Cannabidiol and Marihuana Research Expansion Act
This bill modifies provisions concerning the federal regulation of certain drugs that are deemed to pose a risk of abuse and dependence to facilitate research on, and the use of, medical treatments containing marijuana and its derivatives.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2032 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 2032
To expand research on the cannabidiol and marihuana.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 27, 2019
Mrs. Feinstein (for herself, Mr. Grassley, Mr. Schatz, Mr. Durbin, Ms.
Klobuchar, Mr. Tillis, Mr. Kaine, Ms. Ernst, and Mr. Cramer) introduced
the following bill; which was read twice and referred to the Committee
on the Judiciary
_______________________________________________________________________
A BILL
To expand research on the cannabidiol and marihuana.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Cannabidiol and
Marihuana Research Expansion Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
TITLE I--REGISTRATIONS FOR MARIHUANA RESEARCH
Sec. 101. Marihuana research applications.
Sec. 102. Research protocols.
Sec. 103. Applications to manufacture marihuana for research.
Sec. 104. Adequate and uninterrupted supply.
Sec. 105. Security requirements.
Sec. 106. Prohibition against reinstating interdisciplinary review
process for non-NIH funded researchers.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIHUANA
Sec. 201. Medical research on cannabidiol.
Sec. 202. Registration for the commercial production and distribution
of Food and Drug Administration approved
drugs.
Sec. 203. Importation of cannabidiol for research purposes.
TITLE III--DOCTOR-PATIENT RELATIONSHIP
Sec. 301. Doctor-patient relationship.
TITLE IV--FEDERAL RESEARCH
Sec. 401. Federal research.
SEC. 2. DEFINITIONS.
In this Act--
(1) the term ``appropriately registered'' means that an
individual or entity is registered under the Controlled
Substances Act (21 U.S.C. 801 et seq.) to engage in the type of
activity that is carried out by the individual or entity with
respect to a controlled substance on the schedule that is
applicable to cannabidiol or marihuana, as applicable;
(2) the term ``cannabidiol'' means--
(A) the substance, cannabidiol, as derived from
marihuana that has a tetrahydrocannabinol level that is
greater than 0.3 percent; and
(B) the synthetic equivalent of the substance
described in subparagraph (A);
(3) the terms ``controlled substance'', ``dispense'',
``distribute'', ``manufacture'', ``marihuana'', and
``practitioner'' have the meanings given such terms in section
102 of the Controlled Substances Act (21 U.S.C. 802), as
amended by this Act;
(4) the term ``covered institution of higher education''
means an institution of higher education (as defined in section
101 of the Higher Education Act of 1965 (20 U.S.C. 1001))
that--
(A)(i) has highest or higher research activity, as
defined by the Carnegie Classification of Institutions
of Higher Education; or
(ii) is an accredited medical school or an
accredited school of osteopathic medicine; and
(B) is appropriately registered under the
Controlled Substances Act (21 U.S.C. 801 et seq.);
(5) the term ``drug'' has the meaning given the term in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1));
(6) the term ``medical research for drug development''
means medical research that is--
(A) a preclinical study or clinical investigation
conducted in accordance with section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))
or otherwise permitted by the Department of Health and
Human Services to determine the potential medical
benefits of marihuana or cannabidiol as a drug; and
(B) conducted by a covered institution of higher
education, practitioner, or manufacturer that is
appropriately registered under the Controlled
Substances Act (21 U.S.C. 801 et seq.); and
(7) the term ``State'' means any State of the United
States, the District of Columbia, and any territory of the
United States.
TITLE I--REGISTRATIONS FOR MARIHUANA RESEARCH
SEC. 101. MARIHUANA RESEARCH APPLICATIONS.
