I 

116TH CONGRESS 

1ST SESSION H. R. 3797 

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 

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. 

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 of 2019’’. 


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1 SEC. 2. PRODUCTION AND SUPPLY. 

2 (a) IN GENERAL.—The Secretary of Health and 

3 Human Services— 

4 (1) until the date on which the Secretary deter5 mines that manufacturers and distributors (other 

6 than the Federal Government) can ensure a suffi7 cient supply of marijuana for qualified marijuana re8 searchers intended for medical research, shall— 

9 (A) continue to produce marijuana through 

10 the National Institute on Drug Abuse (NIDA) 

11 Drug Supply Program; and 

12 (B) offer for sale immature marijuana 

13 plants and the seeds of marijuana— 

14 (i) to all qualified marijuana research15 ers who submit a request for such plants 

16 or seeds to engage in research pursuant to 

17 the section 303(f)(3) of the Controlled 

18 Substances Act, as amended by section 3; 

19 and 

20 (ii) in quantities sufficient to produce 

21 an adequate supply of marijuana for such 

22 research; and 

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

24 may, at the Secretary’s discretion, continue to so 

25 produce and supply marijuana. 


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1 (b) REQUIREMENT TO VERIFY REGISTRATION.—Be2 fore supplying marijuana to any person through the Na3 tional Institute on Drug Abuse Drug Supply Program, the 

4 Secretary of Health and Human Services shall— 

5 (1) require the person to submit documentation 

6 demonstrating that the person is a qualified mari7 juana researcher seeking to conduct research pursu8 ant to section 303(f)(3) of the Controlled Substances 

9 Act, as amended by section 3; and 

10 (2) not later than 30 days after receipt of such 

11 documentation, review such documentation and 

12 verify that the marijuana will be used for such re13 search (and for no other purpose authorized pursu14 ant to this Act). 

15 (c) GUIDELINES ON PRODUCTION.—The Commis16 sioner of Food and Drugs, in consultation with the Direc17 tor of the National Institute on Drug Abuse, shall— 

18 (1) not later than 180 days after the date of 

19 enactment of this Act, issue guidelines on the pro20 duction of marijuana by qualified marijuana re21 searchers pursuant to subsection (a)(1)(B); and 

22 (2) encourage researchers and manufacturers 

23 that are authorized to produce or manufacture mari24 juana pursuant to section 303 of the Controlled 

25 Substances Act (21 U.S.C. 823), as amended by this 


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1 Act, to comply with such guidelines to the extent ap2 plicable. 

3 (d) DEFINITION.—In this section: 

4 (1) The term ‘‘immature marijuana plant’’ 

5 means a marijuana plant with no observable flowers 

6 or buds. 

7 (2) The term ‘‘qualified medical marijuana re8 searcher’’ means a researcher who is registered to 

9 conduct research with marijuana under section 

10 303(f)(3) of the Controlled Substances Act, as 

11 amended by section 3. 

12 SEC. 3. FACILITATING MARIJUANA RESEARCH. 

13 (a) IN GENERAL.—Section 303(f) of the Controlled 

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

15 (1) by redesignating paragraphs (1) through 

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

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

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

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

20 inserting the following: 

21 ‘‘(2) Registration applications’’; 

22 (4) in paragraph (2), as so designated, by strik23 ing ‘‘schedule I’’ each place that term appears and 

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


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

2 following: 

3 ‘‘(4) Article 7’’; and 

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

5 designated, the following: 

6 ‘‘(3)(A) The Attorney General shall register a practi7 tioner to conduct research with marijuana if— 

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

9 conduct research with respect to, controlled sub10 stances in schedules II, III, IV, and V under the 

11 laws of the State in which the applicant practices; 

12 ‘‘(ii) the applicant is only using marijuana man13 ufactured by a person registered under subsection 

14 (l); 

15 ‘‘(iii) the applicant’s research protocol— 

16 ‘‘(I) has been reviewed and allowed by— 

17 ‘‘(aa) the Secretary under section 

18 505(i) of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 355(i)); or 

20 ‘‘(bb) the National Institutes of 

21 Health or another Federal agency that 

22 funds scientific research; or 

23 ‘‘(II) in the case of nonhuman research 

24 that is not federally funded, has been volun25 tarily submitted by the applicant to, and apVerDate Sep 11 2014 01:50 Jul 31, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3797.IH H3797

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1 proved by, the National Institutes of Health; 

2 and 

3 ‘‘(iv) the applicant has demonstrated that there 

4 are effective procedures in place to adequately safe5 guard against diversion of the marijuana from legiti6 mate medical or scientific use, in accordance with 

7 subparagraph (E). 

