II 

115TH CONGRESS 

1ST SESSION S. 1803 

To improve medical research on marijuana. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 13, 2017 

Mr. HATCH (for himself, Mr. SCHATZ, Mr. GARDNER, Mr. COONS, and Mr. 

TILLIS) introduced the following bill; which was read twice and referred 

to the Committee on the Judiciary 

A BILL 

To improve medical research on marijuana. 

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 ‘‘Marijuana Effective 

5 Drug Studies Act of 2017’’ or the ‘‘MEDS Act’’. 

6 SEC. 2. MARIJUANA RESEARCH. 

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

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

9 (1) by redesignating paragraphs (1) through 

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


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

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

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

4 inserting the following: 

5 ‘‘(2) Registration applications’’; 

6 (4) in paragraph (2), as so designated, by strik7 ing ‘‘schedule I’’ each place that term appears and 

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

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

10 following: 

11 ‘‘(4) Article 7’’; and 

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

13 designated, the following: 

14 ‘‘(3)(A) The Attorney General shall register a practi15 tioner to conduct research with marijuana if— 

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

17 conduct research with respect to, controlled sub18 stances in schedules II, III, IV, and V under the 

19 laws of the State in which the applicant practices; 

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

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

22 ‘‘(aa) the Secretary under section 

23 505(i) of the Federal Food, Drug, and 

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


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1 ‘‘(bb) the National Institutes of 

2 Health or another Federal agency that 

3 funds scientific research; or 

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

5 that is not federally funded, has been volun6 tarily submitted by the applicant to, and ap7 proved by, the National Institutes of Health; 

8 and 

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

10 are effective procedures in place to adequately safe11 guard against diversion of the marijuana from legiti12 mate medical or scientific use, in accordance with 

13 subparagraph (E). 

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

15 for registration under this paragraph unless the Attorney 

16 General determines that the issuance of the registration 

17 would be inconsistent with the public interest. In deter18 mining the public interest, the following factors shall be 

19 considered: 

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

21 conducting research with respect to, controlled sub22 stances. 

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

24 Federal or State laws relating to the manufacture, 

25 distribution, or dispensing of controlled substances. 


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1 ‘‘(iii) Compliance with applicable State, Fed2 eral, or local laws relating to controlled substances. 

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

4 may threaten the public health and safety. 

5 ‘‘(C) Not later than 90 days after the date of enact6 ment of this paragraph, for purposes of subparagraph 

7 (A)(ii)(II), the National Institutes of Health shall estab8 lish a process that— 

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

10 the research protocol of the researcher for review 

11 and approval; and 

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

13 (i) with a decision not later than 30 days after the 

14 date on which the research protocol is submitted. 

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

16 which the Attorney General receives a complete applica17 tion for registration under this paragraph, the Attorney 

18 General shall— 

19 ‘‘(I) approve the application; or 

20 ‘‘(II) serve an order to show cause upon the ap21 plicant in accordance with section 304(c). 

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

23 be deemed complete when the applicant has submitted 

24 documentation showing that the requirements under sub25 paragraph (A) are satisfied. 


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

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

3 locked, substantially constructed cabinet. 

4 ‘‘(ii) Any other security measures required by the At5 torney General under this paragraph to safeguard against 

6 diversion shall be consistent with those required for practi7 tioners conducting research on other controlled substances 

8 in schedules I and II that have a similar risk of diversion 

9 and abuse. 

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

11 for registration under this paragraph, the applicant may 

12 amend or supplement the research protocol without re13 applying if the applicant does not— 

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

15 drug, or the conditions under which the drug is 

16 stored, tracked, or administered; or 

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

18 ‘‘(ii) If an applicant amends or supplements the re19 search protocol under clause (i), the applicant shall, in 

20 order to renew the registration under this paragraph, pro21 vide notice to the Attorney General of the amended or sup22 plemented research protocol in the applicant’s renewal ma23 terials. 

24 ‘‘(iii)(I) If an applicant amends or supplements the 

25 research protocol in a manner that involves a change to 


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1 the type of drug, the source of the drug, or conditions 

2 under which the drug is stored, tracked, or administered 

3 or otherwise increases the risk of diversion, the applicant 

4 shall provide notice to the Attorney General not later than 

5 30 days before proceeding on such amended or supple6 mental research protocol. 

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

8 the 30-day period following a notification under subclause 

9 (I), the applicant may proceed with the amended or sup10 plemental research protocol. 

11 ‘‘(iv) The Attorney General may object to an amend12 ed or supplemental research protocol under clause (i) or 

13 (iii) if additional security measures are needed to safe14 guard against diversion or abuse. 

15 ‘‘(G) Article 28 of the Single Convention on Narcotic 

16 Drugs shall not be construed to prohibit, or impose addi17 tional restrictions upon, research involving marijuana that 

18 is conducted in accordance with this paragraph and other 

19 applicable provisions of this title. 

20 ‘‘(H) If marijuana or a compound of marijuana is 

21 listed on a schedule other than schedule I— 

22 ‘‘(i) the provisions of this subsection that apply 

23 to research with a controlled substance in the appli24 cable schedule shall apply to research with mari25 juana or that compound, as applicable; and 


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1 ‘‘(ii) subparagraphs (A) through (G) of this 

2 paragraph shall not apply to research with mari3 juana or that compound, as applicable.’’. 

