IB 

Union Calendar No. 508 

116TH CONGRESS 

2D SESSION H. R. 3797 

[Report No. 116–619, Part I] 

To amend the Controlled Substances Act to make marijuana accessible for 

use by qualified marijuana researchers for medical purposes, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 17, 2019 

Mr. BLUMENAUER (for himself, Mr. HARRIS, Ms. LOFGREN, Mr. GRIFFITH, 

Mr. BISHOP of Utah, and Mrs. DINGELL) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

DECEMBER 7, 2020 

Additional sponsors: Mr. GAETZ, Mrs. RODGERS of Washington, Mr. STEWART, Ms. NORTON, Ms. TITUS, Ms. LEE of California, Mr. GRIJALVA, 

Mr. CORREA, Mrs. HARTZLER, Mr. WALDEN, Mr. SMUCKER, Mr. CARTER of Georgia, Ms. BLUNT ROCHESTER, Mr. CURTIS, Mr. STEIL, and 

Mr. CASTEN of Illinois 

DECEMBER 7, 2020 

Reported from the Committee on Energy and Commerce with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

DECEMBER 7, 2020 

Committee on the Judiciary discharged; committed to the Committee of the 

Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on July 17, 2019] 


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A BILL 

To amend the Controlled Substances Act to make marijuana 

accessible for use by qualified marijuana researchers for 

medical purposes, and for other purposes. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Marijuana Re5 search Act’’. 

6 SEC. 2. FACILITATING MARIJUANA RESEARCH. 

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

8 Health and Human Services— 

9 (1) until the date on which the Secretary deter10 mines that manufacturers and distributors (other 

11 than the Federal Government) can ensure a sufficient 

12 supply of marijuana (as defined in section 102 of the 

13 Controlled Substances Act (21 U.S.C. 802), as amend14 ed by section 8) intended for medical research for 

15 qualified marijuana researchers registered pursuant 

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

17 Substances Act (21 U.S.C. 823(f)), as added by sec18 tion 3, shall— 

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

20 cooperative agreements, to produce marijuana 

21 through the National Institute on Drug Abuse 

22 Drug Supply Program; and 

23 (B) offer to qualified marijuana researchers 

24 marijuana products available through State au25 thorized marijuana programs that are consistent 


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1 with the guidance issued under subsection (c); 

2 and 

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

4 may, at the Secretary’s discretion, continue through 

5 grants, contracts, or cooperative agreements, to so 

6 produce and supply marijuana. 

7 (b) REQUIREMENT TO VERIFY REGISTRATION.—Before 

8 supplying marijuana to any person through the National 

9 Institute on Drug Abuse Drug Supply Program or from 

10 State authorized marijuana programs, the Secretary of 

11 Health and Human Services shall— 

12 (1) require the person to submit documentation 

13 demonstrating that the person is a qualified mari14 juana researcher seeking to conduct research pursuant 

15 to section 303(f)(3) of the Controlled Substances Act, 

16 as added by subsection (e) of this section; and 

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

18 documentation, review such documentation and verify 

19 that the marijuana will be used for such research 

20 (and for no other purpose authorized pursuant to this 

21 Act). 

22 (c) GUIDANCE ON USE OF STATE AUTHORIZED MARI23 JUANA PROGRAMS.—Not later than 180 days after the date 

24 of the enactment of this Act, the Secretary of Health and 

25 Human Services shall issue guidance related to the use of 


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1 marijuana from State authorized marijuana programs, in2 cluding necessary quality or production standards for 

3 marijuana intended for use in medical research. 

4 (d) COMPLIANCE WITH GUIDANCE.—The Secretary of 

5 Health and Human Services, acting through the Commis6 sioner of Food and Drugs, shall ensure that a qualified 

7 marijuana researcher is in compliance with guidance issued 

8 by the Food and Drug Administration related to botanical 

9 drug development. 

