Title: Medical Cannabis Research Act of 2018
Policy area: Health

Summary:
Medical Cannabis Research Act of 2018
This bill amends the Controlled Substances Act to establish a new, separate registration process for manufacturers of cannabis for research.
The Drug Enforcement Administration must assess whether there is an adequate and uninterrupted supply of research cannabis and register additional manufacturers.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5634 Introduced in House (IH)]

<DOC>






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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Cannabis Research Act of 
2018''.

SEC. 2. INCREASING THE NUMBER OF FEDERALLY-REGISTERED MANUFACTURERS OF 
              CANNABIS FOR LEGITIMATE RESEARCH PURPOSES.

    (a) In General.--Section 303 of the Controlled Substances Act (21 
U.S.C. 823) is amended--
            (1) by redesignating subsection (k) as subsection (l); and
            (2) by inserting after subsection (j) the following:
    ``(k) Registration of Manufacturers of Cannabis for Legitimate 
Research Purposes.--
            ``(1) In general.--Any manufacturer of cannabis for 
        research shall obtain a separate registration under this 
        subsection for that purpose--
                    ``(A) annually; or
                    ``(B) for a longer period as determined necessary 
                by the Attorney General to supply cannabis for the full 
                duration of a particular multi-year study for 
                legitimate research purposes.
            ``(2) Adequate and uninterrupted supply.--
                    ``(A) Annual assessment.--On an annual basis, the 
                Attorney General shall assess whether there is an 
                adequate and uninterrupted supply of cannabis for 
                legitimate research purposes.
                    ``(B) Initial year.--Not later than 1 year after 
                the date of enactment of the Medical Cannabis Research 
                Act of 2018, of the applicants meeting the requirements 
                of this Act, the Attorney General shall register under 
                subsection (a) and this subsection at least 2 
                applicants to manufacture cannabis for legitimate 
                research purposes in addition to any manufacturers that 
                are registered under subsection (a) to manufacture 
                cannabis as of the date of enactment of the Medical 
                Cannabis Research Act of 2018.
                    ``(C) Subsequent years.--For calendar year 2019 and 
                each subsequent calendar year, of the applicants 
                meeting the requirements of this Act, the Attorney 
                General shall register (including any registration 
                renewal) under subsection (a) and this subsection at 
                least 3 applicants to manufacture cannabis for 
                legitimate research purposes.
            ``(3) Requirements.--A manufacturer registered under this 
        subsection shall--
                    ``(A) comply with all applicable requirements of 
                this Act;
                    ``(B) limit the transfer and sale of any cannabis 
                manufactured pursuant to this section--
                            ``(i) to researchers who are registered 
                        under this Act to conduct research with 
                        controlled substances in schedule I; and
                            ``(ii) for purposes of use in preclinical 
                        research or in a clinical investigation 
                        pursuant to an investigational new drug 
                        exemption under 505(i) of the Federal Food, 
                        Drug, and Cosmetic Act;
                    ``(C) transfer or sell any cannabis manufactured 
                pursuant to this section only with prior, written 
                consent for the transfer or sale by the Attorney 
                General;
                    ``(D) have completed the application and review 
                process under subsection (a) for the bulk manufacture 
                of controlled substances in schedule I;
                    ``(E) have established and begun operation of a 
                process for storage and handling of controlled 
                substances in schedule I, including for inventory 
                control and monitoring security;
                    ``(F) have the ability to provide at least 10 
                unique plant cultivars to ensure plant diversity and 
                scale up to produce bulk plant material on an 
                uninterrupted basis sufficient to supply forecasted 
                demand;
                    ``(G) be licensed, by each State in which the 
                manufacturer conducts its operations pursuant to this 
                subsection, to manufacture cannabis;
                    ``(H) have completed a criminal background check 
                for all personnel involved in the operations of the 
                manufacturer pursuant to this subsection to confirm 
                that such personnel have no conviction for a felony or 
                drug-related misdemeanor;
                    ``(I) have a letter of reference affirming the 
                manufacturer's good standing from each of the 
                applicable State health care and law enforcement 
                authorities in each jurisdiction of the manufacturer's 
                operations pursuant to this subsection; and
                    ``(J) have the ability to test for and isolate at 
                least 12 cannabinoids for the purposes of producing 
                specific products for specific studies by compounding 
                pharmacists or others, labeling, and chemical 
                consistency.
            ``(4) Application contents.--As part of an application to 
        be registered under this subsection, an applicant shall include 
        a written explanation of how the applicant's proposed 
        manufacture of cannabis would augment the Nation's supply of 
        cannabis for legitimate research purposes.
            ``(5) Process.--Not later than 1 year after the date on 
        which the Attorney General receives an application to be 
        registered under this section to manufacture cannabis for 
        research, the Attorney General shall--
                    ``(A) grant, or initiate proceedings under section 
                304(c) to deny, the application; or
                    ``(B) request supplemental information from the 
                applicant.
            ``(6) Rule of construction on registration for purposes 
        other than research.--Nothing in this subsection shall be 
        construed to affect the provisions of this section prohibiting 
        or otherwise pertaining to registration of manufacturers of 
        cannabis for purposes other than research, including for 
        purposes of strictly commercial endeavors funded by the private 
        sector and aimed at drug product development.
            ``(7) No discriminatory treatment by federal government.--
        Notwithstanding any other provision of law, no Federal 
        department or agency shall deny or limit any funding, other 
        assistance, licensing, or other privilege with respect to any 
        person on the basis that such person is, or is legally 
        receiving cannabis from, a manufacturer of cannabis that is--
                    ``(A) registered under this subsection; and
                    ``(B) in compliance with the requirements of this 
                Act.
            ``(8) Special rule.--If cannabis, or any component thereof, 
        is placed in a schedule other than schedule I, the Attorney 
        General may, as the Attorney General determines appropriate--
                    ``(A) treat the reference to `subsection (a)' in 
                paragraph (2)(C) of this subsection as a reference to 
                subsection (d); and
                    ``(B) treat the references to schedule I in 
                paragraph (3) as references to the appropriate 
                schedule.
            ``(9) Definition.--In this subsection, the term `legitimate 
        research purposes' has the meaning given to such term for 
        purposes of subsection (a)(1).''.
    (b) Transitional Provisions.--
            (1) Current registrants.--Notwithstanding paragraph (1) of 
        section 303(k) of the Controlled Substances Act, as added by 
        subsection (a), any manufacturer that is registered under 
        section 303(a) of the Controlled Substances Act (21 U.S.C. 
        823(a)) to manufacture cannabis as of the date of enactment of 
        this Act shall not be required to obtain a separate 
        registration under such section 303(k) for the 1-year period 
        following the date of enactment of this Act.
            (2) Pending applications.--The Attorney General of the 
        United States shall grant or deny, in accordance with section 
        303 of the Controlled Substances Act (21 U.S.C. 823), as 
        amended by subsection (a), each application to manufacture 
        cannabis to supply researchers in the United States that was 
        submitted--
                    (A) pursuant to the policy statement entitled 
                ``Applications To Become Registered Under the 
                Controlled Substances Act To Manufacture Marijuana To 
                Supply Researcher in the United States'' published by 
                the Drug Enforcement Administration in the Federal 
                Register on August 12, 2016 (81 Fed. Reg. 53846); and
                    (B) before February 12, 2017.
    (c) Technical Amendment.--Section 102(16) of the Controlled 
Substances Act (21 U.S.C. 802(16)) is amended by inserting after ``The 
term `marihuana''' the following: ``or `marijuana' or `cannabis'''.

