IIB 

116TH CONGRESS 

2D SESSION H. R. 3797 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 10, 2020 

Received 

DECEMBER 18, 2020 

Read twice and referred to the Committee on the Judiciary 

AN ACT 

To amend the Controlled Substances Act to make marijuana 

accessible for use by qualified marijuana researchers for 

medical purposes, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Marijuana Re3 search Act’’. 

4 SEC. 2. FACILITATING MARIJUANA RESEARCH. 

5 (a) PRODUCTION AND SUPPLY.—The Secretary of 

6 Health and Human Services— 

7 (1) until the date on which the Secretary deter8 mines that manufacturers and distributors (other 

9 than the Federal Government) can ensure a suffi10 cient supply of marijuana (as defined in section 102 

11 of the Controlled Substances Act (21 U.S.C. 802), 

12 as amended by section 8) intended for research by 

13 qualified marijuana researchers registered pursuant 

14 to paragraph (3) of section 303(f) of the Controlled 

15 Substances Act (21 U.S.C. 823(f)), as added by sec16 tion 3, shall— 

17 (A) continue, through grants, contracts, or 

18 cooperative agreements, to produce marijuana 

19 through the National Institute on Drug Abuse 

20 Drug Supply Program; 

21 (B) not later than one year after the date 

22 of enactment of this Act, act jointly with the 

23 Attorney General of the United States to estab24 lish and implement a specialized process for 

25 manufacturers and distributors, notwith26 standing the registration requirements of secVerDate Sep 11 2014 02:01 Dec 19, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3797.RFS H3797

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1 tion 303 of such Act (21 U.S.C. 823), to supply 

2 qualified marijuana researchers with marijuana 

3 products— 

4 (i) available through State-authorized 

5 marijuana programs; and 

6 (ii) consistent with the guidance 

7 issued under subsection (c); and 

8 (C) not later than 60 days after the date 

9 of enactment of this Act, jointly convene with 

10 the Attorney General a meeting to initiate the 

11 development of the specialized process described 

12 in subparagraph (B); and 

13 (2) beyond the date specified in paragraph (1), 

14 may, at the Secretary’s discretion, continue— 

15 (A) through grants, contracts, or coopera16 tive agreements, to so produce marijuana; and 

17 (B) to implement such specialized process. 

18 (b) REQUIREMENT TO VERIFY REGISTRATION.—Be19 fore supplying marijuana to any person through the Na20 tional Institute on Drug Abuse Drug Supply Program or 

21 through implementation of the specialized process estab22 lished under subsection (a)(1)(B), the Secretary of Health 

23 and Human Services shall— 

24 (1) require the person to submit documentation 

25 demonstrating that the person is a qualified mariVerDate Sep 11 2014 02:01 Dec 19, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3797.RFS H3797

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1 juana researcher seeking to conduct research pursu2 ant to section 303(f)(3) of the Controlled Substances 

3 Act, as added by subsection (d) of this section, or 

4 a manufacturer duly registered under section 303(l) 

5 of the Controlled Substances Act, as added by sec6 tion 3 of this Act; and 

7 (2) not later than 60 days after receipt of such 

8 documentation, review such documentation and 

9 verify that the marijuana will be used for such re10 search (and for no other purpose authorized pursu11 ant to this Act or the amendments made by this 

12 Act). 

13 (c) GUIDANCE ON USE OF STATE-AUTHORIZED

14 MARIJUANA PROGRAMS.—Not later than 180 days after 

15 the date of the enactment of this Act, the Secretary of 

16 Health and Human Services shall issue guidance related 

17 to marijuana from State-authorized marijuana programs 

18 for research. 

