[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3797 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 3797
To amend the Controlled Substances Act to make marijuana accessible for
use by qualified marijuana researchers for medical purposes, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 17, 2019
Mr. Blumenauer (for himself, Mr. Harris, Ms. Lofgren, Mr. Griffith, Mr.
Bishop of Utah, and Mrs. Dingell) 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 amend the Controlled Substances Act to make marijuana accessible for
use by qualified marijuana researchers for medical purposes, 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 Marijuana Research Act of
2019''.
SEC. 2. PRODUCTION AND SUPPLY.
(a) In General.--The Secretary of Health and Human Services--
(1) until the date on which the Secretary determines that
manufacturers and distributors (other than the Federal
Government) can ensure a sufficient supply of marijuana for
qualified marijuana researchers intended for medical research,
shall--
(A) continue to produce marijuana through the
National Institute on Drug Abuse (NIDA) Drug Supply
Program; and
(B) offer for sale immature marijuana plants and
the seeds of marijuana--
(i) to all qualified marijuana researchers
who submit a request for such plants or seeds
to engage in research pursuant to the section
303(f)(3) of the Controlled Substances Act, as
amended by section 3; and
(ii) in quantities sufficient to produce an
adequate supply of marijuana for such research;
and
(2) beyond the date specified in paragraph (1), may, at the
Secretary's discretion, continue to so produce and supply
marijuana.
(b) Requirement To Verify Registration.--Before supplying marijuana
to any person through the National Institute on Drug Abuse Drug Supply
Program, the Secretary of Health and Human Services shall--
(1) require the person to submit documentation
demonstrating that the person is a qualified marijuana
researcher seeking to conduct research pursuant to section
303(f)(3) of the Controlled Substances Act, as amended by
section 3; and
(2) not later than 30 days after receipt of such
documentation, review such documentation and verify that the
marijuana will be used for such research (and for no other
purpose authorized pursuant to this Act).
(c) Guidelines on Production.--The Commissioner of Food and Drugs,
in consultation with the Director of the National Institute on Drug
Abuse, shall--
(1) not later than 180 days after the date of enactment of
this Act, issue guidelines on the production of marijuana by
qualified marijuana researchers pursuant to subsection
(a)(1)(B); and
(2) encourage researchers and manufacturers that are
authorized to produce or manufacture marijuana pursuant to
section 303 of the Controlled Substances Act (21 U.S.C. 823),
as amended by this Act, to comply with such guidelines to the
extent applicable.
(d) Definition.--In this section:
(1) The term ``immature marijuana plant'' means a marijuana
plant with no observable flowers or buds.
(2) The term ``qualified medical marijuana researcher''
means a researcher who is registered to conduct research with
marijuana under section 303(f)(3) of the Controlled Substances
Act, as amended by section 3.
SEC. 3. FACILITATING MARIJUANA RESEARCH.
(a) In General.--Section 303(f) of the Controlled Substances Act
(21 U.S.C. 823(f)) is amended--
(1) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively;
(2) by striking ``(f) The Attorney General'' and inserting
``(f)(1) The Attorney General'';
(3) by striking ``Registration applications'' and inserting
the following:
``(2) Registration applications'';
(4) in paragraph (2), as so designated, by striking
``schedule I'' each place that term appears and inserting
``schedule I, except marijuana,'';
(5) by striking ``Article 7'' and inserting the following:
``(4) Article 7''; and
(6) by inserting before paragraph (4), as so designated,
the following:
``(3)(A) The Attorney General shall register a practitioner to
conduct research with marijuana if--
``(i) the applicant is authorized to dispense, or conduct
research with respect to, controlled substances in schedules
II, III, IV, and V under the laws of the State in which the
applicant practices;
``(ii) the applicant is only using marijuana manufactured
by a person registered under subsection (l);
``(iii) the applicant's research protocol--
``(I) has been reviewed and allowed by--
``(aa) the Secretary under section 505(i)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)); or
``(bb) the National Institutes of Health or
another Federal agency that funds scientific
research; or
``(II) in the case of nonhuman research that is not
federally funded, has been voluntarily submitted by the
applicant to, and approved by, the National Institutes
of Health; and
``(iv) the applicant has demonstrated that there are
effective procedures in place to adequately safeguard against
diversion of the marijuana from legitimate medical or
scientific use, in accordance with subparagraph (E).
``(B) The Attorney General shall grant an application for
registration under this paragraph unless the Attorney General
determines that the issuance of the registration would be inconsistent
with the public interest. In determining the public interest, the
following factors shall be considered:
``(i) The applicant's experience in dispensing, or
conducting research with respect to, controlled substances.
``(ii) The applicant's conviction record under Federal or
State laws relating to the manufacture, distribution, or
dispensing of controlled substances.
``(iii) Compliance with applicable State or local laws
relating to controlled substance misuse or diversion.
``(C) Not later than 90 days after the date of enactment of the
Medical Marijuana Research Act of 2019, for purposes of subparagraph
(A)(ii)(II), the National Institutes of Health shall establish a
process that--
``(i) allows a researcher to voluntarily submit the
research protocol of the researcher for review and approval;
and
``(ii) provides a researcher described in clause (i) with a
decision not less than 30 days after the date on which the
research protocol is submitted.