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

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

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

7 ‘marihuana’ ’’. 

8 SEC. 3. MANUFACTURING OF MARIJUANA FOR CLINICAL 

9 USE. 

10 Section 303 of the Controlled Substances Act (21 

11 U.S.C. 823) is amended by adding at the end the fol12 lowing: 

13 ‘‘(k) REGISTRATION OF PERSONS TO MANUFACTURE

14 AND DISTRIBUTE MARIJUANA.— 

15 ‘‘(1) MANUFACTURE AND DISTRIBUTION FOR

16 USE IN RESEARCH.—The Attorney General shall reg17 ister an applicant to manufacture or distribute mari18 juana on behalf of the Federal Government to the 

19 extent that the marijuana is intended to be used ex20 clusively for legitimate research and scientific uses, 

21 in accordance with the applicable requirements 

22 under subsection (a) or (b) for registration of manu23 facturers or distributors of controlled substances in 

24 schedule I or II. 


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1 ‘‘(2) MANUFACTURE AND DISTRIBUTION FOR

2 COMMERCIAL PRODUCTION OF FDA-APPROVED

3 DRUGS.—The Attorney General shall register an ap4 plicant to manufacture or distribute marijuana on 

5 behalf of the Federal Government exclusively for the 

6 purpose of commercial production of a drug con7 taining or derived from marijuana that is approved 

8 by the Secretary under section 505 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 355), in 

10 accordance with the applicable requirements under 

11 subsection (a) or (b) of this section for registration 

12 of manufacturers or distributors of controlled sub13 stances in schedule I or II. 

14 ‘‘(3) NO LIMIT ON NUMBER OF MANUFACTUR15 ERS AND DISTRIBUTORS.—The Attorney General 

16 shall not impose a limit on the number of applicants 

17 eligible to be registered under paragraph (1) or (2). 

18 ‘‘(4) TIMING.—Not later than 30 days after the 

19 date on which the Attorney General receives an ap20 plication for registration under paragraph (1) or (2), 

21 the Attorney General shall— 

22 ‘‘(A) grant the application; or 

23 ‘‘(B) serve an order to show cause upon 

24 the applicant in accordance with section 304(c). 


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1 ‘‘(5) DETERMINATION OF SUPPLY.—In consid2 ering the factors under subsection (a) or (b), as ap3 plicable, for the purposes of registering an applicant 

4 eligible under paragraph (1) or (2) of this sub5 section, the Attorney General shall consider the de6 mand from researchers for an adequate and uninter7 rupted supply of specific strains of marijuana and 

8 for marijuana grown pursuant to specific manufac9 turing processes. 

10 ‘‘(6) RELATION TO THE SINGLE CONVENTION

11 ON NARCOTIC DRUGS.— 

12 ‘‘(A) CONSTRUCTIVE POSSESSION AND

13 CONTROL.—The registration of manufacturers 

14 and distributors of marijuana under paragraphs 

15 (1) and (2) shall constitute constructive posses16 sion and control by the Federal Government for 

17 the purposes of the obligations under the Single 

18 Convention on Narcotic Drugs. 

19 ‘‘(B) ARTICLE 28.—Article 28 of the Sin20 gle Convention on Narcotic Drugs shall not be 

21 construed to prohibit, or impose additional re22 strictions upon, the manufacturing of mari23 juana that is conducted in accordance with 

24 paragraph (1) or (2), as applicable, and other 

25 applicable provisions of this title.’’. 


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1 SEC. 4. GOOD MANUFACTURING PRACTICES. 

2 Not later than 180 days after the date of enactment 

3 of this Act, the National Institute for Drug Abuse shall 

4 develop and publish recommendations for good manufac5 turing practices for growing and producing marijuana (as 

6 defined in section 102 of the Controlled Substance Act (21 

7 U.S.C. 802), as amended by this Act) for research. 

8 SEC. 5. QUOTAS. 

9 Section 306(e) of the Controlled Substances Act (21 

10 U.S.C. 826(e)) is amended in the third sentence by strik11 ing ‘‘exceeds the aggregate of the quotas of all registrants 

12 under this section’’ and inserting ‘‘should be increased to 

13 meet the changing medical, scientific, and industrial needs 

14 for the controlled substance’’. 

15 SEC. 6. TERMINATION OF INTERDISCIPLINARY REVIEW 

16 PROCESS FOR NON-NIH-FUNDED RESEARCH17 ERS. 

18 The Secretary of Health and Human Services may 

19 not— 

20 (1) reinstate the Public Health Service inter21 disciplinary review process described in the guidance 

22 entitled ‘‘Guidance on Procedures for the Provision 

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

24 21, 1999); or 

25 (2) create an additional review of scientific pro26 tocols that is conducted only for research on mariVerDate Sep 11 2014 00:52 Sep 15, 2017 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1803.IS S1803

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1 juana (as defined in section 102 of the Controlled 

2 Substances Act (21 U.S.C. 802), as amended by sec3 tion 2(b)) other than the review of research proto4 cols performed at the request of a researcher con5 ducting nonhuman research that is not federally 

6 funded, in accordance with section 

7 303(f)(3)(A)(ii)(II) of the Controlled Substances Act 

8 (21 U.S.C. 823(f)(3)(A)(ii)(II)), as amended by sec9 tion 2(a). 

Æ 


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