10 (e) RESEARCH.—Section 303(f) of the Controlled Sub11 stances Act (21 U.S.C. 823(f)) is amended— 

12 (1) by redesignating paragraphs (1) through (5) 

13 as subparagraphs (A) through (E), respectively; 

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

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

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

17 inserting the following: 

18 ‘‘(2) Registration applications’’; 

19 (4) in paragraph (2), as so designated, by strik20 ing ‘‘schedule I’’ each place that term appears and in21 serting ‘‘schedule I, except marijuana,’’; 

22 (5) by striking ‘‘Article 7’’ and inserting the fol23 lowing: 

24 ‘‘(4) Article 7’’; and 


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1 (6) by inserting before paragraph (4), as so des2 ignated, the following: 

3 ‘‘(3)(A) The Attorney General shall register a practi4 tioner to conduct research with marijuana if— 

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

6 conduct research with respect to, controlled substances 

7 in schedules II, III, IV, and V under the laws of the 

8 State in which the applicant practices; 

9 ‘‘(ii) the applicant’s research protocol has been 

10 reviewed and approved by the Secretary under section 

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

12 and 

13 ‘‘(iii) the Secretary has determined the applicant 

14 is qualified to conduct bona fide research. 

15 A practitioner so registered shall be referred to in this Act 

16 as a ‘qualified marijuana researcher’. 

17 ‘‘(B)(i) Not later than 60 days after the date on which 

18 the Attorney General receives a complete application for 

19 registration under this paragraph, the Attorney General 

20 shall approve or deny the application. 

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

22 be deemed complete when the applicant has submitted docu23 mentation showing that the requirements under subpara24 graph (A) are satisfied. 


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1 ‘‘(iii) In the case of a denial under clause (i), the At2 torney General shall provide a written explanation of the 

3 basis for the denial. 

4 ‘‘(C) The Attorney General shall grant an application 

5 for registration under this paragraph unless the Attorney 

6 General determines that the issuance of the registration 

7 would be inconsistent with the public interest. In deter8 mining the public interest, the following factors shall be 

9 considered: 

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

11 conducting research with respect to, controlled sub12 stances. 

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

14 Federal or State laws relating to the manufacture, 

15 distribution, or dispensing of controlled substances. 

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

17 laws relating to controlled substance misuse or diver18 sion. 

19 ‘‘(D)(i) A qualified marijuana researcher shall store 

20 marijuana to be used in research in a securely locked, sub21 stantially constructed cabinet. 

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

23 measures required by the Attorney General for practitioners 

24 conducting research with marijuana pursuant to a registra25 tion under this paragraph shall be consistent with the secuVerDate Sep 11 2014 00:38 Dec 08, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H3797.RH H3797

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1 rity measures for practitioners conducting research on other 

2 controlled substances in schedule II that have a similar risk 

3 of diversion and abuse. 

4 ‘‘(E)(i) If the Attorney General grants an application 

5 for registration under this paragraph, the applicant may 

6 amend or supplement the research protocol without re7 applying if the applicant does not change the type of mari8 juana, the source of the marijuana, or the conditions under 

9 which the marijuana is stored, tracked, or administered. 

10 ‘‘(ii) If an applicant amends or supplements the re11 search protocol or initiates research on a new research pro12 tocol under clause (i), the applicant shall, in order to renew 

13 the registration under this paragraph, provide notice to the 

14 Attorney General of the amended or supplemented research 

15 protocol or any new research protocol in the applicant’s re16 newal materials. 

17 ‘‘(iii)(I) If an applicant amends or supplements a re18 search protocol and the amendment or supplement involves 

19 a change to the type of marijuana, the source of the mari20 juana, or conditions under which the marijuana is stored, 

21 tracked, or administered or otherwise increases the risk of 

22 diversion, the applicant shall provide notice to the Attorney 

23 General not later than 30 days before proceeding on such 

24 amended or supplemental research or new research protocol, 

25 as the case may be. 


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

2 the 30-day period following a notification under subclause 

3 (I), the applicant may proceed with the amended or supple4 mental research or new research protocol. 

5 ‘‘(iv) The Attorney General may object to an amended 

6 or supplemental protocol or a new research protocol under 

7 clause (i) or (iii) only if additional security measures are 

8 needed to safeguard against diversion or abuse. 

9 ‘‘(F) If marijuana or a compound of marijuana is list10 ed on a schedule other than schedule I, the provisions of 

11 paragraphs (1), (2), and (4) that apply to research with 

12 a controlled substance in the applicable schedule shall apply 

13 to research with marijuana or that compound, as applica14 ble, in lieu of the provisions of subparagraphs (A) through 

15 (E) of this paragraph. 

16 ‘‘(G) Nothing in this paragraph shall be construed as 

17 limiting the authority of the Secretary under section 505(i) 

18 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 355(i)) or over requirements related to research protocols, 

20 including changes in— 

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

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

23 ‘‘(iii) the number of individuals or patients in24 volved in research.’’. 