19 (d) RESEARCH.—Section 303(f) of the Controlled 

20 Substances Act (21 U.S.C. 823(f)) is amended— 

21 (1) by redesignating paragraphs (1) through 

22 (5) as subparagraphs (A) through (E), respectively; 

23 (2) by striking ‘‘(f) The Attorney General’’ and 

24 inserting ‘‘(f)(1) The Attorney General’’; 


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1 (3) by striking ‘‘Registration applications’’ and 

2 inserting the following: 

3 ‘‘(2) Registration applications’’; 

4 (4) in paragraph (2), as so designated, by strik5 ing ‘‘schedule I’’ each place that term appears and 

6 inserting ‘‘schedule I, except marijuana,’’; 

7 (5) by striking ‘‘Article 7’’ and inserting the 

8 following: 

9 ‘‘(4) Article 7’’; and 

10 (6) by inserting before paragraph (4), as so 

11 designated, the following: 

12 ‘‘(3)(A) The Attorney General shall register the ap13 plicant to conduct research with marijuana if— 

14 ‘‘(i) the applicant is authorized to dispense, or 

15 conduct research with respect to, controlled sub16 stances in schedule I, II, III, IV, or V; 

17 ‘‘(ii) the applicant is compliant with, and au18 thorized to conduct the activities described in clause 

19 (i) under, the laws of the State in which the appli20 cant practices; and 

21 ‘‘(iii) in the case of an applicant pursuing clin22 ical research, the applicant’s clinical research pro23 tocol has been reviewed and authorized to proceed by 

24 the Secretary under section 505(i) of the Federal 

25 Food, Drug, and Cosmetic Act. 


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1 ‘‘(B) An applicant registered under subparagraph (A) 

2 shall be referred to in this section as a ‘qualified mari3 juana researcher’. 

4 ‘‘(C)(i) Not later than 60 days after the date on 

5 which the Attorney General receives a complete applica6 tion for registration under this paragraph, the Attorney 

7 General shall approve or deny the application. 

8 ‘‘(ii) For purposes of clause (i), an application shall 

9 be deemed complete when the applicant has submitted 

10 documentation showing that the requirements under sub11 paragraph (A) are satisfied. 

12 ‘‘(iii) In the case of a denial under clause (i), the At13 torney General shall provide a written explanation of the 

14 basis for the denial. 

15 ‘‘(D) The Attorney General shall grant an application 

16 for registration under this paragraph unless the Attorney 

17 General determines that the issuance of the registration 

18 would be inconsistent with the public interest. In deter19 mining the public interest, the following factors shall be 

20 considered: 

21 ‘‘(i) The applicant’s experience in dispensing, or 

22 conducting research with respect to, controlled sub23 stances. 


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1 ‘‘(ii) The applicant’s conviction record under 

2 Federal or State laws relating to the manufacture, 

3 distribution, or dispensing of controlled substances. 

4 ‘‘(iii) Compliance with applicable State or local 

5 laws relating to controlled substance misuse or diver6 sion. 

7 ‘‘(iv) Such other conduct which may threaten 

8 the public health and safety. 

9 ‘‘(E)(i) A qualified marijuana researcher shall store 

10 marijuana to be used in research in a securely locked, sub11 stantially constructed cabinet. 

12 ‘‘(ii) Except as provided in clause (i), any security 

13 measures required by the Attorney General for applicants 

14 conducting research with marijuana pursuant to a reg15 istration under this paragraph shall be consistent with the 

16 security measures for applicants conducting research on 

17 other controlled substances in schedule II that have a 

18 similar risk of diversion and abuse. 

19 ‘‘(F)(i) If the Attorney General grants an application 

20 for registration under this paragraph, the applicant may 

21 amend or supplement the research protocol and proceed 

22 with the research under such amended or supplemented 

23 protocol, without additional review or approval by the At24 torney General or the Secretary of Health and Human 

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1 juana, the source of the marijuana, or the conditions 

2 under which the marijuana is stored, tracked, or adminis3 tered. 

4 ‘‘(ii) If an applicant amends or supplements the re5 search protocol or initiates research on a new research 

6 protocol under clause (i), the applicant shall, in order to 

7 renew the registration under this paragraph, provide no8 tice to the Attorney General of the amended or supple9 mented research protocol or any new research protocol in 

10 the applicant’s renewal materials. 

11 ‘‘(iii)(I) If an applicant amends or supplements a re12 search protocol and the amendment or supplement in13 volves a change to the type of marijuana, the source of 

14 the marijuana, or conditions under which the marijuana 

15 is stored, tracked, or administered, the applicant shall pro16 vide notice to the Attorney General not later than 30 days 

17 before proceeding on such amended or supplemental re18 search or new research protocol, as the case may be. 