``(D)(i) Not later than 60 days after the date on which the
Attorney General receives a complete application for registration under
this paragraph, the Attorney General shall approve or deny the
application.
``(ii) For purposes of clause (i), an application shall be deemed
complete when the applicant has submitted documentation showing that
the requirements under subparagraph (A) are satisfied.
``(iii) In the case of a denial under clause (i), the Attorney
General shall provide a written explanation of the basis for the denial
and a description of any curative steps that may be taken for such
request to be approved.
``(E)(i) A researcher registered under this paragraph shall store
marijuana to be used in research in a securely locked, substantially
constructed cabinet.
``(ii) Except as provided in clause (i), any security measures
required by the Attorney General for practitioners conducting research
with marijuana pursuant to a registration under this paragraph shall be
consistent with the security measures for practitioners conducting
research on other controlled substances in schedule II that have a
similar risk of diversion and abuse.
``(F)(i) If the Attorney General grants an application for
registration under this paragraph, the applicant may amend or
supplement the research protocol without reapplying if the applicant
does not--
``(I) change the type of drug, the source of the drug, or
the conditions under which the drug is stored, tracked, or
administered; or
``(II) otherwise increase the risk of diversion.
``(ii) If an applicant amends or supplements the research protocol
or initiates research on a new research protocol under clause (i), the
applicant shall, in order to renew the registration under this
paragraph, provide notice to the Attorney General of the amended or
supplemented research protocol or any new research protocol in the
applicant's renewal materials.
``(iii)(I) If an applicant amends or supplements a research
protocol and the amendment or supplement involves a change to the type
of drug, the source of the drug, or conditions under which the drug is
stored, tracked, or administered or otherwise increases the risk of
diversion, the applicant shall provide notice to the Attorney General
not later than 30 days before proceeding on such amended or
supplemental research or new research protocol, as the case may be.
``(II) If the Attorney General does not object during the 30-day
period following a notification under subclause (I), the applicant may
proceed with the amended or supplemental research or new research
protocol.
``(iv) The Attorney General may object to an amended or
supplemental protocol or a new research protocol under clause (i) or
(iii) only if additional security measures are needed to safeguard
against diversion or abuse.
``(G) If marijuana or a compound of marijuana is listed on a
schedule other than schedule I, the provisions of paragraphs (1), (2),
and (4) that apply to research with a controlled substance in the
applicable schedule shall apply to research with marijuana or that
compound, as applicable, in lieu of the provisions of subparagraphs (A)
through (G) of this paragraph.''.
(b) Conforming Amendment.--Section 102(16) of the Controlled
Substances Act (21 U.S.C. 802(16)) is amended by inserting ``or
`marijuana''' after ``The term `marihuana'''.
SEC. 4. MANUFACTURE AND DISTRIBUTION OF MARIJUANA FOR USE IN
LEGITIMATE, MEDICAL RESEARCH.
Section 303 of the Controlled Substances Act (21 U.S.C. 823), as
amended by section 3, is further amended by adding at the end the
following:
``(l) Registration of Persons To Manufacture and Distribute
Marijuana for Use in Legitimate, Medical Research.--
``(1) Registration of manufacturers.--Beginning not later
than the day that is 1 year after the date of enactment of the
Medical Marijuana Research Act of 2019, the Attorney General
shall register an applicant to manufacture marijuana to the
extent the marijuana will be used exclusively by qualified
marijuana researchers for research pursuant to subsection
(f)(3), unless the Attorney General determines that the
issuance of such registration is inconsistent with the public
interest. In determining the public interest, the Attorney
General shall--
``(A) take into consideration--
``(i) maintenance of effective controls
against diversion of marijuana and any
controlled substance compounded therefrom into
other than legitimate medical, scientific, or
research channels;
``(ii) compliance with applicable State and
local laws relating to controlled substance
misuse and diversion; and
``(iii) prior conviction record of the
applicant under Federal or State laws relating
to the manufacture, distribution, or dispensing
of such substances; and
``(B) not take into consideration any factors other
than the factors listed in subparagraph (A).
``(2) Registration of distributors.--Beginning not later
than the day that is 1 year after the date of enactment of the
Medical Marijuana Research Act of 2019, the Attorney General
shall register an applicant to distribute marijuana that is
intended to be used exclusively by qualified medical marijuana
researchers for research pursuant to subsection (f)(3), unless
the Attorney General determines that the issuance of such
registration is inconsistent with the public interest.
``(3) Public interest.--In determining the public interest
under paragraph (2), the Attorney General shall--
``(A) take into consideration--
``(i) maintenance of effective controls
against diversion of marijuana and any
controlled substance compounded therefrom into
other than legitimate medical, scientific, or
research channels;
``(ii) compliance with applicable State and
local law;
``(iii) prior conviction record of the
applicant under Federal or State laws relating
to the manufacture, distribution, or dispensing
of such substances; and
``(iv) past experience in the distribution
of controlled substances, and the existence in
the establishment of effective controls against
diversion; and
``(B) not take into consideration any factors other
than the factors listed in subparagraph (A).
