juana, the source of the marijuana, or the conditions 
under which the marijuana is stored, tracked, or adminis-
tered. 
‘‘(ii) If an applicant amends or supplements the re-
search protocol or initiates research on a new research 
protocol under clause (i), the applicant shall, in order to 
renew the registration under this paragraph, provide no-
tice to the Attorney General of the amended or supple-
mented research protocol or any new research protocol in 
the applicant’s renewal materials. 
‘‘(iii)(I) If an applicant amends or supplements a re-
search protocol and the amendment or supplement in-
volves a change to the type of marijuana, the source of 
the marijuana, or conditions under which the marijuana 
is stored, tracked, or administered, the applicant shall pro-
vide notice to the Attorney General not later than 30 days 
before proceeding on such amended or supplemental re-
search or new research protocol, as the case may be. 
‘‘(II) If the Attorney General does not object during 
the 30-day period following a notification under subclause 
(I), the applicant may proceed with the amended or sup-
plemental research or new research protocol. 
‘‘(iv) The Attorney General may object to an amend-
ed or supplemental protocol or a new research protocol
under clause (i) or (iii) only if additional security meas-
ures are needed to safeguard against diversion or abuse. 
‘‘(G) If marijuana is listed on a schedule other than 
schedule I, the provisions of paragraphs (1), (2), and (4) 
that apply to research with a controlled substance in the 
applicable schedule shall apply to research with marijuana 
or that compound, as applicable, in lieu of the provisions 
of subparagraphs (A) through (F) of this paragraph. 
‘‘(H) Nothing in this paragraph shall be construed 
as limiting the authority of the Secretary under section 
505(i) of the Federal Food, Drug, and Cosmetic Act or 
over requirements related to research protocols, including 
changes in— 
‘‘(i) the method of administration of marijuana; 
‘‘(ii) the dosing of marijuana; and 
‘‘(iii) the number of individuals or patients in-
volved in research.’’. 
SEC. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA 
FOR USE IN LEGITIMATE RESEARCH. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823), as amended by section 2, is further amended 
by adding at the end the following: 
‘‘(l) REGISTRATION OF PERSONS TO MANUFACTURE 
AND DISTRIBUTE MARIJUANA FOR USE IN LEGITIMATE 
RESEARCH.—
‘‘(1) REGISTRATION OF MANUFACTURERS.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than the day that is 1 year after the date of en-
actment of the Medical Marijuana Research 
Act, the Attorney General, pursuant to sub-
section (f)(3) and subject to subparagraph (B) 
of this paragraph, shall register an applicant to 
manufacture marijuana (including any deriva-
tive, extract, preparation, and compound there-
of) that is intended for— 
‘‘(i) the ultimate and exclusive use by 
qualified marijuana researchers for re-
search pursuant to subsection (f)(3); or 
‘‘(ii) subsequent downstream manu-
facture by a duly registered manufacturer 
for the ultimate and exclusive use by quali-
fied marijuana researchers for research 
pursuant to subsection (f)(3). 
‘‘(B) PUBLIC
INTEREST.—The Attorney 
General shall register an applicant under sub-
paragraph (A) unless the Attorney General de-
termines that the issuance of such registration 
is inconsistent with the public interest. In deter-
mining the public interest, the Attorney General 
shall take into consideration—
‘‘(i) maintenance of effective controls 
against diversion of marijuana and any 
controlled substance compounded there-
from into other than legitimate medical, 
scientific, or research channels; 
‘‘(ii) compliance with applicable State 
and local laws relating to controlled sub-
stance misuse and diversion; 
‘‘(iii) prior conviction record of the 
applicant under Federal or State laws re-
lating to the manufacture, distribution, or 
dispensing of such substances; and 
‘‘(iv) such other conduct which may 
threaten the public health and safety. 
‘‘(2) REGISTRATION OF DISTRIBUTORS.— 
‘‘(A) IN
GENERAL.—Beginning not later 
than the day that is 1 year after the date of en-
actment of the Medical Marijuana Research 
Act, the Attorney General shall register an ap-
plicant to distribute marijuana (including any 
derivative, extract, preparation, and compound 
thereof) that is intended for the ultimate and 
exclusive use by qualified marijuana researchers 
for research pursuant to subsection (f)(3) or in-
tended for subsequent downstream manufacture
by a duly registered manufacturer for use by 
qualified marijuana researchers for research 
pursuant to such subsection, unless the Attor-
ney General determines that the issuance of 
such registration is inconsistent with the public 
interest. 
‘‘(B) PUBLIC INTEREST.—In determining 
the public interest under subparagraph (A), the 
Attorney General shall take into consider-
ation— 
‘‘(i) the factors specified in clauses (i), 
(ii), (iii), and (iv) of paragraph (1)(B); and 
‘‘(ii) past experience in the distribu-
tion of controlled substances, and the exist-
ence of effective controls against diversion. 
‘‘(3) NO LIMIT ON NUMBER OF MANUFACTUR-
ERS
AND
DISTRIBUTORS.—Notwithstanding any 
other provision of law, the Attorney General shall 
not impose or implement any limit on the number of 
persons eligible to be registered to manufacture or 
distribute marijuana pursuant to paragraph (1) or 
(2). 