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)(A) Registration applications'';
(4) by striking ``Article 7'' and inserting the following:
``(3) Article 7''; and
(5) by inserting after paragraph (2)(A), as so designated,
the following:
``(B)(i) The Attorney General shall register a practitioner to
conduct research with marihuana if--
``(I) the applicant's research protocol--
``(aa) has been reviewed and allowed--
``(AA) by the Secretary of Health and Human
Services under section 505(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(i));
``(BB) by the National Institutes of Health
or another Federal agency that funds scientific
research; or
``(CC) pursuant to sections 1301.18 and
1301.32 of title 21, Code of Federal
Regulations, or any successors thereto; and
``(II) the applicant has demonstrated to the Attorney
General that there are effective procedures in place to
adequately safeguard against diversion of the controlled
substance for legitimate medical or scientific use pursuant to
section 105 of the Cannabidiol and Marihuana Research Expansion
Act, including demonstrating that the security measures are
adequate for storing the quantity of marihuana the applicant
would be authorized to possess.
``(ii) The Attorney General may deny an application for
registration under this subparagraph only if the Attorney General
determines that the issuance of the registration would be inconsistent
with the public interest. In determining the public interest, the
Attorney General shall consider the factors listed in--
``(I) subparagraphs (B) through (E) of paragraph (1); and
``(II) subparagraph (A) of paragraph (1), if the applicable
State requires practitioners conducting research to register
with a board or authority described in such subparagraph (A).
``(iii)(I) Not later than 60 days after the date on which the
Attorney General receives a complete application for registration under
this subparagraph, the Attorney General shall--
``(aa) approve the application; or
``(bb) request supplemental information.
``(II) For purposes of subclause (I), an application shall be
deemed complete when the applicant has submitted documentation showing
that the requirements under clause (i) are satisfied.
``(iv) Not later than 30 days after the date on which the Attorney
General receives supplemental information as described in clause
(iii)(I)(bb) in connection with an application described in this
subparagraph, the Attorney General shall approve or deny the
application.
``(v) If an application described in this subparagraph is denied,
the Attorney General shall provide a written explanation of the basis
of denial to the applicant.''.
SEC. 102. RESEARCH PROTOCOLS.
(a) In General.--Paragraph (2)(B) of section 303 of the Controlled
Substances Act (21 U.S.C. 823(f)), as amended by section 101 of this
Act, is further amended by adding at the end the following:
``(vi)(I) If the Attorney General grants an application for
registration under clause (i), the registrant may amend or supplement
the research protocol without reapplying if the registrant does not
change--
``(aa) the quantity or type of drug;
``(bb) the source of the drug; or
``(cc) the conditions under which the drug is stored,
tracked, or administered.
``(II)(aa) If a registrant under clause (i) seeks to change the
type of drug, the source of the drug, or conditions under which the
drug is stored, tracked, or administered, the registrant shall notify
the Attorney General via registered mail, or an electronic means
permitted by the Attorney General, not later than 30 days before
implementing an amended or supplemental research protocol.
``(bb) A registrant may proceed with an amended or supplemental
research protocol described in item (aa) if the Attorney General does
not explicitly object during the 30-day period beginning on the date on
which the Attorney General receives the notice under item (aa).
``(cc) The Attorney General may only object to an amended or
supplemental research protocol under this subclause if additional
security measures are needed to safeguard against diversion or abuse.
``(dd) If a registrant under clause (i) seeks to address additional
security measures identified by the Attorney General under item (cc),
the registrant shall notify the Attorney General via registered mail,
or an electronic means permitted by the Attorney General, not later
than 30 days before implementing an amended or supplemental research
protocol.
``(ee) A registrant may proceed with an amended or supplemental
research protocol described in item (dd) if the Attorney General does
not explicitly object during the 30-day period beginning on the date on
which the Attorney General receives the notice under item (dd).
``(III) If a registrant under clause (i) seeks to change the
quantity of marihuana needed for research, the change shall be deemed
approved by the Attorney General on the date on which the registered
mail return receipt is returned to the registrant, or the date on which
the electronic notification, as permitted by the Attorney General, is
received, if the registrant submits to the Attorney General--
``(aa) the Drug Enforcement Administration registration
number of the registrant;
``(bb) the quantity of marihuana already obtained; and
``(cc) the quantity of additional marihuana needed to
complete the research.
