I 

115TH CONGRESS 

2D SESSION H. R. 5634 

To increase the number of manufacturers registered under the Controlled 

Substances Act to manufacture cannabis for legitimate research purposes, 

to authorize health care providers of the Department of Veterans Affairs 

to provide recommendations to veterans regarding participation in federally-approved cannabis clinical trials, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 26, 2018 

Mr. GAETZ (for himself, Mr. BISHOP of Utah, Mr. SWALWELL of California, 

Mr. RUTHERFORD, Mr. TAYLOR, Mr. GARRETT, Mr. RASKIN, Mr. BLUMENAUER, Mr. JOYCE of Ohio, Mr. BUCK, Mrs. HANDEL, Mr. CURBELO

of Florida, Mr. SOTO, Mr. POLIS, Mr. DENHAM, Ms. ROS-LEHTINEN, Mr. 

SANFORD, Mr. CICILLINE, Ms. LEE, Mr. ISSA, Mr. ROHRABACHER, Mr. 

GOODLATTE, Mr. MCCLINTOCK, Mr. HASTINGS, Mr. COHEN, Ms. TITUS, 

Ms. LOFGREN, and Mr. CORREA) introduced the following bill; which was 

referred to the Committee on Energy and Commerce, and in addition to 

the Committees on the Judiciary, and Veterans’ Affairs, 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 increase the number of manufacturers registered under 

the Controlled Substances Act to manufacture cannabis 

for legitimate research purposes, to authorize health care 

providers of the Department of Veterans Affairs to provide recommendations to veterans regarding participation 

in federally-approved cannabis clinical trials, 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 Cannabis Re5 search Act of 2018’’. 

6 SEC. 2. INCREASING THE NUMBER OF FEDERALLY-REG7 ISTERED MANUFACTURERS OF CANNABIS 

8 FOR LEGITIMATE RESEARCH PURPOSES. 

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

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

11 (1) by redesignating subsection (k) as sub12 section (l); and 

13 (2) by inserting after subsection (j) the fol14 lowing: 

15 ‘‘(k) REGISTRATION OF MANUFACTURERS OF CAN16 NABIS FOR LEGITIMATE RESEARCH PURPOSES.— 

17 ‘‘(1) IN GENERAL.—Any manufacturer of can18 nabis for research shall obtain a separate registra19 tion under this subsection for that purpose— 

20 ‘‘(A) annually; or 

21 ‘‘(B) for a longer period as determined 

22 necessary by the Attorney General to supply 

23 cannabis for the full duration of a particular 

24 multi-year study for legitimate research pur25 poses. 


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1 ‘‘(2) ADEQUATE AND UNINTERRUPTED SUP2 PLY.— 

3 ‘‘(A) ANNUAL ASSESSMENT.—On an an4 nual basis, the Attorney General shall assess 

5 whether there is an adequate and uninterrupted 

6 supply of cannabis for legitimate research pur7 poses. 

8 ‘‘(B) INITIAL YEAR.—Not later than 1 

9 year after the date of enactment of the Medical 

10 Cannabis Research Act of 2018, of the appli11 cants meeting the requirements of this Act, the 

12 Attorney General shall register under sub13 section (a) and this subsection at least 2 appli14 cants to manufacture cannabis for legitimate 

15 research purposes in addition to any manufac16 turers that are registered under subsection (a) 

17 to manufacture cannabis as of the date of en18 actment of the Medical Cannabis Research Act 

19 of 2018. 

20 ‘‘(C) SUBSEQUENT YEARS.—For calendar 

21 year 2019 and each subsequent calendar year, 

22 of the applicants meeting the requirements of 

23 this Act, the Attorney General shall register 

24 (including any registration renewal) under sub25 section (a) and this subsection at least 3 appliVerDate Sep 11 2014 02:15 May 05, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5634.IH H5634

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1 cants to manufacture cannabis for legitimate 

2 research purposes. 

3 ‘‘(3) REQUIREMENTS.—A manufacturer reg4 istered under this subsection shall— 

5 ‘‘(A) comply with all applicable require6 ments of this Act; 

7 ‘‘(B) limit the transfer and sale of any 

8 cannabis manufactured pursuant to this sec9 tion— 

10 ‘‘(i) to researchers who are registered 

11 under this Act to conduct research with 

12 controlled substances in schedule I; and 

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

14 research or in a clinical investigation pur15 suant to an investigational new drug ex16 emption under 505(i) of the Federal Food, 

17 Drug, and Cosmetic Act; 

18 ‘‘(C) transfer or sell any cannabis manu19 factured pursuant to this section only with 

20 prior, written consent for the transfer or sale by 

21 the Attorney General; 

22 ‘‘(D) have completed the application and 

23 review process under subsection (a) for the bulk 

24 manufacture of controlled substances in sched25 ule I; 


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1 ‘‘(E) have established and begun operation 

2 of a process for storage and handling of con3 trolled substances in schedule I, including for 

4 inventory control and monitoring security; 

5 ‘‘(F) have the ability to provide at least 10 

6 unique plant cultivars to ensure plant diversity 

7 and scale up to produce bulk plant material on 

8 an uninterrupted basis sufficient to supply fore9 casted demand; 

10 ‘‘(G) be licensed, by each State in which 

11 the manufacturer conducts its operations pursu12 ant to this subsection, to manufacture cannabis; 

13 ‘‘(H) have completed a criminal back14 ground check for all personnel involved in the 

15 operations of the manufacturer pursuant to this 

16 subsection to confirm that such personnel have 

17 no conviction for a felony or drug-related mis18 demeanor; 

19 ‘‘(I) have a letter of reference affirming 

20 the manufacturer’s good standing from each of 

21 the applicable State health care and law en22 forcement authorities in each jurisdiction of the 

23 manufacturer’s operations pursuant to this sub24 section; and 


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1 ‘‘(J) have the ability to test for and isolate 

2 at least 12 cannabinoids for the purposes of 

3 producing specific products for specific studies 

4 by compounding pharmacists or others, label5 ing, and chemical consistency. 