19 ‘‘(II) If the Attorney General does not object during 

20 the 30-day period following a notification under subclause 

21 (I), the applicant may proceed with the amended or sup22 plemental research or new research protocol. 

23 ‘‘(iv) The Attorney General may object to an amend24 ed or supplemental protocol or a new research protocol 


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1 under clause (i) or (iii) only if additional security meas2 ures are needed to safeguard against diversion or abuse. 

3 ‘‘(G) If marijuana is listed on a schedule other than 

4 schedule I, the provisions of paragraphs (1), (2), and (4) 

5 that apply to research with a controlled substance in the 

6 applicable schedule shall apply to research with marijuana 

7 or that compound, as applicable, in lieu of the provisions 

8 of subparagraphs (A) through (F) of this paragraph. 

9 ‘‘(H) Nothing in this paragraph shall be construed 

10 as limiting the authority of the Secretary under section 

11 505(i) of the Federal Food, Drug, and Cosmetic Act or 

12 over requirements related to research protocols, including 

13 changes in— 

14 ‘‘(i) the method of administration of marijuana; 

15 ‘‘(ii) the dosing of marijuana; and 

16 ‘‘(iii) the number of individuals or patients in17 volved in research.’’. 

18 SEC. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA 

19 FOR USE IN LEGITIMATE RESEARCH. 

20 Section 303 of the Controlled Substances Act (21 

21 U.S.C. 823), as amended by section 2, is further amended 

22 by adding at the end the following: 

23 ‘‘(l) REGISTRATION OF PERSONS TO MANUFACTURE

24 AND DISTRIBUTE MARIJUANA FOR USE IN LEGITIMATE

25 RESEARCH.— 


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1 ‘‘(1) REGISTRATION OF MANUFACTURERS.— 

2 ‘‘(A) IN GENERAL.—Beginning not later 

3 than the day that is 1 year after the date of en4 actment of the Medical Marijuana Research 

5 Act, the Attorney General, pursuant to sub6 section (f)(3) and subject to subparagraph (B) 

7 of this paragraph, shall register an applicant to 

8 manufacture marijuana (including any deriva9 tive, extract, preparation, and compound there10 of) that is intended for— 

11 ‘‘(i) the ultimate and exclusive use by 

12 qualified marijuana researchers for re13 search pursuant to subsection (f)(3); or 

14 ‘‘(ii) subsequent downstream manu15 facture by a duly registered manufacturer 

16 for the ultimate and exclusive use by quali17 fied marijuana researchers for research 

18 pursuant to subsection (f)(3). 

19 ‘‘(B) PUBLIC INTEREST.—The Attorney 

20 General shall register an applicant under sub21 paragraph (A) unless the Attorney General de22 termines that the issuance of such registration 

23 is inconsistent with the public interest. In deter24 mining the public interest, the Attorney General 

25 shall take into consideration— 


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1 ‘‘(i) maintenance of effective controls 

2 against diversion of marijuana and any 

3 controlled substance compounded there4 from into other than legitimate medical, 

5 scientific, or research channels; 

6 ‘‘(ii) compliance with applicable State 

7 and local laws relating to controlled sub8 stance misuse and diversion; 

9 ‘‘(iii) prior conviction record of the 

10 applicant under Federal or State laws re11 lating to the manufacture, distribution, or 

12 dispensing of such substances; and 

13 ‘‘(iv) such other conduct which may 

14 threaten the public health and safety. 

15 ‘‘(2) REGISTRATION OF DISTRIBUTORS.— 

16 ‘‘(A) IN GENERAL.—Beginning not later 

17 than the day that is 1 year after the date of en18 actment of the Medical Marijuana Research 

19 Act, the Attorney General shall register an ap20 plicant to distribute marijuana (including any 

21 derivative, extract, preparation, and compound 

22 thereof) that is intended for the ultimate and 

23 exclusive use by qualified marijuana researchers 

24 for research pursuant to subsection (f)(3) or in25 tended for subsequent downstream manufacture 


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1 by a duly registered manufacturer for use by 

2 qualified marijuana researchers for research 

3 pursuant to such subsection, unless the Attor4 ney General determines that the issuance of 

5 such registration is inconsistent with the public 

6 interest. 

