[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>