[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3269 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 3269

 To require the Attorney General to make a determination as to whether 
 cannabidiol should be a controlled substance and listed in a schedule 
   under the Controlled Substances Act and to expand research on the 
     potential medical benefits of cannabidiol and other marijuana 
                              components.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 14, 2016

 Mrs. Feinstein (for herself, Mr. Grassley, Mr. Leahy, and Mr. Tillis) 
introduced the following bill; which was read twice and referred to the 
                       Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
 To require the Attorney General to make a determination as to whether 
 cannabidiol should be a controlled substance and listed in a schedule 
   under the Controlled Substances Act and to expand research on the 
     potential medical benefits of cannabidiol and other marijuana 
                              components.

    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 ``Cannabidiol Research Expansion 
Act''.

SEC. 2. DEFINITIONS.

    In this Act--
            (1) the term ``authorized medical research'' means medical 
        research that is--
                    (A) investigational use research 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;
                    (B) conducted in a State that allows the 
                manufacturing, distribution, dispensing, or possession 
                of, or research with respect to, marihuana or 
                cannabidiol under the laws of the State; and
                    (C) conducted by a covered institution of higher 
                education or registered manufacturer that is 
                appropriately registered under the Controlled 
                Substances Act (21 U.S.C. 801 et seq.);
            (2) the term ``cannabidiol'' means the nonpsychoactive 
        substance, cannabidiol, as derived from marihuana or the 
        synthetic formulation;
            (3) the terms ``controlled substance'', ``dispense'', 
        ``distribute'', ``marihuana'', and ``manufacture'' have the 
        meanings given such terms in section 102 of the Controlled 
        Substances Act (21 U.S.C. 802);
            (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 Cosmetics Act 
        (21 U.S.C. 321(g)(1));
            (6) the term ``registered manufacturer'' means an 
        individual or entity who is appropriately registered to 
        manufacture controlled substances under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.), including an individual 
        or entity appropriately registered to manufacture controlled 
        substances as part of research; and
            (7) the term ``State'' means any State of the United 
        States, the District of Columbia, and any territory of the 
        United States.

SEC. 3. PROCEEDINGS FOR CONTROL OF CANNABIDIOL.

    (a) Scientific and Medical Evaluations.--Not later than 1 year 
after the date of enactment of this Act, the Attorney General and the 
Secretary of Health and Human Services shall each complete the 
scientific and medical evaluation described in section 201(b) of the 
Controlled Substances Act (21 U.S.C. 811(b)) as to cannabidiol, which 
shall take into consideration the factors described in paragraphs (1) 
through (8) of subsection (c) of section 201 of that Act (21 U.S.C. 
811(c)).
    (b) Proceedings To Control Cannabidiol.--After taking into 
consideration the evaluation described in subsection (a), if the 
Attorney General determines that the evaluations, recommendations, and 
all other relevant data warrant control of cannabidiol, the Attorney 
General shall initiate proceedings for control under section 201(a) of 
the Controlled Substances Act (21 U.S.C. 811(a)).

SEC. 4. RESEARCH PROTOCOLS.

    The Attorney General shall amend section 1301.18 of title 21, Code 
of Federal Regulations (as in effect on the date of enactment of this 
Act) by striking subsections (c) and (d) and inserting the following:
    ``(c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall submit a request to the Registration Unit, Drug 
Enforcement Administration, by registered mail, return receipt 
requested. See the Table of DEA Mailing Addresses in Sec.  1321.01 of 
this chapter for the current mailing address. The request shall contain 
the following information: DEA registration number; name of the 
controlled substance or substances and the quantity of each authorized 
in the approved protocol; and the additional quantity of each desired. 
Upon return of the receipt, the registrant shall be authorized to 
purchase and use the additional quantity of the controlled substance or 
substances specified in the request.
    ``(d) In the event the registrant desires to conduct research 
beyond the variations provided in the registrant's approved protocol 
(excluding any increase in the quantity of the controlled substance 
requested for his/her research project as outlined in subsection (c) of 
this section), he/she shall submit three copies by registered mail, 
with a return receipt requested, of a supplemental protocol in 
accordance with subsection (a) of this section describing the new 
research and omitting information in the supplemental protocol which 
has been stated in the original protocol. Unless explicitly denied, 
supplemental protocols shall be considered approved 30 days after the 
date on which the return receipt is returned.''.

SEC. 5. MEDICAL RESEARCH ON CANNABIDIOL.