8 ‘‘(B) The Attorney General shall grant an application 

9 for registration under this paragraph unless the Attorney 

10 General determines that the issuance of the registration 

11 would be inconsistent with the public interest. In deter12 mining the public interest, the following factors shall be 

13 considered: 

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

15 conducting research with respect to, controlled sub16 stances. 

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

18 Federal or State laws relating to the manufacture, 

19 distribution, or dispensing of controlled substances. 

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

21 laws relating to controlled substance misuse or diver22 sion. 

23 ‘‘(C) Not later than 90 days after the date of enact24 ment of the Medical Marijuana Research Act of 2019, for 


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1 purposes of subparagraph (A)(ii)(II), the National Insti2 tutes of Health shall establish a process that— 

3 ‘‘(i) allows a researcher to voluntarily submit 

4 the research protocol of the researcher for review 

5 and approval; and 

6 ‘‘(ii) provides a researcher described in clause 

7 (i) with a decision not less than 30 days after the 

8 date on which the research protocol is submitted. 

9 ‘‘(D)(i) Not later than 60 days after the date on 

10 which the Attorney General receives a complete applica11 tion for registration under this paragraph, the Attorney 

12 General shall approve or deny the application. 

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

14 be deemed complete when the applicant has submitted 

15 documentation showing that the requirements under sub16 paragraph (A) are satisfied. 

17 ‘‘(iii) In the case of a denial under clause (i), the At18 torney General shall provide a written explanation of the 

19 basis for the denial and a description of any curative steps 

20 that may be taken for such request to be approved. 

21 ‘‘(E)(i) A researcher registered under this paragraph 

22 shall store marijuana to be used in research in a securely 

23 locked, substantially constructed cabinet. 

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

25 measures required by the Attorney General for practiVerDate Sep 11 2014 01:50 Jul 31, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3797.IH H3797

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1 tioners conducting research with marijuana pursuant to 

2 a registration under this paragraph shall be consistent 

3 with the security measures for practitioners conducting re4 search on other controlled substances in schedule II that 

5 have a similar risk of diversion and abuse. 

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

7 for registration under this paragraph, the applicant may 

8 amend or supplement the research protocol without re9 applying if the applicant does not— 

10 ‘‘(I) change the type of drug, the source of the 

11 drug, or the conditions under which the drug is 

12 stored, tracked, or administered; or 

13 ‘‘(II) otherwise increase the risk of diversion. 

14 ‘‘(ii) If an applicant amends or supplements the re15 search protocol or initiates research on a new research 

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

17 renew the registration under this paragraph, provide no18 tice to the Attorney General of the amended or supple19 mented research protocol or any new research protocol in 

20 the applicant’s renewal materials. 

21 ‘‘(iii)(I) If an applicant amends or supplements a re22 search protocol and the amendment or supplement in23 volves a change to the type of drug, the source of the drug, 

24 or conditions under which the drug is stored, tracked, or 

25 administered or otherwise increases the risk of diversion, 


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1 the applicant shall provide notice to the Attorney General 

2 not later than 30 days before proceeding on such amended 

3 or supplemental research or new research protocol, as the 

4 case may be. 

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

6 the 30-day period following a notification under subclause 

7 (I), the applicant may proceed with the amended or sup8 plemental research or new research protocol. 

9 ‘‘(iv) The Attorney General may object to an amend10 ed or supplemental protocol or a new research protocol 

11 under clause (i) or (iii) only if additional security meas12 ures are needed to safeguard against diversion or abuse. 

