Medical Cannabis Research Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 601 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 feder- ally approved cannabis clinical trials, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 16, 2019 Mr. GAETZ (for himself, Mr. SOTO, Mr. PANETTA, Mr. BUCK, and Ms. DEGETTE) introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans’ Affairs, for a period to be subsequently de- termined 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 pro- vide recommendations to veterans regarding participation in federally approved cannabis clinical trials, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 2 •HR 601 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Medical Cannabis Re- 2 search Act of 2019’’. 3 SEC. 2. INCREASING THE NUMBER OF FEDERALLY REG- 4 ISTERED MANUFACTURERS OF CANNABIS 5 FOR LEGITIMATE RESEARCH PURPOSES. 6 (a) IN GENERAL.—Section 303 of the Controlled 7 Substances Act (21 U.S.C. 823) is amended— 8 (1) by redesignating subsection (k) as sub- 9 section (l); and 10 (2) by inserting after subsection (j) the fol- 11 lowing: 12 ‘‘(k) REGISTRATION OF MANUFACTURERS OF CAN- 13 NABIS FOR LEGITIMATE RESEARCH PURPOSES.— 14 ‘‘(1) IN GENERAL.—Any manufacturer of can- 15 nabis for research shall obtain a separate registra- 16 tion under this subsection for that purpose— 17 ‘‘(A) annually; or 18 ‘‘(B) for a longer period as determined 19 necessary by the Attorney General to supply 20 cannabis for the full duration of a particular 21 multi-year study for legitimate research pur- 22 poses. 23 ‘‘(2) ADEQUATE AND UNINTERRUPTED SUP- 24 PLY.— 25 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 3 •HR 601 IH ‘‘(A) ANNUAL ASSESSMENT.—On an an- 1 nual basis, the Attorney General shall assess 2 whether there is an adequate and uninterrupted 3 supply of cannabis for legitimate research pur- 4 poses. 5 ‘‘(B) INITIAL YEAR.—Not later than 1 6 year after the date of enactment of the Medical 7 Cannabis Research Act of 2019, of the appli- 8 cants meeting the requirements of this Act, the 9 Attorney General shall register under sub- 10 section (a) and this subsection at least 3 appli- 11 cants to manufacture cannabis for legitimate 12 research purposes in addition to any manufac- 13 turers that are registered under subsection (a) 14 to manufacture cannabis as of the date of en- 15 actment of the Medical Cannabis Research Act 16 of 2019. 17 ‘‘(C) SUBSEQUENT YEARS.—For calendar 18 year 2019 and each subsequent calendar year, 19 of the applicants meeting the requirements of 20 this Act, the Attorney General shall register 21 (including any registration renewal) under sub- 22 section (a) and this subsection at least 4 appli- 23 cants to manufacture cannabis for legitimate 24 research purposes. 25 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 4 •HR 601 IH ‘‘(3) REQUIREMENTS.—A manufacturer reg- 1 istered under this subsection shall— 2 ‘‘(A) comply with all applicable require- 3 ments of this Act; 4 ‘‘(B) limit the transfer and sale of any 5 cannabis manufactured pursuant to this sec- 6 tion— 7 ‘‘(i) to researchers who are registered 8 under this Act to conduct research with 9 controlled substances in schedule I; and 10 ‘‘(ii) for purposes of use in preclinical 11 research or in a clinical investigation pur- 12 suant to an investigational new drug ex- 13 emption under 505(i) of the Federal Food, 14 Drug, and Cosmetic Act; 15 ‘‘(C) have completed the application and 16 review process under subsection (a) for the bulk 17 manufacture of controlled substances in sched- 18 ule I; 19 ‘‘(D) have established and begun operation 20 of a process for storage and handling of con- 21 trolled substances in schedule I, including for 22 inventory control and monitoring security; 23 ‘‘(E) have the ability to provide at least 10 24 unique plant cultivars to ensure plant diversity 25 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 5 •HR 601 IH and scale up to produce bulk plant material on 1 an uninterrupted basis sufficient to supply fore- 2 casted demand; 3 ‘‘(F) be licensed, by each State in which 4 the manufacturer conducts its operations pursu- 5 ant to this subsection, to manufacture cannabis; 6 ‘‘(G) have completed a criminal back- 7 ground check for all personnel involved in the 8 operations of the manufacturer pursuant to this 9 subsection to confirm that such personnel have 10 no conviction for a violent felony; and 11 ‘‘(H) have the ability to test for and isolate 12 at least 12 cannabinoids for the purposes of 13 producing specific products for specific studies 14 by compounding pharmacists or others, label- 15 ing, and chemical consistency. 16 ‘‘(4) APPLICATION CONTENTS.—As part of an 17 application to be registered under this subsection, an 18 applicant shall include a written explanation of how 19 the applicant’s proposed manufacture of cannabis 20 would augment the Nation’s supply of cannabis for 21 legitimate research purposes. 22 ‘‘(5) PROCESS.