I 

115TH CONGRESS 

2D SESSION H. R. 4825 

To improve medical research on marijuana. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 18, 2018 

Mr. BISHOP of Utah (for himself, Mr. CURTIS, Mr. STEWART, Mrs. LOVE, Mr. 

RASKIN, Ms. NORTON, Mr. POLIS, and Mr. BLUMENAUER) 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 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 2018’’ 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— 


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1 (1) by redesignating paragraphs (1) through 

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

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

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

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

6 inserting the following: 

7 ‘‘(2) Registration applications’’; 

8 (4) in paragraph (2), as so designated, by strik9 ing ‘‘schedule I’’ each place that term appears and 

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

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

12 following: 

13 ‘‘(4) Article 7’’; and 

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

15 designated, the following: 

16 ‘‘(3)(A) The Attorney General shall register a practi17 tioner to conduct research with marijuana if— 

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

19 conduct research with respect to, controlled sub20 stances in schedules II, III, IV, and V under the 

21 laws of the State in which the applicant practices; 

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

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


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1 ‘‘(aa) the Secretary under section 

2 505(i) of the Federal Food, Drug, and 

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

4 ‘‘(bb) the National Institutes of 

5 Health or another Federal agency that 

6 funds scientific research; or 

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

8 that is not federally funded, has been volun9 tarily submitted by the applicant to, and ap10 proved by, the National Institutes of Health; 

11 and 

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

13 are effective procedures in place to adequately safe14 guard against diversion of the marijuana from legiti15 mate medical or scientific use, in accordance with 

16 subparagraph (E). 

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

18 for registration under this paragraph unless the Attorney 

19 General determines that the issuance of the registration 

20 would be inconsistent with the public interest. In deter21 mining the public interest, the following factors shall be 

22 considered: 

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

24 conducting research with respect to, controlled sub25 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, Fed5 eral, or local laws relating to controlled substances. 

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

7 may threaten the public health and safety. 

8 ‘‘(C) Not later than 90 days after the date of enact9 ment of this paragraph, for purposes of subparagraph 

10 (A)(ii)(II), the National Institutes of Health shall estab11 lish a process that— 

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

13 the research protocol of the researcher for review 

14 and approval; and 

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

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

17 date on which the research protocol is submitted. 

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

19 which the Attorney General receives a complete applica20 tion for registration under this paragraph, the Attorney 

21 General shall— 

22 ‘‘(I) approve the application; or 

23 ‘‘(II) serve an order to show cause upon the ap24 plicant in accordance with section 304(c). 


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

2 be deemed complete when the applicant has submitted 

3 documentation showing that the requirements under sub4 paragraph (A) are satisfied. 

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

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

7 locked, substantially constructed cabinet. 

8 ‘‘(ii) Any other security measures required by the At9 torney General under this paragraph to safeguard against 

10 diversion shall be consistent with those required for practi11 tioners conducting research on other controlled substances 

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

13 and abuse. 

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

15 for registration under this paragraph, the applicant may 

16 amend or supplement the research protocol without re17 applying if the applicant does not— 

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

19 drug, or the conditions under which the drug is 

20 stored, tracked, or administered; or 

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

22 ‘‘(ii) If an applicant amends or supplements the re23 search protocol under clause (i), the applicant shall, in 

24 order to renew the registration under this paragraph, pro25 vide notice to the Attorney General of the amended or supVerDate Sep 11 2014 05:13 Jan 20, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4825.IH H4825

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1 plemented research protocol in the applicant’s renewal ma2 terials. 

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

4 research protocol in a manner that involves a change to 

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

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

7 or otherwise increases the risk of diversion, the applicant 

8 shall provide notice to the Attorney General not later than 

9 30 days before proceeding on such amended or supple10 mental research protocol. 

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

12 the 30-day period following a notification under subclause 

13 (I), the applicant may proceed with the amended or sup14 plemental research protocol. 

15 ‘‘(iv) The Attorney General may object to an amend16 ed or supplemental research protocol under clause (i) or 

17 (iii) if additional security measures are needed to safe18 guard against diversion or abuse. 

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

20 Drugs shall not be construed to prohibit, or impose addi21 tional restrictions upon, research involving marijuana that 

22 is conducted in accordance with this paragraph and other 

23 applicable provisions of this title. 

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

25 listed on a schedule other than schedule I— 


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

2 to research with a controlled substance in the appli3 cable schedule shall apply to research with mari4 juana or that compound, as applicable; and 

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

6 paragraph shall not apply to research with mari7 juana or that compound, as applicable.’’. 

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

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

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

11 ‘marihuana’ ’’. 