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1 SEC. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA 

2 FOR USE IN LEGITIMATE, MEDICAL RE3 SEARCH. 

4 Section 303 of the Controlled Substances Act (21 

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

6 by adding at the end the following: 

7 ‘‘(l) REGISTRATION OF PERSONS TO MANUFACTURE

8 AND DISTRIBUTE MARIJUANA FOR USE IN LEGITIMATE, 

9 MEDICAL RESEARCH.— 

10 ‘‘(1) REGISTRATION OF MANUFACTURERS.—Be11 ginning not later than the day that is 1 year after 

12 the date of enactment of the Medical Marijuana Re13 search Act, the Attorney General shall register an ap14 plicant to manufacture marijuana (including any de15 rivative, extract, preparation, and compound thereof) 

16 that is intended for the ultimate and exclusive use by 

17 qualified marijuana researchers for research pursuant 

18 to subsection (f)(3), unless the Attorney General deter19 mines that the issuance of such registration is incon20 sistent with the public interest. In determining the 

21 public interest, the Attorney General shall take into 

22 consideration— 

23 ‘‘(A) maintenance of effective controls 

24 against diversion of marijuana and any con25 trolled substance compounded therefrom into 


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1 other than legitimate medical, scientific, or re2 search channels; 

3 ‘‘(B) compliance with applicable State and 

4 local laws relating to controlled substance misuse 

5 and diversion; and 

6 ‘‘(C) prior conviction record of the appli7 cant under Federal or State laws relating to the 

8 manufacture, distribution, or dispensing of such 

9 substances. 

10 ‘‘(2) REGISTRATION OF DISTRIBUTORS.—Begin11 ning not later than the day that is 1 year after the 

12 date of enactment of the Medical Marijuana Research 

13 Act, the Attorney General shall register an applicant 

14 to distribute marijuana (including any derivative, ex15 tract, preparation, and compound thereof) that is in16 tended for the ultimate and exclusive use by qualified 

17 marijuana researchers for research pursuant to sub18 section (f)(3), unless the Attorney General determines 

19 that the issuance of such registration is inconsistent 

20 with the public interest. 

21 ‘‘(3) PUBLIC INTEREST.—In determining the 

22 public interest under paragraph (2), the Attorney 

23 General shall take into consideration— 

24 ‘‘(A) the factors specified in subparagraphs 

25 (A), (B), and (C) of such paragraph; and 


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1 ‘‘(B) past experience in the distribution of 

2 controlled substances, and the existence of effec3 tive controls against diversion. 

4 ‘‘(4) NO LIMIT ON NUMBER OF MANUFACTURERS

5 AND DISTRIBUTORS.—Notwithstanding any other pro6 vision of law, the Attorney General shall not impose 

7 or implement any limit on the number of persons eli8 gible to be registered to manufacture or distribute 

9 marijuana pursuant to paragraph (1) or (2). 

10 ‘‘(5) REQUIREMENT TO VERIFY USE FOR LEGITI11 MATE, MEDICAL RESEARCH.—As a condition on reg12 istration under this section to manufacture or dis13 tribute marijuana, the Attorney General shall require 

14 the registrant— 

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

16 marijuana will be supplied to submit docu17 mentation demonstrating that the marijuana 

18 (including any derivative, extract, preparation, 

19 and compound thereof) will be ultimately used 

20 exclusively by qualified marijuana researchers 

21 for research pursuant to subsection (f)(3); 

22 ‘‘(B) in the case of distribution, to complete, 

23 with respect to that distribution, the DEA Con24 trolled substance order form in accordance with 

25 section 308 and to upload such forms to the sysVerDate Sep 11 2014 00:38 Dec 08, 2020 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H3797.RH H3797

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1 tem used by the Drug Enforcement Agency for 

2 such distribution; 

3 ‘‘(C) to include in the labeling of any mari4 juana so manufactured or distributed— 

5 ‘‘(i) the following statement: ‘This ma6 terial is for biomedical and scientific re7 search purposes only.’; and 

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

9 marijuana; 

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

11 marijuana manufactured under this sub12 section— 

13 ‘‘(i) to researchers who are registered 

14 under this Act to conduct research with 

15 marijuana; and 

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

17 research or in a clinical investigation pur18 suant to an investigational new drug ex19 emption under 505(i) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 355(i)); 

21 and 

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

23 manufactured under this subsection only with 

24 prior, written consent for the transfer or sale by 

25 the Attorney General. 