``(4) No limit on number of manufacturers and
distributors.--Notwithstanding any other provision of law, the
Attorney General shall not impose or implement any limit on the
number of persons eligible to be registered to manufacture or
distribute marijuana pursuant to paragraph (1) or (2).
``(5) Requirement to verify use for legitimate, medical
research.--As a condition on registration under this section to
manufacture or distribute marijuana, the Attorney General shall
require the registrant--
``(A) to require any person to whom the marijuana
will be supplied to submit documentation demonstrating
that the marijuana will be used exclusively by
qualified medical marijuana researchers for research
pursuant to subsection (f)(3);
``(B) in the case of distribution, to complete,
with respect to that distribution, the DEA Controlled
substance order form (DEA 222) (or a successor form)
and the DEA Certificate of Registration (DEA Form 223)
(or a successor form) and to upload such forms to the
system used by the Drug Enforcement Agency for such
distribution;
``(C) to include in the labeling of any marijuana
so manufactured or distributed--
``(i) the following statement: `This
material is for medical and scientific research
purposes only.'; and
``(ii) the name of the requestor of the
marijuana; and
``(D) not later than 30 days after receipt of such
documentation, and before supplying the marijuana to
such person, to review such documentation and verify
that the marijuana will be so used.
``(6) Timing.--Not later than 30 days after receipt of a
request for registration under this subsection to manufacture
or distribute marijuana, the Attorney General shall--
``(A) grant or deny the request; and
``(B) in the case of a denial, provide a written
explanation of the basis for the denial and a
description of any curative steps that may be taken for
such request to be approved.
``(7) Deemed approval.--If the Attorney General fails to
grant or deny a request for registration under this subsection
to manufacture or distribute marijuana within the 30-day period
referred to in paragraph (5), such request is deemed approved.
``(8) Definition.--For purposes of this subsection, the
term `qualified medical marijuana researcher' means a
researcher who is registered to conduct research with marijuana
under subsection (f)(3).''.
SEC. 5. TERMINATION OF INTERDISCIPLINARY REVIEW PROCESS FOR NON-NIH-
FUNDED RESEARCHERS.
The Secretary of Health and Human Services may not--
(1) reinstate the Public Health Service interdisciplinary
review process described in the guidance entitled ``Guidance on
Procedures for the Provision of Marijuana for Medical
Research'' (issued on May 21, 1999); or
(2) create an additional review of scientific protocols
that is only conducted for research on marijuana other than the
review of research protocols performed at the request of a
researcher conducting nonhuman research that is not federally
funded, in accordance with section 303(f)(3)(A)(ii)(II) of the
Controlled Substances Act (21 U.S.C. 823(f)(3)(A)(ii)(II)), as
amended by section 3.
SEC. 6. CONSIDERATION OF RESULTS OF RESEARCH.
Immediately upon the approval by the Food and Drug Administration
of an application for a marijuana-based drug under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and (irrespective
of whether any such approval is granted) not later than the date that
is 5 years after the date of enactment of this Act, the Secretary of
Health and Human Services shall--
(1) conduct a review of existing medical and other research
with respect to marijuana;
(2) submit a report to the Congress on the results of such
review; and
(3) include in such report whether, taking into
consideration the factors listed in section 201(c) of the
Controlled Substances Act (21 U.S.C. 811(c)), as well as any
potential for medical benefits, any gaps in research, and any
impacts of Federal restrictions and policy on research,
marijuana should be transferred to a schedule other than
schedule I (if marijuana has not been so transferred already).
SEC. 7. NO PRODUCTION QUOTAS FOR MARIJUANA GROWN FOR LEGITIMATE,
SCIENTIFIC RESEARCH.
Section 306 of the Controlled Substances Act (21 U.S.C. 826) is
amended by adding at the end the following:
``(j) The Attorney General may only establish a quota for
production of marijuana that is manufactured and distributed in
accordance with the Medical Marijuana Research Act of 2019 that meets
the changing medical, scientific, and industrial needs for marijuana
(as defined by the National Institute on Drug Abuse).''.
SEC. 8. ARTICLE 28 OF THE SINGLE CONVENTION ON NARCOTIC DRUGS.
Article 28 of the Single Convention on Narcotic Drugs shall not be
construed to prohibit, or impose additional restrictions upon, research
involving marijuana, or the manufacture, distribution, or dispensing of
marijuana, that is conducted in accordance with the Controlled
Substances Act (21 U.S.C. 801 et seq.), this Act, and the amendments
made by this Act.
SEC. 9. NO INTERFERENCE BY DEPARTMENT OF JUSTICE.
The Attorney General of the United States, and any officer or
employee of the Department of Justice, shall not interfere with the
production, distribution, and sale of marijuana in accordance with this
Act and the amendments made by this Act.
SEC. 10. DEFINITION.
In this Act, the term ``marijuana'' has the meaning given to the
term ``marihuana'' in section 102 of the Controlled Substances Act (21
U.S.C. 802).
<all>