13 ‘‘(G) If marijuana or a compound of marijuana is 

14 listed on a schedule other than schedule I, the provisions 

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

16 a controlled substance in the applicable schedule shall 

17 apply to research with marijuana or that compound, as 

18 applicable, in lieu of the provisions of subparagraphs (A) 

19 through (G) of this paragraph.’’. 

20 (b) CONFORMING AMENDMENT.—Section 102(16) of 

21 the Controlled Substances Act (21 U.S.C. 802(16)) is 

22 amended by inserting ‘‘or ‘marijuana’ ’’ after ‘‘The term 

23 ‘marihuana’ ’’. 


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1 SEC. 4. 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 3, 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 of 2019, the Attorney General shall reg14 ister an applicant to manufacture marijuana to the 

15 extent the marijuana will be used exclusively by 

16 qualified marijuana researchers for research pursu17 ant to subsection (f)(3), unless the Attorney General 

18 determines that the issuance of such registration is 

19 inconsistent with the public interest. In determining 

20 the public interest, the Attorney General shall— 

21 ‘‘(A) take into consideration— 

22 ‘‘(i) maintenance of effective controls 

23 against diversion of marijuana and any 

24 controlled substance compounded there25 from into other than legitimate medical, 

26 scientific, or research channels; 


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1 ‘‘(ii) compliance with applicable State 

2 and local laws relating to controlled sub3 stance misuse and diversion; and 

4 ‘‘(iii) prior conviction record of the 

5 applicant under Federal or State laws re6 lating to the manufacture, distribution, or 

7 dispensing of such substances; and 

8 ‘‘(B) not take into consideration any fac9 tors other than the factors listed in subpara10 graph (A). 

11 ‘‘(2) REGISTRATION OF DISTRIBUTORS.—Begin12 ning not later than the day that is 1 year after the 

13 date of enactment of the Medical Marijuana Re14 search Act of 2019, the Attorney General shall reg15 ister an applicant to distribute marijuana that is in16 tended to be used exclusively by qualified medical 

17 marijuana researchers for research pursuant to sub18 section (f)(3), unless the Attorney General deter19 mines that the issuance of such registration is incon20 sistent with the public interest. 

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

22 public interest under paragraph (2), the Attorney 

23 General shall— 

24 ‘‘(A) 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 law; 

8 ‘‘(iii) prior conviction record of the 

9 applicant under Federal or State laws re10 lating to the manufacture, distribution, or 

11 dispensing of such substances; and 

12 ‘‘(iv) past experience in the distribu13 tion of controlled substances, and the exist14 ence in the establishment of effective con15 trols against diversion; and 

16 ‘‘(B) not take into consideration any fac17 tors other than the factors listed in subpara18 graph (A). 

19 ‘‘(4) NO LIMIT ON NUMBER OF MANUFACTUR20 ERS AND DISTRIBUTORS.—Notwithstanding any 

21 other provision of law, the Attorney General shall 

22 not impose or implement any limit on the number of 

23 persons eligible to be registered to manufacture or 

24 distribute marijuana pursuant to paragraph (1) or 

25 (2). 


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1 ‘‘(5) REQUIREMENT TO VERIFY USE FOR LE2 GITIMATE, MEDICAL RESEARCH.—As a condition on 

3 registration under this section to manufacture or 

4 distribute marijuana, the Attorney General shall re5 quire the registrant— 

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

7 marijuana will be supplied to submit docu8 mentation demonstrating that the marijuana 

9 will be used exclusively by qualified medical 

10 marijuana researchers for research pursuant to 

11 subsection (f)(3); 

12 ‘‘(B) in the case of distribution, to com13 plete, with respect to that distribution, the 

14 DEA Controlled substance order form (DEA 

15 222) (or a successor form) and the DEA Cer16 tificate of Registration (DEA Form 223) (or a 

17 successor form) and to upload such forms to 

18 the system used by the Drug Enforcement 

19 Agency 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 medical and scientific re24 search purposes only.’; and 


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

2 marijuana; and 

3 ‘‘(D) not later than 30 days after receipt 

4 of such documentation, and before supplying 

5 the marijuana to such person, to review such 

6 documentation and verify that the marijuana 

7 will be so used. 

