet. 
(b) REQUIREMENTS FOR OTHER MEASURES.—Any 
other security measures required by the Attorney General 
to safeguard against diversion shall be consistent with 
those required for practitioners conducting research on 
other controlled substances in schedules I and II in section 
202(c) of the Controlled Substances Act (21 U.S.C. 
812(c)) that have a similar risk of diversion and abuse. 
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SEC. 106. PROHIBITION AGAINST REINSTATING INTER-
DISCIPLINARY REVIEW PROCESS FOR NON- 
NIH-FUNDED RESEARCHERS. 
The Secretary of Health and Human Services may 
not— 
(1) reinstate the Public Health Service inter-
disciplinary review process described in the guidance 
entitled ‘‘Guidance on Procedures for the Provision 
of Marijuana for Medical Research’’ (issued on May 
21, 1999); or 
(2) require another review of scientific protocols 
that is applicable only to research on marijuana or 
its components. 
TITLE 
II—DEVELOPMENT 
OF 
FDA-APPROVED 
DRUGS 
USING 
CANNABIDIOL 
AND 
MARIJUANA 
SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL. 
Notwithstanding any provision of the Controlled Sub-
stances Act (21 U.S.C. 801 et seq.), the Safe and Drug- 
Free Schools and Communities Act (20 U.S.C. 7101 et 
seq.), chapter 81 of title 41, United States Code, or any 
other Federal law, an appropriately registered covered in-
stitution of higher education, practitioner, or manufac-
turer may manufacture, distribute, dispense, or possess 
marijuana or cannabidiol if the marijuana or cannabidiol 
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is manufactured, distributed, dispensed, or possessed, re-
spectively, for purposes of medical research for drug devel-
opment or subsequent commercial production in accord-
ance with section 202. 
SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUC-
TION AND DISTRIBUTION OF FOOD AND 
DRUG ADMINISTRATION-APPROVED DRUGS. 
The Attorney General shall register an applicant to 
manufacture or distribute cannabidiol or marijuana for 
the purpose of commercial production of a drug containing 
or derived from marijuana that is approved by the Sec-
retary of Health and Human Services under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), in accordance with the applicable requirements 
under subsection (a) or (b) of section 303 of the Con-
trolled Substances Act (21 U.S.C. 823). 
TITLE III—DOCTOR-PATIENT 
RELATIONSHIP 
SEC. 301. DOCTOR-PATIENT RELATIONSHIP. 
It shall not be a violation of the Controlled Sub-
stances Act (21 U.S.C. 801 et seq.) for a State-licensed 
physician to discuss— 
(1) the currently known potential harms and 
benefits 
of 
marijuana 
derivatives, 
including 
cannabidiol, as a treatment with the legal guardian 
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of the patient of the physician if the patient is a 
child; or 
(2) the currently known potential harms and 
benefits of marijuana and marijuana derivatives, in-
cluding cannabidiol, as a treatment with the patient 
or the legal guardian of the patient of the physician 
if the patient is a legal adult. 
TITLE IV—FEDERAL RESEARCH 
SEC. 401. FEDERAL RESEARCH. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, in coordination with the Director of the 
National Institutes of Health and the heads of other rel-
evant Federal agencies, shall submit to the Caucus on 
International Narcotics Control, the Committee on the Ju-
diciary, and the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce and the Committee on the Judiciary of the 
House of Representatives a report on— 
(1) 
the 
potential 
therapeutic 
effects 
of 
cannabidiol or marijuana on serious medical condi-
tions, including intractable epilepsy; 
(2) the potential effects of marijuana, includ-
ing— 
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(A) the effect of increasing delta-9- 
tetrahydrocannabinol levels on the human body 
and developing adolescent brains; and 
(B) 
the 
effect 
of 
various 
delta-9- 
tetrahydrocannabinol levels on cognitive abili-
ties, such as those that are required to operate 
motor vehicles or other heavy equipment; and 
(3) the barriers associated with researching 
marijuana or cannabidiol in States that have legal-
ized the use of such substances, which shall in-
clude— 
(A) recommendations as to how such bar-
riers might be overcome, including whether pub-
lic-private partnerships or Federal-State re-
search partnerships may or should be imple-
mented to provide researchers with access to 
additional strains of marijuana and cannabidiol; 
and 
(B) recommendations as to what safe-
guards must be in place to verify— 
(i) the levels of tetrahydrocannabinol, 
cannabidiol, or other cannabinoids con-
tained in products obtained from such 
States is accurate; and 
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Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H8454.IH
H8454
pbinns on DSKJLVW7X2PROD with $$_JOB