‘‘(4) REQUIREMENT TO VERIFY USE FOR LE-
GITIMATE RESEARCH.—As a condition of registra-
tion under this section to manufacture or distribute
marijuana, the Attorney General shall require the 
registrant— 
‘‘(A) to require any person to whom the 
marijuana will be supplied to submit docu-
mentation demonstrating that the marijuana 
(including any derivative, extract, preparation, 
and compound thereof) will be ultimately used 
exclusively by qualified marijuana researchers 
for research pursuant to subsection (f)(3) or for 
subsequent downstream manufacture by a duly 
registered manufacturer for use by qualified 
marijuana researchers for research pursuant to 
such subsection; 
‘‘(B) in the case of distribution, to com-
plete, with respect to that distribution, the ap-
propriate order form in accordance with section 
308 and to upload such forms to the system 
used by the Drug Enforcement Administration 
for such distribution; 
‘‘(C) to include in the labeling of any mari-
juana so manufactured or distributed— 
‘‘(i) the following statement: ‘This 
material is for biomedical and scientific re-
search purposes only.’; and
‘‘(ii) the name of the requestor of the 
marijuana; 
‘‘(D) to limit the transfer and sale of any 
marijuana under this subsection— 
‘‘(i) to researchers who are registered 
under this Act to conduct research with 
marijuana or to manufacturers duly reg-
istered under this subsection; 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 or for the pur-
poses of further manufacturing of mari-
juana; and 
‘‘(E) to transfer or sell any marijuana 
manufactured under this subsection only with 
prior, written consent for the transfer or sale by 
the Attorney General. 
‘‘(5) TIMING.—Not later than 60 days after re-
ceipt of a request for registration under this sub-
section to manufacture or distribute marijuana, the 
Attorney General shall— 
‘‘(A) grant or deny the request; and
‘‘(B) in the case of a denial, provide a 
written explanation of the basis for the denial. 
‘‘(6) DEEMED
APPROVAL.—If the Attorney 
General fails to grant or deny a request for registra-
tion under this subsection to manufacture or dis-
tribute marijuana within the 60-day period referred 
to in paragraph (5), such request is deemed ap-
proved.’’. 
SEC. 4. TERMINATION OF INTERDISCIPLINARY REVIEW 
PROCESS FOR NON-NIH-FUNDED QUALIFIED 
MARIJUANA 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) create an additional review of scientific pro-
tocols that is only conducted for research on mari-
juana other than the review of research protocols 
performed at the request of a qualified marijuana 
researcher conducting nonhuman research that is 
not federally funded, in accordance with section
303(f)(3)(A) of the Controlled Substances Act, as 
added by section 2 of this Act. 
SEC. 5. CONSIDERATION OF RESULTS OF RESEARCH. 
Immediately upon the approval by the Food and 
Drug Administration of an application for a drug that 
contains marijuana (as defined in section 102 of the Con-
trolled Substances Act (21 U.S.C. 802), as amended by 
section 8 of this Act) under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355), and (irre-
spective of whether any such approval is granted) not later 
than the date that is 5 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall— 
(1) conduct a review of existing medical and 
other research with respect to marijuana; 
(2) submit a report to the Congress on the re-
sults of such review; and 
(3) include in such report whether, taking into 
consideration the factors listed in section 201(c) of 
the Controlled Substances Act (21 U.S.C. 811(c)), 
as well as any potential for medical benefits, any 
gaps in research, and any impacts of Federal restric-
tions and policy on research, marijuana should be 
transferred to a schedule other than schedule I (if 
marijuana has not been so transferred already).
SEC. 6. PRODUCTION QUOTAS FOR MARIJUANA GROWN 
FOR LEGITIMATE, SCIENTIFIC RESEARCH. 
Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the fol-
lowing: 
‘‘(j) The Attorney General may only establish a quota 
for production of marijuana that is manufactured and dis-
tributed in accordance with the Medical Marijuana Re-
search Act that meets the changing medical, scientific, and 
industrial needs for marijuana.’’. 
SEC. 7. ARTICLE 28 OF THE SINGLE CONVENTION ON NAR-
COTIC DRUGS. 
Article 28 of the Single Convention on Narcotic 
Drugs shall not be construed to prohibit, or impose addi-
tional restrictions upon, research involving marijuana, or 
the manufacture, distribution, or dispensing of marijuana, 
that is conducted in accordance with the Controlled Sub-
stances Act (21 U.S.C. 801 et seq.), this Act, and the 
amendments made by this Act. 
SEC. 8. DEFINITIONS. 
(a) QUALIFIED MARIJUANA RESEARCHER.—In this 
Act, the term ‘‘qualified marijuana researcher’’ has the 
meaning given the term in section 303(f)(3) of the Con-
trolled Substances Act, as added by section 2(d) of this 
Act.
(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’’. 
SEC. 9. DETERMINATION OF BUDGETARY EFFECTS. 
The budgetary effects of this Act, for the purpose of 
complying with the Statutory Pay-As-You-Go Act of 2010, 
shall be determined by reference to the latest statement 
titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 
Act, submitted for printing in the Congressional Record 
by the Chairman of the House Budget Committee, pro-
vided that such statement has been submitted prior to the 
vote on passage. 
Passed the House of Representatives December 9, 
2020. 
Attest: 
Clerk.
116TH CONGRESS 
2D SESSION 
H. R. 3797 
AN ACT 
To amend the Controlled Substances Act to make 
marijuana accessible for use by qualified mari-
juana researchers for medical purposes, and for 
other purposes.