6 ‘‘(4) APPLICATION CONTENTS.—As part of an 

7 application to be registered under this subsection, an 

8 applicant shall include a written explanation of how 

9 the applicant’s proposed manufacture of cannabis 

10 would augment the Nation’s supply of cannabis for 

11 legitimate research purposes. 

12 ‘‘(5) PROCESS.—Not later than 1 year after the 

13 date on which the Attorney General receives an ap14 plication to be registered under this section to man15 ufacture cannabis for research, the Attorney General 

16 shall— 

17 ‘‘(A) grant, or initiate proceedings under 

18 section 304(c) to deny, the application; or 

19 ‘‘(B) request supplemental information 

20 from the applicant. 

21 ‘‘(6) RULE OF CONSTRUCTION ON REGISTRA22 TION FOR PURPOSES OTHER THAN RESEARCH.— 

23 Nothing in this subsection shall be construed to af24 fect the provisions of this section prohibiting or oth25 erwise pertaining to registration of manufacturers of 


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1 cannabis for purposes other than research, including 

2 for purposes of strictly commercial endeavors funded 

3 by the private sector and aimed at drug product de4 velopment. 

5 ‘‘(7) NO DISCRIMINATORY TREATMENT BY FED6 ERAL GOVERNMENT.—Notwithstanding any other 

7 provision of law, no Federal department or agency 

8 shall deny or limit any funding, other assistance, li9 censing, or other privilege with respect to any person 

10 on the basis that such person is, or is legally receiv11 ing cannabis from, a manufacturer of cannabis that 

12 is— 

13 ‘‘(A) registered under this subsection; and 

14 ‘‘(B) in compliance with the requirements 

15 of this Act. 

16 ‘‘(8) SPECIAL RULE.—If cannabis, or any com17 ponent thereof, is placed in a schedule other than 

18 schedule I, the Attorney General may, as the Attor19 ney General determines appropriate— 

20 ‘‘(A) treat the reference to ‘subsection (a)’ 

21 in paragraph (2)(C) of this subsection as a ref22 erence to subsection (d); and 

23 ‘‘(B) treat the references to schedule I in 

24 paragraph (3) as references to the appropriate 

25 schedule. 


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1 ‘‘(9) DEFINITION.—In this subsection, the term 

2 ‘legitimate research purposes’ has the meaning given 

3 to such term for purposes of subsection (a)(1).’’. 

4 (b) TRANSITIONAL PROVISIONS.— 

5 (1) CURRENT REGISTRANTS.—Notwithstanding 

6 paragraph (1) of section 303(k) of the Controlled 

7 Substances Act, as added by subsection (a), any 

8 manufacturer that is registered under section 303(a) 

9 of the Controlled Substances Act (21 U.S.C. 823(a)) 

10 to manufacture cannabis as of the date of enactment 

11 of this Act shall not be required to obtain a separate 

12 registration under such section 303(k) for the 1-year 

13 period following the date of enactment of this Act. 

14 (2) PENDING APPLICATIONS.—The Attorney 

15 General of the United States shall grant or deny, in 

16 accordance with section 303 of the Controlled Sub17 stances Act (21 U.S.C. 823), as amended by sub18 section (a), each application to manufacture can19 nabis to supply researchers in the United States that 

20 was submitted— 

21 (A) pursuant to the policy statement enti22 tled ‘‘Applications To Become Registered Under 

23 the Controlled Substances Act To Manufacture 

24 Marijuana To Supply Researcher in the United 

25 States’’ published by the Drug Enforcement 


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1 Administration in the Federal Register on Au2 gust 12, 2016 (81 Fed. Reg. 53846); and 

3 (B) before February 12, 2017. 

4 (c) TECHNICAL AMENDMENT.—Section 102(16) of 

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

6 amended by inserting after ‘‘The term ‘marihuana’ ’’ the 

7 following: ‘‘or ‘marijuana’ or ‘cannabis’ ’’. 

8 SEC. 3. PROVISION BY DEPARTMENT OF VETERANS AF9 FAIRS HEALTH CARE PROVIDERS OF INFOR10 MATION REGARDING VETERAN PARTICIPA11 TION IN FEDERALLY-APPROVED CANNABIS 

12 CLINICAL TRIALS. 

13 (a) PROVISION OF INFORMATION AND FORMS.—Not14 withstanding any other provision of law, health care pro15 viders of the Department of Veterans Affairs may— 

16 (1) provide information to veterans regarding 

17 participation in federally-approved cannabis clinical 

18 trials; and 

19 (2) complete forms relating to such participa20 tion. 

21 (b) RECEIPT OF INFORMATION.—Health care pro22 viders and other employees of the Department may accept 

23 information regarding federally-approved cannabis clinical 

24 trials provided by individuals who are not employed by the 

25 Department who are researchers registered under the 


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1 Controlled Substances Act (21 U.S.C. 801 et seq.) to con2 duct research with controlled substances in schedule I of 

3 section 202(c) of such Act (21 U.S.C. 812(c)). 

4 (c) RESEARCH.—The Secretary of Veterans Affairs 

5 may conduct research on cannabis if the employees of the 

6 Department who are conducting such research are re7 searchers registered under the Controlled Substances Act 

8 (21 U.S.C. 801 et seq.) to conduct research with con9 trolled substances in schedule I of section 202(c) of such 

10 Act (21 U.S.C. 812(c)). 

Æ 


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