12 SEC. 3. MANUFACTURING OF MARIJUANA FOR CLINICAL 

13 USE. 

14 Section 303 of the Controlled Substances Act (21 

15 U.S.C. 823) is amended by adding at the end the fol16 lowing: 

17 ‘‘(k) REGISTRATION OF PERSONS TO MANUFACTURE

18 AND DISTRIBUTE MARIJUANA.— 

19 ‘‘(1) MANUFACTURE AND DISTRIBUTION FOR

20 USE IN RESEARCH.—The Attorney General shall reg21 ister an applicant to manufacture or distribute mari22 juana on behalf of the Federal Government to the 

23 extent that the marijuana is intended to be used ex24 clusively for legitimate research and scientific uses, 

25 in accordance with the applicable requirements 


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1 under subsection (a) or (b) for registration of manu2 facturers or distributors of controlled substances in 

3 schedule I or II. 

4 ‘‘(2) MANUFACTURE AND DISTRIBUTION FOR

5 COMMERCIAL PRODUCTION OF FDA-APPROVED

6 DRUGS.—The Attorney General shall register an ap7 plicant to manufacture or distribute marijuana on 

8 behalf of the Federal Government exclusively for the 

9 purpose of commercial production of a drug con10 taining or derived from marijuana that is approved 

11 by the Secretary under section 505 of the Federal 

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

13 accordance with the applicable requirements under 

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

15 of manufacturers or distributors of controlled sub16 stances in schedule I or II. 

17 ‘‘(3) NO LIMIT ON NUMBER OF MANUFACTUR18 ERS AND DISTRIBUTORS.—The Attorney General 

19 shall not impose a limit on the number of applicants 

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

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

22 date on which the Attorney General receives an ap23 plication for registration under paragraph (1) or (2), 

24 the Attorney General shall— 

25 ‘‘(A) grant the application; or 


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

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

3 ‘‘(5) DETERMINATION OF SUPPLY.—In consid4 ering the factors under subsection (a) or (b), as ap5 plicable, for the purposes of registering an applicant 

6 eligible under paragraph (1) or (2) of this sub7 section, the Attorney General shall consider the de8 mand from researchers for an adequate and uninter9 rupted supply of specific strains of marijuana and 

10 for marijuana grown pursuant to specific manufac11 turing processes. 

12 ‘‘(6) RELATION TO THE SINGLE CONVENTION

13 ON NARCOTIC DRUGS.— 

14 ‘‘(A) CONSTRUCTIVE POSSESSION AND

15 CONTROL.—The registration of manufacturers 

16 and distributors of marijuana under paragraphs 

17 (1) and (2) shall constitute constructive posses18 sion and control by the Federal Government for 

19 the purposes of the obligations under the Single 

20 Convention on Narcotic Drugs. 

21 ‘‘(B) ARTICLE 28.—Article 28 of the Sin22 gle Convention on Narcotic Drugs shall not be 

23 construed to prohibit, or impose additional re24 strictions upon, the manufacturing of mari25 juana that is conducted in accordance with 


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

2 applicable provisions of this title.’’. 

3 SEC. 4. GOOD MANUFACTURING PRACTICES. 

4 Not later than 180 days after the date of enactment 

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

6 develop and publish recommendations for good manufac7 turing practices for growing and producing marijuana (as 

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

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

10 SEC. 5. QUOTAS. 

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

12 U.S.C. 826(e)) is amended in the third sentence by strik13 ing ‘‘exceeds the aggregate of the quotas of all registrants 

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

15 meet the changing medical, scientific, and industrial needs 

16 for the controlled substance’’. 

17 SEC. 6. TERMINATION OF INTERDISCIPLINARY REVIEW 

18 PROCESS FOR NON-NIH-FUNDED RESEARCH19 ERS. 

20 The Secretary of Health and Human Services may 

21 not— 

22 (1) reinstate the Public Health Service inter23 disciplinary review process described in the guidance 

24 entitled ‘‘Guidance on Procedures for the Provision 


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

2 21, 1999); or 

3 (2) create an additional review of scientific pro4 tocols that is conducted only for research on mari5 juana (as defined in section 102 of the Controlled 

6 Substances Act (21 U.S.C. 802), as amended by sec7 tion 2(b)) other than the review of research proto8 cols performed at the request of a researcher con9 ducting nonhuman research that is not federally 

10 funded, in accordance with section 

11 303(f)(3)(A)(ii)(II) of the Controlled Substances Act 

12 (21 U.S.C. 823(f)(3)(A)(ii)(II)), as amended by sec13 tion 2(a). 

Æ 


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