I 

114TH CONGRESS 

2D SESSION H. R. 5549 

To amend the Controlled Substances Act to make marijuana accessible for 

use by qualified medical marijuana researchers, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 21, 2016 

Mr. HARRIS (for himself, Mr. BLUMENAUER, Mr. GRIFFITH, and Mr. FARR) 

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 medical marijuana researchers, 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 2016’’. 

6 SEC. 2. PRODUCTION AND SUPPLY. 

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

8 Human Services— 


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1 (1) until the date on which the Secretary deter2 mines that manufacturers and distributors (other 

3 than the Federal Government) can ensure a suffi4 cient supply of marijuana for qualified medical mari5 juana researchers, shall— 

6 (A) continue to produce marijuana through 

7 the National Institute on Drug Abuse (NIDA) 

8 Drug Supply Program; and 

9 (B) offer for sale immature marijuana 

10 plants and the seeds of marijuana— 

11 (i) to all qualified medical marijuana 

12 researchers who submit a request for such 

13 plants or seeds to engage in research pur14 suant to the section 303(f)(3) of the Con15 trolled Substances Act, as amended by sec16 tion 3; and 

17 (ii) in quantities sufficient to produce 

18 an adequate supply of marijuana for such 

19 research; and 

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

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

22 produce and supply marijuana. 

23 (b) REQUIREMENT TO VERIFY REGISTRATION.—Be24 fore supplying marijuana to any person through the NaVerDate Sep 11 2014 23:47 Jun 22, 2016 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5549.IH H5549

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1 tional Institute on Drug Abuse Drug Supply Program, the 

2 Secretary of Health and Human Services shall— 

3 (1) require the person to submit documentation 

4 demonstrating that the person is a qualified medical 

5 marijuana researcher seeking to conduct research 

6 pursuant to the section 303(f)(3) of the Controlled 

7 Substances Act, as amended by section 3; and 

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

9 documentation, review such documentation and 

10 verify that the marijuana will be used for such re11 search. 

12 (c) GUIDELINES ON PRODUCTION.—The Commis13 sioner of Food and Drugs, in consultation with the Direc14 tor of the National Institute on Drug Abuse, shall— 

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

16 enactment of this Act, issue guidelines on the pro17 duction of marijuana by qualified medical marijuana 

18 researchers pursuant to subsection (a)(1)(B); and 

19 (2) encourage researchers and manufacturers 

20 that are authorized to produce or manufacture mari21 juana pursuant to section 303 of the Controlled 

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

23 Act, to comply with such guidelines to the extent ap24 plicable. 

25 (d) DEFINITION.—In this section: 


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

2 means a marijuana plant with no observable flowers 

3 or buds. 

4 (2) The term ‘‘qualified medical marijuana re5 searcher’’ means a researcher who is registered to 

6 conduct research with marijuana under section 

7 303(f)(3) of the Controlled Substances Act, as 

8 amended by section 3. 

9 SEC. 3. FACILITATING MARIJUANA RESEARCH. 

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

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

12 (1) by redesignating paragraphs (1) through 

13 (5) 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 

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

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

23 following: 

24 ‘‘(4) Article 7’’; and 


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

2 designated, 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 sub7 stances in schedules II, III, IV, and V under the 

8 laws of the State in which the applicant practices; 

9 ‘‘(ii) the applicant’s research protocol— 

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

11 ‘‘(aa) the Secretary under section 

12 505(i) of the Federal Food, Drug, and 

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

14 ‘‘(bb) the National Institutes of 

15 Health or another Federal agency that 

16 funds scientific research; or 

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

18 that is not federally funded, has been volun19 tarily submitted by the applicant to, and ap20 proved by, the National Institutes of Health; 

21 and 

22 ‘‘(iii) the applicant has demonstrated that there 

23 are effective procedures in place to adequately safe24 guard against diversion of the marijuana from legitiVerDate Sep 11 2014 23:47 Jun 22, 2016 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5549.IH H5549

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1 mate medical or scientific use, in accordance with 

2 subparagraph (E). 

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

4 for registration under this paragraph unless the Attorney 

5 General determines that the issuance of the registration 

6 would be inconsistent with the public interest. In deter7 mining the public interest, the following factors shall be 

8 considered: 

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

10 conducting research with respect to, controlled sub11 stances. 

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

13 Federal or State laws relating to the manufacture, 

14 distribution, or dispensing of controlled substances. 

15 ‘‘(iii) Compliance with applicable State, Fed16 eral, or local laws relating to controlled substances. 

17 ‘‘(iv) Such other conduct by the applicant that 

18 may threaten the public health and safety. 