8 ‘‘(6) TIMING.—Not later than 30 days after re9 ceipt of a request for registration under this sub10 section to manufacture or distribute marijuana, the 

11 Attorney General shall— 

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

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

14 written explanation of the basis for the denial 

15 and a description of any curative steps that 

16 may be taken for such request to be approved. 

17 ‘‘(7) DEEMED APPROVAL.—If the Attorney 

18 General fails to grant or deny a request for registra19 tion under this subsection to manufacture or dis20 tribute marijuana within the 30-day period referred 

21 to in paragraph (5), such request is deemed ap22 proved. 

23 ‘‘(8) DEFINITION.—For purposes of this sub24 section, the term ‘qualified medical marijuana re25 searcher’ means a researcher who is registered to 


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1 conduct research with marijuana under subsection 

2 (f)(3).’’. 

3 SEC. 5. TERMINATION OF INTERDISCIPLINARY REVIEW 

4 PROCESS FOR NON-NIH-FUNDED RESEARCH5 ERS. 

6 The Secretary of Health and Human Services may 

7 not— 

8 (1) reinstate the Public Health Service inter9 disciplinary review process described in the guidance 

10 entitled ‘‘Guidance on Procedures for the Provision 

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

12 21, 1999); or 

13 (2) create an additional review of scientific pro14 tocols that is only conducted for research on mari15 juana other than the review of research protocols 

16 performed at the request of a researcher conducting 

17 nonhuman research that is not federally funded, in 

18 accordance with section 303(f)(3)(A)(ii)(II) of the 

19 Controlled Substances Act (21 U.S.C. 

20 823(f)(3)(A)(ii)(II)), as amended by section 3. 

21 SEC. 6. CONSIDERATION OF RESULTS OF RESEARCH. 

22 Immediately upon the approval by the Food and 

23 Drug Administration of an application for a marijuana24 based drug under section 505 of the Federal Food, Drug, 

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


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

2 date that is 5 years after the date of enactment of this 

3 Act, the Secretary of Health and Human Services shall— 

4 (1) conduct a review of existing medical and 

5 other research with respect to marijuana; 

6 (2) submit a report to the Congress on the re7 sults of such review; and 

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

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

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

11 as well as any potential for medical benefits, any 

12 gaps in research, and any impacts of Federal restric13 tions and policy on research, marijuana should be 

14 transferred to a schedule other than schedule I (if 

15 marijuana has not been so transferred already). 

16 SEC. 7. NO PRODUCTION QUOTAS FOR MARIJUANA GROWN 

17 FOR LEGITIMATE, SCIENTIFIC RESEARCH. 

18 Section 306 of the Controlled Substances Act (21 

19 U.S.C. 826) is amended by adding at the end the fol20 lowing: 

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

22 for production of marijuana that is manufactured and dis23 tributed in accordance with the Medical Marijuana Re24 search Act of 2019 that meets the changing medical, sciVerDate Sep 11 2014 01:50 Jul 31, 2019 Jkt 089200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H3797.IH H3797

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1 entific, and industrial needs for marijuana (as defined by 

2 the National Institute on Drug Abuse).’’. 

3 SEC. 8. ARTICLE 28 OF THE SINGLE CONVENTION ON NAR4 COTIC DRUGS. 

5 Article 28 of the Single Convention on Narcotic 

6 Drugs shall not be construed to prohibit, or impose addi7 tional restrictions upon, research involving marijuana, or 

8 the manufacture, distribution, or dispensing of marijuana, 

9 that is conducted in accordance with the Controlled Sub10 stances Act (21 U.S.C. 801 et seq.), this Act, and the 

11 amendments made by this Act. 

12 SEC. 9. NO INTERFERENCE BY DEPARTMENT OF JUSTICE. 

13 The Attorney General of the United States, and any 

14 officer or employee of the Department of Justice, shall not 

15 interfere with the production, distribution, and sale of 

16 marijuana in accordance with this Act and the amend17 ments made by this Act. 

18 SEC. 10. DEFINITION. 

19 In this Act, the term ‘‘marijuana’’ has the meaning 

20 given to the term ‘‘marihuana’’ in section 102 of the Con21 trolled Substances Act (21 U.S.C. 802). 

Æ 


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