``(IV) Nothing in this clause shall limit the authority of the
Secretary of Health and Human Services over requirements related to
research protocols, including changes in--
``(aa) the method of administration of marihuana;
``(bb) the dosing of marihuana; and
``(cc) the number of individuals or patients involved in
research.''.
(b) Regulations.--Not later than 1 year after the date of enactment
of this Act, the Attorney General shall promulgate regulations to carry
out the amendment made by this section.
SEC. 103. APPLICATIONS TO MANUFACTURE MARIHUANA FOR RESEARCH.
(a) In General.--Section 303 of the Controlled Substances Act (21
U.S.C. 823) is amended--
(1) by redesignating subsections (c) through (k) as
subsections (d) through (l), respectively;
(2) by inserting after subsection (b) the following:
``(c)(1)(A) As it relates to applications to manufacture marihuana
for research purposes, if the Attorney General places a notice in the
Federal Register to increase the number of entities registered under
this Act to manufacture marihuana to supply appropriately registered
researchers in the United States, the Attorney General shall, not later
than 60 days after the date on which the Attorney General receives a
completed application--
``(i) approve the application; or
``(ii) request supplemental information.
``(B) For purposes of subparagraph (A), an application shall be
deemed complete when the applicant has submitted documentation showing
each of the following:
``(i) The requirements designated in the notice in the
Federal Register are satisfied.
``(ii) The requirements under this Act are satisfied.
``(iii) The applicant will limit the transfer and sale of
any marihuana manufactured under this subsection--
``(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 (21 U.S.C.
355(i)).
``(iv) The applicant will transfer or sell any marihuana
manufactured under this subsection only with prior, written
consent for the transfer or sale by the Attorney General.
``(v) The applicant has completed the application and
review process under subsection (a) for the bulk manufacture of
controlled substances in schedule I.
``(vi) The applicant has established and begun operation of
a process for storage and handling of controlled substances in
schedule I, including for inventory control and monitoring
security in accordance with section 105 of the Cannabidiol and
Marihuana Research Expansion Act.
``(vii) The applicant is licensed by each State in which
the applicant will conduct operations under this subsection, to
manufacture marihuana, if that State requires such a license.
``(C) Not later than 30 days after the date on which the Attorney
General receives supplemental information requested under subparagraph
(A)(ii) with respect to an application, the Attorney General shall
approve or deny the application.
``(2) If an application described in this subsection is denied, the
Attorney General shall provide a written explanation of the basis of
denial to the applicant.'';
(3) in subsection (h)(2), as so redesignated, by striking
``subsection (f)'' each place it appears and inserting
``subsection (g)'';
(4) in subsection (j)(1), as so redesignated, by striking
``subsection (d)'' and inserting ``subsection (e)''; and
(5) in subsection (k), as so redesignated, by striking
``subsection (f)'' each place it appears and inserting
``subsection (g)''.
(b) Technical and Conforming Amendments.--
(1) The Controlled Substances Act (21 U.S.C. 801 et seq.)
is amended--
(A) in section 102 (21 U.S.C. 802)--
(i) in paragraph (16)(B)--
(I) in clause (i), by striking
``or'' at the end;
(II) by redesignating clause (ii)
as (iii); and
(III) by inserting after clause (i)
the following:
``(ii) the synthetic equivalent of hemp-derived
cannabidiol that contains less than 0.3 percent
tetrahydrocannabinol; or'';
(ii) in paragraph (52)(B)--
(I) by striking ``303(f)'' each
place it appears and inserting
``303(g)''; and
(II) in clause (i), by striking
``(d), or (e)'' and inserting ``(e), or
(f)''; and
(iii) in paragraph (54), by striking
``303(f)'' each place it appears and inserting
``303(g)'';
(B) in section 304 (21 U.S.C. 824), by striking
``303(g)(1)'' each place it appears and inserting
``303(h)(1)'';
(C) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by
striking ``303(f)'' and inserting ``303(g)'';
(D) in section 311(h) (21 U.S.C. 831(h)), by
striking ``303(f)'' each place it appears and inserting
``303(g)'';
(E) in section 401(h)(2) (21 U.S.C. 841(h)(2)), by
striking ``303(f)'' each place it appears and inserting
``303(g)'';
(F) in section 403(c)(2)(B) (21 U.S.C.
