I 
115TH CONGRESS 
2D SESSION 
H. R. 5634 
To increase the number of manufacturers registered under the Controlled 
Substances Act to manufacture cannabis for legitimate research purposes, 
to authorize health care providers of the Department of Veterans Affairs 
to provide recommendations to veterans regarding participation in feder-
ally-approved cannabis clinical trials, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 26, 2018 
Mr. GAETZ (for himself, Mr. BISHOP of Utah, Mr. SWALWELL of California, 
Mr. RUTHERFORD, Mr. TAYLOR, Mr. GARRETT, Mr. RASKIN, Mr. BLU-
MENAUER, Mr. JOYCE of Ohio, Mr. BUCK, Mrs. HANDEL, Mr. CURBELO 
of Florida, Mr. SOTO, Mr. POLIS, Mr. DENHAM, Ms. ROS-LEHTINEN, Mr. 
SANFORD, Mr. CICILLINE, Ms. LEE, Mr. ISSA, Mr. ROHRABACHER, Mr. 
GOODLATTE, Mr. MCCLINTOCK, Mr. HASTINGS, Mr. COHEN, Ms. TITUS, 
Ms. LOFGREN, and Mr. CORREA) introduced the following bill; which was 
referred to the Committee on Energy and Commerce, and in addition to 
the Committees on the Judiciary, and Veterans’ Affairs, 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 increase the number of manufacturers registered under 
the Controlled Substances Act to manufacture cannabis 
for legitimate research purposes, to authorize health care 
providers of the Department of Veterans Affairs to pro-
vide recommendations to veterans regarding participation 
in federally-approved cannabis clinical trials, and for 
other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Cannabis Re-
search Act of 2018’’. 
SEC. 2. INCREASING THE NUMBER OF FEDERALLY-REG-
ISTERED 
MANUFACTURERS 
OF 
CANNABIS 
FOR LEGITIMATE RESEARCH PURPOSES. 
(a) IN GENERAL.—Section 303 of the Controlled 
Substances Act (21 U.S.C. 823) is amended— 
(1) by redesignating subsection (k) as sub-
section (l); and 
(2) by inserting after subsection (j) the fol-
lowing: 
‘‘(k) REGISTRATION OF MANUFACTURERS OF CAN-
NABIS FOR LEGITIMATE RESEARCH PURPOSES.— 
‘‘(1) IN GENERAL.—Any manufacturer of can-
nabis for research shall obtain a separate registra-
tion under this subsection for that purpose— 
‘‘(A) annually; or 
‘‘(B) for a longer period as determined 
necessary by the Attorney General to supply 
cannabis for the full duration of a particular 
multi-year study for legitimate research pur-
poses. 
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‘‘(2) ADEQUATE
AND
UNINTERRUPTED
SUP-
PLY.— 
‘‘(A) ANNUAL
ASSESSMENT.—On an an-
nual basis, the Attorney General shall assess 
whether there is an adequate and uninterrupted 
supply of cannabis for legitimate research pur-
poses. 
‘‘(B) INITIAL
YEAR.—Not later than 1 
year after the date of enactment of the Medical 
Cannabis Research Act of 2018, of the appli-
cants meeting the requirements of this Act, the 
Attorney General shall register under sub-
section (a) and this subsection at least 2 appli-
cants to manufacture cannabis for legitimate 
research purposes in addition to any manufac-
turers that are registered under subsection (a) 
to manufacture cannabis as of the date of en-
actment of the Medical Cannabis Research Act 
of 2018. 
‘‘(C) SUBSEQUENT YEARS.—For calendar 
year 2019 and each subsequent calendar year, 
of the applicants meeting the requirements of 
this Act, the Attorney General shall register 
(including any registration renewal) under sub-
section (a) and this subsection at least 3 appli-
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cants to manufacture cannabis for legitimate 
research purposes. 
‘‘(3) REQUIREMENTS.—A manufacturer reg-
istered under this subsection shall— 
‘‘(A) comply with all applicable require-
ments of this Act; 
‘‘(B) limit the transfer and sale of any 
cannabis manufactured pursuant to this sec-
tion— 
‘‘(i) to researchers who are registered 
under this Act to conduct research with 
controlled substances in schedule I; and 
‘‘(ii) for purposes of use in preclinical 
research or in a clinical investigation pur-
suant to an investigational new drug ex-
emption under 505(i) of the Federal Food, 
Drug, and Cosmetic Act; 
‘‘(C) transfer or sell any cannabis manu-
factured pursuant to this section only with 
prior, written consent for the transfer or sale by 
the Attorney General; 
‘‘(D) have completed the application and 
review process under subsection (a) for the bulk 
manufacture of controlled substances in sched-
ule I; 
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‘‘(E) have established and begun operation 
of a process for storage and handling of con-
trolled substances in schedule I, including for 
inventory control and monitoring security; 
‘‘(F) have the ability to provide at least 10 
unique plant cultivars to ensure plant diversity 
and scale up to produce bulk plant material on 
an uninterrupted basis sufficient to supply fore-
casted demand; 
‘‘(G) be licensed, by each State in which 
the manufacturer conducts its operations pursu-
ant to this subsection, to manufacture cannabis; 
‘‘(H) have completed a criminal back-
ground check for all personnel involved in the 
operations of the manufacturer pursuant to this 
subsection to confirm that such personnel have 
no conviction for a felony or drug-related mis-
demeanor; 
‘‘(I) have a letter of reference affirming 
the manufacturer’s good standing from each of 
the applicable State health care and law en-
forcement authorities in each jurisdiction of the 
manufacturer’s operations pursuant to this sub-
section; and 
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‘‘(J) have the ability to test for and isolate 
at least 12 cannabinoids for the purposes of 
producing specific products for specific studies 
by compounding pharmacists or others, label-
ing, and chemical consistency. 