    (a) In General.--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, a covered institution of 
higher education or a registered 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 authorized medical research.
    (b) Registration for Research Involving Cannabidiol.--
            (1) Initial period.--During the period beginning on the 
        date of enactment of this Act and ending on the date on which 
        the Attorney General makes a determination regarding control of 
        cannabidiol, an individual or entity engaged in authorized 
        medical research may distribute, dispense, or possess 
        cannabidiol for purposes of the authorized medical research if 
        the individual or entity is registered under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.) to engage in such 
        activity with a controlled substance in schedule II in section 
        202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
            (2) Completion of ongoing research.--If, as a result of the 
        determination and proceedings described in section 3, 
        cannabidiol is a controlled substance in schedule I in section 
        202(c) of the Controlled Substances Act (21 U.S.C. 812(c)), an 
        individual or entity engaged in authorized medical research may 
        continue to distribute, dispense, or possess cannabidiol for 
        purposes of completing the authorized medical research if the 
        individual or entity--
                    (A) was engaged in the authorized medical research 
                in accordance with paragraph (1) on or before the date 
                on which the proceedings are completed; and
                    (B) is registered under the Controlled Substances 
                Act (21 U.S.C. 801 et seq.) to engage in such activity 
                with a controlled substance in schedule II in section 
                202(c) of the Controlled Substances Act (21 U.S.C. 
                812(c)).
    (c) Timely Processing of Registration Applications.--
            (1) In general.--Not later than 60 days after the Attorney 
        General receives an application for registration under the 
        Controlled Substances Act (21 U.S.C. 801 et seq.) to 
        manufacture, distribute, dispense, or possess controlled 
        substances, the Attorney General shall--
                    (A) grant or deny the application; or
                    (B) request supplemental information.
            (2) Additional information.--Not later than 30 days after 
        the Attorney General receives supplemental information as 
        described in paragraph (1)(B) in connection with an application 
        described in paragraph (1), the Attorney General shall grant or 
        deny the application.
    (d) Information Regarding Denials.--If an application described in 
subsection (c)(1) is denied, the Attorney General shall provide a 
written explanation of the basis of denial to the applicant.

SEC. 6. 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 approved 
        for authorized medical research (as such terms are defined in 
        section 2 of the Cannabidiol Research Expansion Act).''; 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 that has been approved for 
        authorized medical research authorized under section 5 of the 
        Cannabidiol Research Expansion Act.''.

SEC. 7. SAFE HARBOR.

    (a) Definitions.--In this section--
            (1) the term ``adult'' means an individual who is not less 
        than 18 years of age;
            (2) the term ``child'' means an individual who is not more 
        than 17 years of age;
            (3) the term ``intractable epilepsy'' means an epileptic 
        seizure disorder for which standard medical treatment--
                    (A) does not prevent or significantly ameliorate 
                recurring, uncontrollable seizures; or
                    (B) results in harmful side effects; and
            (4) the term ``neurologist'' means an allopathic or 
        osteopathic physician board-certified in neurology in good 
        standing and licensed in the State in which the physician 
        practices neurology.
    (b) Safe Harbor.--Notwithstanding the Controlled Substances Act (21 
U.S.C. 801 et seq.), the Controlled Substances Import and Export Act 
(21 U.S.C. 951 et seq.), or any other Federal law, it shall not be 
unlawful for--
            (1) a legal guardian to possess or transport cannabidiol or 
        any other nonpsychoactive component of marihuana for purposes 
        of dispensing the cannabidiol or other nonpsychoactive 
        component to a child of the legal guardian if--
                    (A) the child has been treated by a neurologist for 
                intractable epilepsy for not less than 6 months;
                    (B) the child's neurologist certifies that other 
                treatment options have been ineffective;
                    (C) the child's neurologist certifies that the 
                benefits of using the cannabidiol or other 
                nonpsychoactive component of marihuana reasonably 
                outweigh the potential risks for the child; and
                    (D) the legal guardian provides documentation for 
                the requirements under subparagraphs (A), (B), and (C);
            (2) an adult to possess or transport cannabidiol or any 
        other nonpsychoactive component of marihuana if--
                    (A) the adult has been treated by a neurologist for 
                intractable epilepsy for not less than 6 months;
                    (B) the adult's neurologist certifies that other 
                treatment options have been ineffective;
                    (C) the adult's neurologist certifies that the 
                benefits of using the cannabidiol or other 
                nonpsychoactive component of marihuana reasonably 
                outweigh the potential risks for the adult; and
                    (D) the adult provides documentation for the 
                requirements under subparagraphs (A), (B), and (C); or
            (3) a physician who is licensed under State law to discuss 
        the potential harms and benefits of cannabidiol or any other 
        nonpsychoactive component of marihuana as a treatment with a 
        patient of the physician, or the legal guardian of the patient 
        if the patient is a child.
    (c) Sunset.--This section shall cease to have force or effect on 
the date that is 4 years after the date of enactment of this Act.
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