—Not later than 1 year after the 23 date on which the Attorney General receives an ap- 24 plication to be registered under this section to man- 25 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 6 •HR 601 IH ufacture cannabis for research, the Attorney General 1 shall— 2 ‘‘(A) grant, or initiate proceedings under 3 section 304(c) to deny, the application; or 4 ‘‘(B) request supplemental information 5 from the applicant. 6 ‘‘(6) RULE OF CONSTRUCTION ON REGISTRA- 7 TION FOR PURPOSES OTHER THAN RESEARCH.— 8 Nothing in this subsection shall be construed to af- 9 fect the provisions of this section prohibiting or oth- 10 erwise pertaining to registration of manufacturers of 11 cannabis for purposes other than research, including 12 for purposes of strictly commercial endeavors funded 13 by the private sector and aimed at drug product de- 14 velopment. 15 ‘‘(7) NO DISCRIMINATORY TREATMENT BY FED- 16 ERAL GOVERNMENT.—Notwithstanding any other 17 provision of law, no Federal department or agency 18 shall deny or limit any funding, other assistance, li- 19 censing, or other privilege with respect to any person 20 on the basis that such person is, or is legally receiv- 21 ing cannabis from, a manufacturer of cannabis that 22 is— 23 ‘‘(A) registered under this subsection; and 24 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 7 •HR 601 IH ‘‘(B) in compliance with the requirements 1 of this Act. 2 ‘‘(8) SPECIAL RULE.—If cannabis, or any com- 3 ponent thereof, is placed in a schedule other than 4 schedule I, the Attorney General may, as the Attor- 5 ney General determines appropriate— 6 ‘‘(A) treat the reference to ‘subsection (a)’ 7 in paragraph (2)(C) of this subsection as a ref- 8 erence to subsection (d); and 9 ‘‘(B) treat the references to schedule I in 10 paragraph (3) as references to the appropriate 11 schedule. 12 ‘‘(9) DEFINITION.—In this subsection, the term 13 ‘legitimate research purposes’ has the meaning given 14 to such term for purposes of subsection (a)(1).’’. 15 (b) TRANSITIONAL PROVISIONS.— 16 (1) CURRENT REGISTRANTS.—Notwithstanding 17 paragraph (1) of section 303(k) of the Controlled 18 Substances Act, as added by subsection (a), any 19 manufacturer that is registered under section 303(a) 20 of the Controlled Substances Act (21 U.S.C. 823(a)) 21 to manufacture cannabis as of the date of enactment 22 of this Act shall not be required to obtain a separate 23 registration under such section 303(k) for the 1-year 24 period following the date of enactment of this Act. 25 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 8 •HR 601 IH (2) PENDING APPLICATIONS.—Except as pro- 1 vided in paragraph (1), the Attorney General of the 2 United States shall grant or deny, in accordance 3 with section 303 of the Controlled Substances Act 4 (21 U.S.C. 823), as amended by subsection (a), each 5 application to manufacture cannabis to supply re- 6 searchers in the United States that was submitted— 7 (A) pursuant to the policy statement enti- 8 tled ‘‘Applications To Become Registered Under 9 the Controlled Substances Act To Manufacture 10 Marijuana To Supply Researchers in the United 11 States’’ published by the Drug Enforcement 12 Administration in the Federal Register on Au- 13 gust 12, 2016 (81 Fed. Reg. 53846); and 14 (B) before the date of enactment of this 15 Act. 16 (c) TECHNICAL AMENDMENT.—Section 102(16) of 17 the Controlled Substances Act (21 U.S.C. 802(16)) is 18 amended by inserting after ‘‘The term ‘marihuana’ ’’ the 19 following: ‘‘or ‘marijuana’ or ‘cannabis’ ’’. 20 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 9 •HR 601 IH SEC. 3. PROVISION BY DEPARTMENT OF VETERANS AF- 1 FAIRS HEALTH CARE PROVIDERS OF INFOR- 2 MATION REGARDING VETERAN PARTICIPA- 3 TION IN FEDERALLY APPROVED CANNABIS 4 CLINICAL TRIALS. 5 (a) PROVISION OF INFORMATION AND FORMS.—Not- 6 withstanding any other provision of law, health care pro- 7 viders of the Department of Veterans Affairs may— 8 (1) provide information to veterans regarding 9 participation in federally approved cannabis clinical 10 trials; and 11 (2) complete forms relating to such participa- 12 tion. 13 (b) RECEIPT OF INFORMATION.—Health care pro- 14 viders and other employees of the Department may accept 15 information regarding federally approved cannabis clinical 16 trials provided by individuals who are not employed by the 17 Department who are researchers registered under the 18 Controlled Substances Act (21 U.S.C. 801 et seq.) to con- 19 duct research with controlled substances in schedule I of 20 section 202(c) of such Act (21 U.S.C. 812(c)). 21 (c) RESEARCH.—The Secretary of Veterans Affairs 22 may conduct research on cannabis if the employees of the 23 Department who are conducting such research are re- 24 searchers registered under the Controlled Substances Act 25 (21 U.S.C. 801 et seq.) to conduct research with con- 26 VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS 10 •HR 601 IH trolled substances in schedule I of section 202(c) of such 1 Act (21 U.S.C. 812(c)). 2 Æ VerDate Sep 11 2014 19:47 Feb 04, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H601.IH H601 pbinns on DSK79D2C42PROD with BILLS