7 ‘‘(B) PUBLIC INTEREST.—In determining 

8 the public interest under subparagraph (A), the 

9 Attorney General shall take into consider10 ation— 

11 ‘‘(i) the factors specified in clauses (i), 

12 (ii), (iii), and (iv) of paragraph (1)(B); and 

13 ‘‘(ii) past experience in the distribu14 tion of controlled substances, and the exist15 ence of effective controls against diversion. 

16 ‘‘(3) NO LIMIT ON NUMBER OF MANUFACTUR17 ERS AND DISTRIBUTORS.—Notwithstanding any 

18 other provision of law, the Attorney General shall 

19 not impose or implement any limit on the number of 

20 persons eligible to be registered to manufacture or 

21 distribute marijuana pursuant to paragraph (1) or 

22 (2). 

23 ‘‘(4) REQUIREMENT TO VERIFY USE FOR LE24 GITIMATE RESEARCH.—As a condition of registra25 tion under this section to manufacture or distribute 


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1 marijuana, the Attorney General shall require the 

2 registrant— 

3 ‘‘(A) to require any person to whom the 

4 marijuana will be supplied to submit docu5 mentation demonstrating that the marijuana 

6 (including any derivative, extract, preparation, 

7 and compound thereof) will be ultimately used 

8 exclusively by qualified marijuana researchers 

9 for research pursuant to subsection (f)(3) or for 

10 subsequent downstream manufacture by a duly 

11 registered manufacturer for use by qualified 

12 marijuana researchers for research pursuant to 

13 such subsection; 

14 ‘‘(B) in the case of distribution, to com15 plete, with respect to that distribution, the ap16 propriate order form in accordance with section 

17 308 and to upload such forms to the system 

18 used by the Drug Enforcement Administration 

19 for such distribution; 

20 ‘‘(C) to include in the labeling of any mari21 juana so manufactured or distributed— 

22 ‘‘(i) the following statement: ‘This 

23 material is for biomedical and scientific re24 search purposes only.’; and 


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1 ‘‘(ii) the name of the requestor of the 

2 marijuana; 

3 ‘‘(D) to limit the transfer and sale of any 

4 marijuana under this subsection— 

5 ‘‘(i) to researchers who are registered 

6 under this Act to conduct research with 

7 marijuana or to manufacturers duly reg8 istered under this subsection; and 

9 ‘‘(ii) for purposes of use in preclinical 

10 research or in a clinical investigation pur11 suant to an investigational new drug ex12 emption under 505(i) of the Federal Food, 

13 Drug, and Cosmetic Act or for the pur14 poses of further manufacturing of mari15 juana; and 

16 ‘‘(E) to transfer or sell any marijuana 

17 manufactured under this subsection only with 

18 prior, written consent for the transfer or sale by 

19 the Attorney General. 

20 ‘‘(5) TIMING.—Not later than 60 days after re21 ceipt of a request for registration under this sub22 section to manufacture or distribute marijuana, the 

23 Attorney General shall— 

24 ‘‘(A) grant or deny the request; and 


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1 ‘‘(B) in the case of a denial, provide a 

2 written explanation of the basis for the denial. 

3 ‘‘(6) DEEMED APPROVAL.—If the Attorney 

4 General fails to grant or deny a request for registra5 tion under this subsection to manufacture or dis6 tribute marijuana within the 60-day period referred 

7 to in paragraph (5), such request is deemed ap8 proved.’’. 