843(c)(2)(B)), by striking ``303(f)'' and inserting
``303(g)''; and
(G) in section 512(c)(1) (21 U.S.C. 882(c)(1)) by
striking ``303(f)'' and inserting ``303(g)''.
(2) Section 1008(c) of the Controlled Substances Import and
Export Act (21 U.S.C. 958(c)) is amended--
(A) in paragraph (1), by striking ``303(d)'' and
inserting ``303(e)''; and
(B) in paragraph (2)(B), by striking ``303(h)'' and
inserting ``303(i)''.
(3) Title V of the Public Health Service Act (42 U.S.C.
290aa et seq.) is amended--
(A) in section 520E-4(c) (42 U.S.C. 290bb-36d(c)),
by striking ``303(g)(2)(B)'' and inserting
``303(h)(2)(B)''; and
(B) in section 544(a)(3) (42 U.S.C. 290dd-3(a)(3)),
by striking ``303(g)'' and inserting ``303(h)''.
SEC. 104. ADEQUATE AND UNINTERRUPTED SUPPLY.
On an annual basis, the Attorney General shall assess whether there
is an adequate and uninterrupted supply of marihuana, including of
specific strains, for research purposes.
SEC. 105. SECURITY REQUIREMENTS.
(a) In General.--An individual or entity engaged in researching
marihuana or its components shall store it in a securely locked,
substantially constructed cabinet.
(b) Requirements for Other Measures.--Any other security measures
required by the Attorney General to safeguard against diversion shall
be consistent with those required for practitioners conducting research
on other controlled substances in schedules I and II in section 202(c)
of the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar
risk of diversion and abuse.
SEC. 106. PROHIBITION AGAINST REINSTATING 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) require another review of scientific protocols that is
applicable only to research on marihuana or its components.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIHUANA
SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL.
Notwithstanding any provision of the Controlled Substances Act (21
U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act
(20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code,
or any other Federal law, an appropriately registered covered
institution of higher education, a practitioner, or a manufacturer may
manufacture, distribute, dispense, or possess marihuana or cannabidiol
if the marihuana or cannabidiol is manufactured, distributed,
dispensed, or possessed, respectively, for purposes of medical research
for drug development or subsequent commercial production in accordance
with section 202.
SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND DISTRIBUTION
OF FOOD AND DRUG ADMINISTRATION APPROVED DRUGS.
The Attorney General shall register an applicant to manufacture or
distribute cannabidiol or marihuana for the purpose of commercial
production of a drug containing or derived from marihuana that is
approved by the Secretary of Health and Human Services 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 section 303 of the Controlled Substances Act (21 U.S.C. 823).
SEC. 203. IMPORTATION OF CANNABIDIOL FOR RESEARCH PURPOSES.
The Controlled Substances Import and Export Act (21 U.S.C. 951 et
seq.) is amended--
(1) in section 1002(a) (21 U.S.C. 952(a))--
(A) in paragraph (1), by striking ``and'' at the
end;
(B) in paragraph (2)(C), by inserting ``and'' after
``uses,''; and
(C) inserting before the undesignated matter
following paragraph (2)(C) the following:
``(3) such amounts of marihuana or cannabidiol (as defined
in section 2 of the Cannabidiol and Marihuana Research
Expansion Act) as are--
``(A) approved for medical research for drug
development (as such terms are defined in section 2 of
the Cannabidiol and Marihuana Research Expansion Act),
or
``(B) necessary for registered manufacturers to
manufacture drugs containing marihuana or cannabidiol
that have been approved for use by the Commissioner of
Food and Drugs under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.),''; and
(2) in section 1007 (21 U.S.C. 957), by amending subsection
(a) to read as follows:
``(a)(1) Except as provided in paragraph (2), no person may--
``(A) import into the customs territory of the United
States from any place outside thereof (but within the United
States), or import into the United States from any place
outside thereof, any controlled substance or list I chemical,
or
``(B) export from the United States any controlled
substance or list I chemical,
unless there is in effect with respect to such person a
registration issued by the Attorney General under section 1008,
or unless such person is exempt from registration under
subsection (b).