‘‘(4) APPLICATION CONTENTS.—As part of an 
application to be registered under this subsection, an 
applicant shall include a written explanation of how 
the applicant’s proposed manufacture of cannabis 
would augment the Nation’s supply of cannabis for 
legitimate research purposes. 
‘‘(5) PROCESS.—Not later than 1 year after the 
date on which the Attorney General receives an ap-
plication to be registered under this section to man-
ufacture cannabis for research, the Attorney General 
shall— 
‘‘(A) grant, or initiate proceedings under 
section 304(c) to deny, the application; or 
‘‘(B) request supplemental information 
from the applicant. 
‘‘(6) RULE OF CONSTRUCTION ON REGISTRA-
TION
FOR
PURPOSES
OTHER
THAN
RESEARCH.— 
Nothing in this subsection shall be construed to af-
fect the provisions of this section prohibiting or oth-
erwise pertaining to registration of manufacturers of 
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cannabis for purposes other than research, including 
for purposes of strictly commercial endeavors funded 
by the private sector and aimed at drug product de-
velopment. 
‘‘(7) NO DISCRIMINATORY TREATMENT BY FED-
ERAL
GOVERNMENT.—Notwithstanding any other 
provision of law, no Federal department or agency 
shall deny or limit any funding, other assistance, li-
censing, or other privilege with respect to any person 
on the basis that such person is, or is legally receiv-
ing cannabis from, a manufacturer of cannabis that 
is— 
‘‘(A) registered under this subsection; and 
‘‘(B) in compliance with the requirements 
of this Act. 
‘‘(8) SPECIAL RULE.—If cannabis, or any com-
ponent thereof, is placed in a schedule other than 
schedule I, the Attorney General may, as the Attor-
ney General determines appropriate— 
‘‘(A) treat the reference to ‘subsection (a)’ 
in paragraph (2)(C) of this subsection as a ref-
erence to subsection (d); and 
‘‘(B) treat the references to schedule I in 
paragraph (3) as references to the appropriate 
schedule. 
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‘‘(9) DEFINITION.—In this subsection, the term 
‘legitimate research purposes’ has the meaning given 
to such term for purposes of subsection (a)(1).’’. 
(b) TRANSITIONAL PROVISIONS.— 
(1) CURRENT REGISTRANTS.—Notwithstanding 
paragraph (1) of section 303(k) of the Controlled 
Substances Act, as added by subsection (a), any 
manufacturer that is registered under section 303(a) 
of the Controlled Substances Act (21 U.S.C. 823(a)) 
to manufacture cannabis as of the date of enactment 
of this Act shall not be required to obtain a separate 
registration under such section 303(k) for the 1-year 
period following the date of enactment of this Act. 
(2) PENDING
APPLICATIONS.—The Attorney 
General of the United States shall grant or deny, in 
accordance with section 303 of the Controlled Sub-
stances Act (21 U.S.C. 823), as amended by sub-
section (a), each application to manufacture can-
nabis to supply researchers in the United States that 
was submitted— 
(A) pursuant to the policy statement enti-
tled ‘‘Applications To Become Registered Under 
the Controlled Substances Act To Manufacture 
Marijuana To Supply Researcher in the United 
States’’ published by the Drug Enforcement 
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Administration in the Federal Register on Au-
gust 12, 2016 (81 Fed. Reg. 53846); and 
(B) before February 12, 2017. 
(c) TECHNICAL AMENDMENT.—Section 102(16) of 
the Controlled Substances Act (21 U.S.C. 802(16)) is 
amended by inserting after ‘‘The term ‘marihuana’ ’’ the 
following: ‘‘or ‘marijuana’ or ‘cannabis’ ’’. 
SEC. 3. PROVISION BY DEPARTMENT OF VETERANS AF-
FAIRS HEALTH CARE PROVIDERS OF INFOR-
MATION REGARDING VETERAN PARTICIPA-
TION IN FEDERALLY-APPROVED CANNABIS 
CLINICAL TRIALS. 
(a) PROVISION OF INFORMATION AND FORMS.—Not-
withstanding any other provision of law, health care pro-
viders of the Department of Veterans Affairs may— 
(1) provide information to veterans regarding 
participation in federally-approved cannabis clinical 
trials; and 
(2) complete forms relating to such participa-
tion. 
(b) RECEIPT OF INFORMATION.—Health care pro-
viders and other employees of the Department may accept 
information regarding federally-approved cannabis clinical 
trials provided by individuals who are not employed by the 
Department who are researchers registered under the 
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