19 ‘‘(C) Not later than 90 days after the date of enact20 ment of the Medical Marijuana Research Act of 2016, for 

21 purposes of subparagraph (A)(ii)(II), the National Insti22 tutes of Health shall establish a process that— 

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

24 the research protocol of the researcher for review 

25 and approval; and 


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

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

3 date on which the research protocol is submitted. 

4 ‘‘(D)(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 ‘‘(E)(i) A researcher registered under this paragraph 

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

14 locked, substantially constructed cabinet. 

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

16 measures required by the Attorney General for practi17 tioners conducting research with marijuana pursuant to 

18 a registration under this paragraph shall be consistent 

19 with the security measures for practitioners conducting re20 search on other controlled substances in schedule II that 

21 have a similar risk of diversion and abuse. 

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

23 for registration under this paragraph, the applicant may 

24 amend or supplement the research protocol without re25 applying if the applicant does not— 


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

2 drug, or the conditions under which the drug is 

3 stored, tracked, or administered; or 

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

5 ‘‘(ii) If an applicant amends or supplements the re6 search protocol or initiates research on a new research 

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

8 renew the registration under this paragraph, provide no9 tice to the Attorney General of the amended or supple10 mented research protocol or any new research protocol in 

11 the applicant’s renewal materials. 

12 ‘‘(iii)(I) If an applicant amends or supplements a re13 search protocol and the amendment or supplement in14 volves a change to the type of drug, the source of the drug, 

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

16 administered or otherwise increases the risk of diversion, 

17 the applicant shall provide notice to the Attorney General 

18 not later than 30 days before proceeding on such amended 

19 or supplemental research or new research protocol, as the 

20 case may be. 

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

22 the 30-day period following a notification under subclause 

23 (I), the applicant may proceed with the amended or sup24 plemental research or new research protocol. 


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1 ‘‘(iv) The Attorney General may object to an amend2 ed or supplemental protocol or a new research protocol 

3 under clause (i) or (iii) only if additional security meas4 ures are needed to safeguard against diversion or abuse. 

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

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

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

8 a controlled substance in the applicable schedule shall 

9 apply to research with marijuana or that compound, as 

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

11 through (G) of this paragraph.’’. 

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

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

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

15 ‘marihuana’ ’’. 

16 SEC. 4. MANUFACTURE AND DISTRIBUTION OF MARIJUANA 

17 FOR USE IN LEGITIMATE, MEDICAL RE18 SEARCH. 

19 Section 303 of the Controlled Substances Act (21 

20 U.S.C. 823), as amended by section 3, is further amended 

21 by adding at the end the following: 

22 ‘‘(k) REGISTRATION OF PERSONS TO MANUFACTURE

23 AND DISTRIBUTE MARIJUANA FOR USE IN LEGITIMATE, 

24 MEDICAL RESEARCH.— 


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1 ‘‘(1) REGISTRATION OF MANUFACTURERS.—Be2 ginning not later than the day that is 1 year after 

3 the date of enactment of the Medical Marijuana Re4 search Act of 2016, the Attorney General shall reg5 ister an applicant to manufacture marijuana to the 

6 extent the marijuana will be used exclusively by 

7 qualified medical marijuana researchers for research 

8 pursuant to subsection (f)(3), unless the Attorney 

9 General determines that the issuance of such reg10 istration is inconsistent with the public interest. In 

11 determining the public interest, the Attorney Gen12 eral shall— 

13 ‘‘(A) take into consideration— 

14 ‘‘(i) maintenance of effective controls 

15 against diversion of marijuana and any 

16 controlled substance compounded there17 from into other than legitimate medical, 

18 scientific, or research channels; 

19 ‘‘(ii) compliance with applicable State 

20 and local law; and 

21 ‘‘(iii) prior conviction record of the 

22 applicant under Federal or State laws re23 lating to the manufacture, distribution, or 

24 dispensing of such substances; and 


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1 ‘‘(B) not take into consideration any fac2 tors other than the factors listed in subpara3 graph (A). 

