Marijuana Effective Drug Studies Act of 2018 or the MEDS Act
This bill amends the Controlled Substances Act to establish a new, separate registration process to facilitate research involving marijuana and the commercial production of drugs made from marijuana.
Specifically, the bill requires the Drug Enforcement Administration to register manufacturers and distributors to supply marijuana: (1) for use in research, and (2) for the commercial production of approved drugs containing or derived from marijuana.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4825 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 4825
To improve medical research on marijuana.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 18, 2018
Mr. Bishop of Utah (for himself, Mr. Curtis, Mr. Stewart, Mrs. Love,
Mr. Raskin, Ms. Norton, Mr. Polis, and Mr. Blumenauer) 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 improve medical research on marijuana.
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 ``Marijuana Effective Drug Studies Act
of 2018'' or the ``MEDS Act''.
SEC. 2. 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'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
``(iii) 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, Federal, or local
laws relating to controlled substances.
``(iv) Such other conduct by the applicant that may
threaten the public health and safety.
``(C) Not later than 90 days after the date of enactment of this
paragraph, 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 later 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--
``(I) approve the application; or
``(II) serve an order to show cause upon the applicant in
accordance with section 304(c).
``(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.
``(E)(i) A researcher registered under this paragraph shall store
marijuana to be used in research in a securely locked, substantially
constructed cabinet.
``(ii) Any other security measures required by the Attorney General
under this paragraph to safeguard against diversion shall be consistent
with those required for practitioners conducting research on other
controlled substances in schedules I and 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
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 in the
applicant's renewal materials.
``(iii)(I) If an applicant amends or supplements the research
protocol in a manner that 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
protocol.
``(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 protocol.
``(iv) The Attorney General may object to an amended or
supplemental research protocol under clause (i) or (iii) if additional
security measures are needed to safeguard against diversion or abuse.
``(G) Article 28 of the Single Convention on Narcotic Drugs shall
not be construed to prohibit, or impose additional restrictions upon,
research involving marijuana that is conducted in accordance with this
paragraph and other applicable provisions of this title.
``(H) If marijuana or a compound of marijuana is listed on a
schedule other than schedule I--
``(i) the provisions of this subsection that apply to
research with a controlled substance in the applicable schedule
shall apply to research with marijuana or that compound, as
applicable; and
``(ii) subparagraphs (A) through (G) of this paragraph
shall not apply to research with marijuana or that compound, as
applicable.''.
(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. 3. MANUFACTURING OF MARIJUANA FOR CLINICAL USE.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
``(k) Registration of Persons To Manufacture and Distribute
Marijuana.--
``(1) Manufacture and distribution for use in research.--
The Attorney General shall register an applicant to manufacture
or distribute marijuana on behalf of the Federal Government to
the extent that the marijuana is intended to be used
exclusively for legitimate research and scientific uses, in
accordance with the applicable requirements under subsection
(a) or (b) for registration of manufacturers or distributors of
controlled substances in schedule I or II.
``(2) Manufacture and distribution for commercial
production of fda-approved drugs.--The Attorney General shall
register an applicant to manufacture or distribute marijuana on
behalf of the Federal Government exclusively for the purpose of
commercial production of a drug containing or derived from
marijuana that is approved by the Secretary under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in
accordance with the applicable requirements under subsection
(a) or (b) of this section for registration of manufacturers or
distributors of controlled substances in schedule I or II.
``(3) No limit on number of manufacturers and
distributors.--The Attorney General shall not impose a limit on
the number of applicants eligible to be registered under
paragraph (1) or (2).
``(4) Timing.--Not later than 30 days after the date on
which the Attorney General receives an application for
registration under paragraph (1) or (2), the Attorney General
shall--
``(A) grant the application; or
``(B) serve an order to show cause upon the
applicant in accordance with section 304(c).
``(5) Determination of supply.--In considering the factors
under subsection (a) or (b), as applicable, for the purposes of
registering an applicant eligible under paragraph (1) or (2) of
this subsection, the Attorney General shall consider the demand
from researchers for an adequate and uninterrupted supply of
specific strains of marijuana and for marijuana grown pursuant
to specific manufacturing processes.
``(6) Relation to the single convention on narcotic
drugs.--
``(A) Constructive possession and control.--The
registration of manufacturers and distributors of
marijuana under paragraphs (1) and (2) shall constitute
constructive possession and control by the Federal
Government for the purposes of the obligations under
the Single Convention on Narcotic Drugs.
``(B) Article 28.--Article 28 of the Single
Convention on Narcotic Drugs shall not be construed to
prohibit, or impose additional restrictions upon, the
manufacturing of marijuana that is conducted in
accordance with paragraph (1) or (2), as applicable,
and other applicable provisions of this title.''.
SEC. 4. GOOD MANUFACTURING PRACTICES.
Not later than 180 days after the date of enactment of this Act,
the National Institute for Drug Abuse shall develop and publish
recommendations for good manufacturing practices for growing and
producing marijuana (as defined in section 102 of the Controlled
Substance Act (21 U.S.C. 802), as amended by this Act) for research.
SEC. 5. QUOTAS.
Section 306(e) of the Controlled Substances Act (21 U.S.C. 826(e))
is amended in the third sentence by striking ``exceeds the aggregate of
the quotas of all registrants under this section'' and inserting
``should be increased to meet the changing medical, scientific, and
industrial needs for the controlled substance''.
SEC. 6. 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 conducted only for research on marijuana (as defined in
section 102 of the Controlled Substances Act (21 U.S.C. 802),
as amended by section 2(b)) 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
2(a).
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
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