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1 ‘‘(6) TIMING.—Not later than 60 days after re2 ceipt of a request for registration under this sub3 section to manufacture or distribute marijuana, the 

4 Attorney General shall— 

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

6 ‘‘(B) in the case of a denial, provide a writ7 ten explanation of the basis for the denial. 

8 ‘‘(7) DEEMED APPROVAL.—If the Attorney Gen9 eral fails to grant or deny a request for registration 

10 under this subsection to manufacture or distribute 

11 marijuana within the 60-day period referred to in 

12 paragraph (5), such request is deemed approved.’’. 

13 SEC. 4. TERMINATION OF INTERDISCIPLINARY REVIEW 

14 PROCESS FOR NON-NIH-FUNDED QUALIFIED 

15 MARIJUANA RESEARCHERS. 

16 The Secretary of Health and Human Services may 

17 not— 

18 (1) reinstate the Public Health Service inter19 disciplinary review process described in the guidance 

20 entitled ‘‘Guidance on Procedures for the Provision of 

21 Marijuana for Medical Research’’ (issued on May 21, 

22 1999); or 

23 (2) create an additional review of scientific pro24 tocols that is only conducted for research on mari25 juana other than the review of research protocols perVerDate Sep 11 2014 00:38 Dec 08, 2020 Jkt 019200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6203 E:\BILLS\H3797.RH H3797

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1 formed at the request of a qualified marijuana re2 searcher conducting nonhuman research that is not 

3 federally funded, in accordance with section 

4 303(f)(3)(A)(iii)(II) of the Controlled Substances Act, 

5 as added by section 2 of this Act. 

6 SEC. 5. CONSIDERATION OF RESULTS OF RESEARCH. 

7 Immediately upon the approval by the Food and Drug 

8 Administration of an application for a drug that contains 

9 marijuana under section 505 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355), and (irrespective of 

11 whether any such approval is granted) not later than the 

12 date that is 5 years after the date of enactment of this Act, 

13 the Secretary of Health and Human Services 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 results 

17 of such review; and 

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

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

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

21 as any potential for medical benefits, any gaps in re22 search, and any impacts of Federal restrictions and 

23 policy on research, marijuana should be transferred to 

24 a schedule other than schedule I (if marijuana has 

25 not been so transferred already). 


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1 SEC. 6. PRODUCTION QUOTAS FOR MARIJUANA GROWN FOR 

2 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 following: 

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

6 for production of marijuana that is manufactured and dis7 tributed in accordance with the Medical Marijuana Re8 search Act that meets the changing medical, scientific, and 

9 industrial needs for marijuana.’’. 

10 SEC. 7. ARTICLE 28 OF THE SINGLE CONVENTION ON NAR11 COTIC DRUGS. 

12 Article 28 of the Single Convention on Narcotic Drugs 

13 shall not be construed to prohibit, or impose additional re14 strictions upon, research involving marijuana, or the man15 ufacture, distribution, or dispensing of marijuana, that is 

16 conducted in accordance with the Controlled Substances Act 

17 (21 U.S.C. 801 et seq.), this Act, and the amendments made 

18 by this Act. 

19 SEC. 8. DEFINITIONS. 

20 (a) QUALIFIED MARIJUANA RESEARCHER.—In this 

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

22 meaning given the term in section 303(f)(3) of the Con23 trolled Substances Act, as added by section 2(d) of this Act. 

24 (b) UPDATING TERM.—Section 102(16) of the Con25 trolled Substances Act (21 U.S.C. 802(16)) is amended— 


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

2 ‘marihuana’ means’’ and inserting ‘‘the terms ‘mari3 huana’ and ‘marijuana’ mean’’; and 

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

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

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


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Union Calendar No. 508 

116TH CONGRESS 

2D SESSION H. R. 3797 

[Report No. 116–619, Part I] 

A BILL 

To amend the Controlled Substances Act to make 

other purposes. juana researchers for medical purposes, and for marijuana accessible for use by qualified mariDECEMBER 7, 2020 

Reported from the Committee on Energy and Commerce 

D

with an amendment 

ECEMBER 7, 2020 

Committee on the Judiciary discharged; committed to the 

Union and ordered to be printed Committee of the Whole House on the State of the 


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