SEC. 3. PROVISION BY DEPARTMENT OF VETERANS AFFAIRS HEALTH CARE 
              PROVIDERS OF INFORMATION REGARDING VETERAN PARTICIPATION 
              IN FEDERALLY-APPROVED CANNABIS CLINICAL TRIALS.

    (a) Provision of Information and Forms.--Notwithstanding any other 
provision of law, health care providers of the Department of Veterans 
Affairs may--
            (1) provide information to veterans regarding participation 
        in federally-approved cannabis clinical trials; and
            (2) complete forms relating to such participation.
    (b) Receipt of Information.--Health care providers and other 
employees of the Department may accept information regarding federally-
approved cannabis clinical trials provided by individuals who are not 
employed by the Department who are researchers registered under the 
Controlled Substances Act (21 U.S.C. 801 et seq.) to conduct research 
with controlled substances in schedule I of section 202(c) of such Act 
(21 U.S.C. 812(c)).
    (c) Research.--The Secretary of Veterans Affairs may conduct 
research on cannabis if the employees of the Department who are 
conducting such research are researchers registered under the 
Controlled Substances Act (21 U.S.C. 801 et seq.) to conduct research 
with controlled substances in schedule I of section 202(c) of such Act 
(21 U.S.C. 812(c)).
                                 <all>