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