9 SEC. 4. TERMINATION OF INTERDISCIPLINARY REVIEW 

10 PROCESS FOR NON-NIH-FUNDED QUALIFIED 

11 MARIJUANA RESEARCHERS. 

12 The Secretary of Health and Human Services may 

13 not— 

14 (1) reinstate the Public Health Service inter15 disciplinary review process described in the guidance 

16 entitled ‘‘Guidance on Procedures for the Provision 

17 of Marijuana for Medical Research’’ (issued on May 

18 21, 1999); or 

19 (2) create an additional review of scientific pro20 tocols that is only conducted for research on mari21 juana other than the review of research protocols 

22 performed at the request of a qualified marijuana 

23 researcher conducting nonhuman research that is 

24 not federally funded, in accordance with section 


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1 303(f)(3)(A) of the Controlled Substances Act, as 

2 added by section 2 of this Act. 

3 SEC. 5. CONSIDERATION OF RESULTS OF RESEARCH. 

4 Immediately upon the approval by the Food and 

5 Drug Administration of an application for a drug that 

6 contains marijuana (as defined in section 102 of the Con7 trolled Substances Act (21 U.S.C. 802), as amended by 

8 section 8 of this Act) under section 505 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 355), and (irre10 spective of whether any such approval is granted) not later 

11 than the date that is 5 years after the date of enactment 

12 of this Act, the Secretary of Health and Human Services 

13 shall— 

14 (1) conduct a review of existing medical and 

15 other research with respect to marijuana; 

16 (2) submit a report to the Congress on the re17 sults of such review; and 

18 (3) include in such report whether, taking into 

19 consideration the factors listed in section 201(c) of 

20 the Controlled Substances Act (21 U.S.C. 811(c)), 

21 as well as any potential for medical benefits, any 

22 gaps in research, and any impacts of Federal restric23 tions and policy on research, marijuana should be 

24 transferred to a schedule other than schedule I (if 

25 marijuana has not been so transferred already). 


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1 SEC. 6. PRODUCTION QUOTAS FOR MARIJUANA GROWN 

2 FOR LEGITIMATE, SCIENTIFIC RESEARCH. 

3 Section 306 of the Controlled Substances Act (21 

4 U.S.C. 826) is amended by adding at the end the fol5 lowing: 

6 ‘‘(j) The Attorney General may only establish a quota 

7 for production of marijuana that is manufactured and dis8 tributed in accordance with the Medical Marijuana Re9 search Act that meets the changing medical, scientific, and 

10 industrial needs for marijuana.’’. 

11 SEC. 7. ARTICLE 28 OF THE SINGLE CONVENTION ON NAR12 COTIC DRUGS. 

13 Article 28 of the Single Convention on Narcotic 

14 Drugs shall not be construed to prohibit, or impose addi15 tional restrictions upon, research involving marijuana, or 

16 the manufacture, distribution, or dispensing of marijuana, 

17 that is conducted in accordance with the Controlled Sub18 stances Act (21 U.S.C. 801 et seq.), this Act, and the 

19 amendments made by this Act. 

20 SEC. 8. DEFINITIONS. 

21 (a) QUALIFIED MARIJUANA RESEARCHER.—In this 

22 Act, the term ‘‘qualified marijuana researcher’’ has the 

23 meaning given the term in section 303(f)(3) of the Con24 trolled Substances Act, as added by section 2(d) of this 

25 Act. 


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1 (b) UPDATING TERM.—Section 102(16) of the Con2 trolled Substances Act (21 U.S.C. 802(16)) is amended— 

3 (1) in subparagraph (A), by striking ‘‘the term 

4 ‘marihuana’ means’’ and inserting ‘‘the terms ‘mari5 huana’ and ‘marijuana’ mean’’; and 

6 (2) in subparagraph (B), by striking ‘‘The term 

7 ‘marihuana’ does not’’ and inserting ‘‘The terms 

8 ‘marihuana’ and ‘marijuana’ do not’’. 

9 SEC. 9. DETERMINATION OF BUDGETARY EFFECTS. 

10 The budgetary effects of this Act, for the purpose of 

11 complying with the Statutory Pay-As-You-Go Act of 2010, 

12 shall be determined by reference to the latest statement 

13 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 

14 Act, submitted for printing in the Congressional Record 

15 by the Chairman of the House Budget Committee, pro16 vided that such statement has been submitted prior to the 

17 vote on passage. 

Passed the House of Representatives December 9, 

2020. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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