``(2) Paragraph (1) shall not apply to the import or export
of marihuana or cannabidiol (as defined in section 2 of the
Cannabidiol and Marihuana Research Expansion Act) that has been
approved for--
``(A) medical research for drug development
authorized under section 201 of the Cannabidiol and
Marihuana Research Expansion Act; or
``(B) use by registered manufacturers to
manufacture drugs containing marihuana or cannabidiol
that have been approved for use by the Commissioner of
Food and Drugs under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).''.
TITLE III--DOCTOR-PATIENT RELATIONSHIP
SEC. 301. DOCTOR-PATIENT RELATIONSHIP.
It shall not be unlawful for a State-licensed physician to
discuss--
(1) the currently known potential harms and benefits of
marihuana derivatives, including cannabidiol, as a treatment
with the legal guardian of the patient of the physician if the
patient is a child; or
(2) the currently known potential harms and benefits of
marihuana and marihuana derivatives, including cannabidiol, as
a treatment with the patient or the legal guardian of the
patient of the physician if the patient is a legal adult.
TITLE IV--FEDERAL RESEARCH
SEC. 401. FEDERAL RESEARCH.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, in
coordination with the Director of the National Institutes of Health and
the heads of other relevant Federal agencies, shall submit to the
Caucus on International Narcotics Control, the Committee on the
Judiciary, and the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce and the
Committee on the Judiciary of the House of Representatives a report
on--
(1) the potential therapeutic effects of cannabidiol or
marihuana on serious medical conditions, including intractable
epilepsy;
(2) the potential effects of marihuana, including--
(A) the effect of increasing delta-9-
tetrahydrocannabinol levels on the human body and
developing adolescent brains; and
(B) the effect of various delta-9-
tetrahydrocannabinol levels on cognitive abilities,
such as those that are required to operate motor
vehicles or other heavy equipment; and
(3) the barriers associated with researching marihuana or
cannabidiol in States that have legalized the use of such
substances, which shall include--
(A) recommendations as to how such barriers might
be overcome, including whether public-private
partnerships or Federal-State research partnerships may
or should be implemented to provide researchers with
access to additional strains of marihuana and
cannabidiol; and
(B) recommendations as to what safeguards must be
in place to verify--
(i) the levels of tetrahydrocannabinol,
cannabidiol, or other cannabinoids contained in
products obtained from such States is accurate;
and
(ii) that such products do not contain
harmful or toxic components.
(b) Activities.--To the extent practicable, the Secretary of Health
and Human Services, either directly or through awarding grants,
contacts, or cooperative agreements, shall expand and coordinate the
activities of the National Institutes of Health and other relevant
Federal agencies to better determine the effects of cannabidiol and
marihuana, as outlined in the report submitted under paragraphs (1) and
(2) of subsection (a).
<all>
Introduced in Senate
Read twice and referred to the Committee on the Judiciary. (Sponsor introductory remarks on measure: CR S4633-4634)
Committee on United States Senate Caucus on International Narcotics Control. Hearings held. Hearings printed: S.Hrg. 116-252.
Senate Committee on the Judiciary discharged by Unanimous Consent.
Senate Committee on the Judiciary discharged by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S7508)
Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.(text of amendment in the nature of a substitute: CR S7504-7507)
Passed Senate with an amendment by Voice Vote. (text of amendment in the nature of a substitute: CR S7504-7507)
Message on Senate action sent to the House.
Received in the House.
Held at the desk.
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