4 ‘‘(2) REGISTRATION OF DISTRIBUTORS.—Begin5 ning not later than the day that is 1 year after the 

6 date of enactment of the Medical Marijuana Re7 search Act of 2016, the Attorney General shall reg8 ister an applicant to distribute marijuana that is in9 tended to be used exclusively by qualified medical 

10 marijuana researchers for research pursuant to sub11 section (f)(3), unless the Attorney General deter12 mines that the issuance of such registration is incon13 sistent with the public interest. In determining the 

14 public interest, the Attorney General shall— 

15 ‘‘(A) take into consideration— 

16 ‘‘(i) maintenance of effective controls 

17 against diversion of marijuana and any 

18 controlled substance compounded there19 from into other than legitimate medical, 

20 scientific, or research channels; 

21 ‘‘(ii) compliance with applicable State 

22 and local law; 

23 ‘‘(iii) prior conviction record of the 

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1 lating to the manufacture, distribution, or 

2 dispensing of such substances; and 

3 ‘‘(iv) past experience in the distribu4 tion of controlled substances, and the exist5 ence in the establishment of effective con6 trols against diversion; and 

7 ‘‘(B) not take into consideration any fac8 tors other than the factors listed in subpara9 graph (A). 

10 ‘‘(3) NO LIMIT ON NUMBER OF MANUFACTUR11 ERS AND DISTRIBUTORS.—Notwithstanding any 

12 other provision of law, the Attorney General shall 

13 not impose or implement any limit on the number of 

14 persons eligible to be registered to manufacture or 

15 distribute marijuana pursuant to paragraph (1) or 

16 (2). 

17 ‘‘(4) REQUIREMENT TO VERIFY USE FOR LE18 GITIMATE, MEDICAL RESEARCH.—As a condition on 

19 registration under this section to manufacture or 

20 distribute marijuana, the Attorney General shall re21 quire the registrant— 

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

23 marijuana will be supplied to submit docu24 mentation demonstrating that the marijuana 

25 will be used exclusively by qualified medical 


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1 marijuana researchers for research pursuant to 

2 subsection (f)(3); and 

3 ‘‘(B) 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 ‘‘(5) 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 ‘‘(6) DEFINITION.—For purposes of this sub16 section, the term ‘qualified medical marijuana re17 searcher’ means a researcher who is registered to 

18 conduct research with marijuana under subsection 

19 (f)(3).’’. 

20 SEC. 5. TERMINATION OF INTERDISCIPLINARY REVIEW 

21 PROCESS FOR NON-NIH-FUNDED RESEARCH22 ERS. 

23 The Secretary of Health and Human Services may 

24 not— 


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1 (1) reinstate the Public Health Service inter2 disciplinary review process described in the guidance 

3 entitled ‘‘Guidance on Procedures for the Provision 

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

5 21, 1999); or 

6 (2) create an additional review of scientific pro7 tocols that is only conducted for research on mari8 juana other than the review of research protocols 

9 performed at the request of a researcher conducting 

10 nonhuman research that is not federally funded, in 

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

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

13 823(f)(3)(A)(ii)(II)), as amended by section 3. 

14 SEC. 6. CONSIDERATION OF RESULTS OF RESEARCH. 

15 Immediately upon the approval by the Food and 

16 Drug Administration of an application for a marijuana17 based drug under section 505 of the Federal Food, Drug, 

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

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

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

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

22 (1) conduct a review of existing medical and 

23 other research with respect to marijuana; 

24 (2) submit a report to the Congress on the re25 sults of such review; and 


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

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

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

4 as well as any potential for medical benefits, any 

5 gaps in research, and any impacts of Federal restric6 tions and policy on research, marijuana should be 

7 transferred to a schedule other than schedule I (if 

8 marijuana has not been so transferred already). 

9 SEC. 7. NO PRODUCTION QUOTAS FOR MARIJUANA GROWN 

10 FOR LEGITIMATE, MEDICAL RESEARCH. 

11 Section 306 of the Controlled Substances Act (21 

12 U.S.C. 826) is amended by adding at the end the fol13 lowing: 

14 ‘‘(i) The Attorney General may only establish a quota 

15 for production of marijuana that is manufactured and dis16 tributed in accordance with the Medical Marijuana Re17 search Act of 2016 that meets the changing medical, sci18 entific, and industrial needs for marijuana.’’. 

19 SEC. 8. ARTICLE 28 OF THE SINGLE CONVENTION ON NAR20 COTIC DRUGS. 

21 Article 28 of the Single Convention on Narcotic 

22 Drugs shall not be construed to prohibit, or impose addi23 tional restrictions upon, research involving marijuana, or 

24 the manufacture, distribution, or dispensing of marijuana, 

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1 stances Act (21 U.S.C. 801 et seq.), this Act, and the 

2 amendments made by this Act. 

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

4 The Attorney General of the United States, and any 

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

6 interfere with the production, distribution, and sale of 

7 marijuana in accordance with this Act and the amend8 ments made by this Act. 

9 SEC. 10. DEFINITION. 

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

11 given to that term in section 102 of the Controlled Sub12 stances Act (21 U.S.C. 802). 

Æ 


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